Safety and Efficacy Study of Vaccine Schedule With Ad26.M... | NCT02919306

ID	Type	Description	Link
VAC89220HTX1001	Other Identifier	Janssen Vaccines & Prevention B.V.

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ad26.Mos.HIV Vaccine or MVA mosaic Vaccine	Experimental	Participants will receive adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (containing 5 * 10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Week 24 and 48.	Biological: Ad26.Mos.HIV Biological: MVA-Mosaic
Placebo	Placebo Comparator	0.5 mL Sodium Chloride Injection United States Pharmacopeia (USP) 0.9% will be administered by intramuscular (IM) injection.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ad26.Mos.HIV	Biological	Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs)	Solicited local AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.	Up to Week 49 (7 days post each vaccination)
Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs	Solicited systemic AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching.	Up to Week 49 (7 days post each vaccination)
Percentage of Participants With Grade 3 or 4 Unsolicited AEs	Unsolicited AE with worst severity grade 3 or 4 and that is thought to be related to study vaccine were reported. Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.	Up to Week 52 (28 days after each vaccination)
Percentage of Participants With Grade 3 or 4 Related AEs	Related AEs of grade 3 or 4 and that is thought to be related to study vaccine were reported.	Up to Week 52 (28 days after each vaccination)
Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination	An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.

Secondary Outcomes

Measure	Description	Time Frame
Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time	The total HIV DNA levels were assessed as a biomarker of the HIV reservoir.	From Week 60 to Week 96
Change in Cluster of Differentiation (CD)4 Count Over Time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed human immunodeficiency virus (HIV)-1 infected and started antiretroviral therapy (ART) during acute infection (Fiebig stages I, II, III or IV) as part of trial RV254
Treatment with current stable antiretroviral therapy (ART) (no changes to treatment) for at least 4 weeks prior to screening
All female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) at the screening visit, and a negative urine pregnancy test prior to vaccination on Day 1 and prior to subsequent study vaccinations
HIV ribonucleic acid (RNA) less than (<)50 copies per milliliter (copies/ml) for at least 48 weeks at screening: a) One blip of HIV RNA greater than (>)50 and <200 copies/ml within 48 weeks is acceptable, provided that the most recent (before screening) HIV RNA <50 copies/ml
Laboratory criteria during screening: a) Hemoglobin: Women: greater than or equal to >=11 gram/deciliter (g/dL); Men >=12.5 g/dL, b) White cell count: 2,500 to 11,000 cells per cubic millimeter (cells/mm^3), c) Platelets: 125,000 to 450,000 per mm^3, d) Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to <=1.5x institutional upper limits of normal (ULN), e) Creatinine <=1.5x institutional ULN, f) CD4 > 400 cells/mm^3, g) Troponin <1x ULN
A woman must be either: a) Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulation hormone [FSH] level >40 International Units Per Liter (IU/L); surgically sterile; or b) Of child-bearing potential and practicing an effective double method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch, or vaginal ring, in conjunction with either a female condom or one of the methods for male contraception before entry and through 3 months after the last vaccination

Exclusion Criteria:

Receipt of any vaccine within 30 days prior to the first vaccination or plans to receive within 30 days post-vaccination. In the case of medically indicated vaccines, the vaccination should be given at least 2 weeks before or after the first vaccination. However, if a vaccine is indicated in a post exposure setting (example, rabies or tetanus), it must take priority over the study vaccine and same rules will apply to subsequent study vaccinations
Any history of HIV-related illness under Centers for Disease Control and Prevention (CDC) category C
History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
Chronic active hepatitis B or active hepatitis C (for example, positive serology with confirmatory positive polymerase chain reaction) or active syphilis infection. Active syphilis documented by examination or serology unless positive serology is due to past treated infection
Receipt of blood products or immunoglobulin in the past 3 months
History of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, or neomycin or streptomycin or egg products
History of chronic urticaria (recurrent hives)
Chronic or recurrent use of medications which modify host immune response, example (e.g.) cancer chemotherapeutic agents, parenteral corticosteroids (short course oral steroids given for non-chronic conditions not expected to recur is not an exclusion criteria, topical steroid use is not an exclusion criteria), etc. but not including ART

Name	Affiliation	Role
Janssen Vaccines & Prevention B.V. Clinical Trial	Janssen Vaccines & Prevention B.V.	Study Director

PubMed Identifier	Type	Citation	Retractions
35275599	Derived	Kroon E, Chottanapund S, Buranapraditkun S, Sacdalan C, Colby DJ, Chomchey N, Prueksakaew P, Pinyakorn S, Trichavaroj R, Vasan S, Manasnayakorn S, Reilly C, Helgeson E, Anderson J, David C, Zulk J, de Souza M, Tovanabutra S, Schuetz A, Robb ML, Douek DC, Phanuphak N, Haase A, Ananworanich J, Schacker TW. Paradoxically Greater Persistence of HIV RNA-Positive Cells in Lymphoid Tissue When ART Is Initiated in the Earliest Stage of Infection. J Infect Dis. 2022 Jun 15;225(12):2167-2175. doi: 10.1093/infdis/jiac089.
32235883

Label	URL
Manual upload due to format issue between PRS and PCM.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 11, 2017	Sep 17, 2021

Arm/Group Information

ID	Title	Description
BG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
BG001	Placebo	Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA >1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts <350/mm^3 twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00017 BG0019 BG00226

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs)

Solicited local AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 49 (7 days post each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.
OG001	Placebo	Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA >1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts <350/mm^3 twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Units	Counts
Participants	OG00017 OG0019

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Primary

Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs

Solicited systemic AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 49 (7 days post each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Grade 3 or 4 Unsolicited AEs

Unsolicited AE with worst severity grade 3 or 4 and that is thought to be related to study vaccine were reported. Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 52 (28 days after each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Grade 3 or 4 Related AEs

Related AEs of grade 3 or 4 and that is thought to be related to study vaccine were reported.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 52 (28 days after each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination

An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.

The Full Analysis Set (FAS) included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 49 (7 days post each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Solicited Systemic AEs for 7 Days After Each Vaccination

Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching were collected and reported for 7 days after each vaccination.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 49 (7 days after each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Unsolicited AEs 28 Days After Each Vaccination

Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 52 (28 days after each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Related AEs and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 52 (28 days after each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With AEs Leading to Discontinuation of Study Vaccination

Percentage of participants with AEs leading to discontinuation of study vaccination were reported.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.

Posted

Number

percentage of participants

Up to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With AEs

Percentage of participants with AEs were reported.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. The data was planned for unsolicited AEs during the 28-day post-vaccination phase.

Posted

Number

percentage of participants

Up to Week 52 (28 days after each vaccination)

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities

Percentage of participants with worst laboratory grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening) and non-graded serum chemistry abnormalities were reported. Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, creatine, hyperglycemia, hypoglycemia, gamma-gutamyl transferase, chloride, urea nitrogen, and bilirubin. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'.

FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.

Posted

Number

percentage of participants

Up to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities

Percentage of participants with worst laboratory toxicity grade 1 (mild) and non-graded hematology abnormalities were reported. Hematology parameters included absolute neutrophil count, basophils/leukocytes, eosinophils/leukocytes, hematocrit, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, erythrocytes, hematocrit, neutrophils, basophils, eosinophils, eosinophils/leukocytes, monocytes, neutrophils and platelet count. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'.

Posted

Number

percentage of participants

Up to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Percentage of Participants With Sustained Viremic Control (Human Immunodeficiency Virus [HIV] Ribonucleic Acid [RNA] Less Than [<]50 Copies Per Milliliter [Copies/mL]) During ATI Phase

Percentage of participants with sustained viremic control (HIV RNA <50 copies/mL) during ATI phase were reported.

The primary Efficacy Population (EP) included all participants who started antiretroviral (ARV) ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.

Posted

Number

percentage of participants

From Week 60 to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Primary

Duration of Sustained Viremic Control With HIV RNA <50 Copies/mL During ATI Phase

Duration of sustained viremic control With HIV RNA <50 copies/mL during ATI Phase was reported.

The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.

Posted

Mean

95% Confidence Interval

weeks

From Week 60 to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time

The total HIV DNA levels were assessed as a biomarker of the HIV reservoir.

The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.

Posted

Mean

Standard Deviation

copies/10E6 cells

From Week 60 to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Change in Cluster of Differentiation (CD)4 Count Over Time

Change in CD4 count over time was reported. Assessment of residual HIV replication and viral reservoir in total CD4+ T cells was measured by quantitative real-time polymerase chain reaction (PCR).

The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.

Posted

Median

Inter-Quartile Range

Median cells per cubic milliliters

Baseline and from Week 60 to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Time to Reinitiating ART

Time to reinitiating ART was reported.

The primary EP included all participants who started ARV ATI at Week 60 (Stage 2), regardless of the time or outcome of treatment interruption.

Posted

Mean

95% Confidence Interval

Weeks

Up to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Number of Participants With Acute Retroviral Syndrome Post-ARV ATI

Number of participants with acute retroviral syndrome post-ARV ATI were reported.

The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.

Posted

Count of Participants

Participants

From Week 60 to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Duration of Acute Retroviral Syndrome Post-ARV ATI

Duration of acute retroviral syndrome post-ARV ATI was reported.

The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.

Posted

Median

Full Range

weeks

From Week 60 to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Percentage of Participants With HIV Resistance to ARV Drugs Who Experienced Rebound Viremia After ARV ATI

Percentage of participants with HIV resistance to ARV drugs who experienced rebound viremia after ARV ATI were reported. An HIV genotype test was done to evaluate and characterize HIV resistance to ARV drugs in participants who experience rebound viremia after ARV ATI.

The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.

Posted

Number

percentage of participants

From Week 60 to Week 96

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50

Frozen peripheral blood mononuclear cell (PBMCs) was analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value >P95 if baseline <P95 or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study.

The Immunogenicity Population (IP) included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.

Posted

Number

percentage of responders

At Week 24, 26, 48 and 50

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers

The Env Clade A (92UG037), B (1990a), and C (Con C), (C97ZA.012) and Mos1- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (>) lower limit of quantification (LLOQ) if baseline less than (<) LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline greater than or equal to (>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, 156.25 and 78.125 endotoxin units per milliliter (EU/mL) for Clade A (92UG037), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012) and Mos1 respectively.

Posted

Number

percentage of responders

At Week 24, 26, 48 and 50

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody

Vaccine-induced binding antibody IgG1, IgG2, and IgG3 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQs for this assay were 12.3, 28.7, and 12.4, for IgG1, IgG2, and IgG3, respectively. Less participants were assessed for IgG2 responses due to lack of sample volume which led to a limit on the number of repeats that the analysis lab could perform. Reportable results were not generated for the remaining participants post vaccination.

The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.

Posted

Number

percentage of responders

Week 50

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Breadth of T Cell Responses Analyzed by ELISPOT Assays

Breadth of T cell responses was assessed at baseline (Week 0), Week 26, and Week 50 by ELISPOT assays.

Posted

Median

Full Range

Median number of subpools

Baseline (Week 0), Week 26 and 50

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time

The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value > limit of detection (LOD) if baseline <LOD or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LOD. The lower limits of detection (LODs) for this assay were 4.28 (phagocytic score) for Mos1.

Posted

Median

Full Range

percentage of ADCP gp antibody

At Week 24, 26, 48 and 50

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Secondary

Percentage of Responders for HIV Neutralizing Antibody (nAb)

The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value >LLOQ.

Posted

Number

percentage of responders

Week 64

ID	Title	Description
OG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine	Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5*10^10 viral particles [vp]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10^8 Plaque-forming unit [pfu]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent [%] of vaccines had an increase of Interferon [IFN]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (<) 350 per cubic millimeter (350/mm^3) twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.	0	17	1	17	15	17
EG001	Placebo	Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA >1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts <350/mm^3 twice at least 2 weeks apart or CD4+ T cell count decline of > 50% from Week 60 prior to ATI up to Week 96.	0	9	0	9	7	9

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Anogenital Dysplasia	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected9 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Feeling Hot	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected17 at risk EG0010 affected9 at risk
Pyrexia	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected9 at risk
Food Allergy	Immune system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Anal Chlamydia Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Chlamydial Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected9 at risk
Oropharyngeal Gonococcal Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Pharyngitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Rhinitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Syphilis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected9 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected17 at risk EG0011 affected9 at risk
Urethritis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Urethritis Chlamydial	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Animal Bite	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Cd4 Lymphocytes Decreased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Hepatic Enzyme Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Liver Function Test Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected17 at risk EG0010 affected9 at risk
Weight Decreased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Abnormal Loss of Weight	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected9 at risk
Folate Deficiency	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Dizziness	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected9 at risk
Headache	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected9 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected9 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk
Tachycardia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected9 at risk
Pyrexia	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected9 at risk