A Clinical Trial to Evaluate Safety, Tolerability, and Im... | NCT05470400

Name	Class
National Institutes of Health (NIH)	NIH
Department of Health and Human Services	FED

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Escalation - Group 1	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.	Biological: FP conjugate vaccine (25 mcg)
Dose Escalation - Group 2	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.	Biological: FP conjugate vaccine (200 mcg)
Dose Escalation - Group 3	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.	Biological: Trimer 6931 (100 mcg)
Dose Escalation - Group 4	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FP conjugate vaccine (25 mcg)	Biological	FP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented	Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented	Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise a	Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.	The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): volunteer demonstrates understanding of this study, completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
18-50 years old, inclusive, on day of enrollment.
Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit.
Agrees not to enroll in another study of an investigational agent during participation in the trial, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) investigational agents that may subsequently obtain emergency use authorization (EUA) or undergo licensure by the FDA. If a potential participant is already enrolled in a SARS-CoV-2 clinical trial, prior approvals from the SARS-COV-2 study sponsor and HVTN 303 PSRT are required prior to enrollment in HVTN 303.
In good general health without clinically significant medical history.
Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity.
Body Mass Index (BMI) ≤ 40.
Assessed as low risk for HIV acquisition.
Suitable injection sites in the deltoid muscle of each arm, as assessed by a clinician.
White blood cells (WBCs) 2,500-12,000/mm3
WBC differential either within institutional normal range or approved by the Investigator of Record (IoR) as "not clinically significant."
Platelets = 125,000 - 500,000/mm3
Hemoglobin
- ≥ 11.0 g/dL for volunteers who were assigned female sex at birth
- ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months
- ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
- For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth
Serum creatinine ≤ 1.1 x upper limit of normal (ULN) based on the institutional normal range.
Alanine aminotransferase (ALT) ≤1.25 x ULN based on the institutional normal range.
Negative for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected.
Negative for Hepatitis B surface antigen.
Agrees to use effective means of birth control from at least 21 days prior to enrollment through 12 weeks after the last product administration.
Negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to each study product administration on the day of study product administration.

Exclusion Criteria:

Active duty and reserve US military personnel.
Breast-feeding or planning to become pregnant from at least 21 days prior to enrollment through 12 weeks after the last product administration.
An investigational HIV vaccine (previous placebo recipients are not excluded).
Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses ≤ 60 mg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment).
Blood products within 60 days prior to enrollment
Monoclonal antibodies (mAbs), whether licensed or investigational. Exceptions may be made by the HVTN 303 PSRT on a case-by-case basis
Receipt of any of the following:
- Within 4 weeks prior to enrollment:
  - Any licensed live, attenuated vaccine
  - Any adenoviral-vectored SARS-CoV-2 vaccine with FDA Emergency Use Authorization (EUA), FDA licensure or World Health Organization (WHO) Emergency Use Listing (EUL)
- Within 2 weeks prior to enrollment:
  - Any licensed killed/subunit/inactivated vaccine
  - Any mRNA based or protein SARS-CoV-2 vaccines with FDA EUA, FDA licensure, or WHO EUL
Investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.
Current allergen immunotherapy with antigen injections, unless on maintenance schedule.
Current anti-TB prophylaxis or therapy.
Serious adverse reactions to vaccines or vaccine components.
Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
Hypertension that is not well controlled.
Asthma is excluded if the participant has ANY of the following:
- Required either oral or parenteral corticosteroids for an exacerbation two or more times within the past year; OR
- Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or co-existing conditions unrelated to asthma); OR
- Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR
- Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA]); OR
- Uses more than one medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than one medication for maintenance therapy daily for greater than two years requires PSRT approval.
Autoimmune disease, current or history, including psoriasis.
Clinically significant immunodeficiency.
AESIs: Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the product(s) administered in this protocol.
History of generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger.).
Diabetes mellitus type 1 or type 2.
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
Asplenia or functional asplenia.
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study).
Any other chronic or clinically significant condition that in the clinical judgement of the investigator would jeopardize the safety or rights of the study participant, including, but not limited to: clinically significant forms of drug or alcohol abuse, serious psychiatric disorders, or cancer that, in the clinical judgement of the site investigator, has a potential for recurrence (excluding basal cell carcinoma).

Name	Affiliation	Role
Troy Martin	HVTN LOC, Fred Hutch	Study Chair
Michael Keefer, M.D.	Univ. of Rochester Med. Ctr., HVTU	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Atlanta - Hope Clinic		Atlanta	Georgia	30308	United States
BIDMC Vcrs [32077]

ID	Title	Description
FG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
FG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 21, 2023	Jan 9, 2025

Arm/Group Information

ID	Title	Description
BG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
BG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
BG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
BG003	Part A, Group 4: 200 mcg Trimer 6931 at w(0)	200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
BG004	Part A Group 5: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
BG005	Part B, Group 6: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
BG006	Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)	200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
BG007	Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)	200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
BG008	Total	Total of all reporting groups

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

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented

Posted

Count of Participants

Participants

Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG003	Part A, Group 4: 200 mcg Trimer 6931 at w(0)	200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
OG004	Part A Group 5: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG005	Part B, Group 6: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
OG006	Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)	200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
OG007	Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)	200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
None	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise a

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.

The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point.

'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Posted

Count of Participants

Participants

T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)

Primary

Number of Participants Reporting Adverse Events (AEs), by Severity Grade

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)

Safety population

Posted

Count of Participants

Participants

28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).

Safety population

Posted

Count of Participants

Participants

28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number of Participants Reporting Serious Adverse Events (SAEs)

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)

Safety population

Posted

Count of Participants

Participants

12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number of Participants Reporting Medically Attended Adverse Events (MAAEs)

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)

Safety population

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number of Participants Reporting Adverse Events of Special Interest (AESIs)

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)

Safety population

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)

Safety population

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Number of Participants With Early Study Termination Associated With an AE or Reactogenicity

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)

Safety population

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
OG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.

Primary

Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.

Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. Group 5 and Group 6 were combined in the summary of IgG response rate.

Overall Number of Participants Analyzed- includes those with samples collected at week 2 for Groups T5+T6, T7, and T8 and week 6 for Groups T7 and T8, who were HIV-uninfected and received the last vaccination. Number Analyzed- counts participants with available data after filtering for assay-specific quality control criteria.

Posted

Count of Participants

Participants

Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.

ID	Title	Description
OG000	Part A and B, Groups 5+6: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0

Primary

Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.

Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. The Unit of Measure is expressed as Mean Electrochemiluminescence Signal*1/dilution to reflect the AUC of responses across serial dilutions. Group 5 and Group 6 were combined in the summary of IgG magnitudes.

Posted

Median

Inter-Quartile Range

Mean ECL Signal*1/dilution

Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.

ID	Title	Description
OG000	Part A and B, Groups 5+6: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.	3	1	3	3	3
EG001	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.	3	0	3	3	3
EG002	Part A, Group 3: 100 mcg Trimer 6931 at w(0)	100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.	3	0	3	3	3
EG003	Part A, Group 4: 200 mcg Trimer 6931 at w(0)	200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.	3	0	3	3	3
EG004	Part A Group 5: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.	3	0	3	3	3
EG005	Part B, Group 6: 200 mcg Trimer 4571 at w(0)	200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0	10	0	10	10	10
EG006	Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)	200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4	10	0	10	10	10
EG007	Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)	200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4	9	0	9	9	9

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG0030 events0 affected3 at risk EG0040 events0 affected3 at risk EG0050 events0 affected10 at risk EG0060 events0 affected10 at risk EG0070 events0 affected9 at risk
Hydrocele	Congenital, familial and genetic disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Nausea (Solicited)	Gastrointestinal disorders	MEDRA 27	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Axillary pain	General disorders	MEDRA 26.1	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Chills (Solicited)	General disorders	MEDRA 27	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events3 affected3 at risk EG0020 events0 affected3 at risk EG003
Fatigue (Solicited)	General disorders	MEDRA 27	Systematic Assessment	EG0003 events3 affected3 at risk EG0013 events3 affected3 at risk EG0022 events2 affected3 at risk EG003
Injection site erythema	General disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Injection site erythema (Solicited)	General disorders	MEDRA 27	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Injection site induration	General disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Injection site pain (Solicited)	General disorders	MEDRA 27	Systematic Assessment	EG0003 events3 affected3 at risk EG0013 events3 affected3 at risk EG0023 events3 affected3 at risk EG003
Injection site rash	General disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Injection site swelling	General disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Injection site swelling (Solicited)	General disorders	MEDRA 27	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Serum sickness	Immune system disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
COVID-19	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Conjunctivitis	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Ear infection	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Gastroenteritis	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Influenza	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Nasopharyngitis	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Oropharyngeal gonococcal infection	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Urinary tract infection	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Vaginal infection	Infections and infestations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Blood creatinine increased	Investigations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Body temperature increased (Solicited)	Investigations	MEDRA 27	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Lymphocyte count decreased	Investigations	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Arthralgia (Solicited)	Musculoskeletal and connective tissue disorders	MEDRA 27	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0020 events0 affected3 at risk EG003
Muscle discomfort	Musculoskeletal and connective tissue disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Myalgia (Solicited)	Musculoskeletal and connective tissue disorders	MEDRA 27	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0021 events1 affected3 at risk EG003
Headache (Solicited)	Nervous system disorders	MEDRA 27	Systematic Assessment	EG0003 events3 affected3 at risk EG0013 events3 affected3 at risk EG0022 events2 affected3 at risk EG003
Depression	Psychiatric disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Cervix inflammation	Reproductive system and breast disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MEDRA 26.1	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003