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| ID | Type | Description | Link |
|---|---|---|---|
| VAC89220HPX2008 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| HVTN 705 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| HVTN 705/VAC89220HPX2008 | Other Identifier | Janssen Vaccines & Prevention B.V. |
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Study was terminated by the sponsor after the last participant completed the Month 24 visit as the pre-specified criteria to continue the study were not met.
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The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive Ad26.Mos4.HIV 5*10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 [microgram] mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12. |
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| Group 2 | Placebo Comparator | Participants will receive Placebo for Ad26.Mos4.HIV as 0.5 mL into the left deltoid on Months 0, 3, 6, and 12 and Placebo for Clade C gp140 / Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.Mos4.HIV | Biological | Participants will receive Ad26.Mos4.HIV 5x10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Number of participants with HIV-1 infection diagnosed between Month 7 to Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | Month 7 up to Month 24 |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Percentage of participants with local reactogenicity signs and symptoms after first vaccination were reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. | Up to 7 days after first vaccination on Day 0 (Day 7) |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Percentage of participants with local reactogenicity signs and symptoms after second vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. | Up to 7 days after second vaccination on Day 84 (Day 91) |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Percentage of participants with local reactogenicity signs and symptoms after third vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. | Up to 7 days after third vaccination on Day 168 (Up to Day 175) |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | Baseline up to Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Lilongwe Project | Lilongwe | Malawi | ||||
| Polana Caniço Health Research and Training Center (CISPOC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40190112 | Derived | Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7. | |
| 39038477 |
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For Participant Flow below, data were summarized based on assigned treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Ad26.Mos.HIV Vaccine | Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) per 0.5 milliliter (mL) via Intramuscular (IM) injection at Months 0, 3, 6, and 12 and Clade C glycoprotein (gp) 140 (250 [micrograms] mcg) mixed with aluminum phosphate adjuvant 425 mcg per 0.5 mL IM injection at Months 6 and 12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2020 | Feb 2, 2023 |
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Sponsor will be also blinded
| Clade C gp140 | Biological | Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12. |
|
| Placebo | Biological | Participants will receive matching placebo. |
|
Percentage of participants with local reactogenicity signs and symptoms after fourth vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after first vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | Up to 7 days after first vaccination on Day 0 (Day 7) |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after second vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | Up to 7 days after second vaccination on Day 84 (Day 91) |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after third vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | Up to 7 days after third vaccination on Day 168 (Up to Day 175) |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after fourth vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) |
| Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | 30 days after first vaccination on Day 0 (Up to Day 30) |
| Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | 30 days after second vaccination on Day 84 (Up to Day 114) |
| Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | 30 days after third vaccination on Day 168 (Up to Day 198) |
| Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | 30 days after fourth vaccination on Day 364 (Up to Day 394) |
| Percentage of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose 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, is a suspected transmission of any infectious agent via a medicinal product. | Up to Month 36 (up to end of the study) |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | Percentage of participants with AESIs was reported. Immune-mediated diseases were considered as AESIs in this study. | Up to Month 36 (up to end of the study) |
| Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product | Percentage of participants with AEs leading to early participant withdrawal or early discontinuation of study product were reported. An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with this treatment. | Up to Month 36 (up to end of the study) |
| Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment |
Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through Month 36 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Baseline up to Month 36 (End of study) |
| Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | Month 13 up to Month 24 |
| Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 36 (end of study) post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | Month 13 up to Month 36 (End of study) |
| Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | A weighted geometric mean of the binding antibody responses to HIV envelope (ENV) gp140 Clade C 97ZA protein analyzed by ELISA was reported. | Months 0, 7, 13 and 24 |
| Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Geometric mean of IFN-gamma T-cells responses analyzed by ELISpot were reported. A weighted geometric mean of the number of spot-forming cells (SFC) per million peripheral blood mononuclear cells (PBMCs) producing Interferon-gamma upon stimulation with potential T-cell epitope (PTE) ENV peptide pools analyzed by ELISpot was reported. Reported responses are the sum of the number of SFCs/10^6 PBMCS for PTE Env1, Env2 and Env3 sub-pools. | Months 0, 7, 13 and 24 |
| Number of Participants With Viral Sequences | Number of participants with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 ribose nucleic acid polymerase chain reaction (RNA PCR) tests from study participants who were diagnosed with HIV-1 infection. | Month 7 up to Month 24 |
| Maputo |
| Mozambique |
| Josha Research | Bloemfontein | 9301 | South Africa |
| Masiphumelele Research Centre | Cape Town | 7975 | South Africa |
| Ndlovu Elandsdoorn Site | Dennilton | 0485 | South Africa |
| Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital | Diepkloof | 1862 | South Africa |
| Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital | Johannesburg | 1862 | South Africa |
| The Aurum Institute Klerksdorp Clinical Research Centre | Klerksdorp | 2571 | South Africa |
| Qhakaza Mbokodo Research Centre | KwaZulu-Natal | 4030 | South Africa |
| South African Medical Research Council Chatsworth Clinical Research Site | KwaZulu-Natal | 4030 | South Africa |
| Centre for the AIDS Programme of Research in South Africa | KwaZulu-Natal | 4110 | South Africa |
| South African Medical Research Council Tongaat Clinical Research Site | KwaZulu-Natal | 4399 | South Africa |
| Stanza Clinical Research Centre : Mamelodi | Mamelodi East | 122 | South Africa |
| Nelson Mandela Academic Clinical Research Unit 'NeMACRU' | Mthatha | 5099 | South Africa |
| MeCRU Clinical Research Unit | Pretoria | 204 | South Africa |
| The Aurum Institute Rustenburg Clinical Research Site | Rustenburg | 300 | South Africa |
| Setshaba Research Centre | Soshanguve | 152 | South Africa |
| The Aurum Institute: Tembisa - Clinic 4 | Tembisa | 1632 | South Africa |
| Centre for Infectious Disease Research in Zambia (CIDRZ) | Lusaka | 10101 | Zambia |
| Center for Family Health Research in Zambia (CFHRZ) | Lusaka | P/BagE891 | Zambia |
| Center for Family Health Research in Zambia (CFHRZ) | Ndola | 240262 | Zambia |
| St Mary's Clinic | Chitungwiza | Zimbabwe |
| University of Zimbabwe-UCSF | Harare - Seke South | Zimbabwe |
| Derived |
| Gray GE, Mngadi K, Lavreys L, Nijs S, Gilbert PB, Hural J, Hyrien O, Juraska M, Luedtke A, Mann P, McElrath MJ, Odhiambo JA, Stieh DJ, van Duijn J, Takalani AN, Willems W, Tapley A, Tomaras GD, Van Hoof J, Schuitemaker H, Swann E, Barouch DH, Kublin JG, Corey L, Pau MG, Buchbinder S, Tomaka F; Imbokodo/HVTN 705/HPX2008 Study Group. Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2024 Nov;24(11):1201-1212. doi: 10.1016/S1473-3099(24)00358-X. Epub 2024 Jul 19. |
| 30047376 | Derived | Barouch DH, Tomaka FL, Wegmann F, Stieh DJ, Alter G, Robb ML, Michael NL, Peter L, Nkolola JP, Borducchi EN, Chandrashekar A, Jetton D, Stephenson KE, Li W, Korber B, Tomaras GD, Montefiori DC, Gray G, Frahm N, McElrath MJ, Baden L, Johnson J, Hutter J, Swann E, Karita E, Kibuuka H, Mpendo J, Garrett N, Mngadi K, Chinyenze K, Priddy F, Lazarus E, Laher F, Nitayapan S, Pitisuttithum P, Bart S, Campbell T, Feldman R, Lucksinger G, Borremans C, Callewaert K, Roten R, Sadoff J, Scheppler L, Weijtens M, Feddes-de Boer K, van Manen D, Vreugdenhil J, Zahn R, Lavreys L, Nijs S, Tolboom J, Hendriks J, Euler Z, Pau MG, Schuitemaker H. Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). Lancet. 2018 Jul 21;392(10143):232-243. doi: 10.1016/S0140-6736(18)31364-3. Epub 2018 Jul 6. |
| FG001 | Group 2: Placebo | Participants received Placebo matching to Ad26.Mos4.HIV as 0.5 mL via IM injection at Months 0, 3, 6, and 12 and Placebo matching to Clade C gp140/aluminum phosphate adjuvant as 0.5 mL IM injection at Months 6 and 12. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Ad26.Mos.HIV Vaccine | Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) per 0.5 milliliter (mL) via Intramuscular (IM) injection at Months 0, 3, 6, and 12 and Clade C glycoprotein (gp) 140 (250 [micrograms] mcg) mixed with aluminum phosphate adjuvant 425 mcg per 0.5 mL IM injection at Months 6 and 12. |
| BG001 | Group 2: Placebo | Participants received Placebo matching to Ad26.Mos4.HIV as 0.5 mL via IM injection at Months 0, 3, 6, and 12 and Placebo matching to Clade C gp140/aluminum phosphate adjuvant as 0.5 mL IM injection at Months 6 and 12. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Number of participants with HIV-1 infection diagnosed between Month 7 to Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | Per protocol (PP) population set included participants from the full analysis set (FAS; all randomized participants who received at least one study vaccine administration) who were HIV-1 uninfected 4 weeks after the third vaccination visit, who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows and had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. | Posted | Count of Participants | Participants | Month 7 up to Month 24 |
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| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Percentage of participants with local reactogenicity signs and symptoms after first vaccination were reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after first vaccination on Day 0 (Day 7) |
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| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Percentage of participants with local reactogenicity signs and symptoms after second vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after second vaccination on Day 84 (Day 91) |
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| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Percentage of participants with local reactogenicity signs and symptoms after third vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after third vaccination on Day 168 (Up to Day 175) |
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| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | Percentage of participants with local reactogenicity signs and symptoms after fourth vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) |
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| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after first vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after first vaccination on Day 0 (Day 7) |
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| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after second vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after second vaccination on Day 84 (Day 91) |
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| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after third vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after third vaccination on Day 168 (Up to Day 175) |
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| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | Percentage of participants with systematic reactogenicity signs and symptoms after fourth vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) |
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| Primary | Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure. | Posted | Number | Percentage of participants | 30 days after first vaccination on Day 0 (Up to Day 30) |
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| Primary | Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | 30 days after second vaccination on Day 84 (Up to Day 114) |
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| Primary | Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | 30 days after third vaccination on Day 168 (Up to Day 198) |
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| Primary | Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. | FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | 30 days after fourth vaccination on Day 364 (Up to Day 394) |
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose 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, is a suspected transmission of any infectious agent via a medicinal product. | FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received. | Posted | Number | Percentage of participants | Up to Month 36 (up to end of the study) |
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| Primary | Percentage of Participants With Adverse Events of Special Interest (AESIs) | Percentage of participants with AESIs was reported. Immune-mediated diseases were considered as AESIs in this study. | FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received. | Posted | Number | Percentage of participants | Up to Month 36 (up to end of the study) |
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| Primary | Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product | Percentage of participants with AEs leading to early participant withdrawal or early discontinuation of study product were reported. An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with this treatment. | FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received. | Posted | Number | Percentage of participants | Up to Month 36 (up to end of the study) |
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| Secondary | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | Modified Intent-to-Treat (MITT) analysis set included participants in the FAS who were HIV-1 uninfected on the date of first vaccination. | Posted | Count of Participants | Participants | Baseline up to Month 24 |
|
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| Secondary | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment | Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through Month 36 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | MITT analysis set included participants in the FAS who were HIV-1 uninfected on the date of first vaccination. | Posted | Count of Participants | Participants | Baseline up to Month 36 (End of study) |
|
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| Secondary | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | Full immunization set (FIS) included participants in the FAS who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. | Posted | Count of Participants | Participants | Month 13 up to Month 24 |
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| Secondary | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 36 (end of study) post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. | FIS included participants in the FAS who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. | Posted | Count of Participants | Participants | Month 13 up to Month 36 (End of study) |
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| Secondary | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | A weighted geometric mean of the binding antibody responses to HIV envelope (ENV) gp140 Clade C 97ZA protein analyzed by ELISA was reported. | FIS included participants in the FAS who were HIV-1 uninfected 4 weeks after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ELISA Units per milliliter (EU/mL) | Months 0, 7, 13 and 24 |
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| Secondary | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Geometric mean of IFN-gamma T-cells responses analyzed by ELISpot were reported. A weighted geometric mean of the number of spot-forming cells (SFC) per million peripheral blood mononuclear cells (PBMCs) producing Interferon-gamma upon stimulation with potential T-cell epitope (PTE) ENV peptide pools analyzed by ELISpot was reported. Reported responses are the sum of the number of SFCs/10^6 PBMCS for PTE Env1, Env2 and Env3 sub-pools. | FIS included participants who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Posted | Geometric Mean | 95% Confidence Interval | SFC/million PBMCs | Months 0, 7, 13 and 24 |
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| Secondary | Number of Participants With Viral Sequences | Number of participants with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 ribose nucleic acid polymerase chain reaction (RNA PCR) tests from study participants who were diagnosed with HIV-1 infection. | PP population set included participants from the FAS; all randomized participants who received at least one study vaccine administration) who were HIV-1 uninfected 4 weeks after the third vaccination visit, who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows and had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. | Posted | Count of Participants | Participants | Month 7 up to Month 24 |
|
Up to Month 36
Full analysis set (FAS) included all randomized participants who received at least 1 vaccine administration. Here, N (total number of participants at risk) signifies participants who were assessed for AEs as safety analyses were performed based on the actual treatment that the participants received. Therefore, number of participants affected for all-cause mortality are different in participant flow section and adverse event section.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Ad26.Mos.HIV Vaccine | Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) per 0.5 milliliter (mL) via Intramuscular (IM) injection at Months 0, 3, 6, and 12 and Clade C glycoprotein (gp) 140 (250 [micrograms] mcg) mixed with aluminum phosphate adjuvant 425 mcg per 0.5 mL IM injection at Months 6 and 12. | 5 | 1,317 | 49 | 1,317 | 798 | 1,317 |
| EG001 | Group 2: Placebo | Participants received Placebo matching to Ad26.Mos4.HIV as 0.5 mL via IM injection at Months 0, 3, 6, and 12 and Placebo matching to Clade C gp140/aluminum phosphate adjuvant as 0.5 mL IM injection at Months 6 and 12. | 4 | 1,319 | 37 | 1,319 | 806 | 1,319 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Congenital anomaly in offspring | Congenital, familial and genetic disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal mass | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gonococcal pelvic inflammatory disease | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| HIV-associated neurocognitive disorder | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Salmonella sepsis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Crush injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Alcohol intolerance | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebral cyst | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Psychogenic seizure | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Anembryonic gestation | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| False labour | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Maternal death during childbirth | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Alcoholic psychosis | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Genitourinary chlamydia infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Genitourinary tract gonococcal infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vulvovaginitis trichomonal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CLINICAL FRANCHISE LEADER | Janssen Vaccines & Prevention B.V | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Feb 2, 2023 | SAP_001.pdf |
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Colored/Mixed |
|
| Indian |
|
| Multiple |
|
| White |
|
| MOZAMBIQUE |
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| SOUTH AFRICA |
|
| ZAMBIA |
|
| ZIMBABWE |
|
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|
| Units | Counts |
|---|---|
| Participants |
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Participants received Placebo matching to Ad26.Mos4.HIV as 0.5 mL via IM injection at Months 0, 3, 6, and 12 and Placebo matching to Clade C gp140/aluminum phosphate adjuvant as 0.5 mL IM injection at Months 6 and 12. |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Counts |
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| Participants |
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| Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
Participants received Placebo matching to Ad26.Mos4.HIV as 0.5 mL via IM injection at Months 0, 3, 6, and 12 and Placebo matching to Clade C gp140/aluminum phosphate adjuvant as 0.5 mL IM injection at Months 6 and 12.
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