Trial · NCT03060629
A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
NCT03060629, Phase 2, Terminated, Janssen Vaccines & Prevention B.V.; results first posted 2023-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa. Trials, record NCT03060629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03060629
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
- NCT number
- NCT03060629
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2,636 participants, actual
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Conditions
- HIV-1
- Interventions
- Ad26.Mos4.HIV, Clade C gp140, Placebo
- First posted
- 2017-02-23
- Last updated
- 2023-04-18
- Results first posted
- 2023-04-18
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Month 7 up to Month 24 | 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. |
| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | 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. |
| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | 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. |
| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | 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. |
| Primary | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | 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. |
| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | 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. |
| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | 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. |
| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | 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. |
| Primary | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | 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. |
| Primary | Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | 30 days after first vaccination on Day 0 (Up to Day 30) | 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Month 7 up to Month 24 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | 30 days after first vaccination on Day 0 (Up to Day 30) | 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. | Percentage of participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Group 1: Ad26.Mos.HIV Vaccine | 54 | Participants | ||
| Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Group 2: Placebo | 65 | Participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Group 1: Ad26.Mos.HIV Vaccine | 34.2 | Percentage of participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Group 2: Placebo | 9.4 | Percentage of participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Group 1: Ad26.Mos.HIV Vaccine | 20.0 | Percentage of participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Group 2: Placebo | 8.1 | Percentage of participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Group 1: Ad26.Mos.HIV Vaccine | 25.2 | Percentage of participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Group 2: Placebo | 8.9 | Percentage of participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | Group 1: Ad26.Mos.HIV Vaccine | 25.7 | Percentage of participants | ||
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | Group 2: Placebo | 8.6 | Percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Ad26.Mos.HIV Vaccine | 1,313 | |
| Overall Study | STARTED | Group 2: Placebo | 1,323 | |
| Overall Study | COMPLETED | Group 1: Ad26.Mos.HIV Vaccine | 78 | |
| Overall Study | COMPLETED | Group 2: Placebo | 88 | |
| Overall Study | NOT COMPLETED | Group 1: Ad26.Mos.HIV Vaccine | 1,235 | |
| Overall Study | NOT COMPLETED | Group 2: Placebo | 1,235 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Genitourinary chlamydia infection | Infections and infestations | Group 1: Ad26.Mos.HIV Vaccine | 528 | 1,317 | |
| other | Genitourinary chlamydia infection | Infections and infestations | Group 2: Placebo | 527 | 1,319 | |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Group 1: Ad26.Mos.HIV Vaccine | 269 | 1,317 | |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Group 2: Placebo | 288 | 1,319 | |
| other | Syphilis | Infections and infestations | Group 1: Ad26.Mos.HIV Vaccine | 69 | 1,317 | |
| other | Syphilis | Infections and infestations | Group 2: Placebo | 79 | 1,319 | |
| other | Upper respiratory tract infection | Infections and infestations | Group 1: Ad26.Mos.HIV Vaccine | 79 | 1,317 | |
| other | Upper respiratory tract infection | Infections and infestations | Group 2: Placebo | 77 | 1,319 | |
| other | Vulvovaginitis trichomonal | Infections and infestations | Group 1: Ad26.Mos.HIV Vaccine | 245 | 1,317 | |
| other | Vulvovaginitis trichomonal | Infections and infestations | Group 2: Placebo | 239 | 1,319 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Ad26.Mos.HIV Vaccine | 5 | 1,317 |
| Total, all-cause mortality | Group 2: Placebo | 4 | 1,319 |
| Total, other adverse events | Group 1: Ad26.Mos.HIV Vaccine | 798 | 1,317 |
| Total, other adverse events | Group 2: Placebo | 806 | 1,319 |
| Total, serious adverse events | Group 1: Ad26.Mos.HIV Vaccine | 49 | 1,317 |
| Total, serious adverse events | Group 2: Placebo | 37 | 1,319 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Trial comparisons |
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment | Trial comparisons |
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: Number of Participants With Viral Sequences | Trial comparisons |
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | Trial comparisons |
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | Trial comparisons |
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: deaths from any cause | Trial comparisons |
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment | Trial comparisons |
| Group 1: Ad26.Mos.HIV Vaccine vs Group 2: Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03060629
GET https://conductscience.org/api/trials/v1/NCT03060629/registered?page=2