Trial · NCT03964415
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
NCT03964415, Phase 3, Completed, Janssen Vaccines & Prevention B.V.; results first posted 2024-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals. Trials, record NCT03964415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03964415
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
- NCT number
- NCT03964415
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,900 participants, actual
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Conditions
- Healthy
- Interventions
- Ad26.Mos4.HIV, Clade C and Mosaic gp140 HIV bivalent vaccine, Placebo
- First posted
- 2019-05-28
- Last updated
- 2024-07-31
- Other registries' IDs
- eudract:2018-003666-13
- Results first posted
- 2024-07-31
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | From Month 7 up to Month 24 | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Primary | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | From Month 7 up to Month 30 | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Secondary | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | Number of participants with solicited local AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site) and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Secondary | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | Number of participants with solicited systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Secondary | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392) | Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participants were not specifically questioned in the participant's diary. |
| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs) | Up to 6 months after the last vaccination (up to Month 18) | Number of participants with AESIs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombotic events and/or thrombocytopenia (defined as platelet count below the lower limit of normal \[LLN\] range for the testing lab) were considered to be potential AESIs. |
| Secondary | Number of Participants With Medically-attended Adverse Events (MAAEs) | From Day 1 up to Month 40 | Number of participants with MAAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Month 40 | Number of participants with SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Secondary | Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | From Day 1 up to Month 40 | Number of participants who discontinued the study or study intervention due to AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Secondary | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 24, Month 0 to 30, Month 0 to 40 | Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | From Month 7 up to Month 24 | The PP set included all participants in the full analysis set (FAS; all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | From Month 7 up to Month 30 | The PP set included all participants in the FAS (all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392) | The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events of Special Interest (AESIs) | Up to 6 months after the last vaccination (up to Month 18) | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically-attended Adverse Events (MAAEs) | From Day 1 up to Month 40 | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Month 40 | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | From Day 1 up to Month 40 | The FAS set included all randomized participants who received at least one vaccine administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 24, Month 0 to 30, Month 0 to 40 | The mITT efficacy population included participants in the FAS who were HIV-1 uninfected at the date of the first vaccination. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group130
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 Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 65 | Participants | ||
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | Group 2: Placebo | 58 | Participants | ||
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 71 | Participants | ||
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | Group 2: Placebo | 67 | Participants | ||
| Number of Participants With Solicited Local Adverse Events (AEs) | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Up to 7 days post dose on Day 1 | 1225 | Participants | |
| Number of Participants With Solicited Local Adverse Events (AEs) | Group 2: Placebo | Up to 7 days post dose on Day 1 | 329 | Participants | |
| Number of Participants With Solicited Local Adverse Events (AEs) | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Up to 7 days post dose on Day 84 | 905 | Participants | |
| Number of Participants With Solicited Local Adverse Events (AEs) | Group 2: Placebo | Up to 7 days post dose on Day 84 | 239 | Participants | |
| Number of Participants With Solicited Local Adverse Events (AEs) | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Up to 7 days post dose on Day 168 | 1010 | Participants | |
| Number of Participants With Solicited Local Adverse Events (AEs) | Group 2: Placebo | Up to 7 days post dose on Day 168 | 319 | Participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 1,948 | |
| Overall Study | STARTED | Group 2: Placebo | 1,952 | |
| Overall Study | Treated: Full Analysis Set (FAS) | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 1,942 | |
| Overall Study | Treated: Full Analysis Set (FAS) | Group 2: Placebo | 1,945 | |
| Overall Study | COMPLETED | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 95 | |
| Overall Study | COMPLETED | Group 2: Placebo | 103 | |
| Overall Study | NOT COMPLETED | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 1,853 | |
| Overall Study | NOT COMPLETED | Group 2: Placebo | 1,849 |
Source ClinicalTrials.gov
Adverse events302
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 | Diarrhoea | Gastrointestinal disorders | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 51 | 1,942 | 60 |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: Placebo | 54 | 1,945 | 61 |
| other | Nausea (Solicited) | Gastrointestinal disorders | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 520 | 1,942 | 758 |
| other | Nausea (Solicited) | Gastrointestinal disorders | Group 2: Placebo | 361 | 1,945 | 552 |
| other | Vomiting (Solicited) | Gastrointestinal disorders | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 128 | 1,942 | 154 |
| other | Vomiting (Solicited) | Gastrointestinal disorders | Group 2: Placebo | 85 | 1,945 | 115 |
| other | Chills (Solicited) | General disorders | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 857 | 1,942 | 1,405 |
| other | Chills (Solicited) | General disorders | Group 2: Placebo | 342 | 1,945 | 533 |
| other | Fatigue (Solicited) | General disorders | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 1,323 | 1,942 | 3,376 |
| other | Fatigue (Solicited) | General disorders | Group 2: Placebo | 928 | 1,945 | 2,018 |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 4 | 1,942 |
| Total, all-cause mortality | Group 2: Placebo | 6 | 1,945 |
| Total, other adverse events | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 1,687 | 1,942 |
| Total, other adverse events | Group 2: Placebo | 1,348 | 1,945 |
| Total, serious adverse events | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | 82 | 1,942 |
| Total, serious adverse events | Group 2: Placebo | 77 | 1,945 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41314741 | DERIVED |
Source PubMed
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline | Trial comparisons |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With Medically-attended Adverse Events (MAAEs) | Trial comparisons |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | Trial comparisons |
Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | Trial comparisons |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With Adverse Events of Special Interest (AESIs) | Trial comparisons |
Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | Trial comparisons |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 vs Group 2: Placebo: deaths from any cause | Trial comparisons |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 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.
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