Trial · NCT03844386
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
NCT03844386, Phase 1, Completed, University of North Carolina, Chapel Hill; results first posted 2022-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults. Trials, record NCT03844386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03844386
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
- NCT number
- NCT03844386
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- HIV-1 Infection
- Interventions
- MVA.tHIVconsv3, MVA.tHIVconsv4, Placebo
- First posted
- 2019-02-18
- Last updated
- 2026-10-08
- Results first posted
- 2022-08-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | First day of study treatment through 28 days following vaccination | The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 will be used to measure safety where Grade 3 is defined as severe and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs will be assessments that are considered related to study product as possible, probable, or definite as defined in the protocol. |
| Secondary | Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | First day of study treatment through Day 168 (Week 24) following vaccination | The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 will be used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs will be assessments that are considered related to study product as possible, probable, or definite as defined in the protocol. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | First day of study treatment through 28 days following vaccination | percentage of participants | NUMBER | |
| SECONDARY | Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | First day of study treatment through Day 168 (Week 24) following vaccination | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | MVA.tHIVconsv3 (M3) | 43 | 95% Confidence Interval 10 to 81 | percentage of participants | |
| Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | MVA.tHIVconsv4 (M4) | 14 | 95% Confidence Interval 0 to 58 | percentage of participants | |
| Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 0 | 95% Confidence Interval 0 to 64 | percentage of participants | |
| Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | Placebo | 0 | 95% Confidence Interval 0 to 60 | percentage of participants | |
| Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | MVA.tHIVconsv3 (M3) | 100 | 95% Confidence Interval 59 to 100 | percentage of participants | |
| Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | MVA.tHIVconsv4 (M4) | 100 | 95% Confidence Interval 59 to 100 | percentage of participants | |
| Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 100 | 95% Confidence Interval 63 to 100 | percentage of participants | |
| Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | Placebo | 75 | 95% Confidence Interval 19 to 99 | percentage of participants |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MVA.tHIVconsv3 (M3) | 7 | |
| Overall Study | STARTED | MVA.tHIVconsv4 (M4) | 7 | |
| Overall Study | STARTED | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 8 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | Completed Day 28 | MVA.tHIVconsv3 (M3) | 7 | |
| Overall Study | Completed Day 28 | MVA.tHIVconsv4 (M4) | 7 | |
| Overall Study | Completed Day 28 | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 8 | |
| Overall Study | Completed Day 28 | Placebo | 3 | |
| Overall Study | COMPLETED | MVA.tHIVconsv3 (M3) | 7 | |
| Overall Study | COMPLETED | MVA.tHIVconsv4 (M4) | 7 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events144
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 | Abdominal Pain | Gastrointestinal disorders | MVA.tHIVconsv3 (M3) | 1 | 7 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | MVA.tHIVconsv4 (M4) | 0 | 7 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 2 | 8 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 4 | 0 |
| other | Diarrhea | Gastrointestinal disorders | MVA.tHIVconsv3 (M3) | 0 | 7 | 0 |
| other | Diarrhea | Gastrointestinal disorders | MVA.tHIVconsv4 (M4) | 1 | 7 | 1 |
| other | Diarrhea | Gastrointestinal disorders | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 0 | 8 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 4 | 0 |
| other | Nausea | Gastrointestinal disorders | MVA.tHIVconsv3 (M3) | 4 | 7 | 4 |
| other | Nausea | Gastrointestinal disorders | MVA.tHIVconsv4 (M4) | 1 | 7 | 1 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MVA.tHIVconsv3 (M3) | 0 | 7 |
| Total, all-cause mortality | MVA.tHIVconsv4 (M4) | 0 | 7 |
| Total, all-cause mortality | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | MVA.tHIVconsv3 (M3) | 7 | 7 |
| Total, other adverse events | MVA.tHIVconsv4 (M4) | 7 | 7 |
| Total, other adverse events | MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) | 8 | 8 |
| Total, other adverse events | Placebo | 4 | 4 |
| Total, serious adverse events | MVA.tHIVconsv3 (M3) | 0 | 7 |
| Total, serious adverse events | MVA.tHIVconsv4 (M4) | 0 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42084923 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI131310 | Phase I therapeutic testing of viral-vectored vaccines that shift CD8+ T cell immunodominance to conserved regions of HIV-1 | GOONETILLEKE, NILU | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2017 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03844386
GET https://conductscience.org/api/trials/v1/NCT03844386/events?page=2