Trial · NCT05604209
Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART
NCT05604209, Phase 1, Completed, University of North Carolina, Chapel Hill; results first posted 2025-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART. Trials, record NCT05604209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05604209
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART
- NCT number
- NCT05604209
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- HIV Vaccine, HIV-1-infection
- Interventions
- ChAdOx1.HIVconsv62, ChAdOx1.tHIVconsv1, MVA.tHIVconsv4, MVA.tHIVconsv3, Placebo
- First posted
- 2022-11-03
- Last updated
- 2025-08-24
- Results first posted
- 2025-08-24
Source ClinicalTrials.gov
Registered outcomes7
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 last vaccination, an average of 2 months | The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was 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 were assessments that were considered related to study product as possible, probable, or definite as defined in the protocol. Confidence intervals around percentages were estimated using the Clopper-Pearson exact method. |
| Secondary | Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | First day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months | The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was 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 were assessments that were considered related to study product as possible, probable, or definite as defined in the protocol. Confidence intervals around percentages were estimated using the Clopper-Pearson exact method. |
| Secondary | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen | Baseline to day 35 | Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-1) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 35 was measured by ex vivo interferon (IFN)-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm). |
| Secondary | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen | Baseline to day 35 | Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-2) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 35 was measured by ex vivo IFN-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm). |
| Secondary | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen | Baseline to day 42 | Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-1) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 42 was measured by ex vivo IFN-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm). |
| Secondary | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen | Baseline to day 42 | Relative changes in magnitude of T-cell responses to HIV-1 conserved region (Mosaic-2) between baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) and day 42 was measured by ex vivo IFN-gamma ELISpot. The relative change within participants (per vaccinated arm) was estimated using a geometric mean ratio and evaluated using either a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm). |
| Secondary | Median Change in Breadth of T-cell Responses Targeting Conserved HIV-1 Immunogen Subpools | Baseline to day 56 | Change in breadth of T-cell response was measured as the difference in the number of ex vivo reactive subpools (P076, PP077, PP078, PP079, PP080) from baseline (one or more of screening, enrolment, pre-vaccination leukapheresis or day 0) to post-vaccination (day 56). The difference in reactive subpools within participants (per vaccinated arm) was estimated and the median value was evaluated using a Wilcoxon signed rank test (within-arm) or Wilcoxon rank-sum test (between-arm). |
Source ClinicalTrials.gov
Outcomes7
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 last vaccination, an average of 2 months | All participants that received C62-M4, C1C62-M3M4, or placebo were included. | 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 196 (20 weeks following second vaccination), an average of 7 months | All participants that received C62-M4, C1C62-M3M4, or placebo were included. | percentage of participants | NUMBER |
| SECONDARY | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen | Baseline to day 35 | Participants who received C62-M4 or C1C62-M3M4 vaccines were included. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups. | log2 fold change | MEDIAN |
| SECONDARY | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen | Baseline to day 35 | Participants who received C62-M4 or C1C62-M3M4 vaccines were included. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups. | log2 fold change | MEDIAN |
| SECONDARY | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen | Baseline to day 42 | Participants who received C62-M4 or C1C62-M3M4 vaccines were included. One participant in the C1C62-M3M4 arm missed the collection visit at day 42 and was unevaluable for this outcome. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups. | log2 fold change | MEDIAN |
| SECONDARY | Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen | Baseline to day 42 | Participants who received C62-M4 or C1C62-M3M4 vaccines were included. One participant in the C1C62-M3M4 arm missed the collection visit at day 42 and was unevaluable for this outcome. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups. | log2 fold change | MEDIAN |
| SECONDARY | Median Change in Breadth of T-cell Responses Targeting Conserved HIV-1 Immunogen Subpools | Baseline to day 56 | Participants that received the C62-M4 or C1C62-M3M4 vaccines were included. However, sufficient sample volume at day 56 was available for 2 participants in the C62-M4 arm and 4 participants in the C1C62-M3M4 arm; only the pooled analysis across C62-M4/C1C62-M3M4 was reported. Placebo participants' samples were collected to maintain blinding but excluded per the analysis plan, as the study focused on (i) changes from baseline to post-vaccination and (ii) differences between vaccine groups. | subpools | MEDIAN |
Source ClinicalTrials.gov
Results by group16
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) | C62-M4 | 12.5 | 95% Confidence Interval 0.32 to 52.7 | percentage of participants | |
| Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | C1C62-M3M4 | 0 | 95% Confidence Interval 0 to 36.9 | percentage of participants | |
| Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) | Placebo | 0 | 95% Confidence Interval 0 to 84.2 | percentage of participants | |
| Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | C62-M4 | 87.5 | 95% Confidence Interval 47.4 to 99.7 | percentage of participants | |
| Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | C1C62-M3M4 | 100 | 95% Confidence Interval 63.1 to 100 | percentage of participants | |
| Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE) | Placebo | 50 | 95% Confidence Interval 1.3 to 98.7 | percentage of participants | |
| Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen | C62-M4 | 1.15 | Inter-Quartile Range 0.32 to 1.92 | log2 fold change | |
| Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-1 Immunogen | C1C62-M3M4 | 1.66 | Inter-Quartile Range 1.29 to 2.26 | log2 fold change | |
| Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen | C62-M4 | 1.79 | Inter-Quartile Range 1.06 to 1.92 | log2 fold change | |
| Median Fold-change in Magnitude of T-cell Response to HIV-1 Mosaic-2 Immunogen | C1C62-M3M4 | 1.66 | Inter-Quartile Range 1.16 to 2.26 | log2 fold change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | C62-M4 | 8 | |
| Overall Study | STARTED | C1C62-M3M4 | 8 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | Enrollment Leukapheresis | C62-M4 | 8 | |
| Overall Study | Enrollment Leukapheresis | C1C62-M3M4 | 8 | |
| Overall Study | Enrollment Leukapheresis | Placebo | 2 | |
| Overall Study | Day 0 Vaccination | C62-M4 | 8 | |
| Overall Study | Day 0 Vaccination | C1C62-M3M4 | 8 | |
| Overall Study | Day 0 Vaccination | Placebo | 2 | |
| Overall Study | Day 28 Vaccination | C62-M4 | 8 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events132
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 | Ear pain | Ear and labyrinth disorders | C62-M4 | 1 | 8 | 1 |
| other | Ear pain | Ear and labyrinth disorders | C1C62-M3M4 | 0 | 8 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 0 | 2 | 0 |
| other | Anal fissure | Gastrointestinal disorders | C62-M4 | 1 | 8 | 1 |
| other | Anal fissure | Gastrointestinal disorders | C1C62-M3M4 | 0 | 8 | 0 |
| other | Anal fissure | Gastrointestinal disorders | Placebo | 0 | 2 | 0 |
| other | Colitis | Gastrointestinal disorders | C62-M4 | 1 | 8 | 1 |
| other | Colitis | Gastrointestinal disorders | C1C62-M3M4 | 0 | 8 | 0 |
| other | Colitis | Gastrointestinal disorders | Placebo | 0 | 2 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | C62-M4 | 1 | 8 | 1 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | C62-M4 | 0 | 8 |
| Total, all-cause mortality | C1C62-M3M4 | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 2 |
| Total, other adverse events | C62-M4 | 8 | 8 |
| Total, other adverse events | C1C62-M3M4 | 8 | 8 |
| Total, other adverse events | Placebo | 2 | 2 |
| Total, serious adverse events | C62-M4 | 0 | 8 |
| Total, serious adverse events | C1C62-M3M4 | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05604209
GET https://conductscience.org/api/trials/v1/NCT05604209/flow?page=2