Phase 2
Completed N=251
African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola
Source: ClinicalTrials.gov NCT03031912 ↗Enrolled (actual)
251
Serious AEs
1.6%
Results posted
Jan 2026
Primary outcomePrimary: Number of Participants With Solicited Adverse Events Following V920 Vaccination — 5; 1; 2; 1 Participants
Summary
This is a randomized, placebo-controlled, multi-site, double-blind trial of V920 (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be conducted in conformance with Good Clinical Practices. The study will take place at 2 Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital) and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Adverse Events Following V920 Vaccination |
9; 2; 15; 2; 6; 0 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events Following V920 Vaccination |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Serious Adverse Events Following V920 Vaccination |
2; 0; 0; 0; 1; 0 | — |
| PRIMARY Geometric Mean Titers Induced by V920 |
8,416.0; 40.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- HIV-infected adult or adolescent male or non-pregnant, non-breastfeeding female, ages 13 to 65 (inclusive) at the time of screening;
- On antiretroviral therapy with an undetectable viral load ( 101°F (38.3ºC) within one week prior to vaccination;
- Pregnant or breastfeeding female, or female who intends to become pregnant during the study period;
- Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period;
- Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.
Data sourced from ClinicalTrials.gov (NCT03031912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.