CompletedPhase 2

African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola

Canada251 participantsStarted 2017-08-01

Plain-language 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.

Who can participate

Age range13 Years – 65 Years

SexALL

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Inclusion criteria

✓. If the female partner is NOT of childbearing potential, the couple will only be required to use condoms, without other adjunctive contraception.
✓. For this study, a woman is considered of childbearing potential unless postmenopausal (≥ 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
✓. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label for example:
✓. Use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
✓. Avoiding the sharing of needles, razors, or toothbrushes
✓. Avoiding open-mouth kissing

What they're measuring

Number of Participants With Solicited Adverse Events Following V920 Vaccination

Timeframe: From vaccine administration up to day 14 following vaccination

Number of Participants With Solicited Adverse Events Following V920 Vaccination

Timeframe: From vaccine administration up to 42 days postvaccination

Number of Participants With Unsolicited Adverse Events Following V920 Vaccination

Timeframe: From vaccine administration up to day 42 postvaccination

Number of Participants With Serious Adverse Events Following V920 Vaccination

Timeframe: From vaccine administration up to day 365 following vaccination

Geometric Mean Titers Induced by V920

Timeframe: Day 28 postvaccination

Geometric Mean Titers Induced by V920

Timeframe: 28 days after LAST (second) dose of vaccine

Trial details

NCT IDNCT03031912

SponsorCanadian Immunization Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2023-03-03

Results submitted2025-06-13

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