African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola (NCT03031912) | Clinical Trial Compass
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 range
13 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Timeframe: From vaccine administration up to day 14 following vaccination
2
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Timeframe: From vaccine administration up to 42 days postvaccination
3
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Timeframe: From vaccine administration up to day 42 postvaccination
4
Number of Participants With Serious Adverse Events Following V920 Vaccination
Timeframe: From vaccine administration up to day 365 following vaccination
5
Geometric Mean Titers Induced by V920
Timeframe: Day 28 postvaccination
6
Geometric Mean Titers Induced by V920
Timeframe: 28 days after LAST (second) dose of vaccine