Ebola Virus Vaccine for People with HIV

Recruiting in Palo Alto (17 mi)

Overseen by Scott Halperin, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cecile Tremblay

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for HIV-infected adults and adolescents aged 13-65 with controlled HIV (undetectable viral load, CD4 count ≥200 cells/mm3). Participants must be on antiretroviral therapy, not pregnant or breastfeeding, in good health as determined by a doctor, willing to attend all study visits, and agree to use effective contraception.

Inclusion Criteria

I am on HIV medication and my viral load is undetectable.

I have read, understood, and signed the consent form for this study.

I am on HIV medication and my viral load is undetectable.

Exclusion Criteria

I have or had cancer, but not skin cancer.

I haven't received immunoglobulins or blood products in the last 120 days and don't plan to during the study.

Is a healthcare worker who has direct contact with patients

Participant Groups

The ACHIV-Ebola trial tests the V920 Ebola vaccine against a saline placebo in HIV-positive individuals. It's randomized (participants are randomly assigned to groups), placebo-controlled (some get no active treatment), multi-site (conducted at different locations), and double-blind (neither participants nor researchers know who gets what treatment).

Group I: Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses Active Control 2 Interventions

Participants will be randomly assigned to receive two dosse of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group II: Group 2: 50 HIV-infected adults CD4 > 350 and < 500 cells/mm^3 Active Control 2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group III: Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3 Active Control 2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of theV920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group IV: Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3 Active Control 2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group V: Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3 Active Control 2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

CHUM Montréal, Canada

Who Is Running the Clinical Trial?

Cecile Tremblay Lead Sponsor

Merck Sharp & Dohme LLC Industry Sponsor

International Development Research Centre, Canada Collaborator

Université de Montréal Collaborator

Canadian Immunization Research Network Collaborator

Dalhousie University Collaborator

Coalition for Epidemic Preparedness Innovations Collaborator

References