Ebola Virus Vaccine for People with HIV

Overseen By Joanne Langley, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Cecile Tremblay

Must be taking: Antiretrovirals

Must not be taking: Glucocorticoids, Cytotoxic drugs

Disqualifiers: Filovirus infection, VSV infection, Healthcare worker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

250 Participants Needed

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.

Research Team

Cecile Tremblay, MD

Principal Investigator

CHUM

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive one or two doses of the V920 Ebola Virus Vaccine or placebo

1 day

1 visit (in-person)

Post-vaccination Follow-up

Participants are monitored for adverse events and immunogenicity, with safety analyses conducted at 42 days post-vaccination

42 days

Multiple visits (in-person and virtual)

Extended Follow-up

Participants are monitored for vaccine-related serious adverse events up to day 365

365 days

Treatment Details

Interventions

• V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine

Trial Overview 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).

Participant Groups

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

Who Is Running the Clinical Trial?

Cecile Tremblay

Lead Sponsor

Trials

1

Recruited

250+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

International Development Research Centre, Canada

Collaborator

Trials

16

Recruited

18,400+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Canadian Immunization Research Network

Collaborator

Trials

12

Recruited

10,600+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Coalition for Epidemic Preparedness Innovations

Collaborator

Trials

37

Recruited

75,800+