Ebola Virus Vaccine for People with HIV

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new Ebola Virus vaccine, V920 (rVSVΔG-ZEBOV-GP), to determine its safety and effectiveness for people living with HIV. Researchers aim to understand how well the vaccine prevents Ebola in those with HIV who are on antiretroviral therapy and have a stable immune system. The trial compares the vaccine to a placebo, a harmless substance that resembles the treatment but has no effect. It suits HIV-positive individuals managing their condition with treatment and without major health issues. Participants will contribute to understanding how to protect vulnerable populations from Ebola. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be on antiretroviral therapy with an undetectable viral load to participate, and you cannot have received certain vaccines or medications recently. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the V920 Ebola Virus Vaccine is likely safe for individuals at risk of Ebola exposure. One study found that healthy adults tolerated the vaccine well, with most side effects being mild, such as headaches and fever. Importantly, early data includes individuals with HIV, suggesting that the vaccine's benefits likely outweigh the risks for them as well. Although still under testing, the vaccine has been safely administered to various groups, including children and pregnant women. This information offers some confidence about its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine because it offers a new way to protect people with HIV from the Ebola virus. This vaccine uses a live, attenuated virus, which is a different approach from current treatments that often focus on supportive care or antiviral drugs. Unlike standard options, this vaccine specifically targets the Ebola virus glycoprotein, potentially offering a more direct and effective immune response. This innovative mechanism could be particularly beneficial for individuals with compromised immune systems, such as those with HIV, potentially offering them better protection against Ebola.

What evidence suggests that the V920 Ebola Virus Vaccine could be effective for people with HIV?

Research has shown that the V920 Ebola Virus Vaccine yields promising results in combating the Ebola virus. Studies indicate that this vaccine improves survival rates for those infected. In this trial, participants with HIV will receive either the V920 Ebola Virus Vaccine or a placebo at random. The vaccine has been tested on various groups, including children, pregnant women, and people with HIV, demonstrating a good balance of benefits and risks. Past studies found the vaccine safe and capable of triggering a strong immune response in both healthy adults and those with HIV. Overall, these findings suggest the V920 vaccine could effectively protect against Ebola, even for people with HIV. ^{5 6 7 8 9}

Who Is on the Research Team?

Cecile Tremblay, MD

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6668225/

rVSVΔG-ZEBOV-GP (also designated V920) recombinant ...

Preliminary data from approximately 20 HIV positive subjects that have ... V920 Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32030996/

Safety, immunogenicity and risk-benefit analysis of rVSV- ...

A good risk-benefit balance of the V920 vaccine in adults, but also in children and pregnant and lactating women and HIV-infected people.

3.

thelancet.com

thelancet.com/journals/laninf/article/PIIS1473-3099(24)00419-5/fulltext

Effectiveness of rVSV-ZEBOV vaccination during the 2018– ...

... individuals were positive ... virus–Zaire ebolavirus vaccine is associated with improved survival among patients with Ebolavirus infection.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02269423

Vaccine Treatment for Ebola Virus in Healthy Adults (V920- ...

Given the recent increase in Ebola virus infections occurring in Africa, there is interest in making an effective vaccine to protect against the infection. V920 ...

5.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2200072

Randomized Trial of Vaccines for Zaire Ebola Virus Disease

ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected ... Vaccines · Viral Infections. Authors. Authors. PREVAC Study Team ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28549145/

Six-Month Safety Data of Recombinant Vesicular Stomatitis ...

... Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. J Infect Dis. 2017 Jun 15;215(12):1789-1798. doi ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02503202

Study Details | NCT02503202 | Evaluation of the Safety ...

Prevention of Ebola Infection ... Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).

8.

academic.oup.com

academic.oup.com/jid/article/215/12/1789/3855263

Six-Month Safety Data of Recombinant Vesicular Stomatitis ...

The study supports the use of the rVSVΔG-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. ... Human infection with the virus of vesicular stomatitis ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590136219300105

rVSVΔG-ZEBOV-GP (also designated V920) recombinant ...

... V920 Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents ... Preliminary data from approximately 20 HIV positive subjects that have ...