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Virus Therapy
Ebola Virus Vaccine for People with HIV
Phase 2
Waitlist Available
Led By Cecile Tremblay, MD
Research Sponsored by Cecile Tremblay
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On antiretroviral therapy with an undetectable viral load (< 40 c/ml)
HIV-infected adult or adolescent male or non-pregnant, non-breastfeeding female, ages 13 to 65 (inclusive) at the time of screening
Must not have
Have an active malignancy or history of metastatic or hematologic malignancy except non-melanoma skin cancers
Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the number of vaccine related sae's from signing the consent form to day 365 will be recorded and summarized.
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing an Ebola virus vaccine in people with HIV. It will be conducted at multiple sites in Canada and Africa. The study will last for 365 days for each participant, not including the
Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
While specific side effects aren't listed here, vaccines like V920 may cause reactions at the injection site, flu-like symptoms such as fever or fatigue, muscle pain, headache or allergic reactions. Side effects can vary from mild to severe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on HIV medication and my viral load is undetectable.
Select...
I am an HIV-positive person aged 13 to 65 and not pregnant or breastfeeding.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had cancer, but not skin cancer.
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I haven't received immunoglobulins or blood products in the last 120 days and don't plan to during the study.
Select...
I have had a filovirus infection or been in a filovirus vaccine study before.
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I have had a VSV infection or received a VSV vaccine.
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I haven't had a fever over 101°F or a severe illness in the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the number of vaccine related sae's from signing the consent form to day 365 will be recorded and summarized.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the number of vaccine related sae's from signing the consent form to day 365 will be recorded and summarized.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HIV Infections
Secondary study objectives
Antibodies, Phospho-Specific
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Active Control
Group I: Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 dosesActive Control2 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^3Active Control2 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^3Active Control2 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^3Active Control2 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^3Active Control2 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 Location
Who is running the clinical trial?
Cecile TremblayLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,553 Total Patients Enrolled
International Development Research Centre, CanadaOTHER_GOV
15 Previous Clinical Trials
18,162 Total Patients Enrolled
Université de MontréalOTHER
221 Previous Clinical Trials
104,042 Total Patients Enrolled
Canadian Immunization Research NetworkNETWORK
11 Previous Clinical Trials
10,720 Total Patients Enrolled
Dalhousie UniversityOTHER
173 Previous Clinical Trials
401,604 Total Patients Enrolled
Coalition for Epidemic Preparedness InnovationsOTHER
36 Previous Clinical Trials
75,701 Total Patients Enrolled
Cecile Tremblay, MDPrincipal InvestigatorCHUM
3 Previous Clinical Trials
104 Total Patients Enrolled
Scott Halperin, MDPrincipal InvestigatorDalhousie University
2 Previous Clinical Trials
860 Total Patients Enrolled