VIR-1388 Vaccine for HIV Prevention
Recruiting at 9 trial locations
SI
Overseen ByStudy Inquiry
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Vir Biotechnology, Inc.
Trial Summary
What is the purpose of this trial?
This trial is testing a new treatment called VIR 1388 in healthy adults aged 18 to 55 who do not have HIV. The study aims to see if the treatment is safe, what side effects it might cause, and how well it helps the immune system. Participants will be monitored closely for any reactions.
Eligibility Criteria
This trial is for adults in good health who do not have HIV but are CMV seropositive. They must be at low risk for HIV, willing to use condoms, and maintain low-risk behaviors throughout the study. Women who can bear children must use two forms of contraception and avoid pregnancy during the trial.Inclusion Criteria
In overall good health as determined by medical history, physical exam, and laboratory values
CMV seropositive
Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
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Exclusion Criteria
Participants having intimate contact with a pregnant partner or partner planning to become pregnant
My immune system is weakened.
Immunocompromised individuals
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Treatment Details
Interventions
- Placebo (Other)
- VIR-1388 (Virus Therapy)
Trial OverviewThe study is testing VIR-1388 against a placebo to assess its safety and how well it stimulates an immune response in healthy individuals without HIV. Participants will receive either VIR-1388 or a placebo without knowing which one they get.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: VIR-1388, 5×10^6 ffuExperimental Treatment1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
Group II: VIR-1388, 5×10^5 ffuExperimental Treatment1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
Group III: VIR-1388, 5×10^4 ffuExperimental Treatment1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
Group IV: PlaceboPlacebo Group1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vir Biotechnology, Inc.
Lead Sponsor
Trials
30
Recruited
13,300+
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Trials
3,361
Recruited
5,516,000+
HIV Vaccine Trials Network
Collaborator
Trials
42
Recruited
10,800+