To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
Completed · Phase 1 · Has a placebo group
Conditions studied: HIV I Infection
In brief
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
Key facts
- Study ID
- NCT05854381
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 93
- Starts
- 2023-09-19
- Expected to finish
- 2025-11-19
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- In overall good health as determined by medical history, physical exam, and laboratory values
- HIV uninfected
- CMV seropositive
- Willing to use condoms during intercourse for the duration of the study
- 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
- Childbearing status
- Part A: Only participants of non-childbearing potential
- Part B: Participants of childbearing potential must be on 2 forms of contraception and not planning on becoming pregnant for the duration of the study
You may not qualify if…
- Participant is immunocompromised
- Participant has an autoimmune disorder
- Participants having intimate contact with immunocompromised individuals
- Participants having intimate contact with a pregnant partner or partner planning to become pregnant
- Participants who are breastfeeding
Where it is running
- Alabama CRS — Birmingham, Alabama, United States
- The Hope Clinic of the Emory Vaccine Center CRS — Decatur, Georgia, United States
- Beth Israel Deconess Medical Center VCRS — Boston, Massachusetts, United States
- Penn Prevention CRS — Philadelphia, Pennsylvania, United States
- University of Pittsburgh CRS — Pittsburgh, Pennsylvania, United States
- Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
- Setshaba Research Centre CRS — Soshanguve, Gauteng, South Africa
- Perinatal HIV Research Unit — Soweto, Gauteng, South Africa
- Isipingo Clinical Research Site — Isipingo, KwaZulu-Natal, South Africa
- Chatsworth Clinical Research Site — Overport, KwaZulu-Natal, South Africa
Full record on ClinicalTrials.gov
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