NCT05854381CompletedPhase 1
To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the HCMV-HIV Vaccine Candidate VIR-1388 in Adult Participants With Overall Good Health and Without HIV
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 12 Apr 2023
- Start date
- 19 Sept 2023
- Primary completion date
- 19 Sept 2025
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Diseases
- HIV
- NCT number
- NCT05854381
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 93
- From 19 Sept 2023 to the primary completion date, 19 Sept 2025
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participant has an autoimmune disorder
Other
- Participant is immunocompromised
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alabama CRS Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Beth Israel Deconess Medical Center VCRS Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The Hope Clinic of the Emory Vaccine Center CRS Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Penn Prevention CRS Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh CRS Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Seattle Vaccine and Prevention CRS Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Isipingo | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Overport | South Africa | Unknown status |
| Setshaba Research Centre CRS Coordinator of this site? Confirm its status | Soshanguve | South Africa | Unknown status |
| Perinatal HIV Research Unit Coordinator of this site? Confirm its status | Soweto | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.