To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
- Conditions
- HIV I Infection
- Interventions
- Biological: Placebo
- Registration Number
- NCT05854381
- Lead Sponsor
- Vir Biotechnology, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
- Detailed Description
This is a Phase 1, randomized, double-blind, placebo-controlled, multicenter study in adults aged 18 to 55 years in overall good health and without HIV. Participants will be enrolled concurrently into 1 of 3 dose levels of VIR-1388 or placebo. The overall study design includes 2 study parts, Part A and Part B. Part A will be a lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential (PONCBP) with a frequent safety monitoring schedule. Part B will expand enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential required to use 2 forms of contraception and maintains a similar overall safety monitoring schedule as Part A . There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 95
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VIR-1388, 5×10^5 ffu VIR-1388 Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. Placebo Placebo Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. VIR-1388, 5×10^4 ffu VIR-1388 Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. VIR-1388, 5×10^6 ffu VIR-1388 Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
- Primary Outcome Measures
Name Time Method Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs) 12 months Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Incidence of solicited local site and systemic reactogenicity events 14 days after administration of each dose Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
- Secondary Outcome Measures
Name Time Method Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells 12 months As determined by flow cytometry analysis
Frequency of HIV-1 Mfuse1-specific CD4 T cells 12 months As measured by intracellular cytokine staining (ICS) and flow cytometry
Frequency of HIV-1 Mfuse1-specific CD8 T cells 12 months As measured by intracellular cytokine staining (ICS) and flow cytometry
Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells 12 months As determined by flow cytometry analysis
Number of participants with VIR-1388 vector viremia in plasma 12 months Detected by quantitative polymerase chain reaction(qPCR) of plasma
Number of participants with VIR-1388 vector shedding in saliva and urine 12 months Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine
Trial Locations
- Locations (10)
Setshaba Research Centre CRS
🇿🇦Soshanguve, Gauteng, South Africa
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
Perinatal HIV Research Unit
🇿🇦Soweto, Gauteng, South Africa
Isipingo Clinical Research Site
🇿🇦Isipingo, Kwa-Zulu Natal, South Africa
Chatsworth Clinical Research Site
🇿🇦Overport, Kwa-Zulu Natal, South Africa