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

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.

Study Overview

• Status: Completed
• Conditions: HIV I Infection
• Intervention / Treatment: Biological: VIR-1388; Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Soshanguve, Gauteng, South Africa, 0152
      • Setshaba Research Centre CRS
    • Soweto, Gauteng, South Africa, 1862
      • Perinatal HIV Research Unit
  • KwaZulu-Natal
    • Isipingo, KwaZulu-Natal, South Africa, 4110
      • Isipingo Clinical Research Site
    • Overport, KwaZulu-Natal, South Africa, 4092
      • Chatsworth Clinical Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • Alabama CRS
  • Georgia
    • Decatur, Georgia, United States, 30030
      • The Hope Clinic of the Emory Vaccine Center CRS
  • Massachusetts
    • Boston, Massachusetts, United States, 32077
      • Beth Israel Deconess Medical Center VCRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Prevention CRS
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh CRS
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Vaccine and Prevention CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIR-1388, 5×10^4 ffu; Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: VIR-1388; VIR-1388 is given by subcutaneous injection
Experimental: VIR-1388, 5×10^5 ffu; Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: VIR-1388; VIR-1388 is given by subcutaneous injection
Experimental: VIR-1388, 5×10^6 ffu; Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: VIR-1388; VIR-1388 is given by subcutaneous injection
Placebo Comparator: Placebo; Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: Placebo; The HT Diluent Placebo is HT buffer (20 mM histidine, 10% trehalose-dihydrate, pH 7.2) and contains no active ingredient and will be administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)	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	12 months
Incidence of solicited local site and systemic reactogenicity events	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	14 days after administration of each dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of HIV-1 Mfuse1-specific CD4 T cells	As measured by intracellular cytokine staining (ICS) and flow cytometry	12 months
Frequency of HIV-1 Mfuse1-specific CD8 T cells	As measured by intracellular cytokine staining (ICS) and flow cytometry	12 months
Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells	As determined by flow cytometry analysis	12 months
Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells	As determined by flow cytometry analysis	12 months
Number of participants with VIR-1388 vector viremia in plasma	Detected by quantitative polymerase chain reaction(qPCR) of plasma	12 months
Number of participants with VIR-1388 vector shedding in saliva and urine	Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine	12 months

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: HIV Vaccine Trials Network

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Actual): September 19, 2025
• Study Completion (Actual): November 19, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Vaccine; Cytomegalovirus; CMV
• Other Study ID Numbers: HVTN 142/VIR-1388-V101; 5UM1AI068614-18 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No