To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV I Infection

Treatments: Biological: VIR-1388; Biological: Placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT05854381

HVTN 142/VIR-1388-V101

5UM1AI068614-18 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 4 patient groups, including a placebo group

VIR-1388, 5×10^4 ffu

Experimental group

Description:

Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.

Treatment:

Biological: VIR-1388

VIR-1388, 5×10^5 ffu

Experimental group

Description:

Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.

Treatment:

Biological: VIR-1388

VIR-1388, 5×10^6 ffu

Experimental group

Description:

Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.

Treatment:

Biological: VIR-1388

Placebo

Placebo Comparator group

Description:

Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.

Treatment:

Biological: Placebo