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

National Institute of Allergy and Infectious Diseases (NIAID)93 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

HIV I Infection

Interventions

VIR-1388BIOLOGICAL

VIR-1388 is given by subcutaneous injection

PlaceboBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 14 days after administration of each dose

Secondary Outcomes

Frequency of HIV-1 Mfuse1-specific CD4 T cells

As measured by intracellular cytokine staining (ICS) and flow cytometry

Time frame: 12 months

Frequency of HIV-1 Mfuse1-specific CD8 T cells

As measured by intracellular cytokine staining (ICS) and flow cytometry

Time frame: 12 months

Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells

As determined by flow cytometry analysis

Time frame: 12 months

Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells

As determined by flow cytometry analysis

Time frame: 12 months

Number of participants with VIR-1388 vector viremia in plasma

Detected by quantitative polymerase chain reaction(qPCR) of plasma

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.