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Completed

NCT Number: NCT05854381

To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants 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.

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Key information

Conditions

HIV I Infection

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Setshaba Research Centre CRS, Soshanguve, Gauteng, South Africa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIR-1388

Biological

VIR-1388 is given by subcutaneous injection

Placebo

Biological

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

Primary outcomes

  1. Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)

    Time frame: 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

  2. Incidence of solicited local site and systemic reactogenicity events

    Time frame: 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 outcomes

  1. Frequency of HIV-1 Mfuse1-specific CD4 T cells

    Time frame: 12 months

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

  2. Frequency of HIV-1 Mfuse1-specific CD8 T cells

    Time frame: 12 months

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

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

    Time frame: 12 months

    As determined by flow cytometry analysis

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

    Time frame: 12 months

    As determined by flow cytometry analysis

  5. Number of participants with VIR-1388 vector viremia in plasma

    Time frame: 12 months

    Detected by quantitative polymerase chain reaction(qPCR) of plasma

  6. Number of participants with VIR-1388 vector shedding in saliva and urine

    Time frame: 12 months

    Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • HIV Vaccine Trials Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 11, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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