NCT05854381

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2023

Typical duration for phase_1

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 19, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2025

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

April 12, 2023

Last Update Submit

March 2, 2026

Conditions

HIV I Infection

Keywords

HIVVaccineCMVCytomegalovirus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

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

    12 months

  • Frequency of HIV-1 Mfuse1-specific CD8 T cells

    12 months

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

    12 months

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

    12 months

  • Number of participants with VIR-1388 vector viremia in plasma

    12 months

  • +1 more secondary outcomes

Study Arms (4)

VIR-1388, 5×10^4 ffu

EXPERIMENTAL

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

Biological: VIR-1388

VIR-1388, 5×10^5 ffu

EXPERIMENTAL

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

Biological: VIR-1388

VIR-1388, 5×10^6 ffu

EXPERIMENTAL

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

Biological: VIR-1388

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

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

Placebo
VIR-1388BIOLOGICAL

VIR-1388 is given by subcutaneous injection

VIR-1388, 5×10^4 ffuVIR-1388, 5×10^5 ffuVIR-1388, 5×10^6 ffu

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Alabama CRS

Birmingham, Alabama, 35222, United States

Location

The Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia, 30030, United States

Location

Beth Israel Deconess Medical Center VCRS

Boston, Massachusetts, 32077, United States

Location

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh CRS

Pittsburgh, Pennsylvania, 15213, United States

Location

Seattle Vaccine and Prevention CRS

Seattle, Washington, 98104, United States

Location

Setshaba Research Centre CRS

Soshanguve, Gauteng, 0152, South Africa

Location

Perinatal HIV Research Unit

Soweto, Gauteng, 1862, South Africa

Location

Isipingo Clinical Research Site

Isipingo, KwaZulu-Natal, 4110, South Africa

Location

Chatsworth Clinical Research Site

Overport, KwaZulu-Natal, 4092, South Africa

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

May 11, 2023

Study Start

September 19, 2023

Primary Completion

September 19, 2025

Study Completion

November 19, 2025

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations

US(6)ZA(4)