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A Clinical Study to Evaluate the Safety and Immunogenicity of a Higher Dose of the Study Vaccine, VIR-1388, in HCMV-seropositive Adult Participants Without HIV

NCT07801456 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-09-03

No results posted yet for this study

Summary

This study is to test an experimental HIV Vaccine. About 12 participants, aged 18-55 years and who already have cytomegalovirus (CMV) will take part in this study. Participants will come to the clinic for scheduled visits about 21 times over 12 months.

Conditions

  • Cytomegalovirus (CMV)
  • HIV (Human Immunodeficiency Virus)

Interventions

BIOLOGICAL

VIR-1388

Treatment 1 (T1): VIR-1388, 6.9 × 10\^7 ffu to be administered as three 1 mL subcutaneous (SC) injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3).

BIOLOGICAL

Placebo

Control 1 (C1): Placebo for VIR-1388 \[HT Diluent Placebo\] to be administered as three 1 mL SC injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-15
Primary Completion
2028-02-02
Completion
2028-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801456 on ClinicalTrials.gov