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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07801456
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • VIR-1388 — BIOLOGICAL
    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).
  • Placebo — BIOLOGICAL
    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).

Study Details

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.

Key Dates

First listed
Sep 3, 2026
Start date
Oct 15, 2026
Status verified
Aug 2026
Primary completion
Feb 2, 2028
Completion
Feb 2, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: VIR-1388
    VIR-1388 will be administered subcutaneously at study week 0 (month 0) and week 12 (month 3).
  • Placebo Comparator: Placebo
    Placebo will be administered subcutaneously at study week 0 (month 0) and week 12 (month 3).

Primary Outcome Measure

Number of Participants with Local Reactions [ Time Frame: Day of vaccination through 14 days after each vaccination ]

Locations (2)

FacilityCityStateZIPSite coordinators
Alabama CRS (Site # 31788)BirminghamAlabama35222-
Beth Israel Deaconess Medical Center / BIDMC VCRS (Site #32077)BostonMassachusetts02215-

Find similar trials in Birmingham, AL

By research site
Alabama CRS· Birmingham, ALBeth Israel Deaconess Medical Center / BIDMC VCRS· Boston, MA

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