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Virus Therapy

VIR-1388 Vaccine for HIV Prevention

Phase 1
Recruiting
Research Sponsored by Vir Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial tests how safe and effective a new vaccine is in healthy adults without HIV.

Who is the study for?
This trial is for adults in good health who do not have HIV but are CMV seropositive. They must be at low risk for HIV, willing to use condoms, and maintain low-risk behaviors throughout the study. Women who can bear children must use two forms of contraception and avoid pregnancy during the trial.Check my eligibility
What is being tested?
The study is testing VIR-1388 against a placebo to assess its safety and how well it stimulates an immune response in healthy individuals without HIV. Participants will receive either VIR-1388 or a placebo without knowing which one they get.See study design
What are the potential side effects?
Possible side effects include reactions where the shot was given, like pain or swelling, general feelings of discomfort such as fever or tiredness, and other body responses that could show up after getting vaccinated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of solicited local site and systemic reactogenicity events
Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)
Secondary outcome measures
Frequency of HIV-1 Mfuse1-specific CD4 T cells
Frequency of HIV-1 Mfuse1-specific CD8 T cells
Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: VIR-1388, 5×10^6 ffuExperimental Treatment1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
Group II: VIR-1388, 5×10^5 ffuExperimental Treatment1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
Group III: VIR-1388, 5×10^4 ffuExperimental Treatment1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
Group IV: PlaceboPlacebo Group1 Intervention
Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,142 Total Patients Enrolled
Vir Biotechnology, Inc.Lead Sponsor
27 Previous Clinical Trials
13,169 Total Patients Enrolled
HIV Vaccine Trials NetworkNETWORK
39 Previous Clinical Trials
10,662 Total Patients Enrolled

Media Library

VIR-1388 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05854381 — Phase 1
HIV Research Study Groups: VIR-1388, 5×10^4 ffu, VIR-1388, 5×10^5 ffu, VIR-1388, 5×10^6 ffu, Placebo
HIV Clinical Trial 2023: VIR-1388 Highlights & Side Effects. Trial Name: NCT05854381 — Phase 1
VIR-1388 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854381 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors admitted to this experiment?

"The accepted range of ages for this clinical trial is between 18 and 55 years old."

Answered by AI

Does my profile match the criteria for enrolling in this research study?

"To qualify for this investigation, candidates must possess the HIV virus and be aged between 18 to 55. The total number of participants being accepted is 95."

Answered by AI

Are there any medical centers in this state that are currently testing out this experiment?

"Presently, the study is being conducted in 6 separate locations: Decatur, Boston and Philadelphia, along with 3 other sites. To minimize transportation needs if you decide to join this trial, it is beneficial to select a nearby site."

Answered by AI

Has the FDA authorized VIR-1388, 5×10^4 ffu for public use?

"Our team at Power gave VIR-1388, 5×10^4 ffu a rating of 1 due to the limited evidence for safety and efficacy in its Phase 1 trial."

Answered by AI

What key outcomes are being sought through this trial?

"The primary focus of this trial, which is evaluated after 14 days post-dosage, will be to measure the presence of unexpected treatment-related adverse events (TEAEs), serious health issues (SAEs), newly developed chronic conditions (NOCDs) and medically attended side effects (MAAEs). Secondary outcomes that need to be monitored include HIV-1 Mfuse1 CD8 T Cell Frequency measured by intracellular cytokine staining/flow cytometry analysis; Memory Phenotype of HIV-1 Mfuse1 CD4 T Cells observed through flow cytometric assessment; Memory Phenotype of HIV-1 Mf"

Answered by AI

Are there any unfilled positions available in this clinical research endeavor?

"According to clinicaltrials.gov, recruitment for this medical study has been paused since May 2nd 2023. Initially posted on June 1st of the same year, this trial is not looking for applicants at present; however, there are 100 other trials actively enrolling patients right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
2023. "To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05854381.
~63 spots leftby Nov 2025
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