VIR-1388 Vaccine for HIV Prevention

Not currently recruiting at 9 trial locations

Overseen By Study Inquiry

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Disqualifiers: Immunocompromised, Autoimmune disorder, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, VIR-1388, to determine its safety and effectiveness in preventing HIV. The study compares different doses of the vaccine with a placebo to assess its safety and impact on the immune system. It seeks healthy adults who do not have HIV, are CMV positive (have antibodies to a common virus), and are at low risk for HIV infection. Participants must be willing to use condoms during the trial to minimize any risk of exposure. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial staff to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the VIR-1388 vaccine is generally safe and well tolerated. In earlier studies, researchers found no major safety problems with VIR-1388. This vaccine is administered through a small injection under the skin, similar to many other vaccines.

The trial under consideration is in its early stages, focusing primarily on assessing the safety of VIR-1388 for people. Early trials typically involve fewer participants, so not all side effects may be known yet. However, current data suggests it is safe for healthy adults without HIV. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for HIV?

Researchers are excited about VIR-1388 because it represents a novel approach to HIV prevention. Unlike current preventive methods, such as daily oral PrEP (pre-exposure prophylaxis) medications, VIR-1388 is a vaccine designed to stimulate the body's immune response against HIV. This vaccine is administered through subcutaneous injections, potentially offering a more convenient and long-term solution compared to daily pills. Additionally, the use of different dosages of the vaccine allows researchers to determine the most effective and safe concentration, which could lead to a breakthrough in HIV prevention strategies.

What evidence suggests that the VIR-1388 vaccine could be effective for HIV prevention?

Research shows that VIR-1388, which participants in this trial may receive, is designed to activate T cells, a type of immune cell that can attack HIV-infected cells. By boosting the body's T cell response, the researchers aim to help prevent HIV infection. Although specific data on VIR-1388's effectiveness is not yet available, similar methods in the RV144 trial showed a moderate 31% protection rate against HIV. This suggests that vaccines working in this way might be promising. However, VIR-1388 remains under study, and further research is needed to confirm its effectiveness. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

In overall good health as determined by medical history, physical exam, and laboratory values

CMV seropositive

Willing to use condoms during intercourse for the duration of the study

Exclusion Criteria

Participants having intimate contact with a pregnant partner or partner planning to become pregnant

Participant has an autoimmune disorder

Immunocompromised individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential with frequent safety monitoring

12 weeks

Frequent visits for safety monitoring

Treatment Part B

Expanded enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential

12 weeks

Frequent visits for safety monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Optional Long-term Follow-up

Optional follow-up study that would lengthen study participation for up to 3 years post-first dose

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• VIR-1388

Trial Overview 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.

How Is the Trial Designed?

Group I: VIR-1388, 5×10^6 ffu Experimental Treatment 1 Intervention

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

Group II: VIR-1388, 5×10^5 ffu Experimental Treatment 1 Intervention

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

Group III: VIR-1388, 5×10^4 ffu Experimental Treatment 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Vir Biotechnology, Inc.

Lead Sponsor

Trials

30

Recruited

13,300+

HIV Vaccine Trials Network

Collaborator

Trials

42

Recruited

10,800+

Published Research Related to This Trial

Over 1500 healthy individuals have participated in studies of HIV-1 vaccines, which have shown good safety profiles with no serious toxicity reported, indicating that these vaccines are well tolerated.

Candidate vaccines, particularly those using gp120 and vaccinia vectors, successfully induce immune responses, including neutralizing antibodies and cytotoxic T cell activity, although they currently only neutralize laboratory-adapted HIV-1 strains, not primary isolates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human studies in the development of human immunodeficiency virus vaccines. Dolin, R.[2019]

The RV144 Phase III trial in Thailand is the only human study to show a statistically significant level of protection against HIV-1 infection, highlighting the potential for developing an effective vaccine.

Despite the modest success of the RV144 trial, further research is crucial to understand the immune mechanisms that provided protection, which could accelerate the development of a more effective HIV vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human immunodeficiency virus (HIV) immunopathogenesis and vaccine development: a review. Girard, MP., Osmanov, S., Assossou, OM., et al.[2011]

The HVTN 120 trial, involving 160 healthy HIV-uninfected adults, demonstrated that the ALVAC-HIV vaccine was generally safe and well tolerated, with no significant safety concerns reported.

Among the different vaccine regimens tested, the 40 μg gp120 protein adjuvanted with AS01B produced the strongest immune responses, showing higher CD4+ T-cell responses and binding antibody levels compared to other formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein dose-sparing effect of AS01B adjuvant in a randomized preventive HIV vaccine trial of ALVAC-HIV (vCP2438) and adjuvanted bivalent subtype C gp120. Chirenje, ZM., Laher, F., Dintwe, O., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05854381

To Investigate Safety, Reactogenicity and Immunogenicity ... The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV. Detailed Description.

2. investors.vir.bio investors.vir.bio/news/news-details/2023/Vir-Biotechnology-Announces-First-Participant-Dosed-in-New-Phase-1-Trial-Evaluating-VIR-1388-an-Investigational-T-Cell-Vaccine-for-the-Prevention-of-HIV-09-20-2023/default.aspx

News Details VIR-1388 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11435826/

HIV Vaccine Development at a Crossroads: New B and T ... The vaccine candidate VIR-1388 is being investigated in 95 individuals in the HVTN 142 study, with enrollment ongoing [NCT05854381].

4. withpower.com withpower.com/trial/phase-1-human-immunodeficiency-virus-type-1-hiv-1-infection-5-2023-a091c

VIR-1388 Vaccine for HIV Prevention · Info for Participants What data supports the effectiveness of the VIR-1388 treatment for HIV prevention? The RV144 trial showed a moderate protective effect of 31% against HIV ...

5. eatg.org eatg.org/hiv-news/last-large-hiv-vaccine-trial-halted/

Last large HIV vaccine trial halted Only one large study—the RV144 trial in Thailand—has shown any effectiveness for HIV prevention. That trial tested a vaccine containing HIV's ...

6. niaid.nih.gov niaid.nih.gov/news-events/clinical-trial-hiv-vaccine-begins-united-states-and-south-africa

Clinical Trial of HIV Vaccine Begins in United States and ... The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people.