VIR-1388 Vaccine for HIV Prevention

Recruiting at 9 trial locations

Overseen By Study Inquiry

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Vir Biotechnology, Inc.

Disqualifiers: Immunocompromised, Autoimmune disorder, others

Compensation: Varies

Number of Visits: Unknown

95 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called VIR 1388 in healthy adults aged 18 to 55 who do not have HIV. The study aims to see if the treatment is safe, what side effects it might cause, and how well it helps the immune system. Participants will be monitored closely for any reactions.

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.

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, which has encouraged further research and development of HIV vaccines. This trial demonstrated that a vaccine could potentially reduce the risk of HIV infection, providing a foundation for future vaccine strategies like VIR-1388. ^{1 2 3 4 5}

Is the VIR-1388 vaccine for HIV prevention safe for humans?

The AVX101 vaccine, similar to VIR-1388, was tested in humans and was generally well tolerated with only modest local reactions. There were 5 serious adverse events reported, but none were linked to the vaccine. ^{1 6 7 8 9}

How is the VIR-1388 treatment for HIV prevention different from other treatments?

The VIR-1388 vaccine for HIV prevention is unique because it aims to stimulate the immune system to prevent HIV infection, unlike other treatments that focus on managing the virus after infection. This approach is part of ongoing efforts to develop a preventive HIV vaccine, building on lessons from previous trials like RV144, which showed that a vaccine could potentially reduce the risk of HIV acquisition. ^{1 2 4 10 11}

Eligibility Criteria

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

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

Exclusion Criteria

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

My immune system is weakened.

Immunocompromised individuals

Timeline

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

Treatment Details

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.

Participant Groups

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?

Vir Biotechnology, Inc.

Lead Sponsor

Trials

30

Recruited

13,300+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

HIV Vaccine Trials Network

Collaborator

Trials

42

Recruited

10,800+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Additional boosting to the RV144 vaccine regimen increased Fc-mediated effector function magnitude but not durability. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Lessons learned from HIV vaccine clinical efficacy trials. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Anticipating policy considerations for a future HIV vaccine: a preliminary study. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

HIV-1 vaccines: challenges and new perspectives. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

HIV Vaccine Efficacy Trials: RV144 and Beyond. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I safety and immunogenicity evaluations of an alphavirus replicon HIV-1 subtype C gag vaccine in healthy HIV-1-uninfected adults. [2021]

7. United States 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. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Human immunodeficiency virus (HIV) immunopathogenesis and vaccine development: a review. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Prophylactic HIV vaccine: vaccine regimens in clinical trials and potential challenges. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Phase III HIV vaccine trial in Thailand: a step toward a protective vaccine for HIV. [2023]