What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), can have various side effects. NRTIs may cause nausea, headache, and, in rare cases, lactic acidosis. NNRTIs can lead to rash and liver toxicity. PIs are associated with gastrointestinal issues and lipid abnormalities. INSTIs might cause insomnia and weight gain. Entry inhibitors can result in injection site reactions and increased risk of infections. These treatments aim to manage HIV by maintaining immune function and reducing viral load, similar to the immune response induction studied in the VIR 1388 trial.

What prior FDA approvals exist?

The FDA has approved several antiretroviral drugs for the treatment of HIV, including zidovudine, which was one of the first drugs approved for this purpose. Other notable antiretroviral drugs include simeprevir and sofosbuvir, which are used in combination therapies. These treatments primarily focus on managing the virus rather than inducing an immune response. While there are no FDA-approved vaccines for HIV that induce an immune response similar to the candidate vaccine VIR 1388, ongoing research and trials aim to develop such vaccines to provide long-term immunity against HIV.

What other types of research exist?

Promising alternatives to VIR 1388 for HIV patients include: 1) mRNA-based HIV vaccines, which have shown robust immune responses in early trials; 2) broadly neutralizing antibodies (bNAbs) that target multiple HIV strains; 3) therapeutic vaccines like the Ad26.Mos4.HIV vaccine, which has demonstrated strong immunogenicity; and 4) long-acting injectable antiretrovirals, which provide sustained viral suppression and improved adherence.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV, primarily antiretroviral therapy (ART), work by targeting various stages of the HIV life cycle. These include nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) that block the reverse transcription process, protease inhibitors (PIs) that inhibit viral protease enzymes, integrase strand transfer inhibitors (INSTIs) that prevent viral DNA integration into the host genome, and entry inhibitors that block the virus from entering host cells. These treatments are essential for reducing viral load and preventing disease progression. Additionally, investigational treatments like the HIV vaccine VIR 1388 aim to induce a strong immune response, which is vital for long-term control and potential eradication of the virus.

IAS Towards an HIV Cure Symposium: people focused, science driven: 18-19 July 2015, Vancouver, Canada.