What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), can have various side effects. Nucleoside reverse transcriptase inhibitors (NRTIs) may cause nausea, headache, and fatigue. Non-nucleoside reverse transcriptase inhibitors (NNRTIs) can lead to rash and liver toxicity. Protease inhibitors (PIs) are associated with gastrointestinal issues, lipid abnormalities, and insulin resistance. Integrase strand transfer inhibitors (INSTIs) generally have fewer side effects but can still cause insomnia and weight gain. The germline-targeting recombinant Env immunogen, which aims to induce VRC01-class antibodies, is still under study, and its specific side effects are not yet fully known.

What prior FDA approvals exist?

The FDA has approved several treatments for HIV, including antiretroviral therapies (ART) that target various stages of the HIV life cycle. One notable approach similar to the germline-targeting recombinant Env immunogen involves the use of broadly neutralizing antibodies (bnAbs) like VRC01. VRC01 is a monoclonal antibody that targets the CD4 binding site of the HIV envelope protein, preventing the virus from entering host cells. This approach aims to induce the maturation of B cells expressing VRC01-like receptors, enhancing the body's immune response to HIV. Other FDA-approved drugs for HIV treatment include reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and entry inhibitors, which collectively help manage the virus and improve patient outcomes.

What other types of research exist?

Promising alternatives to Germline-targeting recombinant Env immunogen for HIV treatment include: 1) Broadly neutralizing antibodies (bNAbs) such as VRC07-523LS and 3BNC117, which have shown potential in preventing HIV infection and reducing viral load. 2) Therapeutic vaccines like the mosaic-based vaccine candidates, which aim to provide broader protection against diverse HIV strains. 3) Long-acting injectable antiretrovirals such as cabotegravir and rilpivirine, which offer sustained viral suppression with less frequent dosing.

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Virus Therapy

HIV Vaccine for HIV Prevention

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

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 through week 64

Summary

This trial is testing two vaccine methods to help people at risk of HIV infection produce special antibodies that can fight many types of HIV. The vaccine works by training the immune system to make strong antibodies that block HIV.

Who is the study for?

Healthy adults aged 18-55, at low risk for HIV, not pregnant or breastfeeding, with stable vital signs and normal blood work. Participants must understand the study details and consent to follow-up visits including lymph node sampling. They should not be on other investigational drugs or have conditions that could affect vaccine response.

What is being tested?

The trial is testing different doses of a 'germline-targeting' HIV vaccine called 426c.Mod.Core-C4b against a placebo. It aims to see if the vaccine can induce special antibodies known as VRC01-class that are effective across all types of HIV strains.

What are the potential side effects?

Specific side effects aren't listed but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, headache, muscle pain. Serious adverse events will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through week 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through week 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 64 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CD4 Antigens

Frequency of VRC01-like BCR sequences

Number of AEs leading to early participant withdrawal or permanent discontinuation

+5 more

Secondary study objectives

Magnitude of serum antibody neutralization of a panel of CD4-bs bnAb precursor-sensitive viruses.

Magnitude of serum antibody neutralization of the vaccine strain

Response rate of serum antibody neutralization of a panel of CD4-bs bnAb precursor-sensitive viruses.

+1 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Optional Boost Regimen with BG505Experimental Treatment1 Intervention

SOSIP.GT1.1 gp140

Group II: Fractionated Delivery, Group 2: First injection - Medium dose, Final injection - Higher doseExperimental Treatment2 Interventions

The first dose for the Fractionated Delivery Arm Group 2 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.

Group III: Fractionated Delivery, Group 1: First injection - Medium dose, Final injection - Lower doseExperimental Treatment2 Interventions

The first dose for the Fractionated Delivery Arm Group 1 will be divided into 6 smaller amounts (2 visits per week for 3 weeks). The second dose will be given about 3 months later and will be given all at once. At each injection visit for the first dose, the patient will get one amount divided into 2 injections - one in the deltoid muscle of each arm.

Group IV: Bolus Delivery, Group 2: First injection - Medium dose, Final injection - Higher doseExperimental Treatment2 Interventions

The Bolus Delivery Arm Group 2 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.

Group V: Bolus Delivery, Group 1: First injection - Medium dose, Final injection - Lower doseExperimental Treatment2 Interventions

The Bolus Delivery Arm Group 1 will receive injections at 2 visits scheduled 3 months apart. At each injection visit the patient will get one dose divided into 2 injections - one in the deltoid muscle of each arm.

Group VI: Bolus Delivery, Group 3: First injection - Placebo, Final injection - PlaceboPlacebo Group1 Intervention

Group VII: Fractionated Delivery, Group 3: First injection - Placebo, Final injection - PlaceboPlacebo Group1 Intervention

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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 HIV treatments, known as antiretroviral therapy (ART), work by targeting various stages of the HIV life cycle to prevent the virus from replicating and spreading. This includes reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and entry inhibitors. These treatments reduce viral load and improve immune function. The germline-targeting recombinant Env immunogen is a novel approach that aims to induce the maturation of broadly neutralizing antibodies (bnAbs) like VRC01-class antibodies by targeting specific B cells. This is important because bnAbs can neutralize a wide range of HIV strains, offering potential for both treatment and prevention.