What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapies, often have side effects that vary depending on the specific drugs used. For example, the combination of dolutegravir and rilpivirine is generally well-tolerated but can cause headaches and nausea. Raltegravir, another integrase inhibitor, is also well-tolerated with common side effects including headache and fatigue. Broadly neutralizing antibodies like 3BNC117 have been shown to be well-tolerated in clinical trials, with favorable pharmacokinetics and minimal adverse effects. Overall, while side effects are generally mild, they can include headaches, nausea, fatigue, and in some cases, more severe reactions such as hypersensitivity or drug interactions.

What prior FDA approvals exist?

The FDA has approved several antiretroviral therapies for the treatment of HIV, focusing on different mechanisms to control the virus. While specific treatments aimed at inducing broadly neutralizing antibodies (bNAbs) like the V3G CH848 Pr-NP1 and V3G CH848 mRNA-Tr2 are still under investigation, other approved treatments include integrase inhibitors (e.g., dolutegravir), protease inhibitors (e.g., darunavir), and reverse transcriptase inhibitors (e.g., tenofovir and emtricitabine). These treatments work by inhibiting various stages of the HIV life cycle, thereby reducing viral load and improving immune function in patients.

What other types of research exist?

Promising novel alternatives to the Prime-Boost Regimen with V3G CH848 Pr-NP1 and V3G CH848 mRNA-Tr2 for HIV treatment include: 1) Other bNAb-based therapies, such as VRC01-class antibodies, which target the CD4 binding site of the HIV envelope. 2) Therapeutic vaccines using different platforms like DNA, protein subunits, or viral vectors to elicit strong immune responses. 3) Long-acting injectable antiretrovirals that provide sustained drug levels and reduce the frequency of dosing. 4) Gene editing technologies like CRISPR/Cas9 aimed at excising HIV proviral DNA from infected cells. These alternatives are in various stages of research and clinical trials and may offer new avenues for effective HIV treatment.

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Virus Therapy

HIV-1 Envelope Trimer 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 2 weeks after the priming regimen and 2 weeks after the boost with v3g ch848 mrna-tr2

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new two-step HIV treatment in humans for the first time. The first shot introduces a protein to help the immune system recognize HIV. The second shot uses mRNA to boost the immune response by teaching the body to make a part of the virus. The goal is to produce antibodies that can neutralize HIV.

Who is the study for?

Adults aged 18-55 in good health, willing to consent and available for follow-up. They must not be at high risk of HIV, agree to avoid risky behaviors, and use effective birth control if applicable. Excluded are those with BMI ≥ 40, diabetes, immunodeficiencies, certain allergies or conditions that could compromise safety.

What is being tested?

The trial tests a prime-boost vaccine strategy against HIV using ferritin nanoparticles (V3G CH848 Pr-NP1) followed by an mRNA lipid nanoparticle (V3G CH848 mRNA-Tr2). It aims to induce antibodies targeting the virus's envelope protein.

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at injection site, fatigue, headache or fever. Since it's a first-in-human study assessing safety and immune response, close monitoring for any unexpected reactions is part of the protocol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks after the priming regimen and 2 weeks after the boost with v3g ch848 mrna-tr2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks after the priming regimen and 2 weeks after the boost with v3g ch848 mrna-tr2

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after the priming regimen and 2 weeks after the boost with v3g ch848 mrna-tr2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency of the V3G-specific precursor IgM+ and IgG+ B cells.

Local reactogenicity signs and symptoms for a minimum of 14 days following receipt of any study vaccine

Systemic reactogenicity signs and symptoms for a minimum of 14 days following receipt of any study vaccine.

Secondary study objectives

Magnitude of CD4+ T-cell responses

Magnitude of serum Ab autologous neutralization of vaccine-matched tier 2 HIV-1 strains

Magnitude of serum IgG binding Abs

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: V3G CH848 Pr-NP1 with ACU-026-001-1Experimental Treatment3 Interventions

3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

Group II: Group 3: V3G CH848 Pr-NP1 with 3M-052-AF + AlumExperimental Treatment4 Interventions

3 doses of V3G CH848 Pr-NP1 (100 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

Group III: Group 2: Low dose V3G CH848 Pr-NP1 with ACU-026-001-1Experimental Treatment3 Interventions

3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with ACU-026-001-1 (2.0 mg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

Group IV: Group 1: Low dose V3G CH848 Pr-NP1 with 3M-052-AF + AlumExperimental Treatment4 Interventions

3 doses of V3G CH848 Pr-NP1 (60 mcg) combined with 3M-052-AF (5 mcg) and Alum (500 mcg) at the month 0, 2, and 6 visits, followed by 1 dose of V3G CH848 mRNA-Tr2 (50 mcg) at the month 10 visit

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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 treatments for HIV include antiretroviral therapy (ART), which uses a combination of drugs to inhibit the virus at different stages of its life cycle. Integrase strand transfer inhibitors (INSTIs) prevent the integration of viral DNA into the host genome, non-nucleoside reverse transcriptase inhibitors (NNRTIs) block the reverse transcription of viral RNA into DNA, and protease inhibitors (PIs) inhibit the protease enzyme, preventing viral maturation. These treatments are crucial for managing HIV, reducing viral load, and preventing disease progression. The trial involving the Prime-Boost Regimen with V3G CH848 Pr-NP1 and V3G CH848 mRNA-Tr2 aims to induce broadly neutralizing antibodies, which could offer a new approach by targeting the virus more effectively and potentially providing long-term immunity.

Comparative efficacy and safety of dolutegravir relative to common core agents in treatment-naïve patients infected with HIV-1: a systematic review and network meta-analysis.Impact of Suboptimal APOBEC3G Neutralization on the Emergence of HIV Drug Resistance in Humanized Mice.Antibody-mediated prevention and treatment of HIV-1 infection.