What side effects are associated with this type of intervention?

Common treatments for HIV infection, such as antiretroviral therapy (ART), often include reverse transcriptase inhibitors and protease inhibitors. These treatments can have side effects such as fatigue, nausea, and gastrointestinal issues. In some cases, more serious adverse events like liver toxicity, kidney problems, and metabolic changes (e.g., lipid abnormalities) can occur. Specific regimens, like those involving TMC310911 with ritonavir, have shown potent antiviral activity with common side effects including fatigue and nausea, but no serious treatment-emergent adverse events were reported. Overall, while ART is effective in managing HIV, patients may experience a range of side effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

The FDA has approved various treatments for HIV infection, primarily focusing on antiretroviral therapies (ART) that target different stages of the HIV life cycle. These include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. While the CH505 TF chTrimer vaccine aims to expand specific B-cell precursors, most FDA-approved treatments focus on inhibiting viral replication rather than enhancing immune responses. Notable examples of ART include drugs like zidovudine (AZT), efavirenz, and dolutegravir. Research continues to explore novel approaches, including therapeutic vaccines and immune-based therapies, to provide more comprehensive HIV management.

What other types of research exist?

Promising novel alternatives to the CH505 TF chTrimer vaccine for HIV infection treatment in 2024 include gene therapy approaches such as CRISPR-edited, CCR5-ablated hematopoietic stem and progenitor cells, and monoclonal antibodies like broadly neutralizing antibodies (bNAbs). These therapies aim to enhance immune response, target viral reservoirs, and potentially provide long-term remission.

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Virus Therapy

CH505 TF chTrimer 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

Must not have

Receipt of any live attenuated vaccine within 4 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thru week 104

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new vaccine called CH505 TF chTrimer in healthy adults. The vaccine is combined with substances to see if it helps the immune system produce strong antibodies. The goal is to ensure the vaccine is safe and effective.

Who is the study for?

Healthy adults aged 18-55 who are not pregnant, breastfeeding, or at high risk for HIV. Participants must be in good health, available for follow-up visits, willing to undergo certain medical procedures like lymph node aspiration and leukapheresis, and agree to use effective birth control. Exclusions include recent receipt of blood products or certain vaccines, serious vaccine reactions, asthma requiring frequent steroid use or emergency care, immune-mediated diseases, drug abuse history.

What is being tested?

The trial is testing the CH505 TF chTrimer vaccine with different doses of the adjuvants 3M-052-AF and Alum to evaluate safety and how well it generates an immune response (immunogenicity). Part A uses a specific dose combination while Part B tests varying doses/combinations to find the best balance between effectiveness and side effects.

What are the potential side effects?

Potential side effects may include local reactions at injection site (pain or swelling), general symptoms like fever or fatigue after vaccination. Since this is a Phase 1 study primarily focused on safety/immunogenicity assessment rather than efficacy against disease transmission; detailed side effect profiles will be determined during the trial.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not received a live vaccine in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ thru week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~thru week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and thru week 104 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 CD4 binding-site-specific IgG+ B cells

Frequency of CH505TF-specific IgG+ B cells

Frequency of v2 apex and V3 glycan- specific IgG+ B cells

+9 more

Secondary study objectives

Magnitude of serum IgG binding antibodies

Magnitude of serum antibody neutralization of heterologous HIV-1 strains

Response rate of serum IgG binding antibodies

+1 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: TreatmentExperimental Treatment2 Interventions

CH505 chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.

Group II: Group 3: TreatmentExperimental Treatment3 Interventions

CH505 cTrimer, 300 mcg admixed with (3 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide Ssuspension (Alum) administered at months 0, 2, 4, 8 and 12.

Group III: Group 2: TreatmentExperimental Treatment2 Interventions

CH505 TF chTrimer 300 mcg admixed with (3 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.

Group IV: Group 1:TreatmentExperimental Treatment3 Interventions

CH505 TF chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide suspension, administered at months 0, 2, 4, 8 and 12.

0 / 1Eligibility criteria met

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 infection include antiretroviral drugs such as reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and entry inhibitors. These drugs work by targeting different stages of the HIV life cycle: reverse transcriptase inhibitors block the conversion of viral RNA into DNA, protease inhibitors prevent the maturation of viral proteins, integrase inhibitors stop the integration of viral DNA into the host genome, and entry inhibitors prevent the virus from entering host cells. These mechanisms are crucial for controlling viral replication and maintaining immune function in HIV patients. The CH505 TF chTrimer vaccine, which aims to expand CH103-like B-cell precursors, represents a novel approach by enhancing the body's immune response to HIV, potentially leading to better control of the virus and improved patient outcomes.

CCR5-edited CD4+ T cells augment HIV-specific immunity to enable post-rebound control of HIV replication.High levels of CC-chemokine expression and downregulated levels of CCR5 during HIV-1/HTLV-1 and HIV-1/HTLV-2 coinfections.The histone deacetylase inhibitor ITF2357 decreases surface CXCR4 and CCR5 expression on CD4(+) T-cells and monocytes and is superior to valproic acid for latent HIV-1 expression in vitro.