What side effects are associated with this type of intervention?

HIV vaccines designed to increase HIV-1-specific T cell responses, such as those studied in the C62-M4 or C1C62-M3M4 trials, generally have a favorable safety profile. Common side effects include mild to moderate injection site reactions (such as pain, redness, and swelling), fever, fatigue, headache, and muscle aches. These side effects are typically short-lived and resolve on their own. Serious adverse events are rare but can include allergic reactions or more severe systemic responses. Overall, these vaccines are considered safe and well-tolerated in individuals with HIV-1 on suppressive antiretroviral therapy.

What prior FDA approvals exist?

As of now, there are no FDA-approved vaccines specifically designed to increase HIV-1-specific T cell responses similar to the C62-M4 or C1C62-M3M4 vaccines being studied. Most FDA-approved treatments for HIV focus on antiretroviral therapy (ART) to manage the infection rather than vaccines. Research and clinical trials are ongoing to develop effective HIV vaccines, but none have yet received FDA approval.

What other types of research exist?

Promising novel alternatives to C62-M4 or C1C62-M3M4 for HIV vaccine patients include: 1) mRNA-based vaccines, which have shown potential in eliciting robust immune responses, 2) Ad26 vector-based vaccines, which have demonstrated efficacy in preclinical and clinical trials, and 3) Mosaic vaccines, designed to provide broader protection by targeting multiple HIV-1 strains. Additionally, the use of novel adjuvants like synthetic monophosphoryl lipid A (MPL) analogues and granulocyte-macrophage colony-stimulating factor (GM-CSF) can enhance the immunogenicity of these vaccines.

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Cancer Vaccine

HIV Vaccines for HIV (CM HIV-Core008 Trial)

Phase 1

Waitlist Available

Led By Cindy L Gay, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months

Summary

This trial is testing two vaccines given as muscle injections to people with HIV who are already on treatment. The goal is to see if these vaccines are safe and if they can help the immune system better fight the virus. Participants will receive the injections and be monitored for any reactions.

Who is the study for?

This trial is for adults aged 18-70 with HIV, on stable ART with undetectable viral load and CD4 count >=350. They must be willing to follow the study plan, have no recent serious illness or hospitalization, not pregnant or planning pregnancy, and agree to use birth control. Excluded are those with certain medical conditions, prior adenovirus vaccines including COVID-19 ones, live vaccines within 60 days, untreated syphilis or HCV treatment recently.

What is being tested?

The trial tests if C62-M4 or C1C62-M3M4 vaccines are safe in HIV-positive individuals on ART and whether they boost immune responses against HIV. Participants will receive intramuscular injections of either vaccine formulation or a placebo and their T cell responses will be monitored.

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at injection site, mild fever, fatigue; allergic reactions; possible impact on underlying condition due to immune response changes. Specific risks related to these experimental vaccines will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and first day of study treatment through day 196 (20 weeks following second vaccination), an average of 7 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE)

Secondary study objectives

Body Weight Changes

Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE)

Relative change in magnitude of T cell responses to HIV-1 conserved regions

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: C62Experimental Treatment2 Interventions

C62 administered at Day 0 and M4 on Day 28

Group II: C1C62Experimental Treatment2 Interventions

C1C62 administered at Day 0 and M3M4 on Day 28

Group III: PlaceboPlacebo Group1 Intervention

Placebo administered on Day 0 and Day 28

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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

HIV vaccines like C62-M4 or C1C62-M3M4 work by targeting conserved regions of the HIV-1 virus to enhance HIV-1-specific T cell responses. These vaccines aim to improve the body's ability to recognize and attack HIV-infected cells, which is crucial for controlling the virus, reducing viral load, and delaying disease progression. By focusing on stable viral regions, these vaccines provide a more consistent target for the immune system, potentially leading to better long-term outcomes for patients.

Efficient entry inhibition of human and nonhuman primate immunodeficiency virus by cell surface-expressed gp41-derived peptides.