What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS include antiretroviral therapy (ART) drugs such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and integrase strand transfer inhibitors (INSTIs). Known side effects of these treatments can include gastrointestinal issues (nausea, diarrhea), liver toxicity, cardiovascular problems, and metabolic changes like lipodystrophy. Treatments that enhance the immune response, such as those using adjuvants like ALFQ, may also cause local skin reactions, systemic allergic reactions, and flu-like symptoms. It is important to monitor for these side effects and manage them in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for HIV/AIDS that enhance the immune response. Notably, antiretroviral therapies (ART) such as protease inhibitors, integrase inhibitors, and reverse transcriptase inhibitors have been the cornerstone of HIV treatment. Additionally, immune-based therapies like interleukin-2 (IL-2) have been explored to boost the immune system. The trial involving A244/B.63521 with ALFQ adjuvant is investigating a novel approach by using a vaccine formulation to stimulate the immune system, which is a different strategy compared to traditional ART but aligns with the broader goal of enhancing immune response in HIV treatment.

What other types of research exist?

Promising alternatives to A244/B.63521 with ALFQ adjuvant for HIV/AIDS patients include: 1) mRNA-based vaccines, which have shown robust immune responses in pre-clinical studies; 2) Recombinant protein vaccines with novel adjuvants like AS01B and AS02A, which have demonstrated high levels of specific antibody induction; 3) Broadly neutralizing antibodies (bNAbs) that target multiple HIV strains and have shown potential in clinical trials; 4) Therapeutic vaccines that aim to boost the immune system's ability to control HIV, such as those using viral vectors or dendritic cell-based approaches.

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Virus Therapy

HIV Vaccine + ALFQ for HIV Prevention (RV575 Trial)

Phase 1

Recruiting

Led By Elyse LeeVan, MD

Research Sponsored by U.S. Army Medical Research and Development Command

Eligibility Criteria Checklist

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

Must have

No reproductive potential due to post-menopausal status (12 months of natural [spontaneous] amenorrhea) or hysterectomy, bilateral oophorectomy, or tubal ligation

Minimum body weight of 110 pounds (50kg)

Must not have

History of arthritis diagnosis other than osteoarthritis

History of other diagnosed rheumatoid disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0 to 393

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine with components A244 and B.63521, plus an immune-boosting substance called ALFQ. ALFQ helps enhance immune responses. The vaccine is for healthy adults without HIV to ensure safety and effectiveness. The vaccine trains the immune system to fight infections, and ALFQ enhances this training.

Who is the study for?

Healthy adults aged 18-55, at low risk for HIV, willing to practice safe sex and effective contraception. Excludes those with immune conditions, serious illnesses, drug abuse history, or plans to become pregnant. Participants must have stable vital signs and agree not to donate blood during the study.

What is being tested?

The trial tests a new HIV vaccine candidate A244/B.63521 with varying doses of ALFQ adjuvant (50μg, 100μg, or 200μg) in three groups via intramuscular injections over three months. It aims to determine the safest and most effective dose for future use.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or swelling, flu-like symptoms such as fever or fatigue, headaches and muscle pains. More severe allergic reactions are rare but will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot have children because I am post-menopausal, or I've had surgery.

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I weigh at least 110 pounds.

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I am a healthy adult aged between 18 and 55.

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I am female at birth and meet specific health criteria.

Exclusion Criteria

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

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I have been diagnosed with a type of arthritis that is not osteoarthritis.

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I have been diagnosed with a rheumatoid disorder.

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I haven't had a fever or acute illness around the time of my study injection.

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I have a history of swelling attacks due to angioedema.

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I have a diagnosed bleeding disorder or experience significant bleeding or bruising.

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I have a history of sickle cell disease or carry the trait.

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I haven't needed emergency care for asthma in the last 2 years.

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I have had my spleen removed.

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I have a thyroid condition, but it's well-controlled hypothyroidism.

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My high blood pressure is not well controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0 to 393

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 0 to 393

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0 to 393 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Adverse Events (AEs), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), and unsolicited AEs

Number of Participants with Local and Systemic Reactions

Secondary study objectives

Number of Participants with HIV-specific Binding Antibodies

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Active Control

Group I: A244/B.63521 + 200 μg of ALFQ adjuvantActive Control3 Interventions

Arm 1: An injection containing 300 μg A244 plus 300 μg B.63521 with 200 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57).

Group II: A244/B.63521 + 100 μg of ALFQ adjuvantActive Control3 Interventions

Arm 2: An injection containing 300 μg A244 plus 300 μg B.63521 with 100 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57).

Group III: A244/B.63521 + 50 μg of ALFQ adjuvantActive Control3 Interventions

Arm 3: An injection containing 300 μg of A244 plus 300 μg B.63521 with 50 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57).

0 / 14Eligibility 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/AIDS, such as antiretroviral therapy (ART), work by inhibiting different stages of the HIV life cycle, including reverse transcription, protease activity, and integrase function, thereby reducing viral replication and improving immune function. The ALFQ adjuvant, used in the A244/B.63521 trial, enhances the immune response by stimulating the immune system, which is crucial for developing effective vaccines and therapies. This is important for HIV/AIDS patients as it can lead to better viral suppression, reduced transmission, and improved overall health outcomes.

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