← Back to Search

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0 to 393

Awards & highlights

RV575 Trial Summary

This trial will test a new HIV vaccine to see if it is safe and causes few side effects. The vaccine will be given to 60 people who do not have HIV, in 3 different groups. All groups will get the same vaccine, but group 1 will get a higher dose of the adjuvant (a substance that helps increase the effectiveness of the vaccine), group 2 will get a lower dose of the adjuvant, and group 3 will get the lowest dose of the adjuvant.

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.Check my eligibility

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.See study design

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.

RV575 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I weigh at least 110 pounds.

Select...

I am a healthy adult aged between 18 and 55.

Select...

I am female at birth and meet specific health criteria.

RV575 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Number of Participants with HIV-specific Binding Antibodies

RV575 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 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandLead Sponsor

286 Previous Clinical Trials

245,699 Total Patients Enrolled

US Military HIV Research ProgramNETWORK

18 Previous Clinical Trials

3,812 Total Patients Enrolled

Henry M. Jackson Foundation for the Advancement of Military MedicineOTHER

92 Previous Clinical Trials

92,829 Total Patients Enrolled

Media Library

A244 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05423418 — Phase 1

HIV/AIDS Research Study Groups: A244/B.63521 + 200 μg of ALFQ adjuvant, A244/B.63521 + 100 μg of ALFQ adjuvant, A244/B.63521 + 50 μg of ALFQ adjuvant

HIV/AIDS Clinical Trial 2023: A244 Highlights & Side Effects. Trial Name: NCT05423418 — Phase 1

A244 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423418 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria for this trial limited to adults aged 20 or above?

"This clinical trial is specifically recruiting patients aged 18 to 55. There are separate trials for those under the age of eighteen and over 65, each containing 149 and 467 studies respectively."

Answered by AI

Are there any available vacancies in this clinical trial?

"According to the information on clinicaltrials.gov, participant recruitment for this trial has temporarily halted since it was last modified on July 20th 2022; however, 637 other trials are actively recruiting patients at present."

Answered by AI

Has the A244/B.63521 + 200 μg of ALFQ adjuvant combination been given regulatory clearance?

"Due to the limited clinical data available that supports its efficacy and safety, A244/B.63521 + 200 μg of ALFQ adjuvant was assigned a rating of 1 on our risk-assessment scale."

Answered by AI

Am I eligible to partake in this clinical trial?

"This trial is recruiting 60 participants with an AIDS diagnosis aged between 18 and 55. The fundamental qualifications for this study are as follows: healthy adults in the aforementioned age range, who can provide written consent; low risk of HIV infection according to the investigator's assessment; willingness to adhere to all research requirements; abstention from blood donation during enrollment period; minimum body weight of 110lbs (50kg); hemoglobin levels >12.0g/dL for women & > 12.5 g/dL for men; white blood cell count 3,500-10,800 cells/mm3 ; platelet counts 140k-450k mm3"

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C Gp120–mf59 in Adults

Gray, Glenda E., Linda-Gail Bekker, Fatima Laher, Mookho Malahleha, Mary Allen, Zoe Moodie, Nicole Grunenberg, et al.. 2021. “Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C Gp120–mf59 in Adults”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2031499.

VaccineJournal

Safety, Toxicity and Immunogenicity of a Malaria Vaccine Based on the Circumsporozoite Protein (FMP013) with the Adjuvant Army Liposome Formulation Containing QS21 (ALFQ)

Cawlfield, Alicia, Christopher J. Genito, Zoltan Beck, Elke S. Bergmann-Leitner, Alexis A. Bitzer, Kimberly Soto, Xiaoyan Zou, et al.. 2019. “Safety, Toxicity and Immunogenicity of a Malaria Vaccine Based on the Circumsporozoite Protein (FMP013) with the Adjuvant Army Liposome Formulation Containing QS21 (ALFQ)”. Vaccine. Elsevier BV. doi:10.1016/j.vaccine.2019.05.059.

Journal of VirologyJournal

Antigenicity and Immunogenicity of Transmitted/founder, Consensus, and Chronic Envelope Glycoproteins of Human Immunodeficiency Virus Type 1

Liao, Hua-Xin, Chun-Yen Tsao, S. Munir Alam, Mark Muldoon, Nathan Vandergrift, Ben-Jiang Ma, Xiaozhi Lu, et al.. 2013. “Antigenicity and Immunogenicity of Transmitted/founder, Consensus, and Chronic Envelope Glycoproteins of Human Immunodeficiency Virus Type 1”. Journal of Virology. American Society for Microbiology. doi:10.1128/jvi.02297-12.

Journal of VirologyJournal