A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults

Stopped early · Phase 1

Conditions studied: HIV

In brief

This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and well tolerated when administered alone, and when co-administered with HIV-1 Trimer 4571, in prime-boost regimens, and will induce detectable immune response.

Key facts

Study ID

NCT05470400

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

44

Starts

2022-08-15

Expected to finish

2024-01-24

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): volunteer demonstrates understanding of this study, completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
• 18-50 years old, inclusive, on day of enrollment.
• Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit.
• Agrees not to enroll in another study of an investigational agent during participation in the trial, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) investigational agents that may subsequently obtain emergency use authorization (EUA) or undergo licensure by the FDA. If a potential participant is already enrolled in a SARS-CoV-2 clinical trial, prior approvals from the SARS-COV-2 study sponsor and HVTN 303 PSRT are required prior to enrollment in HVTN 303.
• In good general health without clinically significant medical history.
• Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity.
• Body Mass Index (BMI) ≤ 40.
• Assessed as low risk for HIV acquisition.
• Suitable injection sites in the deltoid muscle of each arm, as assessed by a clinician.
• White blood cells (WBCs) 2,500-12,000/mm3
• WBC differential either within institutional normal range or approved by the Investigator of Record (IoR) as "not clinically significant."
• Platelets = 125,000 - 500,000/mm3
• Hemoglobin
• ≥ 11.0 g/dL for volunteers who were assigned female sex at birth
• ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months
• ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
• For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth
• Serum creatinine ≤ 1.1 x upper limit of normal (ULN) based on the institutional normal range.
• Alanine aminotransferase (ALT) ≤1.25 x ULN based on the institutional normal range.
• Negative for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
• Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected.
• Negative for Hepatitis B surface antigen.
• Agrees to use effective means of birth control from at least 21 days prior to enrollment through 12 weeks after the last product administration.
• Negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to each study product administration on the day of study product administration.

You may not qualify if…

• Active duty and reserve US military personnel.
• Breast-feeding or planning to become pregnant from at least 21 days prior to enrollment through 12 weeks after the last product administration.
• An investigational HIV vaccine (previous placebo recipients are not excluded).
• Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses ≤ 60 mg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment).
• Blood products within 60 days prior to enrollment
• Monoclonal antibodies (mAbs), whether licensed or investigational. Exceptions may be made by the HVTN 303 PSRT on a case-by-case basis
• Receipt of any of the following:
• Within 4 weeks prior to enrollment:
• Any licensed live, attenuated vaccine
• Any adenoviral-vectored SARS-CoV-2 vaccine with FDA Emergency Use Authorization (EUA), FDA licensure or World Health Organization (WHO) Emergency Use Listing (EUL)
• Within 2 weeks prior to enrollment:
• Any licensed killed/subunit/inactivated vaccine
• Any mRNA based or protein SARS-CoV-2 vaccines with FDA EUA, FDA licensure, or WHO EUL
• Investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.
• Current allergen immunotherapy with antigen injections, unless on maintenance schedule.
• Current anti-TB prophylaxis or therapy.
• Serious adverse reactions to vaccines or vaccine components.
• Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
• Hypertension that is not well controlled.
• Asthma is excluded if the participant has ANY of the following:
• Required either oral or parenteral corticosteroids for an exacerbation two or more times within the past year; OR
• Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or co-existing conditions unrelated to asthma); OR
• Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR
• Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA]); OR
• Uses more than one medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than one medication for maintenance therapy daily for greater than two years requires PSRT approval.

Where it is running

• Atlanta - Hope Clinic — Atlanta, Georgia, United States
• BIDMC Vcrs [32077] — Boston, Massachusetts, United States
• New York Blood Center CRS [31801] — New York, New York, United States
• Columbia P&S CRS [30329] — New York, New York, United States
• University of Rochester Vaccines to Prevent HIV Infection CRS [31467] — Rochester, New York, United States
• University of Pittsburgh CRS [1001] — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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