A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants

Running, not enrolling · Phase 1

Conditions studied: HIV Infections

In brief

This is an open-label, multicenter, randomized phase 1 study to evaluate the safety and immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV trimer mRNA. These trimers are based on the BG505 MD39 native-like trimer reported in Steichen et al. Immunity 2016. The primary hypothesis is that the BG505 MD39.3 soluble and membrane-bound trimer mRNA vaccines will be safe and well-tolerated among HIV-uninfected individuals and will elicit autologous neutralizing antibodies.

Key facts

Study ID

NCT05217641

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

108

Starts

2022-02-11

Expected to finish

2027-06-24

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
• 18-55 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.
• In good general health according to the clinical judgement of the site investigator.
• Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
• Assessed as low risk for HIV acquisition per low risk guidelines, agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking pre-exposure prophylaxis (PrEP) as prescribed for 6 months or longer.
• Hemoglobin
• Greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth
• Greater than or equal to 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
• Greater than or equal to 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
• White blood cell (WBC) count > 3,500/mm3
• Platelets ≥125,000 /mm3
• Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) based on the institutional normal range
• Serum creatinine ≤1.1 x ULN based on the institutional normal range
• Negative results 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.
• For a volunteer capable of becoming pregnant:
• Volunteers who were assigned female sex at birth and are of reproductive potential must agree to use effective means of birth control from at least 21 days prior to enrollment through 3 months after their third vaccination timepoint
• Has negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to study product administration on day of enrollment.

You may not qualify if…

• Volunteer who is breast-feeding or pregnant.
• Hypertension that is not well controlled. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently < 140 mm Hg systolic and < 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be < 140 mm Hg systolic and < 90 mm Hg diastolic at enrollment. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
• Diabetes mellitus type 1 or type 2. (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes).
• Previous or current recipient of an investigational HIV vaccine (previous placebo recipients are not excluded).
• Acutely ill or febrile (temperature ≥ 38.0°C/100.4°F) on the day of the first vaccination. Participants meeting this criterion may be rescheduled within the enrollment window period. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.
• 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 or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.
• Receipt of any of the following:
• Within 4 weeks prior to enrollment:
• Any licensed live, attenuated vaccine
• Any emergency use authorized (EUA) or licensed mRNA-based SARS-CoV-2 vaccine
• Within 2 weeks prior to enrollment:
• Any licensed killed/subunit/inactivated vaccine
• Any EUA or licensed adenoviral-vectored or protein SARS-CoV-2 vaccines Receipt of any SARS-CoV-2 vaccination series should be completed 4 weeks prior to enrollment when possible; however, exceptions may be made by approval of the HVTN 302 PSRT.
• Initiation of antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval.
• Receipt of 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.
• History of serious reaction (eg, hypersensitivity, anaphylaxis) to any vaccine or any component of the study vaccine.
• History of myocarditis and/or pericarditis.
• Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
• Idiopathic urticaria within the past year.
• Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
• Seizure disorder; febrile seizures as a child or seizures secondary to alcohol withdrawal more than 5 years ago are not exclusionary.
• Asplenia or functional asplenia.
• Active duty and reserve US military personnel.
• Any other chronic or clinically significant condition that in the clinical judgement of the investigator would jeopardize the safety or rights of the study participant, including, but not limited to: clinically significant forms of drug or alcohol abuse, serious psychiatric disorders, or cancer that, in the clinical judgement of the site investigator, has a potential for recurrence (excluding basal cell carcinoma).

Where it is running

• Alabama CRS [31788] — Birmingham, Alabama, United States
• UCLA Vine Street Clinic CRS [31607] — Los Angeles, California, United States
• Bidmc Vcrs [32077] — Boston, Massachusetts, United States
• Brigham and Women's Hospital Vaccine CRS [30007] — 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
• Penn Prevention CRS [30310] — Philadelphia, Pennsylvania, United States
• University of Pittsburgh CRS [1001] — Pittsburgh, Pennsylvania, United States
• Seattle Vaccine and Prevention CRS [30331] — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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