HIV InfectionsPhase 1NCT05217641

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

A Phase 1 study testing BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 10 sitesUnited States
Study dates: 11 Feb 2022to 24 Jun 2027
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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).

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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).
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.
A participant with a history of an immune-mediated disease, either active or remote. Not exclusionary: 1) remote history of Bell's palsy (>2 years ago) not associated with other neurologic symptoms, 2) mild psoriasis that does not require ongoing systemic treatment.
Immunodeficiency

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Alabama CRS [31788]
Birmingham, Alabama, 35222
Bidmc Vcrs [32077]
Boston, Massachusetts, 02115
Brigham and Women's Hospital Vaccine CRS [30007]
Boston, Massachusetts, 02115
UCLA Vine Street Clinic CRS [31607]
Los Angeles, California, 90038
New York Blood Center CRS [31801]
New York, New York, 10065
Columbia P&S CRS [30329]
New York, New York, 30329
Penn Prevention CRS [30310]
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS [1001]
Pittsburgh, Pennsylvania, 15213
University of Rochester Vaccines to Prevent HIV Infection CRS [31467]
Rochester, New York, 14642
Seattle Vaccine and Prevention CRS [30331]
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-label 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

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.

Read the detailed description

Participants will receive BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA or BG505 MD39.3 gp151 CD4KO mRNA, at doses of 100 mcg or 250mcg, administered via intramuscular (IM) injections into the deltoid muscle. Participants will be evaluated for safety and immune responses through blood and lymph node fine-needle aspiration collection at specified timepoints throughout the study.

A dose escalation plan will be implemented, whereby sentinel safety groups for each of the three low-dose groups in Part A would be enrolled and evaluated for safety 2 weeks after the first vaccination. If safety criteria are met, then enrollment of the Part B sentinel safety groups and the remainder of the Part A participants would commence. Safety for the sentinel groups in Part B will be assessed after the first vaccination prior to full enrollment of Part B. In addition, standard safety evaluations will occur routinely throughout the trial.

Conditions: HIV Infections
Being tested: BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA, BG505 MD39.3 gp151 CD4KO mRNA
Keywords: Blood-Borne Infections, Communicable Diseases, Infections, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections, Virus Diseases, Immunologic Deficiency Syndromes, Immune System Diseases, Immunologic Factors, Physiological Effects of Drugs
Medical subject headings: HIV Infections, Blood-Borne Infections, Communicable Diseases, Infections, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Lentivirus Infections, Retroviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BG505 MD39.3 mRNABiological
Administered by IM injection
BG505 MD39.3 gp151 mRNABiological
Administered by IM injection
BG505 MD39.3 gp151 CD4KO mRNABiological
Administered by IM injection

Study groups in NCT05217641
Study group	Role	What they receive
Part A, Group 1: Low dose BG505 MD39.3 mRNA	Experimental	18 participants Dose: 100mcg of BG505 MD39.3 mRNA formulated administered at months 0, 2, and 6 Receives: Biological: BG505 MD39.3 mRNA
Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA	Experimental	18 participants Dose: 100mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6 Receives: Biological: BG505 MD39.3 gp151 mRNA
Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA	Experimental	18 participants Dose: 100mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6 Receives: Biological: BG505 MD39.3 gp151 CD4KO mRNA
Part B, Group 1: BG505 MD39.3 mRNA	Experimental	18 participants Dose: 250mcg of BG505 MD39.3 mRNA administered at months 0, 2, and 6 Receives: Biological: BG505 MD39.3 mRNA
Part B, Group 2: BG505 MD39.3 gp151 mRNA	Experimental	18 participants Dose: 250mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6 Receives: Biological: BG505 MD39.3 gp151 mRNA
Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA	Experimental	18 participants Dose: 250mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6 Receives: Biological: BG505 MD39.3 gp151 CD4KO mRNA

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Measured: Measured through 7 days after each vaccine dose
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Measured: Measured through 7 days after each vaccine dose
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Measured: Measured through 7 days after each vaccine dose
Chemistry and Hematology Laboratory Measures - ALT in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured: Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured: Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured: Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured: Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured: Measured during Screening, Days 8, 64, 176 and 225
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
The number (percentage) of participants with lab grade > 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm
Measured: Measured during Screening, Days 8, 64, 176 and 225
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured: 30 days following each injection
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Measured: 30 days following each injection
Number of Participants Reporting Serious Adverse Events (SAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured: Measured through Month 12
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured: Measured through Month 12
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
There were no adverse events of special interest reported by any participant.
Measured: Measured through Month 12.
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured: Measured through Month 12
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Measured: Measured through Month 12.
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Measured: 2 weeks after the 3rd vaccination timepoint (M6.5)
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Measured: 2 weeks after the 3rd vaccination timepoint (M6.5)

Secondary outcomes (6)

Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Measured: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous and Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Measured: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
Measured: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
Measured: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
Measured: 2 weeks after the 3rd vaccination (M6.5)
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
Measured: 2 weeks after the 3rd vaccination (M6.5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 202224 Jun 2027

First posted1 Feb 2022
Study start11 Feb 2022
Primary completion17 Jul 2023
Study completion24 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05217641
Sponsor's protocol ID: HVTN 302
Other IDs: DAIDS-ES ID: 38791
Status last verified: Sep 2025
First submitted: 30 Dec 2021
Last updated: 14 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Parks KR, Moodie Z, Allen MA, Yen C, Furch BD, MacPhee KJ, Ozorowski G, Heptinstall J, Hahn WO, Zheng Z, Lu H, Grant S, Domin E, Duff MO, Seese A, Marini-Macouzet C, Ballweber-Fleming L, Lee WH, Cottrell CA, Liguori A, Georgeson E, Alavi N, Kubitz M, Phelps N, Seaton KE, Cohen KW, Anderson MA, Mondal K, Laufer DS, Kublin JG, Ward AB, Hyrien O, De Rosa SC, Himansu S, Leav B, Reuter C, Tomaras GD, Montefiori D, Walsh SR, Frank I, Sobieszczyk ME, Goepfert PA, Stephenson KE, Baden LR, Van Tieu H, Keefer MC, Clark J, Riddler SA, Schief WR, McElrath MJ. Vaccination with mRNA-encoded membrane-anchored HIV envelope trimers elicited tier 2 neutralizing antibodies in a phase 1 clinical trial. Sci Transl Med. 2025 Jul 30;17(809):eady6831. doi: 10.1126/scitranslmed.ady6831. Epub 2025 Jul 30.
PubMed 40737434
Ramezani-Rad P, Cottrell CA, Marina-Zarate E, Liguori A, Landais E, Torres JL, Myers A, Lee JH, Baboo S, Flynn C, McKenney K, Salcedo E, Zhou X, Kalyuzhniy O, Georgeson E, Phelps N, Lu D, Eskandarzadeh S, Menis S, Kubitz M, Groschel B, Alavi N, Jackson AM, Lee WH, Tran AS, Ben-Akiva E, Kaczmarek Michaels K, Diedrich JK, Enemuo CA, Lewis V, Pradhan A, Kasturi SP, Schiffner T, Steichen JM, Carnathan DG, Himansu S, Yates JR 3rd, Paulson JC, Ozorowski G, Irvine DJ, Silvestri G, Sok D, Ward AB, Crotty S, Schief WR. Vaccination with an mRNA-encoded membrane-bound HIV envelope trimer induces neutralizing antibodies in animal models. Sci Transl Med. 2025 Jul 30;17(809):eadw0721. doi: 10.1126/scitranslmed.adw0721. Epub 2025 Jul 30.
PubMed 40737430
Riddler SA, Moodie Z, Clark J, Yen C, Allen M, Furch BD, Lu H, Grant S, Mondal K, Anderson M, Maenza J, Lemos MP, Woodward Davis AS, Walsh SR, Sobieszczyk ME, Frank I, Goepfert P, Stephenson KE, Baden LR, Tieu HV, Keefer MC, McElrath MJ, Kublin JG, Corey L. High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302). Ann Intern Med. 2025 Jul;178(7):963-974. doi: 10.7326/ANNALS-24-02701. Epub 2025 Apr 29.
PubMed 40294415

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-label 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
ClinicalTrials.gov ID: NCT05217641
Acronym / sponsor ID: HVTN 302
Conditions: HIV Infections
Keywords: Blood-Borne Infections, Communicable Diseases, Infections, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 108 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: National Institutes of Health (NIH), Department of Health and Human Services
Study start: 11 Feb 2022 (actual)
Primary completion: 17 Jul 2023 (actual)
Study completion: 24 Jun 2027 (estimated)
First posted: 1 Feb 2022 (actual)
Results: Posted 31 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Part A, Group 1: Low dose BG505 MD39.3 mRNA	Experimental	Biological: BG505 MD39.3 mRNA18 participants Dose: 100mcg of BG505 MD39.3 mRNA formulated administered at months 0, 2, and 6
Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA	Experimental	Biological: BG505 MD39.3 gp151 mRNA18 participants Dose: 100mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA	Experimental	Biological: BG505 MD39.3 gp151 CD4KO mRNA18 participants Dose: 100mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6
Part B, Group 1: BG505 MD39.3 mRNA	Experimental	Biological: BG505 MD39.3 mRNA18 participants Dose: 250mcg of BG505 MD39.3 mRNA administered at months 0, 2, and 6
Part B, Group 2: BG505 MD39.3 gp151 mRNA	Experimental	Biological: BG505 MD39.3 gp151 mRNA18 participants Dose: 250mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA	Experimental	Biological: BG505 MD39.3 gp151 CD4KO mRNA18 participants Dose: 250mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (22 listed)

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.

Key exclusion criteria (33 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BG505 MD39.3 mRNAAdministered by IM injection	Biological	Part A, Group 1: Low dose BG505 MD39.3 mRNA, Part B, Group 1: BG505 MD39.3 mRNA
BG505 MD39.3 gp151 mRNAAdministered by IM injection	Biological	Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA, Part B, Group 2: BG505 MD39.3 gp151 mRNA
BG505 MD39.3 gp151 CD4KO mRNAAdministered by IM injection	Biological	Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA, Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA

Primary outcome

Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Time frame: Measured through 7 days after each vaccine dose
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Time frame: Measured through 7 days after each vaccine dose
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Time frame: Measured through 7 days after each vaccine dose
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Chemistry and Hematology Laboratory Measures - ALT in U/L
Time frame: Measured during Screening, Days 8, 64, 176 and 225
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Time frame: Measured during Screening, Days 8, 64, 176 and 225
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Time frame: Measured during Screening, Days 8, 64, 176 and 225
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Time frame: Measured during Screening, Days 8, 64, 176 and 225
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Time frame: Measured during Screening, Days 8, 64, 176 and 225
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Time frame: Measured during Screening, Days 8, 64, 176 and 225
The number (percentage) of participants with lab grade > 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Time frame: 30 days following each injection
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Time frame: 30 days following each injection
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: Measured through Month 12
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Time frame: Measured through Month 12
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Time frame: Measured through Month 12.
There were no adverse events of special interest reported by any participant.
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Time frame: Measured through Month 12
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Time frame: Measured through Month 12.
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Time frame: 2 weeks after the 3rd vaccination timepoint (M6.5)
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Time frame: 2 weeks after the 3rd vaccination timepoint (M6.5)
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.

6 secondary outcomes

Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Time frame: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Time frame: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Time frame: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Time frame: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Time frame: 2 weeks after the 3rd vaccination (M6.5)
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Time frame: 2 weeks after the 3rd vaccination (M6.5)

Results and safety

Results posted to the registry on 31 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A, Group 1: Treatment	18	16
Part A, Group 2: Treatment	19	17
Part A, Group 3: Treatment	17	17
Part B, Group 4: Treatment	18	14
Part B, Group 5: Treatment	18	14
Part B, Group 6: Treatment	18	18

Primary outcome: Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness

Time frame: Measured through 7 days after each vaccine dose. Count of participants. Unit: Participants

Measure	Part A, Group 1: Treatment n = 18	Part A, Group 2: Treatment n = 19	Part A, Group 3: Treatment n = 17	Part B, Group 4: Treatment n = 18	Part B, Group 5: Treatment n = 18	Part B, Group 6: Treatment n = 18
None	0	1	1	0	0	0
Mild	10	7	9	8	8	10
Moderate	8	10	4	8	9	8
Severe	0	1	3	2	1	0
Potentially Life-threatening	0	0	0	0	0	0

Primary outcome: Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration

Time frame: Measured through 7 days after each vaccine dose. Count of participants. Unit: Participants

Measure	Part A, Group 1: Treatment n = 18	Part A, Group 2: Treatment n = 19	Part A, Group 3: Treatment n = 17	Part B, Group 4: Treatment n = 18	Part B, Group 5: Treatment n = 18	Part B, Group 6: Treatment n = 18
Erythema/Redness: None	17	13	16	16	15	12
Erythema/Redness: Mild	1	1	0	1	1	2
Erythema/Redness: Moderate	0	4	1	0	2	3
Erythema/Redness: Severe	0	1	0	1	0	1
Erythema/Redness: Potentially Life-threatening	0	0	0	0	0	0
Induration/Swelling: None	16	15	12	14	17	14
Induration/Swelling: Mild	0	1	2	1	1	1
Induration/Swelling: Moderate	2	3	2	2	0	3

Primary outcome: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Time frame: Measured through 7 days after each vaccine dose. Count of participants. Unit: Participants

Measure	Part A, Group 1: Treatment n = 18	Part A, Group 2: Treatment n = 19	Part A, Group 3: Treatment n = 17	Part B, Group 4: Treatment n = 18	Part B, Group 5: Treatment n = 18	Part B, Group 6: Treatment n = 18
Malaise and/or fatigue: None	2	7	2	3	0	3
Malaise and/or fatigue: Mild	11	6	7	6	8	1
Malaise and/or fatigue: Moderate	5	2	6	7	8	12
Malaise and/or fatigue: Severe	0	4	2	2	2	2
Malaise and/or fatigue: Potentially Life-threatening	0	0	0	0	0	0
Myalgia: None	5	11	5	7	0	0
Myalgia: Mild	8	3	7	3	10	8
Myalgia: Moderate	5	3	3	6	8	10

Primary outcome: Chemistry and Hematology Laboratory Measures - ALT in U/L

Time frame: Measured during Screening, Days 8, 64, 176 and 225. Median (Inter-Quartile Range). Unit: U/L

Measure	Part A, Group 1: Treatment n = 18	Part A, Group 2: Treatment n = 19	Part A, Group 3: Treatment n = 17	Part B, Group 4: Treatment n = 18	Part B, Group 5: Treatment n = 18	Part B, Group 6: Treatment n = 18
ALT (U/L) -Screening	15 (13 to 21)	17 (12 to 23)	17 (15 to 28)	15 (12 to 25)	19 (13 to 23)	23 (17 to 31)
ALT (U/L) -V3 - 1 week post-vaccination 1	14 (11 to 19)	16 (14 to 25)	17 (13 to 32)	14.5 (14 to 30)	14.5 (12 to 20)	20 (17 to 24)
ALT (U/L) -V7 - 1 week post-vaccination 2	13 (12 to 16)	17 (13 to 22.5)	17 (12 to 31)	14 (12 to 19)	15 (11 to 19)	22 (17.5 to 35.5)
ALT (U/L) -V11 - 1 week post-Vaccination 3	12 (11 to 18)	13 (10 to 19)	13 (12 to 29)	12 (10 to 17)	13 (12 to 17)	19 (15 to 24)
ALT (U/L) -V14 - 8 weeks post-vaccination 3	–	–	–	28 (28 to 28)	–	–

Population analysed: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A, Group 1: Treatment	1 of 18 (5.6%)	18 of 18 (100%)	0 of 18
Part A, Group 2: Treatment	1 of 19 (5.3%)	19 of 19 (100%)	0 of 19
Part A, Group 3: Treatment	1 of 17 (5.9%)	17 of 17 (100%)	0 of 17
Part B, Group 4: Treatment	0 of 18 (0%)	18 of 18 (100%)	0 of 18
Part B, Group 5: Treatment	0 of 18 (0%)	18 of 18 (100%)	0 of 18
Part B, Group 6: Treatment	0 of 18 (0%)	18 of 18 (100%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40737434Parks KR, Moodie Z, Allen MA, Yen C, Furch BD, MacPhee KJ, Ozorowski G, Heptinstall J, Hahn WO, Zheng Z, Lu H, Grant S, Domin E, Duff MO, Seese A, Marini-Macouzet C, Ballweber-Fleming L, Lee WH, Cottrell CA, Liguori A, Georgeson E, Alavi N, Kubitz M, Phelps N, Seaton KE, Cohen KW, Anderson MA, Mondal K, Laufer DS, Kublin JG, Ward AB, Hyrien O, De Rosa SC, Himansu S, Leav B, Reuter C, Tomaras GD, Montefiori D, Walsh SR, Frank I, Sobieszczyk ME, Goepfert PA, Stephenson KE, Baden LR, Van Tieu H, Keefer MC, Clark J, Riddler SA, Schief WR, McElrath MJ. Vaccination with mRNA-encoded membrane-anchored HIV envelope trimers elicited tier 2 neutralizing antibodies in a phase 1 clinical trial. Sci Transl Med. 2025 Jul 30;17(809):eady6831. doi: 10.1126/scitranslmed.ady6831. Epub 2025 Jul 30.
Derived from this study: PubMed 40737430Ramezani-Rad P, Cottrell CA, Marina-Zarate E, Liguori A, Landais E, Torres JL, Myers A, Lee JH, Baboo S, Flynn C, McKenney K, Salcedo E, Zhou X, Kalyuzhniy O, Georgeson E, Phelps N, Lu D, Eskandarzadeh S, Menis S, Kubitz M, Groschel B, Alavi N, Jackson AM, Lee WH, Tran AS, Ben-Akiva E, Kaczmarek Michaels K, Diedrich JK, Enemuo CA, Lewis V, Pradhan A, Kasturi SP, Schiffner T, Steichen JM, Carnathan DG, Himansu S, Yates JR 3rd, Paulson JC, Ozorowski G, Irvine DJ, Silvestri G, Sok D, Ward AB, Crotty S, Schief WR. Vaccination with an mRNA-encoded membrane-bound HIV envelope trimer induces neutralizing antibodies in animal models. Sci Transl Med. 2025 Jul 30;17(809):eadw0721. doi: 10.1126/scitranslmed.adw0721. Epub 2025 Jul 30.
Derived from this study: PubMed 40294415Riddler SA, Moodie Z, Clark J, Yen C, Allen M, Furch BD, Lu H, Grant S, Mondal K, Anderson M, Maenza J, Lemos MP, Woodward Davis AS, Walsh SR, Sobieszczyk ME, Frank I, Goepfert P, Stephenson KE, Baden LR, Tieu HV, Keefer MC, McElrath MJ, Kublin JG, Corey L. High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302). Ann Intern Med. 2025 Jul;178(7):963-974. doi: 10.7326/ANNALS-24-02701. Epub 2025 Apr 29.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jesse Clark, MD study chair

University of California, Los Angeles

Sharon Riddler, MD study chair

University of Pittsburgh

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness (time frame: Measured through 7 days after each vaccine dose). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05217641, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.