HIVPhase 1NCT05470400

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

A Phase 1 study testing FP conjugate vaccine (25 mcg), FP conjugate vaccine (200 mcg) and Trimer 6931 (100 mcg) in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: FP conjugate vaccine (25 mcg), FP conjugate vaccine (200 mcg) and Trimer 6931 (100 mcg)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 6 sitesUnited States
Study dates: 15 Aug 2022to 24 Jan 2024
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 50 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 (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.

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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.

Who cannot join

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

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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.
Autoimmune disease, current or history, including psoriasis.
Clinically significant immunodeficiency.
AESIs: Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the product(s) administered in this protocol.
History of generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger.).
Diabetes mellitus type 1 or type 2.
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
Asplenia or functional asplenia.
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study).
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).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Atlanta - Hope Clinic
Atlanta, Georgia, 30308
BIDMC Vcrs [32077]
Boston, Massachusetts, 02115
New York Blood Center CRS [31801]
New York, New York, 10065
Columbia P&S CRS [30329]
New York, New York, 30329
University of Pittsburgh CRS [1001]
Pittsburgh, Pennsylvania, 15213
University of Rochester Vaccines to Prevent HIV Infection CRS [31467]
Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine (VRC-HIVVCP0108-00-VP) Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 (VRC-HIVRGP096-00-VP) and HIV-1 Trimer 6931 (VRC-HIVRGP0106-00-VP) Vaccines in Healthy Adults

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.

Read the detailed description

This study has two parts. Part A will evaluate the safety, tolerability, and immunogenicity of single doses of the FP conjugate, Trimer 4571 and Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Part B. Trimer 4571 with alum adjuvant has been previously evaluated in humans but will be tested in Part A with Adjuplex. Part B will evaluate the safety, tolerability, and immunogenicity of FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, or Trimer 6931, or both alone and then both Trimers combined.

Total study duration is 36 months (includes enrollment, planned safety holds and follow-up).

Conditions: HIV
Being tested: FP conjugate vaccine (25 mcg), FP conjugate vaccine (200 mcg), Trimer 6931 (100 mcg), Trimer 6931 (200 mcg), Trimer 4571 (200 mcg)
Keywords: HIV, Vaccine, FP conjugate, Trimer 4571, Trimer 6931, Adjuplex, Dose escalation

What participants receive

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

FP conjugate vaccine (25 mcg)Biological
Also called FP8v1-rTTHC
FP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker.
Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
FP conjugate vaccine (200 mcg)Biological
Also called FP8v1-rTTHC
FP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker.
Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
Trimer 6931 (100 mcg)Biological
Also called HIV-1 Trimer 6931
HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC).
Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
Trimer 6931 (200 mcg)Biological
Also called HIV-1 Trimer 6931
HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC).
Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
Trimer 4571 (200 mcg)Biological
Also called HIV-1 Trimer 4571
HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505.
Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
Trimer 4571 (100 mcg)Biological
Also called HIV-1 Trimer 4571
HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505.
Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.

Study groups in NCT05470400
Study group	Role	What they receive
Dose Escalation - Group 1	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen. Receives: Biological: FP conjugate vaccine (25 mcg)
Dose Escalation - Group 2	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen. Receives: Biological: FP conjugate vaccine (200 mcg)
Dose Escalation - Group 3	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen. Receives: Biological: Trimer 6931 (100 mcg)
Dose Escalation - Group 4	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen. Receives: Biological: Trimer 6931 (200 mcg)
Dose Escalation - Group 5	Experimental	Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen. Receives: Biological: Trimer 4571 (200 mcg)
Prime Boost Regimen - Group 6	Experimental	Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined. Receives: Biological: Trimer 6931 (100 mcg); Biological: Trimer 6931 (200 mcg); Biological: Trimer 4571 (200 mcg); Biological: Trimer 4571 (100 mcg)
Prime Boost Regimen - Group 7	Experimental	Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined. Receives: Biological: FP conjugate vaccine (200 mcg); Biological: Trimer 6931 (100 mcg); Biological: Trimer 6931 (200 mcg); Biological: Trimer 4571 (200 mcg); Biological: Trimer 4571 (100 mcg)
Prime Boost Regimen - Group 8	Experimental	Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined. Receives: Biological: FP conjugate vaccine (200 mcg); Biological: Trimer 6931 (100 mcg); Biological: Trimer 6931 (200 mcg); Biological: Trimer 4571 (200 mcg); Biological: Trimer 4571 (100 mcg)

What is being measured

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

Number of Participants Reporting Local Reactogenicity 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 (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Local Reactogenicity 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 (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second 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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise a
Measured: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point.
Measured: T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252
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: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants With Early Study Termination 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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. Group 5 and Group 6 were combined in the summary of IgG response rate.
Measured: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. The Unit of Measure is expressed as Mean Electrochemiluminescence Signal*1/dilution to reflect the AUC of responses across serial dilutions. Group 5 and Group 6 were combined in the summary of IgG magnitudes.
Measured: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.

Timeline

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

15 Aug 202224 Jan 2024

First posted22 Jul 2022
Study start15 Aug 2022
Primary completion24 Jan 2024
Study completion24 Jan 2024

Why it stopped: The HVTN 303 IND was placed on clinical hold, and recruitment did not resume.

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.
Other trials for HIVStudies 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: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05470400
Sponsor's protocol ID: HVTN 303
Status last verified: Feb 2025
First submitted: 29 Jun 2022
Last updated: 23 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine (VRC-HIVVCP0108-00-VP) Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 (VRC-HIVRGP096-00-VP) and HIV-1 Trimer 6931 (VRC-HIVRGP0106-00-VP) Vaccines in Healthy Adults
ClinicalTrials.gov ID: NCT05470400
Acronym / sponsor ID: HVTN 303
Conditions: HIV
Keywords: HIV, Vaccine, FP conjugate, Trimer 4571, Trimer 6931, Adjuplex, Dose escalation
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The HVTN 303 IND was placed on clinical hold, and recruitment did not resume.
Enrolment: 44 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: 15 Aug 2022 (actual)
Primary completion: 24 Jan 2024 (actual)
Study completion: 24 Jan 2024 (actual)
First posted: 22 Jul 2022 (actual)
Results: Posted 21 Mar 2025

Clinical summary

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

Detailed description

Total study duration is 36 months (includes enrollment, planned safety holds and follow-up).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Dose Escalation - Group 1	Experimental	Biological: FP conjugate vaccine (25 mcg)Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Dose Escalation - Group 2	Experimental	Biological: FP conjugate vaccine (200 mcg)Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Dose Escalation - Group 3	Experimental	Biological: Trimer 6931 (100 mcg)Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Dose Escalation - Group 4	Experimental	Biological: Trimer 6931 (200 mcg)Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Dose Escalation - Group 5	Experimental	Biological: Trimer 4571 (200 mcg)Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Prime Boost Regimen - Group 6	Experimental	Biological: Trimer 6931 (100 mcg), Biological: Trimer 6931 (200 mcg), Biological: Trimer 4571 (200 mcg), Biological: Trimer 4571 (100 mcg)Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined.
Prime Boost Regimen - Group 7	Experimental	Biological: FP conjugate vaccine (200 mcg), Biological: Trimer 6931 (100 mcg), Biological: Trimer 6931 (200 mcg), Biological: Trimer 4571 (200 mcg), Biological: Trimer 4571 (100 mcg)Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined.
Prime Boost Regimen - Group 8	Experimental	Biological: FP conjugate vaccine (200 mcg), Biological: Trimer 6931 (100 mcg), Biological: Trimer 6931 (200 mcg), Biological: Trimer 4571 (200 mcg), Biological: Trimer 4571 (100 mcg)Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (24 listed)

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.

Key exclusion criteria (35 listed)

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

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
FP conjugate vaccine (25 mcg)Also: FP8v1-rTTHCFP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.	Biological	Dose Escalation - Group 1
FP conjugate vaccine (200 mcg)Also: FP8v1-rTTHCFP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.	Biological	Dose Escalation - Group 2, Prime Boost Regimen - Group 7, Prime Boost Regimen - Group 8
Trimer 6931 (100 mcg)Also: HIV-1 Trimer 6931HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC). Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.	Biological	Dose Escalation - Group 3, Prime Boost Regimen - Group 6, Prime Boost Regimen - Group 7, Prime Boost Regimen - Group 8
Trimer 6931 (200 mcg)Also: HIV-1 Trimer 6931HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC). Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.	Biological	Dose Escalation - Group 4, Prime Boost Regimen - Group 6, Prime Boost Regimen - Group 7, Prime Boost Regimen - Group 8
Trimer 4571 (200 mcg)Also: HIV-1 Trimer 4571HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.	Biological	Dose Escalation - Group 5, Prime Boost Regimen - Group 6, Prime Boost Regimen - Group 7, Prime Boost Regimen - Group 8
Trimer 4571 (100 mcg)Also: HIV-1 Trimer 4571HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.	Biological	Prime Boost Regimen - Group 6, Prime Boost Regimen - Group 7, Prime Boost Regimen - Group 8

Primary outcome

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Time frame: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second 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 Reactogenicity Signs and Symptoms: Erythema and/or Induration
Time frame: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second 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 (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second 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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise a
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Time frame: T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point.
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Time frame: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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 Study Product Discontinuation Associated With an AE or Reactogenicity
Time frame: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
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)
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Time frame: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. Group 5 and Group 6 were combined in the summary of IgG response rate.
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Time frame: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. The Unit of Measure is expressed as Mean Electrochemiluminescence Signal*1/dilution to reflect the AUC of responses across serial dilutions. Group 5 and Group 6 were combined in the summary of IgG magnitudes.

Results and safety

Results posted to the registry on 21 Mar 2025, 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: 25 mcg FP Conjugate Vaccine at w(0)	3	2
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	3	3
Part A, Group 3: 100 mcg Trimer 6931 at w(0)	3	3
Part A, Group 4: 200 mcg Trimer 6931 at w(0)	3	3
Part A Group 5: 200 mcg Trimer 4571 at w(0)	3	3
Part B, Group 6: 200 mcg Trimer 4571 at w(0)	10	9
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)	10	10
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)	9	6

Primary outcome: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Time frame: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).. Count of participants. Unit: Participants

Measure	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) n = 3	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) n = 3	Part A, Group 3: 100 mcg Trimer 6931 at w(0) n = 3	Part A, Group 4: 200 mcg Trimer 6931 at w(0) n = 3	Part A Group 5: 200 mcg Trimer 4571 at w(0) n = 3	Part B, Group 6: 200 mcg Trimer 4571 at w(0) n = 10	Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) n = 10	Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) n = 9
None	0	0	0	0	0	0	0	0
Mild	2	2	1	3	2	7	5	4
Moderate	1	1	2	0	1	3	5	4
Severe	0	0	0	0	0	0	0	1
Potentially Life-threatening	0	0	0	0	0	0	0	0

Primary outcome: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Measure	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) n = 3	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) n = 3	Part A, Group 3: 100 mcg Trimer 6931 at w(0) n = 3	Part A, Group 4: 200 mcg Trimer 6931 at w(0) n = 3	Part A Group 5: 200 mcg Trimer 4571 at w(0) n = 3	Part B, Group 6: 200 mcg Trimer 4571 at w(0) n = 10	Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) n = 10	Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) n = 9
Erythema/Redness: None	3	3	3	3	2	9	7	7
Erythema/Redness: Mild	0	0	0	0	0	1	0	0
Erythema/Redness: Moderate	0	0	0	0	0	0	1	1
Erythema/Redness: Severe	0	0	0	0	1	0	2	1
Erythema/Redness: Potentially Life-threatening	0	0	0	0	0	0	0	0
Induration/Swelling: None	3	3	3	3	3	10	10	6
Induration/Swelling: Mild	0	0	0	0	0	0	0	2
Induration/Swelling: Moderate	0	0	0	0	0	0

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

Measure	Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) n = 3	Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) n = 3	Part A, Group 3: 100 mcg Trimer 6931 at w(0) n = 3	Part A, Group 4: 200 mcg Trimer 6931 at w(0) n = 3	Part A Group 5: 200 mcg Trimer 4571 at w(0) n = 3	Part B, Group 6: 200 mcg Trimer 4571 at w(0) n = 10	Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) n = 10	Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) n = 9
Malaise and/or fatigue: None	0	0	1	2	1	0	0	0
Malaise and/or fatigue: Mild	3	2	2	1	1	7	4	1
Malaise and/or fatigue: Moderate	0	1	0	0	1	3	5	6
Malaise and/or fatigue: Severe	0	0	0	0	0	0	1	2
Malaise and/or fatigue: Potentially Life-threatening	0	0	0	0	0	0	0	0
Myalgia: None	2	1	2	2	0	3	2	2
Myalgia: Mild	1	1	1	1	2	4	5	2
Myalgia: Moderate	0	1	0	0	1	3	2	4

Primary outcome: Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.

Time frame: T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252. Count of participants. Unit: Participants

Measure	Part A, Group 3: 100 mcg Trimer 6931 at w(0) n = 3	Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) n = 10	Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) n = 9
ALT (U/L) -Screening	0	0	0
ALT (U/L) -Day 0	0	0	0
ALT (U/L) -Day 7	0	0	0
ALT (U/L) -Day 14	0	1	0
ALT (U/L) -Day 28	1	0	0
ALT (U/L) -Day 35	0	0	0
ALT (U/L) -Day 42	0	0	1
ALT (U/L) -Day 56	0

Adverse events

Time frame: SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A, Group 3: 100 mcg Trimer 6931 at w(0)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A, Group 4: 200 mcg Trimer 6931 at w(0)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A Group 5: 200 mcg Trimer 4571 at w(0)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part B, Group 6: 200 mcg Trimer 4571 at w(0)	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)	0 of 9 (0%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Troy Martin study chair

HVTN LOC, Fred Hutch

Michael Keefer, M.D. study chair

Univ. of Rochester Med. Ctr., HVTU

6 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 24 inclusion and 35 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: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 21 Mar 2025). 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 Reactogenicity Signs and Symptoms: Pain and/or Tenderness (time frame: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).). The study lists 13 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 NCT05470400.

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 23 Apr 2026.