Phase 1 N=16 Randomized Prevention

Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults

Human Immunodeficiency Virus Prevention · Human Immunodeficiency Virus (HIV)

Bottom Line

View on ClinicalTrials.gov: NCT03783130 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration — 1; 1; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: VRC-HIVRGP096-00-VP (Biological); Alum Adjuvant (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration	1; 1; 0; 0; 2; 2	—
PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration	3; 2; 3; 3; 11; 0	—
PRIMARY Number of Participants With Abnormal Laboratory Measures of Safety	1; 0; 0; 0; 1; 0	—
PRIMARY Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)	0; 2; 3; 2; 7; 1	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs)	0; 0; 0; 0; 0	—
SECONDARY Antibody Response to Adjuvanted Trimer 4571 at 2 Weeks After the Final Study Product Administration	81; 53; 62; 50; 674; 924	—

Summary

Background: HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection. Researchers want to test a vaccine called Trimer 4571 for the first time. It was made at the National Institutes of Health (NIH) and contains no HIV. The vaccine is mixed with a substance called alum and injected in the arm. Alum is included to boost the body's immune response to the vaccine. It has been used in licensed vaccines for over 60 years and has been found to be safe. Objectives: To see if the vaccine Trimer 4571 is safe, well-tolerated, and to study immune responses to it. Eligibility: Healthy adults ages 18-50 years Design: Participants were screened with a physical exam and blood tests. They agreed to not become pregnant and to avoid behavior that would put them at high-risk for HIV infection during the study. Participants had about 15 study visits over about 9 months. The first 6 participants received a low dose of the vaccine mixed with alum. Once the low dose was deemed safe, 10 new participants were allocated to receive a higher dose. All participants were randomly assigned to get the vaccine by injection in a muscle or under the skin. All participants received a total of 3 vaccine injections over 20 weeks. Each visit where participants received the vaccine lasted about 5 hours. Participants were watched after each injection. Participants who were able to get pregnant would have a pregnancy test before each injection. Participants received a thermometer and recorded their temperature and symptoms every day for 1 week after each injection. The injection site was checked for redness, swelling, or bruising. At follow-up visits, participants had blood drawn and checked for health changes or problems. Follow up visits lasted about 1-2 hours.

Eligibility Criteria

INCLUSION CRITERIA:

A participant must have met all of the following criteria:

Able and willing to complete the informed consent process.
18-50 years old, inclusive, on day of enrollment.
Available for clinic follow-up through the last study visit.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Willing to donate blood for sample storage to be used for future research.
In good general health without clinically significant medical history.
Physical examination and laboratory results without clinically significant findings.
Body Mass Index (BMI) less than or equal to 40.
Assessed as low risk for human immunodeficiency virus (HIV) acquisition by agreeing to discuss HIV infection risks, agreeing to risk reduction counseling, and agreeing to avoid behavior associated with high risk of HIV exposure through the end of study.
Screening laboratory values within 56 days prior to enrollment that met the following criteria:
Hemoglobin within the institutional normal limits
White blood cell (WBC) count between 2,500-12,000/mm^3
WBC differential absolute cell counts either within institutional normal range or accompanied by site Principal Investigator (PI) or Associate Investigator (AI) approval, except neutrophils and lymphocytes must specifically be within the range of greater than or equal to 0.75 x the lower limit of normal (LLN) and lees than or equal to 1.25 x the upper limit of normal (ULN) for neutrophil and lymphocyte absolute counts
Platelets = 125,000-500,000/m^3
Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN based on the institutional normal range
Serum creatinine less than or equal to 1.1 x ULN based on the institutional normal range
Negative for HIV infection by an FDA approved method of detection

Woman-specific (if presumed to be of childbearing potential):

Agrees to use effective means of birth control from at least 21 days prior to enrollment through the end of the study.
Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment.

EXCLUSION CRITERIA

A participant was excluded if one or more of the following conditions apply:

Woman-specific:

Breast-feeding or planning to become pregnant through the end of study.

Participant has received any of the following:

An investigational HIV vaccine.
Systemic glucocorticoid use equal or greater than prednisone 20mg/day within 4 weeks prior to enrollment, or other medication use likely to impair vaccine response.
Blood products within 16 weeks prior to enrollment.
Live attenuated vaccines within 4 weeks prior to enrollment.
Inactivated vaccines within 2 weeks prior to enrollment.
Investigational research agents within 4 weeks prior to enrollment.
Current allergen immunotherapy with antigen injections, unless on maintenance schedule.
Current anti-tuberculosis (TB) prophylaxis or therapy.

Participant had any of the following:

Serious reactions to vaccines that preclude receipt of study injections as determined by the principal investigator or designee.
Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
Hypertension that is not well controlled.
Evidence of significant autoimmune disease or immunodeficiency.
Idiopathic urticaria within the past year.
Bleeding disorder diagnosed by a doctor (e.g. 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.
Any other chronic or clinically significant condition that in the opinion of the investigator would jeopardize the safety or rights of th

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Data sourced from ClinicalTrials.gov (NCT03783130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.