Status:
COMPLETED
Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Human Immunodeficiency Virus Prevention
Human Immunodeficiency Virus (HIV)
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 calle...
Detailed Description
Design: This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-HIVRGP096-00-VP (Trimer 4571) with aluminum hydroxide suspension (al...
Eligibility Criteria
Inclusion
- 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 the study subject including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, psychiatric disorders, heart disease, or cancer.
Exclusion
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03783130
Start Date
March 7 2019
End Date
June 24 2020
Last Update
August 12 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892