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

Completed · Phase 1

Conditions studied: Human Immunodeficiency Virus Prevention, Human Immunodeficiency Virus (HIV)

In brief

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.

Key facts

Study ID

NCT03783130

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

16

Starts

2019-03-07

Expected to finish

2020-06-24

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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