Safety of and Immune Response to an HIV Preventive Vaccine (HIV-1 Gag DNA Alone or With IL-15 DNA) Given With or Without 2 Different Booster Vaccinations in HIV Uninfected Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2 other adjuvant-containing booster vaccines.

Key facts

Study ID

NCT00115960

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

120

Expected to finish

2008-07-01

Last updated by the study team

2021-10-14

Who can join

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

You may qualify if…

• HIV uninfected
• Access to a participating HIV Vaccine Trials Unit (HVTU)
• Willing to receive HIV test results
• Willing and able to comply with all study requirements
• In good general health
• Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit. More information about this criterion can be found in the protocol.
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive

You may not qualify if…

• HIV vaccines in prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to first vaccination
• Blood products within 120 days prior to first vaccination
• Immunoglobulin within 60 days prior to first vaccination
• Live attenuated vaccines within 30 days prior to first vaccination
• Investigational research agents within 30 days prior to first vaccination
• Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration, or allergy treatment with antigen injections within 30 days prior to first vaccination
• Current tuberculosis (TB) prophylaxis or therapy
• Clinically significant medical condition, physical exam findings, abnormal laboratory results, or past medical history with clinically significant implications for current health
• Any medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with the study
• Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
• Diagnosis of allergy to amide-type local anesthetics
• Serious adverse reaction to vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
• Autoimmune disease or immunodeficiency
• Unstable asthma
• Diabetes mellitus Type 1 or Type 2. Participants with histories of isolated gestational diabetes are not excluded.
• Thyroid disease requiring treatment in the past 12 months
• Serious angioedema within the last 3 years
• Uncontrolled hypertension
• Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, when certain other criteria are met. More information about these criteria can be found in the protocol.
• Bleeding disorder
• Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded.
• Seizure disorder requiring medication within the past 3 years
• Absence of the spleen
• Psychiatric condition, including psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years

Where it is running

• Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
• NY Blood Ctr./Union Square CRS — New York, New York, United States
• HIV Prevention & Treatment CRS — New York, New York, United States
• Univ. of Rochester HVTN CRS — Rochester, New York, United States
• NY Blood Ctr./Bronx CRS — The Bronx, New York, United States
• Miriam Hospital's HVTU — Providence, Rhode Island, United States
• Sao Paulo HVTU - CRT DST/AIDS CRS — São Paulo, Brazil

Full record on ClinicalTrials.gov

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