Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15.

Key facts

Study ID

NCT00528489

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

120

Starts

2007-10-01

Expected to finish

2010-01-01

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-1 and -2 uninfected
• Willing to receive HIV test results
• Good general health
• Certain laboratory values within normal range or with site physician approval
• Negative for Hepatitis B surface antigen
• Negative Hepatitis C test
• Willing to use acceptable methods of contraception

You may not qualify if…

• HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
• Immunosuppressive medications within 168 days prior to first study vaccination. Participants using corticosteroid nasal spray for allergies or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
• Blood products within 120 days prior to first study vaccination
• Receipt of immunoglobulin within 60 days prior to first vaccination
• Live attenuated vaccines within 30 days prior to first study vaccination
• Any vaccine that is not a live attenuated vaccine within 14 days prior to first study vaccination
• Investigational research agents within 60 days prior to first study vaccination
• Current anti-tuberculosis (TB) preventive therapy or treatment clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
• Any medical, psychiatric, social, occupational, or other condition or responsibility that in the opinion of the investigator would interfere with the study. More information about this criterion can be found in the protocol.
• Allergy to amide-type local anesthetics
• Serious adverse reactions to vaccines
• Autoimmune disease or immunodeficiency
• Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
• Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
• Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
• Thyroidectomy or thyroid disease requiring medication during the 12 months prior to study entry
• Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry if episodes are considered serious or have required medication in the 2 years prior to study entry
• Uncontrolled hypertension
• Body Mass Index of 40 or greater OR of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol
• Bleeding disorder
• Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
• Seizure disorder
• Absence of the spleen
• Pregnancy or breastfeeding

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• San Francisco Vaccine and Prevention CRS — San Francisco, California, United States
• 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
• NY Blood Ctr./Bronx CRS — The Bronx, New York, United States
• 3535 Market Street CRS — Philadelphia, Pennsylvania, United States
• Vanderbilt Vaccine CRS — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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