Phase I Study of HIV Adenoviral Vector Vaccine in Healthy Subjects Using Needle or Biojector Injection

Completed · Phase 1

Conditions studied: HIV Infections

In brief

This study will compare the immune response and side effects of an experimental HIV vaccine given by two different methods of administration by needle injection or by use of a needle-free device called the Biojector 2000 (Registered Trademark). The vaccine, called VRC-HIVADV014-00-VP, or rAd5, is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins. It cannot cause HIV or adenoviral infections. Healthy volunteers who are not infected with the HIV virus may be eligible for this study. Subjects are recruited for two study groups: Group 1 comprises volunteers who are 18 to 50 years old and have never received an HIV vaccine and Group 2 comprises volunteers who are 18 to 55 years old and participated in a prior study in which they received at least one injection of the study rAd5 vaccine. Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector 2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days after the injection, record their temperature and symptoms on a diary card at home for 5 days after the injection for later review, and visit the clinic two weeks after the injection for a checkup. The injection is given on the day of enrollment. Additional visits are scheduled at weeks 2, 4, 12 and 24, when subjects are checked for health changes or problems, their use of medications and how they are feeling. Blood samples are collected at all clinic visits. Subjects are tested for HIV at the beginning and end of the study, are asked about their sexual behavior and drug use, and are counseled about HIV risk reduction. Women are tested for pregnancy at the beginning and end of the study. Participants in Group 2 may undergo apheresis at the 4-week visit. This procedure is done to collect white blood cells for tests to examine the immune response to the vaccine. Blood is collected through a needle in the vein of one arm and directed through a machine that separates the cell components. The white cells are removed and the rest of the blood is returned through the same needle. Subjects are asked about any social effects they may have experienced from participating in the study. These effects are monitored to make sure participants receive any needed assistance and to learn ways to prevent these problems in the future.

Key facts

Study ID

NCT00709605

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

31

Starts

2008-06-25

Expected to finish

2014-05-20

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply:
• Women:
• Woman who is breast-feeding or planning to become pregnant during the 24 weeks of study participation.
• Volunteer has received any of the following substances:
• Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months.
• [Note: The following will NOT exclude study participation:
• use of corticosteroid nasal spray for rhinitis;
• topical corticosteroids for an acute uncomplicated dermatitis;
• short-acting beta-agonists in controlled asthmatics; a short course (10 days or less) of corticosteroids for a non-chronic condition completed at least 2 weeks prior to enrollment in this study]
• Blood products within 112 days (16 weeks) prior to HIV screening.
• Immunoglobulin within 56 days (8 weeks) prior to HIV screening.
• Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration.
• Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) prior to study vaccine administration.
• Current anti-tuberculosis prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• Thyroid disease that is not well-controlled
• A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• Generalized idiopathic urticaria within the last 1 years.
• Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.
• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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