Candidate HIV Vaccine

Completed · Phase 1

Conditions studied: HIV Infections

In brief

This study will evaluate whether an experimental vaccine intended to prevent HIV infection is safe and whether it causes any side effects. It will also examine whether the vaccine, called VRC-HIVDNA016-00-VP, causes an immune response, and will monitor participants for the social impact of being in an HIV vaccine study. VRC-HIVDNA016-00-VP contains synthetic DNA that codes for parts of four HIV proteins. It also contains a "promoter" piece of DNA that is needed to start protein production. The promoter DNA is also synthetic and is like the promoter in another virus called cytomegalovirus (CMV). The vaccine contains no live HIV virus or CMV and cannot cause either of these illnesses. Healthy volunteers between 18 and 44 years old who are HIV-negative may be eligible for this 32-week study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants receive three injections of the experimental vaccine approximately 28 days apart. The injections are given with a system called the Biojector 2000 that delivers the vaccine through the skin into the muscle without the use of a needle. Subjects are observed for side effects for at least 30 minutes after each vaccination and are required to telephone the clinic staff 1 to 2 days after the injection to report how they are doing. In addition, they are given a diary card to take home, on which they record their temperature and any symptoms daily for five days. Participants return to the clinic two weeks after each injection. They return the completed diary card and are checked for any health changes or problems since the last visit. They are asked how they are feeling and what medications, if any, they have taken. Blood and urine samples are collected. Some subjects may be asked to have laboratory tests between regular visits if needed to evaluate a change in health. Participants are also asked about any social effects they may have experienced as a result of their participation in the study.

Key facts

Study ID

NCT00089531

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

15

Starts

2004-08-02

Expected to finish

2008-01-15

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 44. Sex: any. Healthy volunteers: 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 32 weeks of study participation.
• Volunteer has received any of the following substances:
• HIV vaccines in a prior clinical trial;
• Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis);
• Blood products within 120 days prior to HIV screening;
• Immunoglobulin within 60 days prior to HIV screening;
• Investigational research agents within 30 days prior to initial study vaccine administration;
• Live attenuated vaccines within 30 days 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 of study vaccine administration;
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, 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.
• History of thyroidectomy or thyroid disease that required medication within the past 12 months.
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
• Hypertension that is not well controlled by medication or is more than 150/100 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.
• Syphilis infection that is active or a positive serology due to a syphilis infection treated less than six months ago.
• Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
• Seizure disorder other than:
• febrile seizures under the age of two,

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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