HIV-1 Vaccine Test in Uninfected Adult Volunteers

Completed · Phase 1

Conditions studied: HIV Seronegativity, AIDS Vaccines

In brief

This study will test the safety of an experimental vaccine against HIV and examine whether it induces an immune response to HIV. A vaccine is a substance given to try to create resistance or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. This study will see if the body then creates an immune response to these proteins. Study participants cannot catch HIV or AIDS from the DNA vaccine or any proteins made from it. Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination and blood and urine tests. Women will also have a pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth control for at least 21 days before beginning the study and throughout its duration. Participants will be randomly assigned to receive either the experimental vaccine or a placebo (a salt solution that does not contain any active substance) and will be divided into three groups, based on their entry into the study. Of the first seven people enrolled (Group 1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an 8-mg dose of vaccine and six will receive placebo. All participants will receive three injections in an upper arm muscle-one injection a month for three months-with a needle-less device called a Biojector 2000® (Registered Trademark). At the time of each injection, participants will be observed for at least 1 hour after immunization. At home, they will record their temperature and any symptoms they may experience, including any effects at the injection site, for at least 7 days, or as long as the symptoms remain. If symptoms occur, participants will report them immediately to the clinic staff and, if necessary, come to the clinic for an examination. Participants will have about 10 clinic visits during the study. Most visits will last about 2 hours; those on vaccination days will last about 4 hours. ...

Key facts

Study ID: NCT00047931
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 50
Starts: 2002-10-17
Expected to finish: 2009-05-05
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older, up to 40. 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:
Woman who is breast-feeding.
Volunteer has received any of the following substances:
HIV vaccines in a prior clinical trial.
Immunosuppressive or cytotoxic medications 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.
Live attenuated vaccines within 30 days prior to initial study vaccine administration.
Investigational research agents 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.
Thyroid disease including history of thyroidectomy and diagnoses that required medication within the past 12 months.
Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 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: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring prolonged treatment more than 3 years ago.
Asplenia or any condition resulting in the absence or removal of the spleen.
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment.

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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