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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00045838 |
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 60 years of age may be eligible for this study. Candidates will provide a medical history, including information on sexual behaviors and drug use. They will have a 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 control substance made up of an inactive salt solution) 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 2 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. At each visit, participants will be checked for health changes or problems and will be asked about medications they are taking. Blood will be drawn for immune system testing. Additional laboratory tests may be requested between visits. Participants will be tested several times for HIV, will be questioned about their sexual behavior and drug use, and about social effects they may have experienced from their participation in the study.
Some of the blood drawn for this study will be used to test for HLA type-a genetic test of immune system markers. For research, HLA testing is sometimes used to try to identify factors associated with the progression of HIV disease or related conditions.
Condition | Intervention | Phase |
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Healthy |
Drug: VCR-HIVDNA006-00-VP |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA006-00-VP, In Uninfected Adult Volunteers |
Estimated Enrollment: | 50 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | April 2003 |
This is a Phase I, randomized, controlled, double-blinded, dose-escalation study to examine tolerability, dose, and immune response of an HIV DNA plasmid vaccine. The hypothesis is that this vaccine will be safe for human administration and elicit immune responses to HIV. The primary objective is to evaluate the safety and tolerability in humans of VCR-HIVDNA006-00-VP and secondary objectives are to evaluate the immuogenicity of the vaccine and social impact of participating in an HIV-1 vaccine trial. A Data and Safety Monitoring Board (DSMB) will review protocol results twice prior to dose escalation to the 8 mg dose level.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
A participant must meet all of the following criteria:
Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
Laboratory Criteria within 28 days prior to enrollment:
Negative anti-HCV or negative HCV PCR if the anti-HCV is positive
Female-Specific Criteria:
No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation.,
Or
Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and throughout the duration of the study,
Or
Participant agrees to consistently practice contraception at least 21 days prior to enrollment and throughout the duration of the study by one of the following methods:
condoms, male or female, with or without a spermicide
diaphragm or cervical cap with spermicide
intrauterine device
contraceptive pills, Norplant, or Depo-Provera
male partner has previously undergone a vasectomy for which there is documentation.
EXCLUSION CRITERIA:
A volunteer will be excluded if one or more of the following is true.
Women:
Woman who is breast-feeding.
Volunteer has received any of the following substances:
Current anti-TB prophylaxis or therapy
Volunteer has a history of any of the following clinically significant conditions:
Study ID Numbers: | 020279, 02-I-0279 |
Study First Received: | September 10, 2002 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00045838 History of Changes |
Health Authority: | United States: Federal Government |
Healthy HIV-Negative Placebo Controlled Volunteer Dose-Escalation |
Healthy Volunteers HV HIV Seronegativity HIV Preventive Vaccine |
HIV Infections Acquired Immunodeficiency Syndrome Healthy |