NIH Clinical Research Studies

Protocol Number: 01-I-0079

Active Followup, Protocols NOT Recruiting New Patients

Title:
Evaluation of an HIV-1 DNA Vaccine Encoding a Modified Gag-Pol Protein in Uninfected Adult Volunteers
Number:
01-I-0079
Summary:
This study will test the safety of an experimental vaccine against HIV and will examine whether it causes an immune response to HIV virus proteins. A vaccine is 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 two HIV proteins called "gag" and "pol." 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 proteins that may be 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 activity and drug use. They will have a physical examination, blood tests, urine test and chest X-ray. All candidates enrolled in the study must use a barrier method of contraception for sexual intercourse from the start of the study until 3 months after the last vaccination.

Participants will be assigned to one of two treatment groups: one will receive the experimental vaccine; the other will receive a control substance (inactive salt solution). The first five people assigned to the vaccine group will receive the lowest study dose of the vaccine. If this dose is safe, it will be increased three times for the next group of five and then eight times for the last group of five. Each group will have a total of seven people - five will receive the vaccine and two will get the salt solution.

Before the first injection, and possibly the second and third, a catheter (thin plastic tube) will be placed into a vein so that treatment can be given quickly if there is a reaction to the vaccine. 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. For each injection, the volunteer will

- be observed for at least 1 hour after immunization

- record temperature and symptoms, including any effects at the injection site, for 2 days and report them to the clinic staff

- immediately report any side effects to a study physician or nurse.

Volunteers will have physical examinations and laboratory tests at certain times while they receive the vaccine and for a period afterwards. These procedures will require about 14 clinic visits of about 1 to 2 hours each, and up to 6 hours on vaccination days. Blood will be drawn at all visits. Some of the blood will be used for genetic tests, and some will be stored for future tests of the immune system and the body's response to the study vaccine. The study will last about 12 months from the date of the first injection. After it is completed, clinic staff may contact volunteers once or twice a year for at least 3 years to follow up.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Follow-up Of Previously Enrolled Subjects Only
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions: Currently Not Provided
Disease Category:
PROTICD
Keywords:
Vaccine
HIV
Codon-Optimized
HIV Vaccine
Recruitment Keywords:
Healthy Volunteer
HIV-1 DNA Vaccine
HIV Seronegativity
HIV Preventive Vaccine
Conditions:
Healthy
HIV Seronegativity
Investigational Drug(s):
VRC4302
Investigational Device(s):
None

Contacts:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:
Gene vaccination: plasmid DNA is more than just a blueprint

Priming of cytotoxic T lymphocytes by DNA vaccines: requirement for professional antigen presenting cells andevidence for antigen transfer from myocytes

Generation of MHC class I-restricted cytotoxic T lymphocytes by expression of a viral protein in muscle cells: antigen presentation by non-muscle cells

Active Followup, Protocols NOT Recruiting New Patients

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