Candidate HIV Vaccine
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a 6-Plasmid Multiclade HIV-1 DNA Vaccine, VRC-HIVDNA016-00-VP, in Uninfected Adult Volunteers|
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||January 2008|
Study Design: This is a Phase I open label study to evaluate safety, tolerability, and immune response of a 6-plasmid multiclade HIV-1 DNA vaccine, VRC-HIVDNA016-00-VP. The hypothesis is that this regimen will be safe for human administration and elicit immune responses to HIV-1 clade B Gag, Pol and Nef proteins, as well as clades A, B and C Env proteins. The primary objective is to evaluate the safety and tolerability in humans of the investigational vaccine and secondary objectives are to evaluate the immunogenicity of the vaccine as measured by intracellular cytokine staining (ICS) in the 4 weeks after the second or third dose of vaccine and the social impact of participating in an HIV-1 vaccine trial.
Product Description: VRC-HIVDNA016-00-VP is composed of 6 closed, circular DNA plasmids that are each 16.67 percent (by weight) of the vaccine. Each of the 6 plasmids in this vaccine expresses a single gene product. Plasmids VRC 4401, VRC 4409 and VRC 4404 are designed to express clade B HIV-1 Gag, Pol and Nef, respectively. VRC 5736, VRC 5737, and VRC 5738 are designed to express HIV-1 Env glycoprotein from clade A, clade B, and clade C, respectively. Vaccine vials will be supplied at 4 mg/mL. Each DNA vaccination will be 1 mL of vaccine administered intramuscularly (in deltoid muscle) using the Biojector 2000 Needle-Free Injection Management System.
Subjects: Healthy adult volunteers (18 to 44 years old) will be enrolled.
Study Plan: Fifteen volunteers will be enrolled, as shown in the schema:
Name of Vaccine: VRC-HIVDNA016-00-VP
Number of Subjects: 15
Vaccine Injection Schedule: (at least 21 days between injections)
Day 0: 4 mg
Day 28 plus or minus 7: 4 mg
Day 56 plus or minus 7: 4 mg
Study Duration: 32 weeks clinical follow-up for each participant.
Study Endpoints: The primary endpoint is safety of the regimen; secondary endpoints are
cellular immune responses as measured by ICS within the first 4 weeks after the second and
third doses and social impact at Week 32. Exploratory analyses will include HIV-specific
antibody assays, ICS or other immunological assays at intervals between Day 0 and Week 32.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|