Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089531
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-08-05
Brief Title:
Candidate HIV Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-01-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 1667 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 mgmL 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
Product Description VRC-HIVDNA016-00-VP is composed of 6 closed circular DNA plasmids that are each 1667 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 mgmL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-I-0254 | None | None | None |