Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047931
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-10-22
Brief Title:
HIV-1 Vaccine Test in Uninfected Adult Volunteers
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 Multiclade HIV-1 DNA Plasmid Vaccine VRC-HIVDNA009-00-VP in Uninfected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2009-05-05
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 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 eg 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
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 eg 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
Detailed Description:
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 VRC-HIVDNA009-00-VP and secondary objectives are to evaluate the immunogenicity of the vaccine and social impact of participating in an HIV-1 vaccine trial
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 |
|---|---|---|---|
| 03-I-0022 | None | None | None |