Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009685
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-02-02
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:
Evaluation of an HIV-1 DNA Vaccine Encoding a Modified Gag-Pol Protein in Uninfected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2005-03
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 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 bodys 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
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 bodys 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
Detailed Description:
This is a Phase I randomized controlled double-blinded dose escalation study to examine toxicity dose and immune response of an HIV plasmid DNA vaccine The vector used in this study has been optimized for improved safety expression and immunogenicity We hypothesize that this vaccine will elicit immune responses to HIV All work will be conducted at the National Institutes of Health
Healthy HIV-negative volunteers will be recruited and pre-screened to confirm that they meet all of the eligibility requirements for participation Educational materials on DNA vaccines will be reviewed with and provided to participants before enrollment into the study There will be 3 groups of 7 volunteers Each group will receive a constant dose of the vaccine pGagdel fsPol delta PR delta RT delta INh 5 people or a phosphate buffered saline PBS control 2 people by intramuscular inoculation Once safety has been established successive groups will receive a higher dose Study groups will receive three immunizations containing either 05 mg Group 1 15 mg Group 2 or 40 mg Group 3 of a DNA vaccine Dose escalation will be initiated 5 weeks after the last volunteer in the previous dose group receives their first inoculation providing there are no significant toxicities
Vaccine-related adverse reactions will be evaluated at scheduled study visits and by study participant report Immune response will be evaluated as described in Appendix II Specimens to evaluate immunogenicity will be taken at baseline and at the time points indicated in Appendix VIII Unless contraindicated subsequent inoculations using repeat plasmid vaccinations will be given 28 and 56 days after the first vaccinations The estimated duration for each volunteer to complete immunizations and follow-up is 12 months
Healthy HIV-negative volunteers will be recruited and pre-screened to confirm that they meet all of the eligibility requirements for participation Educational materials on DNA vaccines will be reviewed with and provided to participants before enrollment into the study There will be 3 groups of 7 volunteers Each group will receive a constant dose of the vaccine pGagdel fsPol delta PR delta RT delta INh 5 people or a phosphate buffered saline PBS control 2 people by intramuscular inoculation Once safety has been established successive groups will receive a higher dose Study groups will receive three immunizations containing either 05 mg Group 1 15 mg Group 2 or 40 mg Group 3 of a DNA vaccine Dose escalation will be initiated 5 weeks after the last volunteer in the previous dose group receives their first inoculation providing there are no significant toxicities
Vaccine-related adverse reactions will be evaluated at scheduled study visits and by study participant report Immune response will be evaluated as described in Appendix II Specimens to evaluate immunogenicity will be taken at baseline and at the time points indicated in Appendix VIII Unless contraindicated subsequent inoculations using repeat plasmid vaccinations will be given 28 and 56 days after the first vaccinations The estimated duration for each volunteer to complete immunizations and follow-up is 12 months
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 |
|---|---|---|---|
| 01-I-0079 | None | None | None |