Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115960
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2005-06-26
Brief Title:
Safety of and Immune Response to an HIV Preventive Vaccine HIV-1 Gag DNA Alone or With IL-15 DNA Given With or Without 2 Different Booster Vaccinations in HIV Uninfected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Gag DNA Vaccine Alone or With IL-15 DNA Boosted With HIV-1 Gag DNA IL-15 DNA or HIV-1 Gag DNA IL-12 DNA in Healthy HIV-1 Uninfected Adult Participants
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine HIV-1 gag DNA with and without an IL-15 DNA adjuvant at escalating doses of 100 500 and 1500 mcg This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2 other adjuvant-containing booster vaccines
Detailed Description:
The HIV epidemic is a major global health challenge causing tremendous human suffering and economic loss throughout the world The need for a safe effective and affordable HIV preventive vaccine is critical This 2-part study will determine the safety and immunogenicity of the experimental HIV vaccine HIV-1 gag DNA with or without IL-15 adjuvant boosted with either the HIV-1 gag DNA and IL-15 adjuvant vaccine or the HIV-1 gag DNA and IL-12 adjuvant vaccine
There are two parts to this study Part A will last 12 months In Part A 48 participants will be randomly assigned to 1 of 4 groups in sequential order dose escalation All participants will receive 3 vaccinations Group 1 will receive 3 vaccinations of the HIV-1 gag DNA vaccine or placebo Group 2 will receive 3 vaccinations of either the HIV-1 gag DNA vaccine with a low dose of IL-15 adjuvant or a placebo Group 3 will receive 3 vaccinations of either the HIV-1 gag vaccine with a medium dose of IL-15 adjuvant or a placebo Group 4 will receive 3 vaccinations of either the HIV-1 gag vaccine with a high dose of IL-15 adjuvant or a placebo Vaccinations will be given at Months 0 1 and 3 There will be 11 study visits in Part A A physical exam pregnancy prevention counseling medication history and adverse event reporting will occur at most visits Urine and blood collection will occur at some visits Participants will also be asked to complete questionnaires at certain visits
Part B will last 15 months In Part B 72 participants will be randomly assigned to 1 of 2 groups All Part B participants will receive 5 vaccinations Group 5 will receive 5 vaccinations of either the HIV-1 gag vaccine plus IL-15 DNA or placebo the vaccinations will occur at Months 0 1 3 6 and 9 Group 7 will receive 3 vaccinations of the HIV-1 gag vaccine with a high dose of IL-15 adjuvant maximum tolerated dose from Part A followed by 2 vaccinations of the gag DNA vaccine with IL-12 DNA adjuvant Some participants will receive placebo instead of this vaccine regimen For Group 7 the HIV-1 gag vaccine with IL-15 adjuvant vaccinations will be given at Months 0 1 and 3 and booster vaccinations will be given at Months 6 and 9 There will be 13 study visits in Part B A physical exam pregnancy prevention counseling medication history and adverse event reporting will occur at most visits Urine and blood collection will occur at some visits Participants will also be asked to complete questionnaires at certain visits
There are two parts to this study Part A will last 12 months In Part A 48 participants will be randomly assigned to 1 of 4 groups in sequential order dose escalation All participants will receive 3 vaccinations Group 1 will receive 3 vaccinations of the HIV-1 gag DNA vaccine or placebo Group 2 will receive 3 vaccinations of either the HIV-1 gag DNA vaccine with a low dose of IL-15 adjuvant or a placebo Group 3 will receive 3 vaccinations of either the HIV-1 gag vaccine with a medium dose of IL-15 adjuvant or a placebo Group 4 will receive 3 vaccinations of either the HIV-1 gag vaccine with a high dose of IL-15 adjuvant or a placebo Vaccinations will be given at Months 0 1 and 3 There will be 11 study visits in Part A A physical exam pregnancy prevention counseling medication history and adverse event reporting will occur at most visits Urine and blood collection will occur at some visits Participants will also be asked to complete questionnaires at certain visits
Part B will last 15 months In Part B 72 participants will be randomly assigned to 1 of 2 groups All Part B participants will receive 5 vaccinations Group 5 will receive 5 vaccinations of either the HIV-1 gag vaccine plus IL-15 DNA or placebo the vaccinations will occur at Months 0 1 3 6 and 9 Group 7 will receive 3 vaccinations of the HIV-1 gag vaccine with a high dose of IL-15 adjuvant maximum tolerated dose from Part A followed by 2 vaccinations of the gag DNA vaccine with IL-12 DNA adjuvant Some participants will receive placebo instead of this vaccine regimen For Group 7 the HIV-1 gag vaccine with IL-15 adjuvant vaccinations will be given at Months 0 1 and 3 and booster vaccinations will be given at Months 6 and 9 There will be 13 study visits in Part B A physical exam pregnancy prevention counseling medication history and adverse event reporting will occur at most visits Urine and blood collection will occur at some visits Participants will also be asked to complete questionnaires at certain visits
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 |
|---|---|---|---|
| 10058 | REGISTRY | DAIDS ES | None |