Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111605
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2005-05-23
Brief Title:
Study of an HIV Preventive Vaccine Given With or Without an Adjuvant 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 an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant Boosted With Homologous Plasmids 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 evaluate the safety and tolerability of an experimental HIV vaccine The vaccine will be given with or without IL-12 DNA adjuvant at three escalating doses of 100 500 and 1500 mcg respectively a substance that helps the body respond to a vaccine This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants
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 study will determine the safety and immunogenicity of an experimental HIV vaccine HIV-1 gag DNA given with or without an IL-12 adjuvant and boosted HIV-1 gag DNA with or without IL-12 DNA adjuvant
This study will comprise two parts Parts A and B Part A will last 9 months and Part B 15 months Part A will consist of 48 participants enrolled in 4 groups Group 1 participants will be randomly assigned to receive the gag DNA vaccine or placebo Participants in Groups 2 3 and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg 500 mcg or 1500 mcg IL-12 DNA or placebo Vaccinations for Groups 1 through 4 will be given intramuscularly and will occur at study entry and at Months 1 and 3
Part B will consist of 96 participants enrolled in 3 groups Participants in Part B will receive their first vaccination 2 weeks after Part A participants receive their second vaccination Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1 3 6 and 9 Group 7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study entry and at Months 1 and 3 Throughout the study blood and urine collections will occur physical exams will be conducted HIV testing and counseling will be offered and interviews and questionnaires will be completed
This study will comprise two parts Parts A and B Part A will last 9 months and Part B 15 months Part A will consist of 48 participants enrolled in 4 groups Group 1 participants will be randomly assigned to receive the gag DNA vaccine or placebo Participants in Groups 2 3 and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg 500 mcg or 1500 mcg IL-12 DNA or placebo Vaccinations for Groups 1 through 4 will be given intramuscularly and will occur at study entry and at Months 1 and 3
Part B will consist of 96 participants enrolled in 3 groups Participants in Part B will receive their first vaccination 2 weeks after Part A participants receive their second vaccination Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1 3 6 and 9 Group 7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study entry and at Months 1 and 3 Throughout the study blood and urine collections will occur physical exams will be conducted HIV testing and counseling will be offered and interviews and questionnaires will be completed
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 |
|---|---|---|---|
| 10057 | REGISTRY | DAIDS ES | None |