Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01266616
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2010-12-23
Brief Title:
Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 IL-12 in HIV-1 Infected 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 Randomized Partially Double-Blind Placebo-Controlled Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a Cytokine Enhanced HIV-1 Multi-Antigen HIV MAG pDNA Vaccine Delivered Intramuscularly Followed by in Vivo Electroporation IMEP or Intramuscularly in HIV-1 Infected Adults Receiving ART
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:
Therapeutic HIV vaccines are designed to control HIV infection by boosting the bodys natural immune response There are currently no FDA-approved therapeutic HIV vaccines This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 IL-12 is safe and effective This study will also test a new way of giving the vaccine called electroporation EP
Detailed Description:
Although highly active antiretroviral therapy HAART has greatly reduced HIV infection-related morbidity and mortality individual response to therapy can be variable Therapeutic vaccination works by augmenting virus-specific immunity and can be given with or without immunomodulatory agents or adjuvants In conjunction with HAART therapeutic vaccination may be a more effective treatment for the suppression of HIV-1 replication This study will examine the safety and efficacy of giving an investigational vaccine with or without IL-12 in HIV-1 infected adults receiving HAART This study will also test whether delivering the vaccine using EP is safe and increases the efficacy of the vaccine
Participation in this study will last approximately 36 weeks Participants will be randomly assigned to one of five cohorts Cohort 1 will receive the HIV multi-antigen plasmid DNA HIV MAG pDNA vaccine or placebo intramuscularly IM in the upper arm followed by EP Cohorts 2 through 4 will receive the HIV MAG pDNA vaccine and sequentially increasing doses of GENEVAX IL-12 pDNA or placebo by IMEP Cohort 5 will receive the HIV MAG pDNA vaccine with the highest dose of IL-12 pDNA or placebo by needle and syringe in the upper arm
Participants receive two injections at Weeks 0 4 and 12 Participants will complete a questionnaire that assesses the acceptability of the vaccine and remain at the clinic 30 minutes for observation after each vaccination Participants will be contacted by telephone 2 to 3 days post-vaccination to assess vaccination-related signs andor symptoms All participants will be asked to record their temperatures and any symptoms they experience daily for 4 days following each vaccination on a Vaccination Report Card VRC All nonstudy vaccines or medications should also be recorded on the VRC Study visits will occur at Weeks 0 1 2 4 5 6 8 12 13 14 16 24 and 36 At most visits participants will undergo a physical examination Women of reproductive potential will also undergo pregnancy testing before receiving injections on Weeks 0 4 and 12 Blood will be drawn at various time points to evaluate participants health and measure immunologic markers CD4 and CD8 T-cell counts and cytokine levels Blood and plasma will also be stored for future exploratory studies
Participation in this study will last approximately 36 weeks Participants will be randomly assigned to one of five cohorts Cohort 1 will receive the HIV multi-antigen plasmid DNA HIV MAG pDNA vaccine or placebo intramuscularly IM in the upper arm followed by EP Cohorts 2 through 4 will receive the HIV MAG pDNA vaccine and sequentially increasing doses of GENEVAX IL-12 pDNA or placebo by IMEP Cohort 5 will receive the HIV MAG pDNA vaccine with the highest dose of IL-12 pDNA or placebo by needle and syringe in the upper arm
Participants receive two injections at Weeks 0 4 and 12 Participants will complete a questionnaire that assesses the acceptability of the vaccine and remain at the clinic 30 minutes for observation after each vaccination Participants will be contacted by telephone 2 to 3 days post-vaccination to assess vaccination-related signs andor symptoms All participants will be asked to record their temperatures and any symptoms they experience daily for 4 days following each vaccination on a Vaccination Report Card VRC All nonstudy vaccines or medications should also be recorded on the VRC Study visits will occur at Weeks 0 1 2 4 5 6 8 12 13 14 16 24 and 36 At most visits participants will undergo a physical examination Women of reproductive potential will also undergo pregnancy testing before receiving injections on Weeks 0 4 and 12 Blood will be drawn at various time points to evaluate participants health and measure immunologic markers CD4 and CD8 T-cell counts and cytokine levels Blood and plasma will also be stored for future exploratory studies
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 |
|---|---|---|---|
| 10846 | REGISTRY | DAIDS ES Registry Number | None |