Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-07 @ 9:57 AM
Study NCT ID:
NCT02431767
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2015-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Immunogenicity of PENNVAX®-GP DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-Uninfected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX®-GP (Gag, Pol, Env) DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-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 study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
Detailed Description:
The purpose of this study is to evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and IL-12 DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults. All study injections will be given using an EP device, which uses an electric pulse to briefly open tiny pores in the cells. Researchers will evaluate whether EP increases the immune response to the vaccine.
The study will enroll participants in four groups. Within each group, participants will be randomly assigned to receive the PENNVAX®-GP DNA vaccine/IL-12 DNA adjuvant or placebo. Each group will receive different doses of the vaccine. Enrollment will begin with Group 1, which will receive a low dose of the vaccine and adjuvant. Study staff will review safety data from Group 1 before enrolling people in Groups 2, 3, and 4 at higher doses. Participants in all groups will receive injections at study entry (Day 0) and Months 1, 3, and 6. At each injection visit, participants in Groups 1 and 4 will receive injections in one arm, and participants in Groups 2 and 3 will receive injections in both arms. Groups 1, 2, and 3 will receive ID injections, and Group 4 will receive IM injections.
Participants will attend study visits at Day 0, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. Visits will include physical examinations, urine collection, blood collection, HIV and risk reduction counseling, and assessments and questionnaires. Some participants may have photographs taken of the injection site (this is optional). Study staff will contact participants at Month 18 for follow-up health monitoring.
The study will enroll participants in four groups. Within each group, participants will be randomly assigned to receive the PENNVAX®-GP DNA vaccine/IL-12 DNA adjuvant or placebo. Each group will receive different doses of the vaccine. Enrollment will begin with Group 1, which will receive a low dose of the vaccine and adjuvant. Study staff will review safety data from Group 1 before enrolling people in Groups 2, 3, and 4 at higher doses. Participants in all groups will receive injections at study entry (Day 0) and Months 1, 3, and 6. At each injection visit, participants in Groups 1 and 4 will receive injections in one arm, and participants in Groups 2 and 3 will receive injections in both arms. Groups 1, 2, and 3 will receive ID injections, and Group 4 will receive IM injections.
Participants will attend study visits at Day 0, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. Visits will include physical examinations, urine collection, blood collection, HIV and risk reduction counseling, and assessments and questionnaires. Some participants may have photographs taken of the injection site (this is optional). Study staff will contact participants at Month 18 for follow-up health monitoring.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11890 | REGISTRY | DAIDS-ES | View |