Ignite Creation Date:
2024-05-06 @ 12:25 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01578889
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2012-04-13
Brief Title:
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy 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 1 Trial to Evaluate the Safety Tolerability and Immunogenicity of an IL-12 pDNA Enhanced HIV-1 Multiantigen pDNA Vaccine Delivered Intramuscularly With Electroporation With an HIV-1 rVSV Vaccine Boost 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:
Some vaccines may work better when given together with another substance known as an adjuvant or when given with an experimental procedure called electroporation EP EP is a method where an electric pulse is administered to the same muscle where the vaccine injection is given The addition of the adjuvant to the vaccine and the delivery with EP may increase a persons immune response to the vaccine Combination approaches such as a DNA vaccine followed by live vector boost may also increase a persons immune response to the vaccine components All of these interventions will be tested in this study
This study will evaluate the safety and tolerability of and immune response to an HIV DNA vaccine with or without plasmid IL-12 adjuvant when given by EP and followed by a live vector vaccine given IM by needle and syringe in healthy HIV-uninfected adults
This study will evaluate the safety and tolerability of and immune response to an HIV DNA vaccine with or without plasmid IL-12 adjuvant when given by EP and followed by a live vector vaccine given IM by needle and syringe in healthy HIV-uninfected adults
Detailed Description:
The effectiveness of a vaccine may be increased when combined with an adjuvant andor when given with EP The addition of an adjuvant or EP may increase a persons immune response to a vaccine Furthermore the immune response to HIV antigens may be improved by giving a DNA vaccine boosted with a live vector vaccine The purpose of this study is to evaluate the safety tolerability and immunogenicity of an HIV DNA vaccine HIV-MAG alone or in combination with an IL-12 pDNA adjuvant delivered IM via EP followed by a Vesicular Stomatitis Virus VSV HIV gag vaccine boost given IM by needle and syringe in healthy HIV-uninfected adults
Participants will be enrolled into the study in one of four groups Each of the four groups will receive 3 mg of the HIV-MAG vaccine alone or combined with one of three different doses of the IL-12 pDNA adjuvant followed by the VSV HIV gag vaccine boost Within each of the four groups participants will be randomly assigned to receive the study vaccines or placebo At study entry Day 0 all participants will undergo a physical examination and blood collection Female participants will also take a pregnancy test Participants will complete questionnaires and receive counseling on HIV risk reduction They will also receive their first vaccination Participants will remain in the clinic for 30 minutes after the vaccination for observation and monitoring
Additional vaccination study visits will occur at Months 1 3 and 6 At Months 1 and 3 participants will receive the same vaccine or placebo they received at study entry at Month 6 participants will receive the VSV HIV gag vaccine or placebo For 3 days after the study entry and Months 1 and 3 vaccination visits participants will record their symptoms in a diary After the Month 6 vaccination visit participants will record their symptoms for 7 days
Participants in Groups 1 and 3 will attend additional study visits on Days 1 3 14 42 91 98 169 171 175 182 273 and 364 Participants in Groups 2 and 4 will attend additional study visits on Days 14 42 98 182 273 and 364 Most study visits will include a physical examination blood collection oral mucosa examination interviews and questionnaires and oral mucosa examination If participant has any oral sores oral swabs may be collected Saliva also may be collected Select study visits will include a mini mental state exam urine collection HIV testing and risk reduction counseling Study researchers will contact participants at Months 15 24 and 36 for follow-up health monitoring
Participants will be enrolled into the study in one of four groups Each of the four groups will receive 3 mg of the HIV-MAG vaccine alone or combined with one of three different doses of the IL-12 pDNA adjuvant followed by the VSV HIV gag vaccine boost Within each of the four groups participants will be randomly assigned to receive the study vaccines or placebo At study entry Day 0 all participants will undergo a physical examination and blood collection Female participants will also take a pregnancy test Participants will complete questionnaires and receive counseling on HIV risk reduction They will also receive their first vaccination Participants will remain in the clinic for 30 minutes after the vaccination for observation and monitoring
Additional vaccination study visits will occur at Months 1 3 and 6 At Months 1 and 3 participants will receive the same vaccine or placebo they received at study entry at Month 6 participants will receive the VSV HIV gag vaccine or placebo For 3 days after the study entry and Months 1 and 3 vaccination visits participants will record their symptoms in a diary After the Month 6 vaccination visit participants will record their symptoms for 7 days
Participants in Groups 1 and 3 will attend additional study visits on Days 1 3 14 42 91 98 169 171 175 182 273 and 364 Participants in Groups 2 and 4 will attend additional study visits on Days 14 42 98 182 273 and 364 Most study visits will include a physical examination blood collection oral mucosa examination interviews and questionnaires and oral mucosa examination If participant has any oral sores oral swabs may be collected Saliva also may be collected Select study visits will include a mini mental state exam urine collection HIV testing and risk reduction counseling Study researchers will contact participants at Months 15 24 and 36 for follow-up health monitoring
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 |
|---|---|---|---|
| 11673 | REGISTRY | DAIDS ES Registry Number | None |