Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384787
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2006-10-04
Brief Title:
Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given Three Different Ways to 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 Ib Clinical Trial to Compare the Safety Tolerability and Immunogenicity of an HIV-1 Adenoviral Vector Boost Administered Intramuscularly Intradermally or Subcutaneously After an HIV-1 DNA Plasmid Vaccine Prime Administered Intramuscularly to Healthy Adenovirus Type 5 Seropositive HIV-1-Uninfected Adults
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 immune response to and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine The adenoviral vaccine will be given into arm muscle intramuscularly between skin layers intradermally or under the skin subcutaneously
NOTE In October 2007 vaccinations with the adenoviral vaccine VRC-HIVADV014-00-VP were discontinued In December 2007 vaccinations with the DNA vaccine were also discontinued Participants will be followed for safety and immune responses at regular study visits
NOTE In October 2007 vaccinations with the adenoviral vaccine VRC-HIVADV014-00-VP were discontinued In December 2007 vaccinations with the DNA vaccine were also discontinued Participants will be followed for safety and immune responses at regular study visits
Detailed Description:
One factor that may affect safety and immunogenicity to an HIV vaccine is the route of vaccine administration Administration into the skin intradermal or subcutaneous tissue may be more immunogenic or provide a different pattern of immune responses than administration by the intramuscular route Previous studies with other preventive vaccines suggest that the resulting immunogenicity following intradermal or subcutaneous vaccine administration is comparable or better than immunogenicity observed following intramuscular administration Increased immunogenicity though use of a particular route will likely result in greater demonstrated efficacy requiring fewer or lower doses of vaccine to elicit a sufficient immune response
The DNA HIV vaccine VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials in one trial the DNA vaccine demonstrated a nearly 100 CD4 T-cell response rate The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity when given intramuscularly and has appeared safe and well tolerated in prior vaccine trials in HIV uninfected adults The DNA plasmids in both vaccines code for proteins from HIV subtypes A B and C This study will evaluate the safety immunogenicity and tolerability to a DNA HIV vaccine followed by an adenoviral vaccine boost given either intramuscularly intradermally or subcutaneously in HIV uninfected adults
All participants will receive three doses of the DNA vaccine intramuscularly at study entry and Months 1 and 2 Participants will be randomly assigned to one of three groups differing by how they will receive the adenoviral vaccine boost
Group 1 participants will receive the vaccine boost intramuscularly at Month 6
Group 2 participants will receive the vaccine boost intradermally at Month 6
Group 3 participants will receive the vaccine boost subcutaneously at Month 6
This study will last 1 year There will be 12 study visits a physical exam medication history and risk reductionpregnancy prevention compliance counseling will occur at all visits Urine and blood collection will occur at selected visits Participants will be asked to complete a social impact assessment at Months 2 6 and 12 and an outside testing and belief questionnaire at Months 6 and 12 Participants will be asked to record their temperature and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects
NOTE In October 2007 vaccinations with the adenoviral vaccine VRC-HIVADV014-00-VP were discontinued In December 2007 vaccinations with the DNA vaccine were also discontinued Participants will be followed for safety and immune responses at regular study visits and will be asked to continue in long term follow-up for purposes of safety surveillance to a total of 5 years following initial vaccination
The DNA HIV vaccine VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials in one trial the DNA vaccine demonstrated a nearly 100 CD4 T-cell response rate The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity when given intramuscularly and has appeared safe and well tolerated in prior vaccine trials in HIV uninfected adults The DNA plasmids in both vaccines code for proteins from HIV subtypes A B and C This study will evaluate the safety immunogenicity and tolerability to a DNA HIV vaccine followed by an adenoviral vaccine boost given either intramuscularly intradermally or subcutaneously in HIV uninfected adults
All participants will receive three doses of the DNA vaccine intramuscularly at study entry and Months 1 and 2 Participants will be randomly assigned to one of three groups differing by how they will receive the adenoviral vaccine boost
Group 1 participants will receive the vaccine boost intramuscularly at Month 6
Group 2 participants will receive the vaccine boost intradermally at Month 6
Group 3 participants will receive the vaccine boost subcutaneously at Month 6
This study will last 1 year There will be 12 study visits a physical exam medication history and risk reductionpregnancy prevention compliance counseling will occur at all visits Urine and blood collection will occur at selected visits Participants will be asked to complete a social impact assessment at Months 2 6 and 12 and an outside testing and belief questionnaire at Months 6 and 12 Participants will be asked to record their temperature and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects
NOTE In October 2007 vaccinations with the adenoviral vaccine VRC-HIVADV014-00-VP were discontinued In December 2007 vaccinations with the DNA vaccine were also discontinued Participants will be followed for safety and immune responses at regular study visits and will be asked to continue in long term follow-up for purposes of safety surveillance to a total of 5 years following initial vaccination
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 |
|---|---|---|---|
| 10391 | REGISTRY | DAIDS ES Registry Number | None |