Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027261
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2001-11-29
Brief Title:
Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine 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 I Trial to Evaluate the Safety Tolerability and Immunogenicity of High-Dose Live Recombinant Canarypox ALVAC-HIV Vaccine vCP1452 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 see if the experimental vaccine ALVAC-HIV vCP1452 is safe and to study how the immune system responds to the vaccine This trial is designed to determine whether a higher vaccine dose 6 times the usual dose will elicit a higher immune response
As of May 2001 over 200 people received the ALVAC-HIV vCP1452 vaccine at the lower dose The higher dose of the vaccine to be used in this study has not been given to humans previously High doses of a similar vaccine have been given to a few people without serious side effects In a recent study done in mice higher doses of ALVAC-HIV produced stronger immune responses It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain the HVTN will use the highest dose that can be manufactured
As of May 2001 over 200 people received the ALVAC-HIV vCP1452 vaccine at the lower dose The higher dose of the vaccine to be used in this study has not been given to humans previously High doses of a similar vaccine have been given to a few people without serious side effects In a recent study done in mice higher doses of ALVAC-HIV produced stronger immune responses It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain the HVTN will use the highest dose that can be manufactured
Detailed Description:
To date adverse reactions to immunization with the various ALVAC-HIV candidate vaccines including ALVAC-HIV vCP1452 have been similar to those observed in healthy adults who have received other licensed vaccines of similar types In a previous trial even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors the data demonstrated more robust immune responses with higher doses of ALVAC-HIV vCP1452 in mice It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte CTL response As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection the HVTN will utilize the highest dose that can be currently manufactured
All study products are to be administered intramuscularly Participants will receive 1 of 3 injections Group A will receive a high dose of vaccine group B will receive a low dose of vaccine and group C will receive a placebo Participants are inoculated at 4 time points Assessment of product safety includes clinical observation monitoring of hematological chemical and immunologic parameters and a social harms questionnaire Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses
All study products are to be administered intramuscularly Participants will receive 1 of 3 injections Group A will receive a high dose of vaccine group B will receive a low dose of vaccine and group C will receive a placebo Participants are inoculated at 4 time points Assessment of product safety includes clinical observation monitoring of hematological chemical and immunologic parameters and a social harms questionnaire Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses
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 |
|---|---|---|---|
| 10200 | REGISTRY | DAIDS ES Registry Number | None |