Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133484
Status:
TERMINATED
Last Update Posted:
2010-08-27
First Post:
2005-08-19
Brief Title:
UMD rPA Regimen Trial in 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 II Study to Assess the Safety Tolerability Immunogenicity and Optimal Primary Schedule of 3 Recombinant Protective Antigen rPA Anthrax Vaccines Administered in Two Intramuscular Doses to Healthy Adults
Status:
TERMINATED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives are To confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines 3 products administered by the intramuscular IM route to healthy adultsTo describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the responses to those following administration of Anthrax Vaccine Adsorbed AVA or BioThraxTM the currently available vaccine The primary immunologic outcome is the proportion of volunteers in each group that mounts an antibody response defined as a 4-fold or greater increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal concentration of 10 µgml as measured by ELISA Secondary outcomes are time to peak response and GMC of anti-PA antibody at peak for each group In addition the following immunologic assays will be performed toxin neutralization assay oral fluid ELISA antibody avidity IgG subclasses and B-cell memoryT-cell memory and effector subpopulations
Detailed Description:
Anthrax CVD 3000 A Phase II Study to Assess the Safety Tolerability Immunogenicity and Optimal Primary Schedule of 3 Recombinant Protective Antigen rPA Anthrax Vaccines Administered in Two Intramuscular Doses to Healthy Adults aged 18 to 50 years The targeted number of subjects is 270The study objectives areTo confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines 3 products administered by the intramuscular IM route to healthy adultsTo describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the responses to those following administration of Anthrax Vaccine Adsorbed AVA or BioThraxTM the currently available vaccine The primary immunologic outcome is the proportion of volunteers in each group that mounts an antibody response defined as a 4-fold or greater increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal concentration of 10 µgml as measured by ELISA Secondary outcomes are time to peak response and GMC of anti-PA antibody at peak for each group In addition the following immunologic assays will be performed toxin neutralization assay oral fluid ELISA antibody avidity IgG subclasses and B-cell memoryT-cell memory and effector subpopulationsThis is a two center study in which 270 healthy adults aged 18 to 50 years are randomly assigned to 1 of 9 groups knowledge of rPA product received is double-masked but schedule and receipt of AVA are unmasked The duration of study participation is 12 months per volunteer following a screening period of no more than 30 days administration over a 1- to 4-week period of two doses of IM rPA or 3 doses of SQ AVA with 12-14 follow-up visits A subset of the approximately 45 volunteers who have agreed to participate in the special immunology subgroup those with continued antibody responses at 1 year will be offered extended participation beyond 1 year in which blood is drawn at 18 months 2 years 3 years and 4 years for examination of long-term 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 |
|---|---|---|---|
| Anthrax CVD 3000 | None | None | None |