Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063843
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2003-07-07
Brief Title:
Anthrax-rPA Safety Tolerability Immunogenicity
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 Dose-Escalating Study to Assess the Safety Tolerability and Immunogenicity of Recombinant Anthrax Protective Antigen Vaccine rPA Administered in Two Intramuscular Doses to Healthy Adults
Status:
COMPLETED
Status Verified Date:
2006-05
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:
The primary objective is to determine the tolerability and safety from days 0 to 210 of escalating doses of rPA either with or without Alhydrogel an adjuvant used to increase the action of the principle drug given in a two-dose intramuscular regimen to health adults The secondary objective is to evaluate antibody responses to rPA from days 0 to 210 following one of four escalating doses of vaccine given with and without Alhydrogel given in a two-dose series to healthy adults and to compare immune responses following rPA with those following BioThrax tm given by either the intramuscular or SQ route The tertiary objective is to describe the antibody kinetics following vaccination This information will be used to determine the most probable optimal dose of rPA andor Alhydrogel that is safe well tolerated and maximally immunogenic for use in future phase II trials
Detailed Description:
This Phase I Dose-Escalating clinical study is designed to examine the immunologic response to rPA in the presence and absence of Alhydrogel at the 2 lowest dose levels The study will investigate whether use of an aluminum-based adjuvant results in an increase in the magnitude or the duration of the antibody response thus providing information on the necessity of aluminum-based adjuvants in formulations used in the phase II clinical trials The rationale for the use of BioThrax by two administration routes in this trial is to allow for preliminary comparisons of the immune response following the currently available vaccine to the response following the new recombinant product Approximately 80 outpatient community volunteers from the Baltimore-Washington area aged 18-40 years will be recruited on the basis of good health expressed interest in the study and availability for follow-up as determined at a preliminary interview Each eligible subject will be enrolled in 1 of 4 study groups each with three arms for 7 months The subjects randomly assigned and double-masked to Arms A and B will have a 30 day screening period in which they will receive two doses of IM rPA or IM rPAAlhydrogel or IM BioThrax one month apart with follow up days on 1 2 7 14 28 29 30 35 42 120 and 210 The subjects randomly assigned but unmasked to arms 1-C or 2-C will receive 3 doses of SQ BioThrax at 14 day intervals with follow up on days 1 2 7 14 15 16 21 28 29 30 35 42 120 and 210 The information gathered from the study objectives will be used to determine the most probable optimal doses of rPA - Alhydrogel that are safe well tolerated and maximally immunogenic for use in future phase II trials
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 1000 | None | None | None |