Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170469
Status:
COMPLETED
Last Update Posted:
2008-09-15
First Post:
2005-09-09
Brief Title:
Safety Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed
Sponsor:
PharmAthene UK Limited
Organization:
PharmAthene UK Limited
Study Overview
Official Title:
A Phase II Dose Ranging Multi-Centre Single Blind Parallel-Group Controlled Study of the Safety Tolerability and Immunogenicity of Recombinant rPA Based Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed in a Healthy Population
Status:
COMPLETED
Status Verified Date:
2008-09
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:
This is a dose ranging study comparing different vaccine schedules of rPA vaccine for Anthrax to the licensed dose of AVA another Anthrax vaccine Safety and the capability to induce an immune response will be evaluated
Detailed Description:
Anthrax is a zoonotic disease occurring in wild and domestic mammals caused by the spore-forming bacterium Bacillus anthracis B anthracis Anthrax occurs in humans when they are exposed to infected animals tissue from infected animals or when they are directly exposed to B anthracis or its spores Depending on the route of infection anthrax disease can occur in three forms cutaneous gastrointestinal and inhalation In the United States of America USA the annual incidence of human anthrax has declined from approximately 130 cases annually in the early 1900s to no cases during 1999 to 2000 However in the USA shortly after September 11th 2001 there were 22 cases 18 confirmed of inhaled and cutaneous anthrax infection that were related to contaminated mail The development of a new anthrax vaccine is necessary because the current AVA vaccine requires the growth of B anthracis in its manufacturing process and has a complex administration regimen of six administrators of vaccine in 18 months As protective antigen PA is a central virulence factor in anthrax pathogenesis and a major immunogen in the current vaccine a recombinant acellular protective antigen-based anthrax vaccine could offer an improved manufacturing process and a simpler dosing schedule Furthermore the vaccine could offer improved protection against inhaled B anthracis and could when used in conjunction with antibiotics form part of the management of anthrax exposed individuals This is a dose ranging study comparing different primary vaccine schedules of rPA Anthrax vaccine to the licensed dose of Anthrax Vaccine Adsorbed The study is designed to measure the immune response and to evaluate the safety and tolerability of different doses of rPA Anthrax Vaccine After subjects have given informed consent they will undergo physical exams medical history screening pregnancy tests ECG HIV Hepatitis B C tests safety blood tests and urine drug and alcohol screen Subjects will be asked to complete a diary card to record any symptoms they may experience The subjects that receive AVA will be offered the opportunity to complete the licensed course of vaccination which would involve AVA vaccinations at 6 12 and 18 months
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 |
|---|---|---|---|
| PA-8645-02 | None | None | None |