A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
- Conditions
- Anthrax
- Interventions
- Biological: AnthraxBiological: Alhdryogel or PBS
- Registration Number
- NCT00057525
- Lead Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
- Brief Summary
This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.
- Detailed Description
This is a safety study with an open-label part (2 groups), followed by a dose-ranging part evaluating safety and immunogenicity using a double-blind, sequential-group design with randomization and placebo-control within each of the 6 groups. Volunteers in each dose group will receive two IM injections at Day 0 and Month 1
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anthrax vaccine with or without PBS Anthrax Administor 1 dose 5 μg rPA with PBS (5 Volunteers) Placebo Alhdryogel or PBS Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combinedwith phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr
🇺🇸Rockville, Maryland, United States