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A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults

2014-08-27 03:55:21 | BioPortfolio

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.

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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Anthrax

Intervention

Vaccine

Location

Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr
Rockville
Maryland
United States
20850

Status

Completed

Source

DynPort Vaccine Company LLC, A CSC Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:21-0400

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Medical and Biotech [MESH] Definitions

An acute infection caused by the spore-forming bacteria BACILLUS ANTHRACIS. It commonly affects hoofed animals such as sheep and goats. Infection in humans often involves the skin (cutaneous anthrax), the lungs (inhalation anthrax), or the gastrointestinal tract. Anthrax is not contagious and can be treated with antibiotics.

ANTHRAX outbreak that occurred in 1979 and was associated with a research facility in Sverdlovsk, in the Ural mountain region of central RUSSIA. Most victims worked or lived in a narrow zone extending from the facility. The zone of anthrax-caused livestock mortality paralleled the northerly wind that prevailed shortly before the outbreak. It was concluded that an escape of ANTHRAX caused outbreak.

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

Vaccines or candidate vaccines used to prevent ANTHRAX.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

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