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Trial of rPA-102 Vaccine in Healthy Adult Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Trial of rPA-102 Vaccine in Healthy Adult Volunteers

A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers

NCT00100724•VaxGen

Summary

The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Able to understand the study and give written informed consent. A signed informed consent must be in place before the initiation of any study interventions.
•Healthy male or female aged 18-55 years old (inclusive) without significant physical or clinical laboratory abnormalities.
•Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.
•For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 2 months of the study.
•Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.
•Willingness to complete the Volunteer Diary and to report concomitant medications and adverse events (AEs) to the study site monitors during the study period.

Exclusion Criteria

•Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
•Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
•Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis, or emergency first responders.
•Expected to be noncompliant with study visits or planning to move within 12 months.
•Body mass index of \>35 or \<19.
•Known allergy to aluminum hydroxide, kanamycin, or any other aminoglycoside antibiotics (such as gentamicin).
•Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.
•HIV positive (by history or screening ELISA).
•Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).
•Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.
+10 more criteria

Locations (12)

UCLA Ctr for Vaccine Research, LA Biomedical Research Institute

Torrance, California, United States

Emory Children's Clinic, Pediatric Infectious Disease

Atlanta, Georgia, United States

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Johns Hopkins University, Bloomberg School of Public Health

Baltimore, Maryland, United States

Mayo Clinic College of Medicine

Rochester, Minnesota, United States

St. Louis University, SoLUtions

St Louis, Missouri, United States

Infectious Disease Unit, University of Rochester Medical Center

Rochester, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Pediatric Clinical Trials Int'l, Inc. (PCTI)

Columbus, Ohio, United States

Primary Physicians Research, Inc.

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

April 1, 2004

Completion Date

July 1, 2005

Last Updated

January 12, 2006

Enrollment

480

Estimated participants

Conditions

Anthrax

Interventions

rPA102

BIOLOGICAL

Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

NCT00050310

AnthraxBacillus Infections

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NOT_YET_RECRUITING

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

NCT03569514

Anthrax

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of rPA-102 Vaccine in Healthy Adult Volunteers

Inclusion Criteria

Exclusion Criteria

Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.

Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System

An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis

Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers