NCT00100724

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

January 12, 2006

Status Verified

January 1, 2006

First QC Date

January 5, 2005

Last Update Submit

January 10, 2006

Conditions

Anthrax

Keywords

AnthraxrPA102vaccine

Outcome Measures

Primary Outcomes (1)

  • Safety and immune response to vaccine.

Interventions

rPA102BIOLOGICAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.
  • Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.
  • Received or plans to receive licensed live vaccines within 30 days of study vaccination.
  • Received or plans to receive licensed killed vaccines within 14 days of study vaccination.
  • Received or plans to receive immunoglobulin or other blood products within 60 days of study vaccination.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

UCLA Ctr for Vaccine Research, LA Biomedical Research Institute

Torrance, California, 90502, United States

Location

Emory Children's Clinic, Pediatric Infectious Disease

Atlanta, Georgia, 30322, United States

Location

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536-0093, United States

Location

Johns Hopkins University, Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

St. Louis University, SoLUtions

St Louis, Missouri, 63104, United States

Location

Infectious Disease Unit, University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

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

Columbus, Ohio, 43205, United States

Location

Primary Physicians Research, Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Vermont College of Medicine, Vermont Vaccine Evaluation Center

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 5, 2005

First Posted

January 6, 2005

Study Start

April 1, 2004

Study Completion

July 1, 2005

Last Updated

January 12, 2006

Record last verified: 2006-01

Locations

US(12)