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

Anthrax Clinical Trial

Official title:

A Phase 1 Study of Safety and Immunogenicity of E. Coli-Derived Recombinant Protective Antigen (rPA), a New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057525
• Other study ID #: rPA-EC-02
• Secondary ID: Anthrax
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2003
• Last updated: June 29, 2011
• Start date: April 2003
• Est. completion date: August 2004

Study information

• Verified date: June 2011
• Source: DynPort Vaccine Company LLC, A CSC Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Volunteers are eligible for this study if they meet all the following criteria:

• Citizens of the U.S.

• Age 18 to 40 years.

• For women, a negative serum pregnancy test will be required at study entry and within 24 hours prior to each vaccination, as well as verbal assurance that adequate birth control measures are applied prior to initial vaccination and for 3 months after the last vaccination.

• Good health as determined by medical history, physical examination, and clinical judgment.

• Normal Baseline Clinical Laboratory Values at screening including:

• Complete Blood Count (CBC) including:

• White Blood Cell Count: 3.8 -10.8

• Red Blood Cell Count (Mill/MCL)

• Male: 4.20 - 5.80

• Female: 3.80 - 5.10

• Hemoglobin (G/DL)

• Male: 13.2 - 17.1

• Female: 11.7 - 15.5

• Hematocrit (%)

• Male: 38.5- 50.0

• Female: 35.0 - 45.0

• Platelet Count: 140 - 440 (THOUS/MCL)

• Differential

• Urine dipstick for protein and blood: negative or trace. If either is = 1+, obtain complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or proteinuria = 1+, the volunteer is ineligible.

• Negative serology for HIV infection (ELISA test).

• CPK within normal limits

• Hepatic Function Tests including AST, ALT, ALK PHOS.

• Total bilirubin, BUN, serum creatinine, serum electrolytes

• Availability for at least 13 months of follow-up from the time of the screening visit.

• Successful completion of the Test of Understanding defined as 90% correct with three opportunities to take test. Errors will be reviewed with volunteer after each test.

• Commitment for trial participation and signature of the approved consent form.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anthrax

Intervention

Biological:
• Anthrax
Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
• Alhdryogel or PBS
Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DynPort Vaccine Company LLC, A CSC Company

Country where clinical trial is conducted

United States,