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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00057525
Enrollment
70
Registered
2003-04-07
Start date
2003-04-30
Completion date
2004-08-31
Last updated
2011-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anthrax

Keywords

Anthrax

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

Interventions

BIOLOGICALAnthrax

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

BIOLOGICALAlhdryogel 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

Sponsors

DynPort Vaccine Company LLC, A GDIT Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026