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

NCT ID: NCT00057525

Last Updated: 2011-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2004-08-31

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

Conditions

Anthrax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Anthrax vaccine with or without PBS

Administor 1 dose 5 μg rPA with PBS (5 Volunteers)

Group Type: EXPERIMENTAL

Anthrax

Intervention Type: BIOLOGICAL

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

Placebo

Doses will range from 5 \_g to 100 \_g rPA, and at each dose-level, rPA will either be combinedwith phosphate-buffered saline (PBS) or adsorbed to Alhydrogel

Group Type: PLACEBO_COMPARATOR

Alhdryogel or PBS

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DynPort Vaccine Company LLC, A GDIT Company

INDUSTRY

Sponsor Role: lead

Responsible Party

DynPort Vaccine Company, LLC

Principal Investigators

Merlin L Robb, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Rockville, Maryland, United States

Countries

United States

References

Brown BK, Cox J, Gillis A, VanCott TC, Marovich M, Milazzo M, Antonille TS, Wieczorek L, McKee KT Jr, Metcalfe K, Mallory RM, Birx D, Polonis VR, Robb ML. Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. PLoS One. 2010 Nov 5;5(11):e13849. doi: 10.1371/journal.pone.0013849.

Reference Type: DERIVED

PMID: 21079762 (View on PubMed)

Other Identifiers

Anthrax

Identifier Type: -

Identifier Source: secondary_id

rPA-EC-02

Identifier Type: -

Identifier Source: org_study_id