Expired Study
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Rockville, Maryland 20850


Purpose:

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.


Study summary:

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


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.


Study is Available At:


Original ID:

rPA-EC-02


NCT ID:

NCT00057525


Secondary ID:

Anthrax


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

DynPort Vaccine Company LLC, A CSC Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Actual


Overall Contact Information

Official Name:Merlin L Robb, MD
Principal Investigator
Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Cente

Study Dates

Start Date:April 2003
Completion Date:August 2004
Completion Type:Actual
Primary Completion Date:April 2004
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 29, 2011
First Received Date:April 3, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:Anthrax
Description: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
Arm Name:Anthrax vaccine with or without PBS
Intervention Type:Biological
Name:Alhdryogel or PBS
Description: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
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Anthrax vaccine with or without PBS
Description:Administor 1 dose 5 μg rPA with PBS (5 Volunteers)
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description: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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:DynPort Vaccine Company LLC, A CSC Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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