A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults

Fraunhofer, Center for Molecular Biotechnology1 site in 1 country30 target enrollmentAugust 2014

ConditionsAnthrax

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Anthrax
Sponsor: Fraunhofer, Center for Molecular Biotechnology
Enrollment: 30
Locations: 1
Primary Endpoint: Number of Participants with Adverse Events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

May 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fraunhofer, Center for Molecular Biotechnology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Citizen or permanent resident of the US
•Male or female aged 18 to 49 years inclusive
•Able to give written informed consent
•Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
•Females should fulfill one of the following criteria:
•At least one year post-menopausal
•Surgically sterile
•Willing to use a medically approved form of contraception (eg, oral, implantable, transdermal, or injectable hormonal contraceptive; intrauterine device; barrier protection to include female condom, diaphragm, cervical cap, or male condoms in conjunction with spermicide) for 30 days prior to first vaccination and through the end of the study
•Willing to abstain from sexual intercourse for 30 days prior to first vaccination and through the end of the study
•Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose

Exclusion Criteria

•History of anthrax disease or receipt of anthrax vaccine
•Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
•Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
•Pregnancy or lactation
•Cancer or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma
•Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus, per the investigator's discretion
•Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system
•This includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids (oral or injectable; 20 mg/day x 14 days or longer)
•Radiation therapy
•Intranasal and topical corticosteroids will be allowed