A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines

Completed · Phase 1 · Has a placebo group

Conditions studied: Anthrax Infection

In brief

The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the positive (vaccine) control as studied in normal healthy volunteers.

Key facts

Study ID

NCT01979406

Run by

Emergent BioSolutions

People needed

120

Starts

2013-11-01

Expected to finish

2015-09-01

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand the study and give written informed consent.
• Healthy men or women aged 18-40 years old,
• BMI between 18 to 36 kg/m2
• Women of child bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to vaccination on all vaccination days; they must also be willing to use adequate birth control for the duration of the study and have additional pregnancy tests if indicated.
• Intact upper arms with sufficient muscular tissue in the deltoid region for IM vaccine administration.
• Subject must be available for the study duration
• Subject must avoid strenuous exercise for at least 72 hours prior to each study vaccine administration.

You may not qualify if…

• Subject is a healthcare worker who has direct contact with patients or has an household contact (HHC) who is immunodeficient or HIV-positive, pregnant, has an unstable medical condition, or is under the age of 18.
• Subject is a childcare worker or a parent who has direct contact with children 5 years old and younger.
• Subject directly prepares food in the food industry.
• Pregnant or breastfeeding throughout the duration of the study until the final visit
• Military service between 1971 and 1999, or after 2012 when Ad4 vaccine was/is routinely given
• Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to B. anthracis
• Received previous Ad4 vaccination or experimental Ad4 vector vaccines
• Received previous anthrax vaccine
• Received or plans to receive any other approved or investigational vaccines from 30 days prior to the first study vaccination until 30 days after the final study vaccination for live attenuated vaccines and from 15 days prior to the first study vaccination until 15 days after the final study vaccination for inactivated vaccines
• HIV or Hepatitis B or C positive
• Immunodeficient or has an unstable medical condition including psychiatric conditions
• Active or past history of acute or chronic gastrointestinal conditions
• Active or past history of cancer except basal cell carcinoma
• Recipient of bone marrow or solid organ transplant
• Received or plans to receive systemic antiviral medication, within 30 days prior to the first study vaccination
• Known allergy to any component of the study vaccine
• Known allergy to, or known medical condition that precludes use of any systemic antiviral medication
• Received or plans to receive medications indicated for decreasing acidity of stomach including:
• Proton pump inhibitors or antacids or histamine 2-receptor antagonists
• Received or plans to receive immunoglobulin or other blood products within 60 days prior to the first study vaccination
• Received or plans to receive other investigational drugs within 30 days prior to the first study vaccination
• Received or plans to receive systemic immunosuppressive therapy, radiation therapy, or inhaled steroids within 30 days prior to the first study vaccination
• Asthmatic or requires asthmatic medications on a daily basis
• Use of systemic chemotherapy within 5 years prior to study
• Body temperature >38.1°C or acute illness within 3 days prior to vaccination

Where it is running

• The Center for Pharmaceutical Research — Kansas City, Kansas, United States
• Walter Reed Army Institute for Research — Silver Spring, Maryland, United States
• St. Louis University — St Louis, Missouri, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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