Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B

Completed · Phase 2 · Has a placebo group

Conditions studied: Botulism Vaccine

In brief

This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.

Key facts

Study ID

NCT00764634

Run by

DynPort Vaccine Company LLC, A GDIT Company

People needed

440

Starts

2008-09-01

Expected to finish

2010-12-01

Last updated by the study team

2011-12-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The volunteer has signed the informed consent form.
• The volunteer is 18 to 55 years of age.
• The volunteer agrees not to donate blood or blood product for therapeutic or research purposes.
• The volunteer is willing to comply with the requirements of the protocol.
• The volunteer has no clinically significant abnormalities on electrocardiogram.
• Female volunteers of childbearing potential must not be pregnant or lactating and agree to use two types of an acceptable form of FDA-approved contraception through Day 365 ± 7 days.
• The volunteer is in good health.
• The volunteer has clinical laboratory test results within the ranges listed in the protocol.

You may not qualify if…

• The volunteer has a history of botulism or prior receipt of any botulinum vaccine, toxoid or antitoxin.
• The volunteer has previously been treated or expects to be treated with any therapeutic products containing BoNTs such as Botox®, Myobloc®/Neurobloc™ and Botox® Cosmetic.
• The volunteer has a history of hypersensitivity or significant adverse reaction to other vaccines, aluminum compounds or yeast.
• The volunteer has donated one or more units of blood or undergone plasmapheresis within the past 28 days.
• The volunteer received any blood product or immunoglobulin in the previous 6 months.
• The volunteer received any investigational vaccine in the previous 6 months.
• The volunteer received any licensed nonliving vaccine within 14 days before or after a scheduled vaccination.
• The volunteer received any licensed live vaccine within 60 days before or after a scheduled vaccination.
• The volunteer received any investigational drug therapy within 30 days before the first vaccination or before the last scheduled visit.
• The volunteer received therapy with immunosuppressive agents, including use of moderate to high-dose oral inhaled or systemic corticosteroids (prednisone-equivalent dose of ≥ 20 mg/day).
• The volunteer had neurological conditions associated with spasticity or abnormal muscle contraction, demyelination, other abnormalities of smooth or skeletal muscle function, migraine headache, or hyperhidrosis.
• The volunteer had systemic or recurrent disease or condition that would place the volunteer at an unacceptable risk of injury or requires frequent or continuous medical intervention for treatment, has required hospitalization, or is likely to require surgical intervention during the course of the study.
• The volunteer has a history of immunodeficiency or autoimmune disease.
• The volunteer has a systemic medical condition that is ongoing or has required hospitalization or administration of antimicrobial agents within 6 months before screening.
• The volunteer has a history of arthritis on more than one occasion not related to trauma or any episode of non-trauma-related arthritis within the previous 6 months.
• The volunteer has an acute self-limited illness that has not resolved by the time of first vaccination including oral temperature greater than 99.5 °F.
• The volunteer has a history of abuse of alcohol or drugs within the 12 months before study screening.
• The volunteer has occupational or other responsibilities that would prevent completion of participation in the study.
• The volunteer has a body mass index ≥ 35 kg/m2.
• The volunteer has a confirmed positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids.
• The volunteer was seropositive on screening tests for human immunodeficiency virus, hepatitis C virus or hepatitis B surface antigen.
• The volunteer is currently on active duty in the U.S. military.

Where it is running

• Miami Research Associates — Miami, Florida, United States
• University Clinical Research, Inc — Pembroke Pines, Florida, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Clinical Research Associates of Tidewater — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.