WithdrawnPhase 3

Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B

Stopped: Sponsor decision due to product manufacturing and redesign of clinical trial.

0Started 2017-10

Plain-language summary

This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. The volunteer is a U.S. citizen or permanent resident alien of the U.S.
✓. 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 through the last scheduled visit.
✓. The volunteer is accessible by telephone or electronic mail to receive reminders from the investigative site.
✓. 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 end of study.
✓. The volunteer is in good health.

Exclusion criteria

✕. 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 a history of severe allergic reactions or anaphylaxis.
✕. The volunteer has donated one or more units of blood (≥ 450 mL) or undergone plasmapheresis within the past 28 days prior to receiving first administration of study product.
✕. The volunteer received any blood product or immunoglobulin in the previous 6 months prior to receiving first vaccination or plans to receive such products during the clinical trial.
✕. The volunteer received any investigational vaccine in the previous 6 months.
✕. The volunteer received or intends to receive any licensed nonliving vaccine within 14 days before or after a scheduled administration of study product.

What they're measuring

The primary safety objective is to demonstrate the safety of rBV A/B through Day 365.

Timeframe: 1 year after first dose [Dose 1] / 6 months after the last dose [Dose 3]

The primary immunogenicity objectives are to demonstrate lot consistency for three lots of rBV A/B and to infer clinical benefit of rBV A/B.

Timeframe: Study Day 210, approximately 28 days after the last dose [Dose 3]

Trial details

NCT IDNCT01940315

SponsorDynPort Vaccine Company LLC, A GDIT Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03

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