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 range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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