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BotulismPhase 3rBV A/BNCT01940315

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

A Phase 3 study testing rBV A/B in people with Botulism, run by DynPort Vaccine Company LLC, A GDIT Company.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Botulism
What is being tested?
rBV A/B
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2017to Sep 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.
  • The volunteer has clinical laboratory tests within acceptable ranges listed in the protocol.

Who cannot join

  • 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.
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  • 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.
  • The volunteer received or intends to receive any licensed live vaccine, including FluMist® within 60 days before or after a scheduled administration of study product.
  • Vaccination with commercially available inactivated or non-living influenza vaccine preparations (other than FluMist®) if received 14 days before and after a scheduled administration of study product.
  • 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 has or develops medically diagnosed chronic migraine headaches (persistent and recurrent) or a neurological condition associated with a cranial nerve or spasticity or abnormal muscle contraction, demyelination, other abnormalities of smooth or skeletal muscle function 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 current active mental illness, history of mental illness or hospitalization for mental illness within the past 12 months prior to first of administration of study product is exclusionary.
  • 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 or active rheumatoid arthritis or any autoimmune mediated arthritis.
  • 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 clinical trial screening.
  • The volunteer has occupational or other responsibilities that would prevent completion of participation in the clinical trial in the opinion of the Investigator.
  • The volunteer has a body mass index (BMI) ≥ 35 kg/m2.
  • The volunteer is a member of the team conducting this clinical trial or is in a dependent relationship with the clinical trial investigator.
  • 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 HIV, Hepatitis C virus or hepatitis B surface antigen.

About this study

Official title: A Phase 3, Double Blind, Placebo Controlled, Randomized, Multicenter Clinical Trial to Demonstrate the Safety, Lot Consistency and Clinical Benefit of Recombinant Botulinum Vaccine A/B (rBV A/B)

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.

Read the detailed description

Currently, there are no licensed vaccines or pre-exposure prophylactic medical countermeasures available to provide protection against botulism. The rBV A/B is under development to provide protection of adults 18 to 55 years of age from fatal botulism caused by inhalational intoxication with botulinum neurotoxin complex (BoNT) serotype A, subtype A1 (BoNT/A1) and botulinum neurotoxin complex serotype B, subtype B1 (BoNT/B1). Volunteers will not be exposed to botulism. Protective antibody titers will be measured in serum after vaccination.

Conditions
Botulism
Being tested
rBV A/B, Placebo (USP sterile saline for injection)
Keywords
Defender Study, experimental vaccine, inhalational intoxication
Medical subject headings
Botulism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rBV A/BBiological

    0.5 mL dose of rBV A/B (40 µg) given at Days 0, 28 ± 5 days, and 182 ± 9 days

  • Placebo (USP sterile saline for injection)Biological

    0.5 mL dose of Placebo will be given at Days 0, 28 ± 5 days, and 182 ± 9 days

Study groups in NCT01940315
Study groupRoleWhat they receive
rBV A/BActive comparator0.5 mL dose of rBV A/B (40 µg) will be administered intramuscularly (IM) in a three-dose dosing schedule given at Days 0, 28 ± 5 days, and 182 ± 9 days
Receives: Biological: rBV A/B
PlaceboPlacebo comparator0.5 mL dose of placebo will be administered intramuscularly (IM) given at Days 0, 28 ± 5 days, and 182 ± 9 days
Receives: Biological: Placebo (USP sterile saline for injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The primary safety endpoints are the incidence, severity and relationship to treatment of solicited local, systemic and neuromuscular adverse events (AEs) with onset on the day of and for 7 days after each administration of study product; treatment-emergent AEs (TEAEs) with onset within 28 days after each administration of study product; and medically-attended AEs (MAEs), neuromuscular AEs and serious AEs (SAEs) from the time of first dose (Day 0) through 6 months after the last dose (Day 365).

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

  2. 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.

    • The criterion to demonstrate lot consistency will be based on the geometric mean ratios of neutrailzing antibodies concentrations (NAC) to vaccine antigens BoNT/A1 and BoNT/B1.
    • The criterion to demonstrate clinical benefit is the proportion of volunteers with NAC values at or above the putative protective levels for anti-BoNT/A1 and anti-BoNT/B1 simultaneously.

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

Secondary outcomes (2)

  1. The secondary safety objective is to demonstrate the safety of rBV A/B from Day 365 through Day 547.

    The secondary safety endpoints are the incidence, severity and relationship to treatment of MAEs, neuromuscular AEs and SAEs.

    Measured: 1 year after last dose [Dose 3] in a subset of volunteers

  2. The secondary immunogenicity endpoints is duration of protection through Day 547.

    The criterion to demonstrate duration of protection is the proportion of volunteers with NAC values at or above the putative protective levels for anti-BoNT/A1 and anti-BoNT/B1 simultaneously.

    Measured: Evalution through Study Days 365 and 547 (6 months and 1 year after last dose [Dose 3])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2013 (estimated)
  2. Study startOct 2017 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Why it stopped: Sponsor decision due to product manufacturing and redesign of clinical trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940315
Sponsor's protocol ID
rBV A/B-03
Acronym
rBV A/B
Status last verified
Nov 2018
First submitted
6 Sep 2013
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rBV A/B in people with Botulism, run by DynPort Vaccine Company LLC, A GDIT Company.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary safety objective is to demonstrate the safety of rBV A/B through Day 365. (time frame: 1 year after first dose [Dose 1] / 6 months after the last dose [Dose 3]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01940315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.

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