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BotulismPhase 2NCT01701999

Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid

A Phase 2 study testing rBV A/B in people with Botulism, run by California Department of Public Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the pentavalent botulinum (PBT) toxoid. Read more about this study

Who is it for?
Ages 18 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Botulism
What is being tested?
rBV A/B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesUnited States
Study dates
Feb 2013to Oct 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The volunteer has received pentavalent botulinum toxoid for occupational protection under BB IND 0161, with the previous pentavalent botulinum toxoid dose at least 6 months prior to the planned rBV A/B dose.
  • The volunteer is between the ages of 18 and 69 years at the time of consent.
  • The volunteer is healthy and has an acceptable medical history.
  • The volunteer meets the subject suitability requirements and recommendations for source plasma donors (for Part 2 subjects only).
  • The volunteer, if female and of childbearing potential, is not pregnant or lactating, and agrees to use an acceptable form of FDA-approved contraception for the duration of the study.
  • The volunteer has the ability to understand the requirements of the study and provide informed consent.
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  • The volunteer agrees to complete the subject diary on a daily basis for 7 days post-vaccination and to report concomitant medication and adverse events during the study period.
  • The volunteer provides written authorization for use and disclosure of protected health information.
  • The volunteer agrees not to donate blood or blood products (outside of study procedures) during the course of the study.
  • The volunteer has personal health insurance.

Who cannot join

  • Be pregnant or nursing
  • The volunteer has a history of laboratory evidence of syphilis, acquired immunodeficiency syndrome, Creutzfeldt-Jakob disease, or infection with human immunodeficiency viruses 1 or 2, human T cell lymphotropic virus 1, hepatitis B virus, or hepatitis C virus.
  • The volunteer had prior severe local or severe systemic reaction to last immunization with pentavalent botulinum toxoid.
  • The volunteer has a known allergy to aluminum compounds, yeast, or other components of the vaccine.
  • The volunteer has donated one or more units of blood or undergone plasmapheresis within 28 days before screening.
  • The volunteer has received a blood product or immunoglobulin within 6 months of screening or plans to receive such products during the study.
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  • The volunteer has received licensed nonliving vaccine within 14 days before study entry or licensed live vaccine within 60 days before study entry.
  • The volunteer has received investigational products (drugs, biologics, vaccines, or implantable devices) 60 days prior to study entry or plans to receive experimental products at any time during the study.
  • The volunteer has received prescription immunosuppressive or immunomodulatory agents, including parenteral, inhaled, or oral corticosteroids within 3 months before screening or plans on receiving such therapy at any time during the study with the exceptions (Subjects who have used prescription topical steroids may be enrolled 2 weeks after the therapy is completed; Intra-articular, bursal, or tendon injectable steroids are permitted; Any over-the-counter topical steroid use is permitted; Ophthalmic and intranasal steroids are permitted).
  • The volunteer has received cytotoxic therapy at any time in the previous 5 years to study entry.
  • The volunteer has an active systemic or recurrent disease that would place the subject at unacceptable risk of injury, require hospitalization, or require surgical intervention.
  • The volunteer has a history of alcohol or drug abuse within 12 months before screening.
  • The volunteer has past, present, or suspected illicit injection drug use.
  • The volunteer has inflammatory, vasculitic, or rheumatic disease, including systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma.
  • The volunteer has clinically recognized hepatic or renal insufficiency.
  • The volunteer has uncontrolled hypertension.
  • The volunteer has moderate to severe asthma, chronic obstructive pulmonary disease, or other significant pulmonary disease.
  • The volunteer has a seizure disorder.
  • The volunteer has moderate or severe illness or oral temperature of 100.4°F or greater within 3 days prior to immunization.
  • The volunteer is determined by the investigator to be unsuitable for participation in this trial for any reason.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • California Department of Public Health

    Richmond, California, 94804

  • Battelle Biomedical Research Center

    West Jefferson, Ohio, 43162

Other trials in United States

About this study

Official title: Phase 2b, Two-part, Open-label, Uncontrolled Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single 40-µg Dose of Recombinant Botulinum Vaccine A/B (rBV A/B) for the Production of BabyBIG® in Volunteers Previously Immunized With Pentavalent Botulinum Toxoid for Occupational Protection

Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the pentavalent botulinum (PBT) toxoid. This study is designed to determine neutralizing antibody levels for botulinum toxin types A and B in healthy subjects who were previously immunized with the PBT for occupational protection and who receive the rBV A/B. Subjects with titers of the neutralizing antibodies against the toxins would be candidates for plasma donation for BabyBIG production.

Conditions
Botulism
Being tested
rBV A/B
Keywords
Botulism Vaccine
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

    rBV A/B injections will consist of a single 40 µg injection of total antigen (20 µg of Antigen A and 20 µg of Antigen B) adsorbed to 0.2% (wt/vol) Alhydrogel™, in a total dose volume of 0.5 mL. The vaccine will be administered by intramuscular injection in the deltoid muscle, preferably in the nondominant arm.

Study groups in NCT01701999
Study groupRoleWhat they receive
VaccineExperimentalNot described
Receives: Biological: rBV A/B

What is being measured

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

  1. Four-Fold Increase in Neutralizing Antibody Concentration (NAC)

    Proportion of participants achieving a four-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success).

    Measured: Week 0 to Week 4

Secondary outcomes (2)

  1. Three-Fold Increase in Neutralizing Antibody Concentration (NAC)

    Proportion of participants achieving a three-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success)

    Measured: Week 0 to Week 4

  2. Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve

    Proportion of participants achieving a two-fold increase in the area under the plasma NAC-time curve between Week 0 and Week 12 in comparison with a straight-line extension of the Week 0 NAC to Week 12 for both botulinum toxin A and toxin B. A proportion ≥ 0.50 was considered a success.

    Measured: Week 0 to Week 12

Timeline

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

  1. First posted5 Oct 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionJun 2015
  4. Study completionOct 2015

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 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701999
Sponsor's protocol ID
rBV A/B-CL-001
Status last verified
Apr 2017
First submitted
3 Oct 2012
Last updated
16 May 2017
Data monitoring committee
Yes

Publications

  • Khouri JM, Motter RN, Arnon SS. Safety and immunogenicity of investigational recombinant botulinum vaccine, rBV A/B, in volunteers with pre-existing botulinum toxoid immunity. Vaccine. 2018 Apr 5;36(15):2041-2048. doi: 10.1016/j.vaccine.2018.02.042. Epub 2018 Feb 21.

    PubMed 29475762

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rBV A/B in people with Botulism, run by California Department of Public Health at 2 sites in United States.

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 10 inclusion and 20 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: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Four-Fold Increase in Neutralizing Antibody Concentration (NAC) (time frame: Week 0 to Week 4). 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 NCT01701999, which also lists 1 linked publication.

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 16 May 2017.

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