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Trial record 1 of 2 for:    human botulinum neurotoxin a/b immune globulin
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Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®

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ClinicalTrials.gov Identifier: NCT03676634
Recruitment Status : Active, not recruiting
First Posted : September 19, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
California Department of Public Health

Brief Summary:
This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection will be conducted to collect source plasma for potential use in the production of BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a 12-week period, with a follow-up safety assessment at 6 months.

Condition or disease Intervention/treatment Phase
Botulism Biological: rBV A/B Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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 With Existing Botulinum Immunity
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botulism

Arm Intervention/treatment
Experimental: Vaccine
rBV A/B
Biological: rBV A/B
Recombinant Botulinum Vaccine A/B, rBV A/B




Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: Week 0 to Week 4 ]
    The primary immunogenicity endpoint is the proportion of participants achieving a four times or greater increase in NAC by Week 4 compared with Week 0. A positive response will be defined as achieving this level of increase in at least 50% of the participants for botulinum toxin type A and type B.


Secondary Outcome Measures :
  1. Immunogenicity-AUC [ Time Frame: Week 0 to Week 12 ]
    The proportion of participants achieving a two times increase in the area under the plasma concentration-time curve between Week 0 and Week 12 in NAC in comparison to a straight-line extension of the Week 0 NAC to Week 12. A positive response will be defined as achieving this level of increase in at least 50% of the participants for botulinum toxin type A and type B.

  2. Immunogenicity [ Time Frame: Week 0 to Week 4 ]
    The proportion of participants achieving a three times or greater increase in NAC by Week 4 compared with Week 0. A positive response will be defined as achieving this level of increase in at least 50% of the participants for botulinum toxin type A and type B.

  3. Select severe adverse events and all serious adverse events. [ Time Frame: Week 0 to Week 12 ]
    Frequency and severity of select severe adverse events and all serious adverse events.


Other Outcome Measures:
  1. Collected Plasma Volume [ Time Frame: Week 0 to Week 12 (or Week 14) ]
    Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have received pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection under BB IND 0161 (or BB-IND-0161 and IND 015155)
  2. Be 18 to 69 years old at the time of consent
  3. Be healthy and have an acceptable medical history that will not interfere with the objectives of the study
  4. Meet the participant suitability requirements and recommendations for source plasma donors outlined in Appendix A.
  5. If female, and of childbearing potential, have a negative pregnancy test at screening and within 24 hours prior to vaccination and must not plan to become pregnant until after the last plasma donation or until the Week 12 visit ([whichever occurs last].
  6. Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by the Committee for the Protection of Human Subjects, and have agreed to abide by the study restrictions and to return for the required assessments
  7. Agree to complete the participant home diary on a daily basis for 7 days post vaccination, as well as to report any adverse events and concomitant medications during the study period
  8. Have provided written authorization for use and disclosure of protected health information
  9. Agree not to donate blood or blood products (outside of study procedures) until after the last plasma donation or until the Week 12 visit (whichever occurs last)
  10. Have personal health insurance

Exclusion Criteria:

  1. Be pregnant or nursing
  2. Have a history of laboratory evidence of syphilis, acquired immunodeficiency syndrome, Creutzfeldt-Jakob disease, or infection with human immunodeficiency viruses (HIV) 1 or 2, human T-cell lymphotropic virus 1, hepatitis B virus (HBV), or hepatitis C virus (HCV)
  3. Have had a prior severe (Grade 3 or higher) local or severe (Grade 3 or higher) systemic reaction to last immunization with pentavalent botulinum toxoid or a prior severe immediate hypersensitivity reaction or severe systemic reaction to last vaccination on Day 0 with rBV A/B
  4. Have known allergy to aluminum, yeast, or other components of the vaccine
  5. Have donated one or more units of blood or undergone plasmapheresis within 49 days of the Vaccination Visit (Day 0)
  6. Have received blood product or immunoglobulin within 6 months prior to study entry or plans to receive such products during the study period (exclusive of returned red blood cells as part of the plasmapheresis procedure). For participants who choose to donate plasma, this will apply until their last plasma donation or at the Week 12 visit (whichever occurs last)
  7. Have received licensed nonliving vaccine within 14 days prior to study entry, or licensed live vaccine within 60 days prior to study entry
  8. Have 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 period. For participants who choose to donate plasma, this will apply until their last plasma donation or at the Week 12 visit (whichever occurs last)
  9. Have received prescription immunosuppressive or immunomodulatory agents, including parenteral, inhaled, or oral corticosteroids within 3 months of study entry or plans on receiving such therapy at any time during the study period [For participants who choose to donate plasma, this will apply until their last plasma donation or at the Week 12 visit (whichever occurs last)], with the exceptions mentioned below

    • Participants 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
  10. Have received cytotoxic therapy at any time in the previous 5 years before study entry
  11. Have an active systemic or recurrent disease that would place the participant at unacceptable risk of injury, require hospitalization, or require surgical intervention (This includes active mental illness or history of mental illness not responsive to treatment.)
  12. Have a history of alcohol or drug abuse or dependence within 12 months of study entry
  13. Have past, present, or suspected illicit injection drug use
  14. Have inflammatory, vasculitic, or rheumatic disease, including systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma (Stable osteoarthritis treated with physical therapy and nonsteroidal anti inflammatory drugs is not an exclusion criterion.)
  15. Have any acute or chronic neuromuscular or neurologic disorder
  16. Have clinically confirmed hepatic or renal insufficiency
  17. Have uncontrolled hypertension, as defined a systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 90 mmHg
  18. Have moderate to severe asthma, chronic obstructive pulmonary disease, or other significant pulmonary disease
  19. Have a seizure disorder
  20. Have moderate or severe illness or oral temperature of 100.4°F or greater within 3 days of Vaccination Visit (Day 0)
  21. Be unsuitable for participation in this study for any reason, as assessed by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676634


Locations
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United States, California
California Department of Public Health
Richmond, California, United States, 94804
United States, Ohio
Battelle Biomedical Research Center
West Jefferson, Ohio, United States, 43162
Sponsors and Collaborators
California Department of Public Health
Investigators
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Principal Investigator: Stephen Arnon, M.D., M.P.H. California Department of Public Health

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Responsible Party: California Department of Public Health
ClinicalTrials.gov Identifier: NCT03676634     History of Changes
Other Study ID Numbers: rBV A/B-CL-002
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Botulism
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Foodborne Diseases
Poisoning
Chemically-Induced Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs