BotulismPhase 2NCT03676634
Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
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.
Trial 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… 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
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2019to 3 Jul 2020
- 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
- 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)
- Be 18 to 69 years old at the time of consent
- Be healthy and have an acceptable medical history that will not interfere with the objectives of the study
- Meet the participant suitability requirements and recommendations for source plasma donors outlined in Appendix A.
- 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].
- 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
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- 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
- Have provided written authorization for use and disclosure of protected health information
- 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)
- Have personal health insurance
Who cannot join
- Be pregnant or nursing
- 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)
- 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
- Have known allergy to aluminum, yeast, or other components of the vaccine
- Have donated one or more units of blood or undergone plasmapheresis within 49 days of the Vaccination Visit (Day 0)
- 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)
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- Have received licensed nonliving vaccine within 14 days prior to study entry, or licensed live vaccine within 60 days prior to study entry
- 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)
- 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
- Have received cytotoxic therapy at any time in the previous 5 years before study entry
- 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.)
- Have a history of alcohol or drug abuse or dependence within 12 months of study entry
- Have past, present, or suspected illicit injection drug use
- 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.)
- Have any acute or chronic neuromuscular or neurologic disorder
- Have clinically confirmed hepatic or renal insufficiency
- Have uncontrolled hypertension, as defined a systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 90 mmHg
- Have moderate to severe asthma, chronic obstructive pulmonary disease, or other significant pulmonary disease
- Have a seizure disorder
- Have moderate or severe illness or oral temperature of 100.4°F or greater within 3 days of Vaccination Visit (Day 0)
- Be unsuitable for participation in this study for any reason, as assessed by the investigator
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
About this study
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
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.
- Conditions
- Botulism
- Being tested
- rBV A/B
- 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
Recombinant Botulinum Vaccine A/B, rBV A/B
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | rBV A/B Receives: Biological: rBV A/B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)
Neutralizing Antibody Concentration in Plasma
Measured: Week 0 to Week 4
Secondary outcomes (1)
Proportion of Subjects Achieving Greater Than 2-Fold Increase in Neutralizing Antibody Concentration (NAC)
Neutralizing Antibody Concentration in Plasma
Measured: Week 0 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start7 Mar 2019
- Primary completion25 Apr 2020
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BotulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Department of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Arnon, M.D., M.P.H., Principal investigator, California Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676634
- Sponsor's protocol ID
- rBV A/B-CL-002
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2018
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03676634
- Acronym / sponsor ID
- rBV A/B-CL-002
- Conditions
- Botulism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- California Department of Public HealthUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 19 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: rBV A/BrBV A/B |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- Be 18 to 69 years old at the time of consent
- Be healthy and have an acceptable medical history that will not interfere with the objectives of the study
- Meet the participant suitability requirements and recommendations for source plasma donors outlined in Appendix A.
- 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].
Key exclusion criteria (25 listed)
- Be pregnant or nursing
- 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)
- 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
- Have known allergy to aluminum, yeast, or other components of the vaccine
- Have donated one or more units of blood or undergone plasmapheresis within 49 days of the Vaccination Visit (Day 0)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rBV A/BRecombinant Botulinum Vaccine A/B, rBV A/B | Biological | Vaccine |
Primary outcome
Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)
Time frame: Week 0 to Week 4
Neutralizing Antibody Concentration in Plasma
1 secondary outcome
Proportion of Subjects Achieving Greater Than 2-Fold Increase in Neutralizing Antibody Concentration (NAC)
Time frame: Week 0 to 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Botulism
Enrolling by invitationPhase 4
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
Botulism
RecruitingPhase 3
Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
Carpometacarpal Sprain, Thumb Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Arnon, M.D., M.P.H. principal investigator
California Department of Public Health
2 sites in 1 country: see every site and its status.
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 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: finished, as of the sponsor's last update on 19 Oct 2021. 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 19 Oct 2021). 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?
Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases 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?
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 19 Oct 2021.