RECOMBINANT BOTULINUM VACCINE A/BPhase 1NCT00098098
Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults
A Phase 1 study testing rBV A/B in people with RECOMBINANT BOTULINUM VACCINE A/B, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site in United States.
Trial summary
The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- RECOMBINANT BOTULINUM VACCINE A/B
- What is being tested?
- rBV A/B
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 2005
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteer is between 18 to 40 (inclusive) years of age at the time of the first dose of rBV A/B.
- The volunteer is in good health as determined by the Investigator (Study Doctor) from a medical history and physical examination.
- The volunteer has clinical chemistry, hematology and urinalysis laboratory values within 10 % above the upper or within 10 % below the lower limit of the normal range as established by the University of Kentucky clinical laboratory which are not considered clinically significant by the Investigator and/or the Sponsor Medical Monitor.
- The volunteer has a normal electrocardiogram (ECG). However, if a potential volunteer is reported to have a benign ECG abnormality (e.g., sinus bradycardia) the results may be discussed with the Sponsor Medical Monitor. With the agreement of the Sponsor Medical Monitor and documentation of the consultation in the volunteer's study record, the Investigator may include the volunteer in the study.
- The volunteer is willing to have his or her blood samples stored for future botulinum research studies.
- The volunteer has signed the Informed Consent Form, successfully completed (at least 90 % correct) the Test of Understanding, and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form.
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- The volunteer agrees not to donate blood for at least 30 days following vaccination.
- The volunteer is willing to comply with the requirements of the protocol through the post-vaccination Day 168 (± 7 days) visit.
- Female volunteers must be of non-childbearing potential (i.e., surgically sterilized or postmenopausal), or must not be pregnant (as indicated by a negative serum pregnancy test within 24 hours prior to rBV A/B administration) or nursing, and must use two types of acceptable form of FDA-approved birth control methods including: 1) hormonal types of birth control (such as implants or birth control pills) or an intrauterine device (IUD) and 2) an additional barrier type of birth control measure (i.e. condoms, diaphragms, cervical caps, spermicide, etc.) during the period beginning from 30 days before vaccination through completion of the study. Completion of the study is defined as completing the post-vaccination Day 168 (± 7 days) visit.
Who cannot join
- The volunteer has frequent or severe headaches of any etiology.
- The volunteer has chronic, severe or recurrent joint pain or arthritis of any etiology.
- The volunteer has a history of alcohol or drug abuse within the 12 months prior to study screening or any history of injectable drug use.
- The volunteer has a positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and cannabinoids. (If positive on screen, confirmatory testing shall be performed where applicable).
- The volunteer has a previous diagnosis of any serious psychiatric disorder. For this purpose, serious psychiatric disorder is defined as illness requiring hospitalization within the previous 12 months; routine administration of more than one medication to control anxiety, mood or sleep disorder; or history of suicide attempt.
- The volunteer has received any blood products or immune globulin in the previous six months.
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- The volunteer has donated blood within the past 56 days.
- The volunteer received any investigational drug therapy within 30 days before the first dose of rBV A/B or intends to receive any other investigational drug therapy before the post-vaccination Day 168 (± 7 days) visit.
- Licensed vaccines are not exclusionary but should be given at least 30 days before or after immunization (if live vaccine: 60 days before or after immunization) to avoid potential confusion of adverse reactions.
- The volunteer has received any other investigational Botulinum Vaccine or Toxoid.
- The volunteer has received previous treatment with approved therapeutic products containing botulinum neurotoxins such as Botox, Myobloc, and Botox Cosmetic.
- The volunteer has a clinically significant abnormality on the ECG.
- The volunteer has a known hypersensitivity to aluminum compounds or yeast.
- The volunteer has any laboratory values greater than 10 % above the upper or greater than 10 % below the lower limit of normal or clinically significant as assessed by the Investigator and/or Sponsor Medical Monitor.
- The volunteer tests positive for Human Immunodeficiency Virus (HIV); Hepatitis C Virus (HCV) or Hepatitis B surface Antigen (HBsAg).
- The volunteer has a body mass index > 40 kg/m2 or is > 100 lbs. over ideal body weight.
- The volunteer has an acute illness, evidence of significant active infection, or evidence of systemic disease at time of enrollment that in the opinion of the Investigator would place the volunteer at an unacceptable risk for injury.
- The volunteer has a temperature > 100.4 °F at the time of enrollment.
- The volunteer has occupational or other responsibilities that would prevent completion of participation in the study.
- The volunteer has a history of anaphylaxis or other serious adverse reactions to vaccines.
- The volunteer has a personal or family history of multiple sclerosis.
- The female volunteer is pregnant (must have a negative serum pregnancy test within 24 hours prior to each dose of rBV A/B), lactating or unwilling to use two types of an acceptable form of FDA-approved contraception for 30 days prior to first dose of rBV A/B through the post-vaccination Day 168 (± 7 days) visit.
- The volunteer requires chemotherapeutic and immunosuppressive agents or a total corticosteroid dose of 2 mg/kg or 20 mg/day within the 3 months prior to the study or burst steroid therapy within 14 days before vaccination.
- The volunteer is currently on active duty in the US military.
- The volunteer is a US military veteran that received other botulinum products for vaccination or research purposes.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
Official title: A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults
The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.
Read the detailed description
The Phase 1 clinical trial is designed as a single-center, open-label, non-randomized study to evaluate the safety, tolerability and immunogenicity of a two-dose schedule of rBV A/B in healthy volunteers at three ascending dosage levels, 5 ug, 10 ug and 20 ug serotype-specific antigen (10 ug, 20 ug and 40 ug total immunizing protein) in three dosing cohorts and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level. Approximately 44 volunteers (11 per cohort) are expected to be enrolled. Cohorts will enroll consecutively beginning with the lowest dosage level. Volunteers in each cohort will receive a two injection series at the assigned dosage level given as a 0.5 mL intramuscular (i.m.) injection on Day 0 and Day 28. Potential volunteers for study participation will undergo qualification screening for this study during the 21 days prior to the date scheduled for vaccination. After successful completion of the informed consent process and all screening assessments, volunteers will be scheduled for vaccination. Volunteers will report acute adverse events daily for 28 days after each vaccination and return to the clinic at regular intervals according to the Schedule of Study Assessments with the last scheduled follow-up 168 days (± 7 days) after the initial vaccination (Day 0).
- Conditions
- RECOMBINANT BOTULINUM VACCINE A/B
- Being tested
- rBV A/B
- Keywords
- Botulinum, Recombinant Botulinum Vaccine, botulinum neurotoxins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rBV A/BBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of rBV A/B in healthy volunteers at three ascending dosage levels by cohort and a two-dose regimen of a formulation containing only antigens at the 40 ug dosage level.
Secondary outcomes (2)
To evaluate the neutralizing antibody concentration of rBV A/B
Evaluate human toxin neutralizing antibody as a correlate of protective immunity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2004 (estimated)
- Study startAug 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RECOMBINANT BOTULINUM VACCINE A/BStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Greenberg, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098098
- Sponsor's protocol ID
- rBV A/B-01
- Status last verified
- Aug 2012
- First submitted
- 3 Dec 2004
- Last updated
- 23 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults
- ClinicalTrials.gov ID
- NCT00098098
- Acronym / sponsor ID
- rBV A/B-01
- Conditions
- RECOMBINANT BOTULINUM VACCINE A/B
- Keywords
- Botulinum, Recombinant Botulinum Vaccine, botulinum neurotoxins
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 6 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.
Detailed description
The Phase 1 clinical trial is designed as a single-center, open-label, non-randomized study to evaluate the safety, tolerability and immunogenicity of a two-dose schedule of rBV A/B in healthy volunteers at three ascending dosage levels, 5 ug, 10 ug and 20 ug serotype-specific antigen (10 ug, 20 ug and 40 ug total immunizing protein) in three dosing cohorts and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level. Approximately 44 volunteers (11 per cohort) are expected to be enrolled. Cohorts will enroll consecutively beginning with the lowest dosage level. Volunteers in each cohort will receive a two injection series at the assigned dosage level given as a 0.5 mL intramuscular (i.m.) injection on Day 0 and Day 28. Potential volunteers for study participation will undergo qualification screening for this study during the 21 days prior to the date scheduled for vaccination. After successful completion of the informed consent process and all screening assessments, volunteers will be scheduled for vaccination. Volunteers will report acute adverse events daily for 28 days after each vaccination and return to the clinic at regular intervals according to the Schedule of Study Assessments with the last scheduled follow-up 168 days (± 7 days) after the initial vaccination (Day 0).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The volunteer is between 18 to 40 (inclusive) years of age at the time of the first dose of rBV A/B.
- The volunteer is in good health as determined by the Investigator (Study Doctor) from a medical history and physical examination.
- The volunteer has clinical chemistry, hematology and urinalysis laboratory values within 10 % above the upper or within 10 % below the lower limit of the normal range as established by the University of Kentucky clinical laboratory which are not considered clinically significant by the Investigator and/or the Sponsor Medical Monitor.
- The volunteer has a normal electrocardiogram (ECG). However, if a potential volunteer is reported to have a benign ECG abnormality (e.g., sinus bradycardia) the results may be discussed with the Sponsor Medical Monitor. With the agreement of the Sponsor Medical Monitor and documentation of the consultation in the volunteer's study record, the Investigator may include the volunteer in the study.
- The volunteer is willing to have his or her blood samples stored for future botulinum research studies.
Key exclusion criteria (25 listed)
- The volunteer has frequent or severe headaches of any etiology.
- The volunteer has chronic, severe or recurrent joint pain or arthritis of any etiology.
- The volunteer has a history of alcohol or drug abuse within the 12 months prior to study screening or any history of injectable drug use.
- The volunteer has a positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and cannabinoids. (If positive on screen, confirmatory testing shall be performed where applicable).
- The volunteer has a previous diagnosis of any serious psychiatric disorder. For this purpose, serious psychiatric disorder is defined as illness requiring hospitalization within the previous 12 months; routine administration of more than one medication to control anxiety, mood or sleep disorder; or history of suicide attempt.
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/B | Biological | – |
Primary outcome
To evaluate the safety and tolerability of rBV A/B in healthy volunteers at three ascending dosage levels by cohort and a two-dose regimen of a formulation containing only antigens at the 40 ug dosage level.
2 secondary outcomes
To evaluate the neutralizing antibody concentration of rBV A/B
Evaluate human toxin neutralizing antibody as a correlate of protective immunity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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.
Richard Greenberg, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rBV A/B in people with RECOMBINANT BOTULINUM VACCINE A/B, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site 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 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: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety and tolerability of rBV A/B in healthy volunteers at three ascending dosage levels by cohort and a two-dose regimen of a formulation containing only antigens at the 40 ug dosage level.. 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 23 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.