Botulism VaccinePhase 2NCT00764634

Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B

A Phase 2 study testing rBV A/B-40 vaccine in people with Botulism Vaccine, run by DynPort Vaccine Company LLC, A GDIT Company at 6 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

This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Botulism Vaccine
What is being tested?: rBV A/B-40 vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 440 participants
Where: 6 sitesUnited States
Study dates: Sep 2008to Dec 2010
Phase: Phase 2
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 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.
The volunteer has no clinically significant abnormalities on electrocardiogram.
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 Day 365 ± 7 days.
The volunteer is in good health.
The volunteer has clinical laboratory test results within the 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 donated one or more units of blood or undergone plasmapheresis within the past 28 days.
The volunteer received any blood product or immunoglobulin in the previous 6 months.
The volunteer received any investigational vaccine in the previous 6 months.

Show all 22Show fewer

The volunteer received any licensed nonliving vaccine within 14 days before or after a scheduled vaccination.
The volunteer received any licensed live vaccine within 60 days before or after a scheduled vaccination.
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 had neurological conditions associated with spasticity or abnormal muscle contraction, demyelination, other abnormalities of smooth or skeletal muscle function, migraine headache, 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 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 arthritis on more than one occasion not related to trauma or any episode of non-trauma-related arthritis within the previous 6 months.
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 study screening.
The volunteer has occupational or other responsibilities that would prevent completion of participation in the study.
The volunteer has a body mass index ≥ 35 kg/m2.
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 immunodeficiency virus, hepatitis C virus or hepatitis B surface antigen.
The volunteer is currently on active duty in the U.S. military.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
University Clinical Research, Inc
Pembroke Pines, Florida, 33024
Wake Research Associates
Raleigh, North Carolina, 27612

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Dosing Schedule and Antibody Kinetics of Recombinant Botulinum Vaccine A/B, rBV A/B-40, in Healthy Adults

This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.

Read the detailed description

The study includes 18 months (547 days) of follow-up after the first vaccination for all randomized volunteers who receive at least one vaccination. Analysis of cumulative data collected through Day 547 ± 14 days will be reported in the final clinical study report.

Conditions: Botulism Vaccine
Being tested: Placebo (USP sterile saline for injection), rBV A/B-40 vaccine

What participants receive

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

Placebo (USP sterile saline for injection)Biological
Also called placebo
0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
rBV A/B-40 vaccineBiological
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182
Placebo (USP sterile saline for injection)Biological
Also called placebo
0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
rBV A/B-40 vaccineBiological
Also called rBV A/B vaccine
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182

Study groups in NCT00764634
Study group	Role	What they receive
1 Placebo	Placebo comparator	Not described Receives: Biological: Placebo (USP sterile saline for injection)
2 rBV A/B Vaccine	Active comparator	Not described Receives: Biological: rBV A/B-40 vaccine
3 Placebo	Placebo comparator	Not described Receives: Biological: Placebo (USP sterile saline for injection)
4 rBV A/B Vaccine	Active comparator	Not described Receives: Biological: rBV A/B-40 vaccine

What is being measured

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

The primary safety objective is to assess rBV A/B-40 vaccine or placebo given to volunteers with an observation period of 30 weeks (Day 210 ± 7 days). The primary immunogenicity objective is to evaluate neutralizing antibody rate.
Measured: 30 weeks (Day 210 ± 7 days)

Secondary outcomes (1)

The secondary safety objective is to assess rBV A/B-40 vaccine or placebo given to volunteers with an observation period of 18 months (Day 547 ± 14 days). The secondary immunogenicity objectives include evaluating antibody kinetics.
Measured: 18 months (Day 547 ± 14 days)

Timeline

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

Sep 2008Dec 2010

First posted2 Oct 2008 (estimated)
Study startSep 2008
Primary completionMar 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Botulism VaccineStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 440 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00764634
Sponsor's protocol ID: rBV A/B-02
Status last verified: Nov 2011
First submitted: 30 Sep 2008
Last updated: 2 Dec 2011
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Dosing Schedule and Antibody Kinetics of Recombinant Botulinum Vaccine A/B, rBV A/B-40, in Healthy Adults
ClinicalTrials.gov ID: NCT00764634
Acronym / sponsor ID: rBV A/B-02
Conditions: Botulism Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 440 participants (actual)
Lead sponsor: DynPort Vaccine Company LLC, A GDIT CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Mar 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 2 Oct 2008 (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.

This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
1 Placebo	Placebo comparator	Biological: Placebo (USP sterile saline for injection)
2 rBV A/B Vaccine	Active comparator	Biological: rBV A/B-40 vaccine
3 Placebo	Placebo comparator	Biological: Placebo (USP sterile saline for injection)
4 rBV A/B Vaccine	Active comparator	Biological: rBV A/B-40 vaccine

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.
The volunteer has no clinically significant abnormalities on electrocardiogram.

Key exclusion criteria (22 listed)

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 donated one or more units of blood or undergone plasmapheresis within the past 28 days.
The volunteer received any blood product or immunoglobulin in the previous 6 months.

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
Placebo (USP sterile saline for injection)Also: placebo0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182	Biological	1 Placebo
rBV A/B-40 vaccine0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182	Biological	2 rBV A/B Vaccine
Placebo (USP sterile saline for injection)Also: placebo0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182	Biological	3 Placebo
rBV A/B-40 vaccineAlso: rBV A/B vaccine0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182	Biological	4 rBV A/B Vaccine

Primary outcome

The primary safety objective is to assess rBV A/B-40 vaccine or placebo given to volunteers with an observation period of 30 weeks (Day 210 ± 7 days). The primary immunogenicity objective is to evaluate neutralizing antibody rate.
Time frame: 30 weeks (Day 210 ± 7 days)

1 secondary outcome

The secondary safety objective is to assess rBV A/B-40 vaccine or placebo given to volunteers with an observation period of 18 months (Day 547 ± 14 days). The secondary immunogenicity objectives include evaluating antibody kinetics.
Time frame: 18 months (Day 547 ± 14 days)

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 2 Dec 2011.

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.

William Swiderski study director

DynPort Vaccine Company LLC

George A. Saviolakis, M.D. study director

DynPort Vaccine Company LLC

6 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-40 vaccine in people with Botulism Vaccine, run by DynPort Vaccine Company LLC, A GDIT Company at 6 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 8 inclusion and 22 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 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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 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?

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?

The primary safety objective is to assess rBV A/B-40 vaccine or placebo given to volunteers with an observation period of 30 weeks (Day 210 ± 7 days). The primary immunogenicity objective is to evaluate neutralizing antibody rate. (time frame: 30 weeks (Day 210 ± 7 days)). 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 NCT00764634.

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 2 Dec 2011.