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

NCT00764634 | Completed Phase 2 DMC

• 1 other identifier: rBV A/B-02
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Botulism Vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  18 months (Day 547 ± 14 days)

Study Arms (4)

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

Interventions

Placebo (USP sterile saline for injection) BIOLOGICAL

0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182

Also known as: placebo

1 Placebo

rBV A/B-40 vaccine BIOLOGICAL

0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182

2 rBV A/B Vaccine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DynPort Vaccine Company LLC, A GDIT Company: lead

Study Sites (6)

Miami Research Associates

Miami, Florida, 33143, United States

Location

University Clinical Research, Inc

Pembroke Pines, Florida, 33024, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• William Swiderski

  DynPort Vaccine Company LLC

  STUDY DIRECTOR

• George A. Saviolakis, M.D.

  DynPort Vaccine Company LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 2, 2011

Record last verified: 2011-11

Locations

US (6)