Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 55
Updated:11/23/2013
Start Date:October 2013
End Date:September 2015

Use our guide to learn which trials are right for you!

A Phase 3, Double Blind, Placebo Controlled, Randomized, Multicenter Clinical Trial to Demonstrate the Safety, Lot Consistency and Clinical Benefit of Recombinant Botulinum Vaccine A/B (rBV A/B)


This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter
investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.


Currently, there are no licensed vaccines or pre-exposure prophylactic medical
countermeasures available to provide protection against botulism. The rBV A/B is under
development to provide protection of adults 18 to 55 years of age from fatal botulism caused
by inhalational intoxication with botulinum neurotoxin complex (BoNT) serotype A, subtype A1
(BoNT/A1) and botulinum neurotoxin complex serotype B, subtype B1 (BoNT/B1). Volunteers will
not be exposed to botulism. Protective antibody titers will be measured in serum after
vaccination.

Inclusion Criteria:

1. The volunteer is a U.S. citizen or permanent resident alien of the U.S.

2. The volunteer has signed the informed consent form.

3. The volunteer is 18 to 55 years of age.

4. The volunteer agrees not to donate blood or blood product for therapeutic or research
purposes.

5. The volunteer is willing to comply with the requirements of the protocol through the
last scheduled visit.

6. The volunteer is accessible by telephone or electronic mail to receive reminders from
the investigative site.

7. 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
end of study.

8. The volunteer is in good health.

9. The volunteer has clinical laboratory tests within acceptable ranges listed in the
protocol.

Exclusion Criteria:

1. The volunteer has a history of botulism or prior receipt of any botulinum vaccine,
toxoid or antitoxin.

2. 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.

3. The volunteer has a history of hypersensitivity or significant adverse reaction to
other vaccines, aluminum compounds or yeast.

4. The volunteer has a history of severe allergic reactions or anaphylaxis.

5. The volunteer has donated one or more units of blood (≥ 450 mL) or undergone
plasmapheresis within the past 28 days prior to receiving first administration of
study product.

6. The volunteer received any blood product or immunoglobulin in the previous 6 months
prior to receiving first vaccination or plans to receive such products during the
clinical trial.

7. The volunteer received any investigational vaccine in the previous 6 months.

8. The volunteer received or intends to receive any licensed nonliving vaccine within 14
days before or after a scheduled administration of study product.

9. The volunteer received or intends to receive any licensed live vaccine, including
FluMist® within 60 days before or after a scheduled administration of study product.

10. Vaccination with commercially available inactivated or non-living influenza vaccine
preparations (other than FluMist®) if received 14 days before and after a scheduled
administration of study product.

11. The volunteer received any investigational drug therapy within 30 days before the
first vaccination or before the last scheduled visit.

12. 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).

13. The volunteer has or develops medically diagnosed chronic migraine headaches
(persistent and recurrent) or a neurological condition associated with a cranial
nerve or spasticity or abnormal muscle contraction, demyelination, other
abnormalities of smooth or skeletal muscle function or hyperhidrosis.

14. 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.

15. The volunteer has current active mental illness, history of mental illness or
hospitalization for mental illness within the past 12 months prior to first of
administration of study product is exclusionary.

16. The volunteer has a history of immunodeficiency or autoimmune disease.

17. The volunteer has a systemic medical condition that is ongoing or has required
hospitalization or administration of antimicrobial agents within 6 months before
screening.

18. The volunteer has a history of or active rheumatoid arthritis or any autoimmune
mediated arthritis.

19. 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.

20. The volunteer has a history of abuse of alcohol or drugs within the 12 months before
clinical trial screening.

21. The volunteer has occupational or other responsibilities that would prevent
completion of participation in the clinical trial in the opinion of the Investigator.

22. The volunteer has a body mass index (BMI) ≥ 35 kg/m2.

23. The volunteer is a member of the team conducting this clinical trial or is in a
dependent relationship with the clinical trial investigator.

24. 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.

25. The volunteer was seropositive on screening tests for human HIV, Hepatitis C virus or
hepatitis B surface antigen.
We found this trial at
47
sites
Jacksonville, Florida 32205
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
500 Helendale Rd
Irondequoit, New York 14609
585-288-0890
?
mi
from
Irondequoit, NY
Click here to add this to my saved trials
4085 University Blvd S # 1
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
3100 Duraleigh Road
Meredith, North Carolina 27612
919-781-2514
?
mi
from
Meredith, NC
Click here to add this to my saved trials
1156 Bowman Road
Mt Pleasant, South Carolina 29464
843-856-3784
?
mi
from
Mt Pleasant, SC
Click here to add this to my saved trials
9 Medical Parkway
Northeast, Texas 75234
281-579-1938
?
mi
from
Northeast, TX
Click here to add this to my saved trials
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Akron, Ohio 44311
?
mi
from
Akron, OH
Click here to add this to my saved trials
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Bellevue, Nebraska 68005
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Binghamton, New York 13901
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Chicago, Illinois 60654
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Cleveland, Ohio 44122
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbia, Maryland 21045
?
mi
from
Columbia, MD
Click here to add this to my saved trials
Columbus, Ohio 43212
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80239
?
mi
from
Denver, CO
Click here to add this to my saved trials
Endwell, New York 13760
?
mi
from
Endwell, NY
Click here to add this to my saved trials
Garden Grove, California 92844
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Greer, South Carolina 29650
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64114
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Las Vegas, Nevada 89109
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lenexa, Kansas 66219
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
Lexington, Kentucky 40509
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Meridian, Idaho 83642
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Norman, OK
Click here to add this to my saved trials
Omaha, Nebraska 68134
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Pembroke Pines, Florida
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Phoenix, Arizona 85050
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Redding, CA
Click here to add this to my saved trials
Sacramento, California 95822
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Angelo, Texas 76904
?
mi
from
San Angelo, TX
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94102
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
St. Louis, Missouri 63141
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Tucson, Arizona 85710
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
West Jordan, Utah 84088
?
mi
from
West Jordan, UT
Click here to add this to my saved trials