NCT01641991

Brief Summary

A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 28, 2014

Completed
Last Updated

May 28, 2014

Status Verified

April 1, 2014

Enrollment Period

8 months

First QC Date

July 5, 2012

Results QC Date

April 17, 2014

Last Update Submit

April 24, 2014

Conditions

Bacillus Anthracis (Anthrax)

Keywords

Bacillus anthracis, anthrax, vaccine, BioThrax®, dose-sparing

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer

    Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.

    Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100

Secondary Outcomes (18)

  • Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)

    Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.

  • Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity

    Days 0-7 after vaccination at Day 0

  • Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity

    Days 0-7 after vaccination at Day 14

  • Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity

    Days 0-7 after vaccination at Day 28

  • Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity

    Days 0-7 after vaccination at Month 6

  • +13 more secondary outcomes

Study Arms (4)

Arm B: 0.50mL BioThrax®

EXPERIMENTAL

BioThrax® 0.50mL subcutaneously on Days 0, 28 and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects

Biological: BioThrax®

Arm C: 0.50mL BioThrax®

EXPERIMENTAL

BioThrax® 0.50mL subcutaneously on Days 0, 14, 28 and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects

Biological: BioThrax®

Arm D: 0.25mL BioThrax®

EXPERIMENTAL

BioThrax® 0.25mL subcutaneously on Days 0,14, and 28,and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects

Biological: BioThrax®

Arm A: 0.50mL BioThrax®

EXPERIMENTAL

BioThrax® 0.50 ml subcutaneously on Days 0, 14, and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects

Biological: BioThrax®

Interventions

BioThrax®BIOLOGICAL

BioThrax® is a sterile, milky white suspension made from cell free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, will be administered as a 0.50mL IM injection 6 month boost for all groups

Arm A: 0.50mL BioThrax®Arm B: 0.50mL BioThrax®Arm C: 0.50mL BioThrax®Arm D: 0.25mL BioThrax®

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject able to provide informed consent;
  • Female or male, 18 through 65 years of age, inclusive;
  • If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus) or use acceptable contraception, initiated at least 30 days prior to the first study vaccination through 56 days after the 6 month boost vaccination in order to avoid pregnancy:
  • A woman is considered of childbearing potential unless post-menopausal (\>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
  • Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other Food and Drug Administration (FDA)-approved contraceptive method
  • Be willing and able to return for all visits and blood collections for the duration of the study;
  • Be able to understand and comply with planned study procedures;
  • Agree to complete the memory aid and to report concomitant medications and Adverse Events during the study period.

You may not qualify if:

  • History of gestational diabetes;
  • Type II diabetes controlled with diet or oral hypoglycemic medications;
  • Treated, controlled, uncomplicated hypertension;
  • History of coronary artery disease, asymptomatic (New York Heart Association \[NYHA\] Function Class I), on a stable medical regimen. Persons meeting these criteria must be at least two years post-myocardial infarction, cardiac bypass surgery and/or percutaneous coronary interventions (e.g., angioplasty, stent placement) in order to qualify. Persons with a history of cardiac disease must be under the care of a physician;
  • Cured, non-metastatic cancer (excluding hematologic malignancies), disease-free for five years;
  • Localized skin cancer, resected (including squamous cell and basal cell carcinomas). Participants with a history of melanoma must be disease-free for five years;
  • Exercise-induced bronchospasm controlled with inhaled medication(s) only;
  • Mild asthma: Subjects who have not been hospitalized for asthma in the past two years and use only inhalers to control their symptoms will be eligible. Only low to medium doses of inhaled steroids, defined as \</=3 puffs a day, are allowed. Persons who require oral or parenteral steroids will not be eligible.
  • Subjects with isolated entrapment neuropathies, such as carpal tunnel syndrome, or compression neuropathies, such as lumbar radiculopathy, that are not associated with systemic disease or immune dysfunction may be eligible for enrollment. If the subject's condition has been stable for six months, surgery is not planned for the condition, the neurologic examination is normal (specifically no weakness or paresthesias), and the mononeuropathy will not interfere with the assessment of reactogenicity, the subject is eligible.
  • Subjects with vitiligo who are otherwise healthy and the vitiligo is not widespread in the area of the vaccinations may be eligible for enrollment.
  • Subjects with seasonal allergies are eligible provided the dose of nasal steroids that are used is \< 800µg/day.
  • Have a prior history of anthrax or immunization against anthrax;
  • Intend to enlist in the military during the study;
  • Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex;
  • Have received experimental products within 30 days before study entry or plan to receive experimental products at any time during the study;
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory Children's Center - Pediatric Infectious Diseases

Atlanta, Georgia, 30322-1014, United States

Location

Cincinnati Children's Hospital Medical Center - Infectious Diseases

Cincinnati, Ohio, 45229-3026, United States

Location

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

Group Health Research Institute - Seattle

Seattle, Washington, 98101-1466, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Biothrax

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
David Bernstein, MD, MA
Organization
Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center
david.bernstein@cchmc.org
513-636-7625

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 17, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

May 28, 2014

Results First Posted

May 28, 2014

Record last verified: 2014-04

Locations

US(4)