Back to resultsTetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
Primary Purpose
Tetanus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tetanus Immune Globulin (Human)
Diphtheria-Tetanus Toxoids Adsorbed
Sponsored by
About this trial
This is an interventional prevention trial for Tetanus focused on measuring trismus, lockjaw
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 90 years.
- Signed a written informed consent prior to initiation of any study-related procedures.
- No known primary immunization history with TT/dT or >10 years have passed since the last dose of tetanus containing vaccine was received. Subjects with unknown or uncertain previous vaccination histories are considered to have no previous tetanus and toxoid doses. Subjects who have had military service since 1941 will be considered to have had 1 dose of tetanus vaccine.
- Subjects must have documented tetanus antibody levels that are non-protective levels (< 0.15 IU/ml).
- Subjects must be free of any presenting wound or wound infection
Exclusion Criteria:
- History or suspicion of significant allergic reaction to intravenous immune globulin, and or blood products
- A history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
- Congestive heart failure (New York Association stage greater than Class II)
- Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
- Subjects who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
- TIG therapy within the previous six months
- Investigational drug therapy within the previous three months
- History of Thromboembolism
Sites / Locations
- Long Island Jewish Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Entered study
Arm Description
Outcomes
Primary Outcome Measures
Antibody titer serum level at each time point
Cmax
Tmax
Secondary Outcome Measures
Full Information
NCT ID
NCT00437671
First Posted
February 20, 2007
Last Updated
January 18, 2016
Sponsor
Grifols Therapeutics LLC
1. Study Identification
Unique Protocol Identification Number
NCT00437671
Brief Title
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
Official Title
Pharmacokinetics Of Active And Passive Tetanus Immunization Given Concurrently In Subjects With No Known Primary Immunization History Or In Subjects With Tetanus Antibody Levels Below Protective Levels
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Study terminated for cGCP non-compliance. Analyses could not be performed.
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grifols Therapeutics LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given concurrently with strict control on the anatomical location and timing of administration of TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate titer protection provided by TIG and TT given in combination will be assessed using a standardized administration regimen and standardized antibody assay procedure. This study may provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage for anyone with the potential of developing tetanus.
Detailed Description
This is a prospective, open-label, single-center trial including a single group of subjects with no known primary immunization history with TT or >10 years have passed since the last dose of tetanus containing vaccine was received. The study will enroll six subjects who would receive both dT and TIG concurrently on Day 1.
All dosed subjects will be followed for 40 days during which Day 1, 2, 3, 4, 5, 7, 14, 21, 30 and 40 time levels of tetanus antibodies will be measured in order to determine the serum level vs. time curve, Cmax, Tmax, and duration of protective antibody levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus
Keywords
trismus, lockjaw
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Entered study
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tetanus Immune Globulin (Human)
Other Intervention Name(s)
HyperTET S/D, BayTet, BAY 19-8515, TAL-05-00013, NDC 13533-634-02
Intervention Description
Based on package insert recommendation and recommendations of WHO
Intervention Type
Biological
Intervention Name(s)
Diphtheria-Tetanus Toxoids Adsorbed
Intervention Description
Based on package insert recommendations and recommendations of WHO
Primary Outcome Measure Information:
Title
Antibody titer serum level at each time point
Time Frame
40 days
Title
Cmax
Time Frame
40 days
Title
Tmax
Time Frame
40 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 90 years.
Signed a written informed consent prior to initiation of any study-related procedures.
No known primary immunization history with TT/dT or >10 years have passed since the last dose of tetanus containing vaccine was received. Subjects with unknown or uncertain previous vaccination histories are considered to have no previous tetanus and toxoid doses. Subjects who have had military service since 1941 will be considered to have had 1 dose of tetanus vaccine.
Subjects must have documented tetanus antibody levels that are non-protective levels (< 0.15 IU/ml).
Subjects must be free of any presenting wound or wound infection
Exclusion Criteria:
History or suspicion of significant allergic reaction to intravenous immune globulin, and or blood products
A history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
Congestive heart failure (New York Association stage greater than Class II)
Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
Subjects who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
TIG therapy within the previous six months
Investigational drug therapy within the previous three months
History of Thromboembolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kumar Alagappan, MD
Organizational Affiliation
Long Island Jewish Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
FDA approved labeling information
Available IPD/Information URL
http://www.talecris-pi.info/inserts/hypertet.pdf
Learn more about this trial
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
We'll reach out to this number within 24 hrs