Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | March 2007 |
| End Date: | September 2007 |
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
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.
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.
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.
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.
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
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Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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