Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00437671
• Other study ID #: 060002
• Status: Terminated
• Phase: Phase 4
• First received: February 20, 2007
• Last updated: January 18, 2016
• Start date: March 2007
• Est. completion date: September 2007

Study information

• Verified date: January 2016
• Source: Grifols Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tetanus

Intervention

Drug:
• Tetanus Immune Globulin (Human)
Based on package insert recommendation and recommendations of WHO

Biological:
• Diphtheria-Tetanus Toxoids Adsorbed
Based on package insert recommendations and recommendations of WHO

Locations

Country	Name	City	State
United States	Long Island Jewish Medical Center	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Grifols Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titer serum level at each time point		40 days	No
Primary	Cmax		40 days	No
Primary	Tmax		40 days	No