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

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.

Study Overview

• Status: Terminated
• Conditions: Tetanus
• Intervention / Treatment: Drug: Tetanus Immune Globulin (Human); Biological: Diphtheria-Tetanus Toxoids Adsorbed

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Entered study	Drug: Tetanus Immune Globulin (Human); Based on package insert recommendation and recommendations of WHO; Other Names: HyperTET S/D; BayTet; BAY 19-8515; TAL-05-00013; NDC 13533-634-02; Biological: Diphtheria-Tetanus Toxoids Adsorbed; Based on package insert recommendations and recommendations of WHO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antibody titer serum level at each time point	40 days
Cmax	40 days
Tmax	40 days

Collaborators and Investigators

• Sponsor: Grifols Therapeutics LLC
• Investigators: Principal Investigator: Kumar Alagappan, MD, Long Island Jewish Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: February 20, 2007
• First Submitted That Met QC Criteria: February 20, 2007
• First Posted (Estimate): February 21, 2007

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 18, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: trismus; lockjaw
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Neurologic Manifestations; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Tetanus; Tetany; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: 060002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No