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

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

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Antibody titer serum level at each time point


Condition

Tetanus

Intervention

Tetanus Immune Globulin (Human)

Study Arms / Comparison Groups

 Entered study
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

6

Start Date

March 2007

Completion Date

September 2007

Primary Completion Date

September 2007

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
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kumar Alagappan, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00437671

Organization ID

060002


Responsible Party

Sponsor

Study Sponsor

Grifols Therapeutics LLC


Study Sponsor

Kumar Alagappan, MD, Principal Investigator, Long Island Jewish Medical Center


Verification Date

January 2016