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Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673255
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : December 16, 2019
Sponsor:
Collaborators:
Hammond Clinical Trial Consulting, LLC
Axio Research. LLC
Information provided by (Responsible Party):
Biomat USA, Inc.

Brief Summary:

Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease.

The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis.

In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac).

The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days.

The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.


Condition or disease Intervention/treatment Phase
Healthy Biological: Tetanus and Diphtheria (Td) Vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program
Actual Study Start Date : August 22, 2016
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : July 29, 2019


Arm Intervention/treatment
Experimental: Sanofi Pasteur (Tenivac)
Tetanus and Diphtheria (Td) Vaccine, Manufacturer: Sanofi Pasteur (Tenivac), Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year.
Biological: Tetanus and Diphtheria (Td) Vaccine
Experimental: MassBiologics
Tetanus and Diphtheria (Td) Vaccine, Manufacturer: MassBiologics, Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year.
Biological: Tetanus and Diphtheria (Td) Vaccine



Primary Outcome Measures :
  1. Percentage of participants with a positive tetanus titer response following immunization [ Time Frame: Through study completion, average 18 months. ]
    A "positive response" is defined as a 4-fold increase if the pre-vaccination titer was less than or equal to 2.7IU/mL or a 2-fold increase if the pre-vaccination titer was greater than 2.7IU/mL


Secondary Outcome Measures :
  1. Number of participants experiencing vaccine-related adverse events [ Time Frame: Through study completion, average 18 months. ]
    Number of related adverse events will be compared with prescribing information for the vaccine and with historic data on adverse event rates among Normal Source plasma donors and Hyper-Immunized plasma donors. Severity grading of vaccine-related adverse events is based on a modified version of FDA guidance dated September 2007 titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials."



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female ≥18* years of age at Visit 1.
  2. Subject has met all suitability criteria that would allow donation as a Normal Source Plasma donor
  3. Subject has not been immunized for tetanus within the prior three (3) months
  4. Subject is not participating in any other immunization program
  5. Subject possesses a pre-existing antibody for tetanus of at least 0.15 IU/mL

Exclusion Criteria:

  1. Pregnant.
  2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  3. Subject has a hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.)
  4. Subject has history of a severe reaction to any immunization
  5. Subject has a history of Guillain-Barré Syndrome
  6. Subject is unable to read and/or write due to illiteracy or a physical impairment.
  7. The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for adverse event assessment

    • Or legal adult according to local law. Participants in NE limited to individuals age 19-69 years due to age of majority laws in NE.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673255


Locations
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United States, California
Biomat Bellflower
Bellflower, California, United States, 90706
United States, Nebraska
Biomat Lincoln
Lincoln, Nebraska, United States, 68510
United States, Tennessee
Biomat Clarksville
Clarksville, Tennessee, United States, 37042
United States, Utah
Biomat Salt Lake City 1
Salt Lake City, Utah, United States, 84116
Sponsors and Collaborators
Biomat USA, Inc.
Hammond Clinical Trial Consulting, LLC
Axio Research. LLC
Investigators
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Principal Investigator: Marilyn Rosa-Bray, MD Biomat USA, Inc. (Sponsor)
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Responsible Party: Biomat USA, Inc.
ClinicalTrials.gov Identifier: NCT02673255    
Other Study ID Numbers: GB-0115
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Biomat USA, Inc.:
Plasma
Plasma Donor
Plasma Donation
Tetanus
Td
Immunoglobulin
Hyper-immunization
Additional relevant MeSH terms:
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Tetanus
Diphtheria
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections