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

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.

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Key information

Conditions

Healthy Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections Tetanus

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biomat Bellflower, Bellflower, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnant.
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.
Subject has a hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.)
Subject has history of a severe reaction to any immunization
Subject has a history of Guillain-Barré Syndrome
Subject is unable to read and/or write due to illiteracy or a physical impairment.
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.

Treatment and study plan

Tetanus and Diphtheria (Td) Vaccine

Biological

Primary outcomes

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 outcomes

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."

Sponsors and collaborators

Lead sponsor

Biomat USA, Inc.

Industry

Collaborators

Axio Research. LLC
Hammond Clinical Trial Consulting, LLC

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Feb 3, 2016
Registry last updated: Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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