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

NCT02673255 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-07-20

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Tetanus and Diphtheria (Td) Vaccine

Sponsors & Collaborators

  • Hammond Clinical Trial Consulting, LLC

    collaborator UNKNOWN

  • Axio Research. LLC

    collaborator INDUSTRY

  • Biomat USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Marilyn Rosa-Bray, MD · Biomat USA, Inc. (Sponsor)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-22
Primary Completion
2019-07-29
Completion
2019-07-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02673255 on ClinicalTrials.gov