Can extra tdap shots boost Life-Saving plasma?
NCT ID NCT05662852
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study looks at whether giving the Tdap vaccine every 3 months for a year is safe for healthy plasma donors. Normally, this vaccine is given once every 10 years. The goal is to see if more frequent vaccination produces high levels of tetanus antibodies in the plasma, which could be used to make treatments for infections. Participants will receive five vaccinations over 12 months and be monitored for side effects and antibody levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tdap vaccine (tetanus, diphtheria, and acellular pertussis)
- What this could lead to
- If safe, this could allow more frequent Tdap vaccination in plasma donors, potentially boosting antibody-rich plasma for treating infections.
- What could go wrong
- This is a small, early-phase study. Giving the vaccine more often than recommended may cause unexpected side effects or weaker immune responses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
107 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 63 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female ages 18 to 63 years * Females of childbearing potential who agree to employ highly effective birth control measures during the study * Signed the informed consent form (ICF) * Met all of the criteria required to be a Normal Source Plasma donor * Subject is not participating in any other immunization program * Subject has not had a Tdap vaccination in the last 90 days before the first study vaccination Exclusion Criteria: * Subject is pregnant * Subject has a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data * Subject has repeated reactions or hypersensitivity to components in the vaccine * Subject has history of a severe reaction to any immunization * Subject has a history of Guillain-Barré Syndrome * The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for AE assessment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ABO Plasma
Glassboro, New Jersey, 08028, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.