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Spit test could replace needles for tetanus check

NCT ID NCT07446166

Diagnosis Sponsor: University of Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to create a quick, non-invasive test using saliva to see if someone has enough antibodies to fight tetanus. Instead of drawing blood, a small saliva sample on a test strip would give results in 10-15 minutes. The test is designed for low- and middle-income areas where lab access is limited, helping people know if they need a vaccine booster. About 390 healthy volunteers, including children, adults, and pregnant women, will take part to see how well the saliva test matches standard blood tests.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Able and willing to provide informed consent to take part in the study; either directly or from a parent/guardian, where appropriate * \[Group A\] Aged 5-10 years inclusive, and determined as healthy by a member of the study team * \[Group B\] Aged 18-25yrs inclusive, and determined as healthy by a member of the study team * \[Group C\] Currently pregnant at any stage of pregnancy, prior to receipt of a tetanus booster vaccine in pregnancy, and determined as healthy by a member of the study team and safe to provide a blood sample * \[Group D\] Adults aged 18-45 years with one or more of the medical conditions that may affect antibody response to vaccination. Exclusion Criteria: * Participants or parents/guardians unwilling or unable to provide informed consent to take part * Unwilling or unable to comply with study procedures * Have a bleeding disorder deemed significant by study doctor * \[Groups A, B and C only\] Any health condition which, in the opinion of a study physician which could 1. mean blood sampling has the potential for harm and/or 2. affect immune response to a vaccine for example known/suspected impairment of immune function (with the exception of Group D)

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Conditions

The condition(s) this trial relates to.

tetanus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tetanus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Family Health Research

    Kigali, Rwanda

More trials for these conditions

Other studies related to the condition(s) this trial covers.