TETANUS Antibody Detection in Saliva Study
Starting soon · Not applicable
Conditions studied: Tetanus
In brief
This study aims to design, develop and optimise a non-invasive, saliva sample-based point-of-care lateral flow test for use in low and middle income settings that can return a qualitative result on whether an individual has or has not immunity to tetanus within 10-15mins. If successful, this approach would not require blood sampling or laboratory facilities, empower personalised decision making on vaccine needs and support the development of population level data-driven public health policies.
Key facts
- Study ID
- NCT07446166
- Run by
- University of Birmingham
- People needed
- 390
- Starts
- 2026-02-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 5 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- mean blood sampling has the potential for harm and/or
- affect immune response to a vaccine for example known/suspected impairment of immune function (with the exception of Group D)
Where it is running
- Center for Family Health Research — Kigali, Rwanda
Full record on ClinicalTrials.gov
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