TETANUS Antibody Detection in Saliva Study

ConditionTetanus

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age5-45

SponsorUniversity of Birmingham

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Point of care, saliva-based lateral flow test
Blood based immunoassay

Treatment groups

390 Participants

are divided into 1 treatment group

Sponsors and collaborators

University of Birmingham

Lead sponsor

Rwanda Biomedical Centre

Collaborator

Center for Family Health Research/Projet San Francisco

Collaborator

Source ClinicalTrials.gov