TETANUS Antibody Detection in Saliva Study

NCT07446166 | Not Yet Recruiting

• 1 other identifier: TETANUS
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tetanus

Keywords

point-of-care; Lateral Flow Test; Rapid Diagnostic; Immune Diagnostic

Outcome Measures

Primary Outcomes (2)

• The clinical diagnostic performance of the saliva-based lateral flow test in determining immune status as compared to bead-based multiplexed assay on serum.

  Immune status according to the saliva-based lateral flow test. Any pigment on the test line will be interpreted as immune.

  Day 1

• The clinical diagnostic performance of the saliva-based lateral flow test in determining immune status as compared to bead-based multiplexed assay on serum.

  Immune status as measured on serum by bead-based multiplex assay. Antibody titres at or above the WHO antibody immune correlate for protection of 0.1 IU/mL will be classed as immune.

  Day 1

Secondary Outcomes (4)

• Perspectives of healthcare workers and the public

  Day 1

• Serum anti-tetanus toxoid antibody concentration

  Day 1

• Serum antibody titres to other EPI vaccine antigens

  Day 1

• Vaccination history

  Day 1

Study Arms (1)

All participants

EXPERIMENTAL

All participants will receive the same interventions.

Diagnostic Test: Point of care, saliva-based lateral flow test; Diagnostic Test: Blood based immunoassay

Interventions

Point of care, saliva-based lateral flow test DIAGNOSTIC_TEST

Measurement of anti-tetanus toxoid antibody concentration in saliva

All participants

Blood based immunoassay DIAGNOSTIC_TEST

Measurement of anti-tetanus toxoid antibody concentration in blood

All participants

Eligibility Criteria

• Age: 5 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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)

Sponsors & Collaborators

• University of Birmingham: lead
• Rwanda Biomedical Centre: collaborator
• Center for Family Health Research/Projet San Francisco: collaborator

Study Sites (1)

Center for Family Health Research

Kigali, Rwanda

Location

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Karishma Gokani

CONTACT

+44(0)121 414 4069; k.gokani@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting immediately after article publication and the data will be made accessible for up to 5 years. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a methodologically sound research proposal. Data must be required to achieve the aims in the approved proposal. Data requests should be directed to c.a.green.2@bham.ac.uk.

Locations

RW (1)