TETANUS Antibody Detection in Saliva Study (TETANUS)

Development of Novel Diagnostics That Use Point-of-care Lateral Flow Testing Technology for Non-invasive, Individual Assessment of Antibody Protection to Tetanus and Vaccine Need

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tetanus
• Intervention / Treatment: Diagnostic test: Point of care, saliva-based lateral flow test; Diagnostic test: Blood based immunoassay

Detailed Description

The development of non-invasive point-of-care (POC) diagnostic testing for the detection of protective immunity to tetanus would empower LMICs to identify immunity gaps and individuals who are a priority for vaccination and generate sero-epidemiology models for future public health decision around tetanus control. Given tetanus antigen is included as polyvalent vaccine formulations for infants as part of the WHO EPI schedule for LMICS, the absence of anti-tetanus toxoid antibody might also indicate missed vaccine doses that would have conferred protection to other infectious diseases.

This is a cross-sectional, non-interventional, biological sampling study. This study will be conducted at the Center for Family Health Research in Kigali, Rwanda, in collaboration with Rwanda Biomedical Centre, the national health implementation agency for Rwanda, and the University of Birmingham, United Kingdom. WHO/UNICEF estimates DTP3 coverage in Rwanda at 97% following extensive SIA activity after vaccination coverage dropped to 88% in 2021. Rwanda hosts a significant number of refugees (135,000 at the end of April 2024), nearly half of these are children and many are from the Democratic Republic of the Congo where only just over half of children are fully immunised.

The overall aim of this study is to assess the real-world performance and the diagnostic clinical accuracy of a novel, saliva-based, point-of-care lateral flow test in determining the immune status to tetanus for individuals in Rwanda.

Participants will be recruited from the following groups:

• Group A: Healthy children aged 5-10 years (n=250)
• Group B: Healthy younger adults aged 18-25 years (n=35)
• Group C: Healthy pregnant women (n=30)
• Group D: Adults with known immune suppression (see table 1) aged 18-45 years (n=75)

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karishma Gokani; Phone Number: +44(0)121 414 4069; Email: k.gokani@bham.ac.uk

Study Locations

• Rwanda
  • Kigali, Rwanda
    • Center for Family Health Research
    • Contact: Julien Nyombayire; Phone Number: +250 252 503 233; Email: jnyombayire@rzhrg-mail.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; All participants will receive the same interventions.	Diagnostic test: Point of care, saliva-based lateral flow test; Measurement of anti-tetanus toxoid antibody concentration in saliva; Diagnostic test: Blood based immunoassay; Measurement of anti-tetanus toxoid antibody concentration in blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perspectives of healthcare workers and the public	Perceptions and acceptability of this approach from healthcare workers and members of the public around using a novel salivary point-of-care lateral flow test for tetanus and vaccination decisions. This will be determined by thematic analysis of transcripts from focus groups of 5-15 people who have either been a participant in the study or helped with delivery of the study.	Day 1
Serum anti-tetanus toxoid antibody concentration	Serum anti-tetanus toxoid antibody concentration as measured by bead-based multiplex assay.	Day 1
Serum antibody titres to other EPI vaccine antigens	Serum antibody titres to diptheria, haemophilus influenzae, hepatitis B and measles as measured by multiplex assay or enzyme-linked immunosorbent assay.	Day 1
Vaccination history	Vaccination history either by electronic healthcare records, vaccination card or maternal recall.	Day 1

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Rwanda Biomedical Centre; Center for Family Health Research/Projet San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: point-of-care; Lateral Flow Test; Rapid Diagnostic; Immune Diagnostic
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Tetanus
• Other Study ID Numbers: TETANUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study are not openly available to protect the confidentiality of study participants. Fully anonymised data are, however, available from the authors upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No