TetanusTETANUSNCT07446166
TETANUS Antibody Detection in Saliva Study
A study testing Point of care, saliva-based lateral flow test and Blood based immunoassay in people with Tetanus, run by University of Birmingham at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- Point of care, saliva-based lateral flow test and Blood based immunoassay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rwanda1 site
Center for Family Health Research
Kigali
Julien Nyombayire, +250 252 503 233, jnyombayire@rzhrg-mail.org
About this study
Official title: 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.
Read the 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)
- Conditions
- Tetanus
- Being tested
- Point of care, saliva-based lateral flow test, Blood based immunoassay
- Keywords
- point-of-care, Lateral Flow Test, Rapid Diagnostic, Immune Diagnostic
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care, saliva-based lateral flow testDiagnostic test
Measurement of anti-tetanus toxoid antibody concentration in saliva
Blood based immunoassayDiagnostic test
Measurement of anti-tetanus toxoid antibody concentration in blood
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will receive the same interventions. Receives: Diagnostic Test: Point of care, saliva-based lateral flow test; Diagnostic Test: Blood based immunoassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Secondary outcomes (4)
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.
Measured: Day 1
Serum anti-tetanus toxoid antibody concentration
Serum anti-tetanus toxoid antibody concentration as measured by bead-based multiplex assay.
Measured: 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.
Measured: Day 1
Vaccination history
Vaccination history either by electronic healthcare records, vaccination card or maternal recall.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Biomedical Centre, Center for Family Health Research/Projet San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446166
- Sponsor's protocol ID
- TETANUS
- Acronym
- TETANUS
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07446166
- Acronym / sponsor ID
- TETANUS / TETANUS
- Conditions
- Tetanus
- Keywords
- point-of-care, Lateral Flow Test, Rapid Diagnostic, Immune Diagnostic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Rwanda Biomedical Centre, Center for Family Health Research/Projet San Francisco
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Diagnostic Test: Point of care, saliva-based lateral flow test, Diagnostic Test: Blood based immunoassayAll participants will receive the same interventions. |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care, saliva-based lateral flow testMeasurement of anti-tetanus toxoid antibody concentration in saliva | Diagnostic test | All participants |
| Blood based immunoassayMeasurement of anti-tetanus toxoid antibody concentration in blood | Diagnostic test | All participants |
Primary outcome
The clinical diagnostic performance of the saliva-based lateral flow test in determining immune status as compared to bead-based multiplexed assay on serum.
Time frame: Day 1
Immune status according to the saliva-based lateral flow test. Any pigment on the test line will be interpreted as immune.
The clinical diagnostic performance of the saliva-based lateral flow test in determining immune status as compared to bead-based multiplexed assay on serum.
Time frame: Day 1
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.
4 secondary outcomes
Perspectives of healthcare workers and the public
Time frame: Day 1
Serum anti-tetanus toxoid antibody concentration
Time frame: Day 1
Serum antibody titres to other EPI vaccine antigens
Time frame: Day 1
Vaccination history
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care, saliva-based lateral flow test and Blood based immunoassay in people with Tetanus, run by University of Birmingham at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karishma Gokani (+44(0)121 414 4069, k.gokani@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical diagnostic performance of the saliva-based lateral flow test in determining immune status as compared to bead-based multiplexed assay on serum. (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.