TetanusPhase 1NCT06123663
A Study to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population Aged 18 Years and Over
A Phase 1 study testing TTVA and TT in people with Tetanus, run by CanSino Biologics Inc. at 1 site in China.
Trial summary
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups, Subjects who gave informed consent and passed the questioning screen were randomly assigned 1:1 to be immunized with 1 dose of Tetanus Vaccine, Adsorbed (TTVA) or control vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- TTVA and TT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 18 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older, able to provide valid proof of identity for himself/herself.
- Ability to understand the requirements and process of the study and to agree to participate in the clinical trial and to sign an informed consent form.
- Ability to comply with the requirements of the clinical trial protocol and complete all follow-up studies.
Who cannot join
- Previously diagnosed tetanus infection.
- Vaccination against tetanus or vaccines containing tetanus toxoid antigen components (e.g., DPT, DPT, RCV, etc.) within 5 years.
- Axillary temperature >37.0°C on the day of enrollment.
- Women with a positive urine pregnancy test or during pregnancy or breastfeeding.
- Women of childbearing age, male volunteers and male volunteers whose partner is a woman of childbearing age have a pregnancy plan or birth plan during the study period.
- Persons suffering from thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy that may contraindicate intramuscular injection.
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- Suffering from serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, serious infectious or allergic skin diseases, hypertension that cannot be controlled by medication (at the time of on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), and being in the period of acute disease or chronic disease activity within 7 days.
- History of severe neurological disorders such as epilepsy, convulsions, encephalopathy, or history of psychiatric disorders.
- Previous history of severe allergy to vaccination or medication (anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction), etc.).
- Allergy to certain components of the vaccine used in this clinical trial (mainly tetanus toxoid, aluminum hydroxide, sodium chloride, etc.) or allergy to the above components from previous vaccination.
- Known or suspected immunological abnormalities (e.g., HIV infection, history of thyroid, pancreas, liver, spleen, kidney disease or resection), immunosuppressive therapy, cytotoxic therapy, systemic glucocorticosteroid medication (≥14 days) within 6 months prior to enrollment (excluding spray corticosteroid therapy for allergic rhinitis, surface corticosteroid therapy for acute uncomplicated dermatitis, etc.) topical medications).
- Received blood products (whole blood, component blood, immune globulin, etc.) in the previous 3 months or plan to use such products within 1 month of vaccination.
- Vaccination with live attenuated vaccine within 14 days, subunit vaccine or inactivated vaccine within 7 days.
- Plans to participate or is participating in clinical studies of any other drug.
- Abnormalities in preimmunization blood counts and blood biochemistry that are judged by the investigator to be clinically significant.
- Any circumstances that, in the judgment of the researcher, are likely to influence the assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Center for Disease Control and Prevention, Qixingguan District, Bijie City
Bijie, Guizhou
About this study
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups, Subjects who gave informed consent and passed the questioning screen were randomly assigned 1:1 to be immunized with 1 dose of Tetanus Vaccine, Adsorbed (TTVA) or control vaccine.
Read the detailed description
Tetanus can be prevented with tetanus toxoid-containing vaccines (TT-containing vaccines, TTCVs), which are included globally in routine immunization programs for children, and in many countries at the time of prenatal care. China eliminated neonatal tetanus in 2012, but non-neonatal tetanus remains a serious public health problem. TT vaccine was first produced in 1924 and is used as a single antigen vaccine and combination vaccine component to prevent other vaccine-preventable diseases, including diphtheria, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b (Hib), and other vaccine-preventable diseases. Haemophilus influenzae type b (Hib)
- Conditions
- Tetanus
- Being tested
- TTVA, TT
- Keywords
- Vaccine, Positive-controlled, Safety, ≥18 years
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTVABiological
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
TTBiological
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Tetanus Vaccine, Adsorbed (TTVA) | Experimental | 1 dose of (TTVA) (0.5ml) Receives: Biological: TTVA |
| Tetanus Vaccine, Adsorbed (TT) | Active comparator | 1 dose of (TT) (0.5ml) Receives: Biological: TT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions (AR) in subjects
Measured: 0-30 days after immunization
Secondary outcomes (5)
Incidence of AR
Measured: 30 minutes after immunization
Incidence of adverse events (AE)
Measured: 0-30 days after immunization
Incidence of AR/AE
Measured: 0-7 days post-immunization
Proportion of laboratory safety indicators with clinically significant changes (CS), including hemoglobin level (HGB), white blood cell count (WBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBIL)
Measured: Day 8 post-immunization
Incidence of serious adverse events (SAEs)
Measured: 6 months post-immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start20 Dec 2023
- Primary completion23 Jan 2024
- Study completion18 Jun 2024
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.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiguang Lei, Principal investigator, Guizhou Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123663
- Sponsor's protocol ID
- CTP-TTVA-001
- Status last verified
- Oct 2023
- First submitted
- 1 Nov 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population Aged 18 Years and Over
- ClinicalTrials.gov ID
- NCT06123663
- Acronym / sponsor ID
- CTP-TTVA-001
- Conditions
- Tetanus
- Keywords
- Vaccine, Positive-controlled, Safety, ≥18 years
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 9 Nov 2023 (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 is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups, Subjects who gave informed consent and passed the questioning screen were randomly assigned 1:1 to be immunized with 1 dose of Tetanus Vaccine, Adsorbed (TTVA) or control vaccine.
Detailed description
Tetanus can be prevented with tetanus toxoid-containing vaccines (TT-containing vaccines, TTCVs), which are included globally in routine immunization programs for children, and in many countries at the time of prenatal care. China eliminated neonatal tetanus in 2012, but non-neonatal tetanus remains a serious public health problem. TT vaccine was first produced in 1924 and is used as a single antigen vaccine and combination vaccine component to prevent other vaccine-preventable diseases, including diphtheria, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b (Hib), and other vaccine-preventable diseases. Haemophilus influenzae type b (Hib)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetanus Vaccine, Adsorbed (TTVA) | Experimental | Biological: TTVA1 dose of (TTVA) (0.5ml) |
| Tetanus Vaccine, Adsorbed (TT) | Active comparator | Biological: TT1 dose of (TT) (0.5ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older, able to provide valid proof of identity for himself/herself.
- Ability to understand the requirements and process of the study and to agree to participate in the clinical trial and to sign an informed consent form.
- Ability to comply with the requirements of the clinical trial protocol and complete all follow-up studies.
Key exclusion criteria (16 listed)
- Previously diagnosed tetanus infection.
- Vaccination against tetanus or vaccines containing tetanus toxoid antigen components (e.g., DPT, DPT, RCV, etc.) within 5 years.
- Axillary temperature >37.0°C on the day of enrollment.
- Women with a positive urine pregnancy test or during pregnancy or breastfeeding.
- Women of childbearing age, male volunteers and male volunteers whose partner is a woman of childbearing age have a pregnancy plan or birth plan during the study period.
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 |
|---|---|---|
| TTVAIntramuscular injection, 1 dose of 0.5ml inoculated on Day 0 | Biological | Tetanus Vaccine, Adsorbed (TTVA) |
| TTIntramuscular injection, 1 dose of 0.5ml inoculated on Day 0 | Biological | Tetanus Vaccine, Adsorbed (TT) |
Primary outcome
Incidence of adverse reactions (AR) in subjects
Time frame: 0-30 days after immunization
5 secondary outcomes
Incidence of AR
Time frame: 30 minutes after immunization
Incidence of adverse events (AE)
Time frame: 0-30 days after immunization
Incidence of AR/AE
Time frame: 0-7 days post-immunization
Proportion of laboratory safety indicators with clinically significant changes (CS), including hemoglobin level (HGB), white blood cell count (WBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBIL)
Time frame: Day 8 post-immunization
Incidence of serious adverse events (SAEs)
Time frame: 6 months post-immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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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. This study is not recruiting at the moment.
Shiguang Lei principal investigator
Guizhou Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTVA and TT in people with Tetanus, run by CanSino Biologics Inc. at 1 site in China.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 29 Nov 2024. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (AR) in subjects (time frame: 0-30 days after immunization). 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 29 Nov 2024.