Phase I Clinical Trial of Adsorbed Tetanus Vaccine

A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Adsorbed Tetanus Vaccine in Participants Aged ≥18 Years

This is a randomized, double-blind, parallel-controlled Phase I clinical trial of Adsorbed Tetanus Vaccine. Participants aged ≥18 years will receive one dose of the vaccine to evaluate its safety and immunogenicity.

Study Overview

• Status: Not yet recruiting
• Conditions: Tetanus
• Intervention / Treatment: Biological: Tetanus Vaccine, Adsorbed; Biological: Tetanus Vaccine, Adsorbed

Detailed Description

This trial will adopt a randomized, double-blind, parallel-controlled design. A total of 80 participants aged ≥18 years will be enrolled, with 40 participants in the 18-59 years group and 40 participants in the ≥60 years group. Participants in each age group will be randomized at a 1:1 ratio into the investigational vaccine group and the control vaccine group to receive one dose of investigational vaccine or control vaccine. Participants aged 18-59 years will be enrolled first and will receive a 7-day safety observation after vaccination. If the trial suspension criteria are not met, enrollment of participants aged ≥60 years will be initiated subsequently.

All participants will be observed for adverse events (AEs) within 30 days after vaccination, and for serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancy events within 6 months after vaccination. In addition, all participants will undergo complete blood count, blood biochemistry and routine urinalysis tests before vaccination and on Day 3 after vaccination.

All participants will have peripheral venous blood samples collected before vaccination and on Day 30 after vaccination to determine serum tetanus antibody levels.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Siquan Wang, Principal Investigator; Phone Number: +8618627961881; Email: 58935442@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Provincial Center for Disease Control and Prevention
      • Contact: Siquan Wang; Phone Number: +8618627961881; Email: 58935442@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participants aged ≥ 18 years.
2. Able to provide valid personal identification.
3. Able to provide their own informed consent, voluntarily participate in the trial, and sign the informed consent form; able to use a thermometer and ruler, and complete diary/contact cards as required.
4. Able to comply with the trial protocol, attend scheduled examinations, and cooperate with follow-up visits.

Exclusion Criteria:

The following criteria will be assessed during screening/enrollment. Participants meeting any of the following conditions will be excluded from the trial. (Participants meeting only the exclusion criteria marked with an asterisk (*) may be rescheduled for screening.)

1. History of confirmed tetanus infection.
2. Receipt of tetanus vaccine or vaccines containing tetanus toxoid component (such as DTaP, DT, or vaccines using tetanus toxoid as carrier) within 10 years; or administration of tetanus immunoglobulin (human or animal origin) within 6 months.
3. Axillary temperature > 37.0 ℃ on the day of vaccination before inoculation*.
4. Abnormal laboratory findings in complete blood count, blood biochemistry and routine urinalysis during the screening period, which are judged to be clinically significant by the investigator.
5. Presence of any acute disease or acute exacerbation of chronic disease within 3 days before vaccination.

6. Receipt of the following medications or vaccines before vaccination*:

   • Have used antipyretic, analgesic or anti-allergic drugs within 3 days before vaccination;
   • Have received inactivated vaccines, subunit vaccines or other non-live vaccines within 7 days (inclusive);
   • Have received live attenuated vaccines within 14 days (inclusive);
   • Have used blood products including gamma globulin or immunoglobulin therapy within 3 months;
   • Have used long-term (continuous use ≥ 14 days) immunosuppressants or other immunomodulatory drugs (e.g., corticosteroids such as prednisone or similar drugs) within 6 months; however, topical medications (e.g., ointments, eye drops, inhalants or nasal sprays) are permitted, provided the dose should not exceed the recommended dose in the product labeling.
7. Positive urine pregnancy test, inability to rule out pregnancy before vaccination, or breastfeeding status; For women of childbearing potential who are pre-menopausal: last menstrual period more than 1 month ago, or plan to become pregnant within 6 months after enrollment (applicable only to female participants of childbearing potential).
8. History of severe allergic diseases or severe adverse reactions to vaccines (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioneurotic edema, etc.), or allergy to any component of the investigational vaccine.
9. History of confirmed thrombocytopenia or other coagulation disorders that may constitute a contraindication to intramuscular injection.
10. History of congenital or acquired immunodeficiency or autoimmune diseases, such as autoimmune diseases (e.g., systemic lupus erythematosus), immunodeficiency (e.g., acquired immunodeficiency syndrome), lymphoma, leukemia, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other immune-related diseases or immunocompromised conditions that may interfere with trial evaluation as judged by the investigator.
11. Asplenia or functional asplenia, and asplenia or splenectomy caused by any conditions.
12. Presence of congenital malformations affecting organ function, developmental disorders, Down syndrome, sickle cell anemia, or any severe or potentially severe diseases that may interfere with trial completion; including but not limited to respiratory diseases such as asthma, uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), pulmonary diseases, cardiovascular and cerebrovascular diseases, hepatic and renal diseases, malignant tumors, type I diabetes, uncontrolled type Ⅱ diabetes, infectious or allergic skin diseases.
13. History of neurological diseases such as epilepsy, Parkinson's disease, Guillain-Barré syndrome, convulsions (excluding simple febrile seizures), or progressive neurological disorders.
14. Previous or current history of psychiatric/psychological disorders including dementia, schizophrenia, depression, autism, delusional disorder, abulia, bipolar disorder, etc.
15. Currently participating in or planning to participate in other clinical trials during this trial period.
16. Plan to permanently move from the local area before the end of the trial, or plan to leave the local area for a long period that will affect scheduled trial visits.
17. Any other condition that may interfere with the trial evaluation as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational vaccine group; Participants will receive one dose of the investigational vaccine.	Biological: Tetanus Vaccine, Adsorbed; This investigational vaccine is manufactured by AIM Persistence Biopharmaceutical Co., Ltd. Participants will receive one dose of adsorbed tetanus vaccine via intramuscular injection into the deltoid muscle of the upper arm.; Biological: Tetanus Vaccine, Adsorbed; This control vaccine is manufactured by Chengdu Olymvax Biopharmaceuticals Inc. Participants will receive one dose of adsorbed tetanus vaccine via intramuscular injection into the deltoid muscle of the upper arm.
Active Comparator: Control vaccine group; Participants will receive one dose of the control vaccine.	Biological: Tetanus Vaccine, Adsorbed; This investigational vaccine is manufactured by AIM Persistence Biopharmaceutical Co., Ltd. Participants will receive one dose of adsorbed tetanus vaccine via intramuscular injection into the deltoid muscle of the upper arm.; Biological: Tetanus Vaccine, Adsorbed; This control vaccine is manufactured by Chengdu Olymvax Biopharmaceuticals Inc. Participants will receive one dose of adsorbed tetanus vaccine via intramuscular injection into the deltoid muscle of the upper arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) and adverse reactions (ARs).	The incidence of AEs and ARs within 7 days after vaccination.	Within 7 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs and ARs.	The incidence of AEs and ARs within 30 days after vaccination.	Within 30 days after vaccination
Stratified incidence of AEs and ARs.	The incidence of AEs and ARs within 30 days after vaccination, stratified by injection site vs. non-injection site, severity, system organ class (SOC), and preferred term (PT).	Within 30 days after vaccination
Incidence of abnormal and clinically significant laboratory parameters.	The incidence of abnormal and clinically significant changes in laboratory parameters (including complete blood count, blood biochemistry, and routine urinalysis) on Day 3 after vaccination.	Day 3 after vaccination
The occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs).	The occurrence of SAEs and AESIs within 6 months after vaccination.	Within 6 months after vaccination
Rates of anti-tetanus antibody responses (seroconversion rate (SCR), seroprotection rate, and percentage of participants with anti-tetanus antibody ≥1.0 IU/mL).	The SCR, seroprotection rate, and percentage of participants with anti-tetanus antibody ≥1.0 IU/mL of serum tetanus antibody on Day 30 after vaccination in each group.	Day 30 after vaccination
Geometric mean concentration (GMC) of anti-tetanus antibody.	The GMC of serum anti-tetanus antibody on Day 30 after vaccination in each group.	Day 30 after vaccination
Geometric mean increase (GMI) of anti-tetanus antibody.	The GMI of serum anti-tetanus antibody on Day 30 after vaccination in each group.	Day 30 after vaccination

Collaborators and Investigators

• Sponsor: Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 21, 2026
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): March 21, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Tetanus; Biological Products; Complex Mixtures; Vaccines; Toxoids; Tetanus Toxoid
• Other Study ID Numbers: AIM-1804-I-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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