Phase I Clinical Trial of Adsorbed Tetanus Vaccine

NCT07598890 | Not Yet Recruiting Phase 1

• 1 other identifier: AIM-1804-I-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tetanus Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of AEs and ARs.

  Within 30 days after vaccination

• Stratified incidence of AEs and ARs.

  Within 30 days after vaccination

• Incidence of abnormal and clinically significant laboratory parameters.

  Day 3 after vaccination

• The occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs).

  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).

  Day 30 after vaccination

Study Arms (2)

Investigational vaccine group

EXPERIMENTAL

Participants will receive one dose of the investigational vaccine.

Biological: Tetanus Vaccine, Adsorbed

Control vaccine group

ACTIVE COMPARATOR

Participants will receive one dose of the control vaccine.

Biological: Tetanus Vaccine, Adsorbed

Interventions

Tetanus Vaccine, Adsorbed BIOLOGICAL

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.

Investigational vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged ≥ 18 years.
• Able to provide valid personal identification.
• 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.
• Able to comply with the trial protocol, attend scheduled examinations, and cooperate with follow-up visits.

You may not qualify if:

• History of confirmed tetanus infection.
• 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.
• Axillary temperature \> 37.0 ℃ on the day of vaccination before inoculation\*.
• 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.
• Presence of any acute disease or acute exacerbation of chronic disease within 3 days before vaccination.
• 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.
• 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).
• 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.
• History of confirmed thrombocytopenia or other coagulation disorders that may constitute a contraindication to intramuscular injection.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

Tetanus Toxoid

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Siquan Wang, Principal Investigator

CONTACT

+8618627961881; 58935442@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 20, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): March 21, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)