A Phase Ⅲ Clinical Study of SNA02-48 Injection

A Multicenter, Randomized, Double-Blind, Active-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of SNA02-48 Injection in Populations With High-Risk Tetanus Exposure

The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.

Study Overview

• Status: Not yet recruiting
• Conditions: Tetanus
• Intervention / Treatment: Drug: SNA02-48; Drug: Human tetanus immunoglobulin (HTIG)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chuanlin Wang, MD; Phone Number: +86 13911883012; Email: wangchuanlinvip@163.com

Study Locations

• China
  • Anhui
    • Fuyang, Anhui, China, 236699
      • Taihe County People's Hospital
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospital Affiliated to Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510150
      • The Third Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510900
      • The Fifth Affiliated Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510440
      • Guangzhou Eighth People's Hospital, Guangzhou Medical University
    • Shenzhen, Guangdong, China, 518025
      • Shenzhen Second People's Hospital
    • Shenzhen, Guangdong, China, 518100
      • Longhua District People's Hospital of Shenzhen
  • Guangxi
    • Liuzhou, Guangxi, China, 545000
      • Liuzhou Worker's Hospital
    • Liuzhou, Guangxi, China, 545200
      • Liuzhou people's Hospital
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Affiliated Hospital of Zunyi Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
  • Hunan
    • Hengyang, Hunan, China, 421010
      • Affiliated Nanhua Hospital, University of South China
  • Jiangsu
    • Taizhou, Jiangsu, China, 225300
      • Taizhou People's Hospital
    • Yangzhou, Jiangsu, China, 225000
      • Affiliated Hospital of Yangzhou University
    • Zhenjiang, Jiangsu, China, 212013
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • The Second Affiliated Hospital of Nanchang University
    • Pingxiang, Jiangxi, China, 337000
      • Pingxiang People's Hospital
  • Shandong
    • Weifang, Shandong, China, 261000
      • Weifang People's Hospital
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Linfen Central Hospital
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
    • Yuncheng, Shanxi, China, 044099
      • Yuncheng Central Hospital, Shanxi Province
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Zhejiang
    • Lishui, Zhejiang, China, 323020
      • Lishui Central Hospital
    • Ningbo, Zhejiang, China, 315000
      • Ningbo Medical Center Li Huili Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or females aged 18 years and above;
2. Participants who can understand and voluntarily sign the informed consent form;
3. Participants with high-risk tetanus exposure;
4. Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures from the time the participant signs the informed consent form until 6 months after administration, with no plans for sperm or egg donation.

Exclusion Criteria:

1. Suspected or confirmed tetanus ;
2. A history of previous tetanus infection;
3. A known history of 3 or more doses of tetanus toxoid or vaccines containing tetanus toxoid, or fewer than 3 previous doses but with the last dose of tetanus toxoid or vaccines containing tetanus toxoid administered within 6 months prior to the administration of the investigational product;
4. Known hypersensitivity to the investigational product (including excipients, HTIG, and other therapeutic monoclonal antibodies), or suffering from severe allergic diseases that, in the investigator's judgment, may impair the participant's safety; Other protocol defined Inclusion/Exclusion criteria may apply.

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
Active Comparator: Human tetanus immunoglobulin (HTIG); If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG	Drug: Human tetanus immunoglobulin (HTIG); IM gluteal injection
Experimental: SNA02-48; If randomized to SNA02-48, participant will receive a single IM gluteal injection of SNA02-48	Drug: SNA02-48; IM gluteal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.	Baseline up to 12 hours after receipt of study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of tetanus	Up to 105 days after receipt of study drug
anti-tetanus neutralizing antibody titers	Up to 90 days after receipt of study drug
Incidence of adverse events	Up to 105 days after receipt of study drug
Incidence of severe adverse events (SAEs)	Up to 105 days after receipt of study drug
To evaluate the plasma concentration of SNA02-48	Up to 90 days after receipt of study drug
Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab)	Up to 90 days after receipt of study drug

Collaborators and Investigators

• Sponsor: Sinovac Life Sciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 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
• Other Study ID Numbers: PRO-SNA02-48-3001

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