Tetanus
Conditions
Brief summary
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.
Interventions
DRUGSNA02-48
IM gluteal injection
IM gluteal injection
Sponsors
Sinovac Life Sciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| 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
| 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 |
Countries
China
Contacts
CONTACTChuanlin Wang, MD
Outcome results
None listed