A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine (NCT07495202) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine
China180 participantsStarted 2026-03-30
Plain-language summary
This study is a randomized, double-blind, placebo-controlled Phase I clinical trial representing the first-in-human (FIH) investigation of the Monkeypox recombinant protein vaccine JT118. The primary objectives are to evaluate the safety, tolerability, and immunogenicity of two doses of JT118 in healthy adults and to conduct preliminary exploration of vaccination regimens.
The study will sequentially proceed from the low-dose group to the high-dose group with Subgroup 1 (participants without prior Smallpox vaccination history) and Subgroup 2 (participants with prior Smallpox vaccination history) being conducted concurrently within each dose group. It will explore single-dose, two-dose, and three-dose vaccination regimens with approximately 180 healthy adult participants planned for enrollment.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. Male or female participants aged 18 to 59 years (inclusive) at the time of signing the informed consent form.
✓. Participants with fertility (including male participants) and their spouses are willing to avoid pregnancy (including sperm donation and egg donation plans) from 14 days before screening until six months after the last administration of the investigational vaccine, and are willing to use effective contraception.
✓. Ability to understand the study procedures, sign a written informed consent form, and complete the study according to the protocol requirements.
✓. Body temperature \<37.3°C (axillary temperature) on the day of enrollment.
Exclusion criteria
✕. Individuals with a history of Smallpox infection or Monkeypox infection or close contact with individuals infected with Monkeypox.
✕. Individuals whose medical history or clinical evidence indicates presence of significant comorbidities (including but not limited to cardiovascular system disorders; respiratory system disorders; digestive system disorders; urinary system disorders; neurological disorders; hematological disorders; immunological disorders; endocrine/metabolic disorders; infectious diseases; psychiatric/psychological disorders) where the investigator determines them unsuitable for enrollment.
What they're measuring
1
Solicited adverse events Incidence Rate
Timeframe: up to 70 days
2
Unsolicited adverse events Incidence Rate
Timeframe: up to 84 days
3
Incidence Rate of Laboratory Test Abnormal Findings
✕. Individuals whose pre-vaccination baseline assessments (including vital signs examination/physical examination/laboratory test/ECG) show clinically significant abnormalities where the investigator determines them unsuitable for enrollment.
✕. Individuals testing positive for human immunodeficiency virus antibody/HBV surface antigen (HBsAg)/HCV virus antibody/Syphilis spirochete antibody .
✕. Individuals who have previously received an approved or investigational Monkeypox vaccine.
✕. Use of any immunosuppressive drugs within 28 days before the first dose.
✕. Receipt of an inactivated vaccine within 14 days before the first dose or receipt of a live attenuated vaccine within 30 days before the first dose.