A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine (NCT07495202) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine
China180 participantsStarted 2026-05-18
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 range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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.
. 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.