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New treatment option for Health Volunteer
Official title A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine
ClinicalTrials.gov ID: NCT07495202
What this study is testing
What is JT118 experimental group?
JT118 experimental group is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for health volunteer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Individuals whose pre-vaccination baseline assessments (including vital signs examination/physical examination/laboratory test/ECG) show clinically...
- 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.
See the full eligibility 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...
- 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.
- 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...
- Individuals whose pre-vaccination baseline assessments (including vital signs examination/physical examination/laboratory test/ECG) show clinically significant abnormalities where the investigator determines them...
- 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. 8 .Major surgery received within six months before receiving the first...
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.