A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine

June 3, 2026 updated by: Shanghai JunTop Biosciences Co., LTD

A Phase I Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Monkeypox Protein Vaccine JT118 in Healthy Adults.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518112
        • Recruiting
        • Shenzhen Third People's Hospital
        • Principal Investigator:
          • Hongzhou Lu, Ph.D
        • Contact:
        • Contact:
          • PP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female participants aged 18 to 59 years (inclusive) at the time of signing the informed consent form.
  2. 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.
  3. Ability to understand the study procedures, sign a written informed consent form, and complete the study according to the protocol requirements.
  4. Body temperature <37.3°C (axillary temperature) on the day of enrollment.

Exclusion Criteria:

  1. Individuals with a history of Smallpox infection or Monkeypox infection or close contact with individuals infected with Monkeypox.
  2. 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.
  3. 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.
  4. Individuals testing positive for human immunodeficiency virus antibody/HBV surface antigen (HBsAg)/HCV virus antibody/Syphilis spirochete antibody .
  5. Individuals who have previously received an approved or investigational Monkeypox vaccine.
  6. Use of any immunosuppressive drugs within 28 days before the first dose.
  7. 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 dose or anticipated major surgery during study participation.

9. Blood donation history (excluding physiological female bleeding) or significant haemorrhage (≥200 mL) within three months prior to receiving the first dose; or planned blood donation (including component blood donation) within one hundred eighty days after last vaccination.

10. Use of immunoglobulins and/or any blood products within three months prior to receiving initial vaccination; or planned use during trial participation.

11 .Participants who have used any investigational or unregistered products (including drugs, vaccines, biologics, or devices) within 3 months prior to receiving the first dose of study medication, or plan to use such products during the study period.

12. Participants with known allergy to any excipient(s) of this product. 13 .Participants with extensive scars or skin disorders at potential injection sites.

14 .Women who are pregnant or lactating/breastfeeding. 15 .Participants with a history of drug abuse within 12 months prior to screening OR positive drug screen results before randomization.

16. History of alcohol dependence within 6 months prior to screening, or positive alcohol breath test result before randomization.

17. Participants deemed unsuitable for participation by investigators due to other reasons (e.g., presence of concomitant medical conditions/history, poor compliance).

18 .Participants who experienced a severe allergic reaction after administration of the first or second dose* of vaccination.

19. Participants who experienced a serious adverse event (SAE) likely or definitely related to investigational vaccine following administration of first/second dose*, with decision on continued participation made by investigators.

20. Participants who failed initial dose eligibility criteria (inclusion/exclusion) following administration of first/second dose*, with decision on continued participation made by investigators .

21 .Presence of any other medical condition considered unsuitable for vaccination by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental：JT118
The vaccine was administered by Subcutaneous Injection
Biological: JT118 experimental group
The vaccine was administered by Subcutaneous Injection
Experimental: Placebo :JT118
The vaccine was administered by Subcutaneous Injection
Biological: JT118 placebo group
The vaccine was administered by Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Solicited adverse events Incidence Rate
Time Frame: up to 70 days
Rate of solicited adverse events (Adverse event) occurring within 14 days after each dose of vaccination
up to 70 days
Unsolicited adverse events Incidence Rate
Time Frame: up to 84 days
Incidence rate of unsolicited adverse events within 28 days after each dose of vaccination
up to 84 days
Incidence Rate of Laboratory Test Abnormal Findings
Time Frame: up to 70 days
Incidence rate of Laboratory test abnormal 、Electrocardiogram abnormalities within 14 days after each vaccine dose
up to 70 days
Incidence Rate of Serious Adverse Events (SAE)
Time Frame: up to 416 days
Incidence rate of serious adverse events (SAEs) within 12 months after the last dose
up to 416 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of cellular immune responses (IFN-γ)
Time Frame: up to 416 days
Cellular Immune Response (IFN-γ) Status at Days 14 and Day 28 Post-Vaccination Per Dose，Participants were followed up for a period of 12 months after their last vaccination, and the durability of the immune response to JT-007 was monitored.
up to 416 days
incidence o of binding antibodies
Time Frame: up to 84 days
The production status of binding antibodies 28 days after each vaccination dose.
up to 84 days
incidence o of Neutralising antibodies
Time Frame: up to 84 days
The production status of Neutralising antibodies 28 days after each vaccination dose.
up to 84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai JunTop Biosciences Co., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JT118-001-I

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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