Health VolunteerPhase 1NCT07495202
A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine
A Phase 1 study testing JT118 experimental group in people with Health Volunteer, run by Shanghai JunTop Biosciences Co., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer
- What is being tested?
- JT118 experimental group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 7 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Health Volunteer
- Being tested
- JT118 experimental group, JT118 placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JT118 experimental groupBiological
The vaccine was administered by Subcutaneous Injection
JT118 placebo groupBiological
The vaccine was administered by Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental：JT118 | Experimental | The vaccine was administered by Subcutaneous Injection Receives: Biological: JT118 experimental group |
| Placebo :JT118 | Experimental | The vaccine was administered by Subcutaneous Injection Receives: Biological: JT118 placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited adverse events Incidence Rate
Rate of solicited adverse events (Adverse event) occurring within 14 days after each dose of vaccination
Measured: up to 70 days
Unsolicited adverse events Incidence Rate
Incidence rate of unsolicited adverse events within 28 days after each dose of vaccination
Measured: up to 84 days
Incidence Rate of Laboratory Test Abnormal Findings
Incidence rate of Laboratory test abnormal 、Electrocardiogram abnormalities within 14 days after each vaccine dose
Measured: up to 70 days
Incidence Rate of Serious Adverse Events (SAE)
Incidence rate of serious adverse events (SAEs) within 12 months after the last dose
Measured: up to 416 days
Secondary outcomes (3)
Incidence of cellular immune responses (IFN-γ)
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.
Measured: up to 416 days
incidence o of binding antibodies
The production status of binding antibodies 28 days after each vaccination dose.
Measured: up to 84 days
incidence o of Neutralising antibodies
The production status of Neutralising antibodies 28 days after each vaccination dose.
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start18 May 2026
- Primary completion7 Nov 2027 (estimated)
- Study completion7 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JunTop Biosciences Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495202
- Sponsor's protocol ID
- JT118-001-I
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07495202
- Acronym / sponsor ID
- JT118-001-I
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai JunTop Biosciences Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 7 Nov 2027 (estimated)
- Study completion
- 7 Nov 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental：JT118 | Experimental | Biological: JT118 experimental groupThe vaccine was administered by Subcutaneous Injection |
| Placebo :JT118 | Experimental | Biological: JT118 placebo groupThe vaccine was administered by Subcutaneous Injection |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JT118 experimental groupThe vaccine was administered by Subcutaneous Injection | Biological | Experimental：JT118 |
| JT118 placebo groupThe vaccine was administered by Subcutaneous Injection | Biological | Placebo :JT118 |
Primary outcome
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
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
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
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
3 secondary outcomes
Incidence of cellular immune responses (IFN-γ)
Time frame: up to 416 days
incidence o of binding antibodies
Time frame: up to 84 days
incidence o of Neutralising antibodies
Time frame: up to 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JT118 experimental group in people with Health Volunteer, run by Shanghai JunTop Biosciences Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited adverse events Incidence Rate (time frame: up to 70 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.