MonkeypoxPhase 1NCT06771479
A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine
A Phase 1 study testing MVA strain monkeypox attenuated live vaccine (low dose) and MVA strain monkeypox attenuated live vaccine (high dose) in people with Monkeypox, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
This is a randomized, double blinded, controlled phase I clinical study. To evaluate the safety and immunogenicity of receiving two doses of MVA strain monkeypox attenuated live vaccine in individuals aged 18 years and above. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monkeypox
- What is being tested?
- MVA strain monkeypox attenuated live vaccine (low dose) and MVA strain monkeypox attenuated live vaccine (high dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2025to 30 May 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- On the day of enrollment, individuals aged 18 years or older with a history of smallpox vaccination must have been born before 1980;
- Can provide legal proof of identity;
- Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment;
- Be able to participate in all planned follow-up visits and comply with all trial procedures (such as completing diary/contact cards and being able to return for visits);
- On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature);
- Men and women of childbearing age who have no plans to have children within 6 months and agree to take effective contraceptive measures within 6 months after receiving the experimental vaccine.
Who cannot join
- Individuals with a history of smallpox, monkeypox, or close contact with monkeypox in the past;
- Individuals who are allergic to any ingredients of eggs, vaccines, or substances used in production processes, or have a history of other severe allergies;
- Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period;
- Currently using salicylate drugs or planning long-term use during the trial period;
- Have used any experimental or unregistered products within one month prior to administering the trial vaccine, or plan to use them during the trial period;
- Administer inactivated vaccine within 14 days before administering the experimental vaccine or attenuated live vaccine within 30 days before administering the experimental vaccine;
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- Chronic disease patients are in the acute or progressive phase of chronic disease;
- Long term use of immunosuppressants or other immunomodulatory drugs within 6 months prior to vaccination with the experimental vaccine;
- Having undergone chemotherapy or radiation therapy or organ and bone marrow transplantation related treatments for cancer or other diseases;
- Diseases or medical measures that lead to immune dysfunction, such as congenital immunodeficiency, organ and bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma or malignant tumors, etc;
- Moderate or severe acute illness/infection, or febrile illness on the day of vaccination;
- Individuals with a history of thrombocytopenia or other coagulation disorders may be contraindicated for subcutaneous injection;
- Suffering from serious cardiovascular disease, serious liver and kidney disease, and diabetes that cannot be controlled by drugs;
- Previous history of mental or neurological disorders or family history;
- Currently suffering from various infectious, suppurative, and allergic skin diseases;
- Women of childbearing age: pregnant or lactating, or with a positive blood pregnancy test;
- Plan to move before the end of the trial or leave the local area for a long time during the scheduled trial visit;
- Abnormal blood routine, blood biochemistry, urine routine, electrocardiogram or heart disease related indicators before vaccination (except for minor abnormalities judged by doctors to have no clinical significance);
- Researchers believe that any situation that may affect the evaluation of the experiment;
- Active tuberculosis patients;
- For HIV infected individuals, the plasma HIV-1 RNA level during screening should be ≥ 200 copies/mL, or positive test for hepatitis B, hepatitis C and syphilis;
- For healthy people and men and women who have sex with each other, hepatitis B, hepatitis C, syphilis and HIV) are positive;
- Individuals who experience severe allergic reactions after the first dose of vaccination;
- Serious adverse events that are definitely related to the first dose of vaccination;
- For those who are newly discovered or occur after the first dose of vaccination and do not meet the inclusion criteria or the exclusion criteria for the first dose, the researcher shall determine whether to continue participating in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Li contact
China1 site, 1 recruiting
- Recruiting
Henan Infectious Disease Hospital
Zhengzhou, Henan
Shuang Li, 8613938529645, li36918@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine for Individuals Aged 18 and Above
This is a randomized, double blinded, controlled phase I clinical study. To evaluate the safety and immunogenicity of receiving two doses of MVA strain monkeypox attenuated live vaccine in individuals aged 18 years and above.
Read the detailed description
This is a randomized, double blinded, controlled phase I clinical study. The study plans to recruit 120 participants aged 18 years and above. The experimental vaccine MVA strain monkeypox attenuated live vaccine has two different doses (low dose and high dose). The ratio of low-dose experimental group, high-dose experimental group, and placebo group is 1:1:1. Participants will be divided into three groups: healthy individuals, men who have sex with men, and HIV infected individuals, with a ratio of 2:1:1. Different groups will be divided into individuals with a history of vaccination against smallpox and those without a history of immunization, based on whether each population has a history of vaccination against smallpox. Each participant will receive one dose of the experimental vaccine or placebo on day 0 and day 28, respectively.
- Conditions
- Monkeypox
- Being tested
- MVA strain monkeypox attenuated live vaccine (low dose), MVA strain monkeypox attenuated live vaccine (high dose), Placebo
- Keywords
- Monkeypox vaccine, safety, vaccine, immunogenicity, Monkeypox
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA strain monkeypox attenuated live vaccine (low dose)Biological
Low dose MVA strain monkeypox attenuated live vaccine
MVA strain monkeypox attenuated live vaccine (high dose)Biological
High dose MVA strain monkeypox attenuated live vaccine
PlaceboOther
Vaccine excipient
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Participants without a history of immunization against smallpox Receives: Biological: MVA strain monkeypox attenuated live vaccine (low dose) |
| Experimental group 2 | Experimental | Participants without a history of immunization against smallpox Receives: Biological: MVA strain monkeypox attenuated live vaccine (high dose) |
| Experimental group 3 | Experimental | Participants with a history of immunization against smallpox Receives: Biological: MVA strain monkeypox attenuated live vaccine (low dose) |
| Experimental group 4 | Experimental | Participants with a history of immunization against smallpox Receives: Biological: MVA strain monkeypox attenuated live vaccine (high dose) |
| Control group 1 | Placebo comparator | Participants without a history of immunization against smallpox Receives: Other: Placebo |
| Control group 2 | Placebo comparator | Participants with a history of immunization against smallpox Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate adverse events
The occurrence of any adverse events within 60 minutes after each dose of vaccine immunization.
Measured: 60 minutes after each dose of vaccination
Solicited Adverse Events
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Measured: 14 days after each dose of vaccination
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Measured: 28 or 30 days after each dose of vaccination
Abnormal incidence rate of electrocardiogram
Abnormal electrocardiogram after 14 days of vaccination with each dose.
Measured: 14 days after each dose of vaccination
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Measured: 12 months after the last dose
Adverse Event of Special Interest (AESI)
Adverse events that require special attention as specified in the experimental protocol.
Measured: 12 months after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start22 Jan 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuang Li, Master, Principal investigator, Henan Infectious Disease HospitalQingxia zhao, Bachelor, Principal investigator, Henan Infectious Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771479
- Sponsor's protocol ID
- SIBP-V08-Ⅰ
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine for Individuals Aged 18 and Above
- ClinicalTrials.gov ID
- NCT06771479
- Acronym / sponsor ID
- SIBP-V08-Ⅰ
- Conditions
- Monkeypox
- Keywords
- Monkeypox vaccine, safety, vaccine, immunogenicity, Monkeypox
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 13 Jan 2025 (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 is a randomized, double blinded, controlled phase I clinical study. To evaluate the safety and immunogenicity of receiving two doses of MVA strain monkeypox attenuated live vaccine in individuals aged 18 years and above.
Detailed description
This is a randomized, double blinded, controlled phase I clinical study. The study plans to recruit 120 participants aged 18 years and above. The experimental vaccine MVA strain monkeypox attenuated live vaccine has two different doses (low dose and high dose). The ratio of low-dose experimental group, high-dose experimental group, and placebo group is 1:1:1. Participants will be divided into three groups: healthy individuals, men who have sex with men, and HIV infected individuals, with a ratio of 2:1:1. Different groups will be divided into individuals with a history of vaccination against smallpox and those without a history of immunization, based on whether each population has a history of vaccination against smallpox. Each participant will receive one dose of the experimental vaccine or placebo on day 0 and day 28, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Biological: MVA strain monkeypox attenuated live vaccine (low dose)Participants without a history of immunization against smallpox |
| Experimental group 2 | Experimental | Biological: MVA strain monkeypox attenuated live vaccine (high dose)Participants without a history of immunization against smallpox |
| Experimental group 3 | Experimental | Biological: MVA strain monkeypox attenuated live vaccine (low dose)Participants with a history of immunization against smallpox |
| Experimental group 4 | Experimental | Biological: MVA strain monkeypox attenuated live vaccine (high dose)Participants with a history of immunization against smallpox |
| Control group 1 | Placebo comparator | Other: PlaceboParticipants without a history of immunization against smallpox |
| Control group 2 | Placebo comparator | Other: PlaceboParticipants with a history of immunization against smallpox |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- On the day of enrollment, individuals aged 18 years or older with a history of smallpox vaccination must have been born before 1980;
- Can provide legal proof of identity;
- Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment;
- Be able to participate in all planned follow-up visits and comply with all trial procedures (such as completing diary/contact cards and being able to return for visits);
- On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature);
Key exclusion criteria (25 listed)
- Individuals with a history of smallpox, monkeypox, or close contact with monkeypox in the past;
- Individuals who are allergic to any ingredients of eggs, vaccines, or substances used in production processes, or have a history of other severe allergies;
- Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period;
- Currently using salicylate drugs or planning long-term use during the trial period;
- Have used any experimental or unregistered products within one month prior to administering the trial vaccine, or plan to use them during the trial period;
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 |
|---|---|---|
| MVA strain monkeypox attenuated live vaccine (low dose)Low dose MVA strain monkeypox attenuated live vaccine | Biological | Experimental group 1, Experimental group 3 |
| MVA strain monkeypox attenuated live vaccine (high dose)High dose MVA strain monkeypox attenuated live vaccine | Biological | Experimental group 2, Experimental group 4 |
| PlaceboVaccine excipient | Other | Control group 1, Control group 2 |
Primary outcome
Immediate adverse events
Time frame: 60 minutes after each dose of vaccination
The occurrence of any adverse events within 60 minutes after each dose of vaccine immunization.
Solicited Adverse Events
Time frame: 14 days after each dose of vaccination
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Unsolicited Adverse Events
Time frame: 28 or 30 days after each dose of vaccination
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Abnormal incidence rate of electrocardiogram
Time frame: 14 days after each dose of vaccination
Abnormal electrocardiogram after 14 days of vaccination with each dose.
Serious Adverse Events (SAE)
Time frame: 12 months after the last dose
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Adverse Event of Special Interest (AESI)
Time frame: 12 months after the last dose
Adverse events that require special attention as specified in the experimental protocol.
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 3 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Monkeypox
Active, not recruitingPhase 1
A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine
Health Volunteer
RecruitingObservational study
Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
Mpox (Monkeypox), Mpox
Enrolling by invitationObservational study
New York City Observational Study of Mpox Immunity
Monkeypox, Mpox
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
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.
Li contact
Shuang Li, Master principal investigator
Henan Infectious Disease Hospital
Qingxia zhao, Bachelor principal investigator
Henan Infectious Disease Hospital
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 MVA strain monkeypox attenuated live vaccine (low dose) and MVA strain monkeypox attenuated live vaccine (high dose) in people with Monkeypox, run by Shanghai Institute Of Biological Products 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 6 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Hao Zhou, Bachelor (86-021-62800991, zhouhao5@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate adverse events (time frame: 60 minutes after each dose of vaccination). The study lists 6 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 3 Oct 2025.