Monkeypox (Mpox)Phase 2NCT07253675
Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo
A Phase 2 study testing MVA-SIBP low dose, MVA-SIBP high dose and MVA-BN in people with Monkeypox (Mpox), run by Shanghai Institute Of Biological Products.
Trial summary
To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC). Read more about this study
- Who is it for?
- Ages 2 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Monkeypox (Mpox)
- What is being tested?
- MVA-SIBP low dose, MVA-SIBP high dose and MVA-BN
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 28 Feb 2027
- Phase
- Phase 2
- 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 2 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults: 18 to 45 years inclusive at the time of informed consent. Adolescents: 12 to 17 years inclusive at the time of consent/assent. Children: 2 to 11 years inclusive at the time of consent/assent.
- Participant is in good general health as determined by medical history, targeted physical examination, and clinical judgment of the investigator.
- Adults: Able to read and understand the written informed consent, and willing to comply with all study procedures and availability for the entire study duration. Adolescents: Parent(s) or legally acceptable representative(s) able and willing to provide written informed consent; participant able and willing to provide appropriate assent per local regulations and IRB requirements. Children: Parent(s) or legally acceptable representative(s), with the relationship to the child similarly verified and documented on the consent form, and able and willing to provide written informed consent.
- Willing and able to comply with all study procedures, visit schedule, and follow-up requirements as judged by the investigator.
- No history of smallpox or mpox vaccination. No history of confirmed or suspected infection with monkeypox, cowpox, or vaccinia virus.
- Negative serum or urine pregnancy test at screening and prior to each vaccination. Willing to use highly effective contraception from 30 days prior to first vaccination through 60 days after the last dose. Breastfeeding.
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- Resides in the study catchment area and has no plans to relocate for the duration of the study. Has reliable access to a telephone and/or other means of contact.
- Adults must have been born in 1980 or later. Able to provide direct written informed consent.
- Adolescents: Able to provide written or written assent as appropriate. Children: Parent(s)/guardian(s) able to provide written informed consent; child able to provide assent if developmentally appropriate.
Who cannot join
- Any prior smallpox or mpox vaccination. History of confirmed or suspected infection with monkeypox, cowpox, or vaccinia virus.
- Close contact, as defined by WHO.
- Known or suspected immunocompromised state as specified in the protocol.
- Acute febrile illness (≥38.0°C) or clinically significant infection within 72 hours prior to vaccination. Any acute illness requiring systemic therapy or hospitalization within 14 days prior to enrollment.
- History of severe allergy or anaphylaxis to any vaccine or vaccine component. History of severe allergic asthma or asthmatic reactions.
- Pregnant or breastfeeding at screening or planning to become pregnant during the study period.
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- Participation in another clinical trial with an investigational product or vaccine within 6 months prior to enrollment or planned during the study.
- Receipt of any live vaccine within 28 days or inactivated vaccine within 14 days prior to enrollment or planned within 28 days after any study vaccination.
- Any medical disease or condition that, in the opinion of the investigator, would place the participant at unacceptable risk, interfere with study objectives, or compromise protocol compliance.
- Blood transfusion within three months before inclusion. Significant laboratory test result abnormalities should be added as exclusion criteria. Any condition that, in the opinion of the investigator, would preclude safe participation or successful completion of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 2 Double-Blind, Randomized, Controlled Study of MVA-SIBP Vaccine for Mpox in Age De-escalation in the Democratic Republic of the Congo
To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC).
Read the detailed description
Given the urgent need for pediatric data and the high burden of mpox in the DRC, this trial will evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, DRC. The trial is designed to generate critical data to support regulatory approval and broader access to affordable, stable, and scalable mpox vaccines for Africa.
- Conditions
- Monkeypox (Mpox)
- Being tested
- MVA-SIBP low dose, MVA-SIBP high dose, MVA-BN
- Keywords
- Monkeypox, vaccine, safety, immunogenicity
- 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-SIBP low doseBiological
Participants received one subcutaneous dose of 0.5ml MVA-SIBP low dose on days 0 and 28, respectively, for a total of two doses.
MVA-SIBP high doseBiological
Participants received one subcutaneous dose of 0.5ml MVA-SIBP high dose on days 0 and 28, respectively, for a total of two doses.
MVA-BNBiological
Participants received one subcutaneous dose of 0.5ml MVA-BN low dose on days 0 and 28, respectively, for a total of two doses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | MVA-SIBP low dose: low dose monkeypox vaccine produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) Receives: Biological: MVA-SIBP low dose |
| Experimental group 2 | Experimental | MVA-SIBP high dose: high dose monkeypox vaccine produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) Receives: Biological: MVA-SIBP high dose |
| Control group | Active comparator | MVA-BN: monkeypox vaccine produced by Bavarian Nordic(BN) Receives: Biological: MVA-BN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsolicited adverse events
An unsolicited AE is any AE reported in addition to those solicited during the clinical study.
Measured: Day 28 after each dose
Solicited local adverse events
That is frequency of occurrence of events pain, erythema, swelling, induration, pruritus at injection site and recorded by memory aid.
Measured: Day 8 after each dose
Solicited systemic adverse events
That is frequency of occurrence of events headache, fatigue, myalgia, fever, chills, nausea and recorded by memory aid.
Measured: Day 8 after each dose
Serious Adverse Events(SAEs)
To evaluate the incidence of SAE after vaccination.
Measured: Day 365 after the first dose
Adverse Events of Special Interest(AESIs)
To evaluate the incidence of AESI after vaccination.
Measured: Day 365 after the first dose
Medically Attended Adverse Events(MAAEs)
To evaluate the incidence of MAAE after vaccination.
Measured: Day 365 after the first dose
Grade 3+ related adverse events
Grade 3+ incidence of adverse events related to vaccination.
Measured: Day 28 after each dose
Secondary outcomes (4)
Plaque Reduction Neutralization Test(PRNT) Geometric Mean Titers(GMT) of vaccinia
Neutralizing antibody titer by PRNT against vaccinia virus.
Measured: Day 0, 28, 56, 181, 365
PRNTest GMTof mpox
Neutralizing antibody titer by PRNT against mpox virus.
Measured: Day 0, 28, 56, 181, 365
Seroconversion rate of vaccinia
Seroconversion rate is ≥4-fold rise in PRNT titer vs. baseline.
Measured: Day 28, 56, 181, 365
Seroconversion rate of mpox
Seroconversion rate is ≥4-fold rise in PRNT titer vs. baseline.
Measured: Day 28, 56, 181, 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start31 Dec 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monkeypox (Mpox)Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hypolite Muhindo Mavoko, Principal investigator, University of Kinshasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253675
- Sponsor's protocol ID
- SIBP-V08-02
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Double-Blind, Randomized, Controlled Study of MVA-SIBP Vaccine for Mpox in Age De-escalation in the Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT07253675
- Acronym / sponsor ID
- SIBP-V08-02
- Conditions
- Monkeypox (Mpox)
- Keywords
- Monkeypox, vaccine, safety, immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 28 Nov 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.
To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC).
Detailed description
Given the urgent need for pediatric data and the high burden of mpox in the DRC, this trial will evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, DRC. The trial is designed to generate critical data to support regulatory approval and broader access to affordable, stable, and scalable mpox vaccines for Africa.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Biological: MVA-SIBP low doseMVA-SIBP low dose: low dose monkeypox vaccine produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) |
| Experimental group 2 | Experimental | Biological: MVA-SIBP high doseMVA-SIBP high dose: high dose monkeypox vaccine produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) |
| Control group | Active comparator | Biological: MVA-BNMVA-BN: monkeypox vaccine produced by Bavarian Nordic(BN) |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Adults: 18 to 45 years inclusive at the time of informed consent. Adolescents: 12 to 17 years inclusive at the time of consent/assent. Children: 2 to 11 years inclusive at the time of consent/assent.
- Participant is in good general health as determined by medical history, targeted physical examination, and clinical judgment of the investigator.
- Adults: Able to read and understand the written informed consent, and willing to comply with all study procedures and availability for the entire study duration. Adolescents: Parent(s) or legally acceptable representative(s) able and willing to provide written informed consent; participant able and willing to provide appropriate assent per local regulations and IRB requirements. Children: Parent(s) or legally acceptable representative(s), with the relationship to the child similarly verified and documented on the consent form, and able and willing to provide written informed consent.
- Willing and able to comply with all study procedures, visit schedule, and follow-up requirements as judged by the investigator.
- No history of smallpox or mpox vaccination. No history of confirmed or suspected infection with monkeypox, cowpox, or vaccinia virus.
Key exclusion criteria (10 listed)
- Any prior smallpox or mpox vaccination. History of confirmed or suspected infection with monkeypox, cowpox, or vaccinia virus.
- Close contact, as defined by WHO.
- Known or suspected immunocompromised state as specified in the protocol.
- Acute febrile illness (≥38.0°C) or clinically significant infection within 72 hours prior to vaccination. Any acute illness requiring systemic therapy or hospitalization within 14 days prior to enrollment.
- History of severe allergy or anaphylaxis to any vaccine or vaccine component. History of severe allergic asthma or asthmatic reactions.
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-SIBP low doseParticipants received one subcutaneous dose of 0.5ml MVA-SIBP low dose on days 0 and 28, respectively, for a total of two doses. | Biological | Experimental group 1 |
| MVA-SIBP high doseParticipants received one subcutaneous dose of 0.5ml MVA-SIBP high dose on days 0 and 28, respectively, for a total of two doses. | Biological | Experimental group 2 |
| MVA-BNParticipants received one subcutaneous dose of 0.5ml MVA-BN low dose on days 0 and 28, respectively, for a total of two doses. | Biological | Control group |
Primary outcome
Unsolicited adverse events
Time frame: Day 28 after each dose
An unsolicited AE is any AE reported in addition to those solicited during the clinical study.
Solicited local adverse events
Time frame: Day 8 after each dose
That is frequency of occurrence of events pain, erythema, swelling, induration, pruritus at injection site and recorded by memory aid.
Solicited systemic adverse events
Time frame: Day 8 after each dose
That is frequency of occurrence of events headache, fatigue, myalgia, fever, chills, nausea and recorded by memory aid.
Serious Adverse Events(SAEs)
Time frame: Day 365 after the first dose
To evaluate the incidence of SAE after vaccination.
Adverse Events of Special Interest(AESIs)
Time frame: Day 365 after the first dose
To evaluate the incidence of AESI after vaccination.
Medically Attended Adverse Events(MAAEs)
Time frame: Day 365 after the first dose
To evaluate the incidence of MAAE after vaccination.
Grade 3+ related adverse events
Time frame: Day 28 after each dose
Grade 3+ incidence of adverse events related to vaccination.
4 secondary outcomes
Plaque Reduction Neutralization Test(PRNT) Geometric Mean Titers(GMT) of vaccinia
Time frame: Day 0, 28, 56, 181, 365
PRNTest GMTof mpox
Time frame: Day 0, 28, 56, 181, 365
Seroconversion rate of vaccinia
Time frame: Day 28, 56, 181, 365
Seroconversion rate of mpox
Time frame: Day 28, 56, 181, 365
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 28 Nov 2025.
- 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.
Hypolite Muhindo Mavoko principal investigator
University of Kinshasa
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-SIBP low dose, MVA-SIBP high dose and MVA-BN in people with Monkeypox (Mpox), run by Shanghai Institute Of Biological Products.
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dandan Chen (+862162800991, ddchen.sh@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unsolicited adverse events (time frame: Day 28 after each dose). The study lists 7 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 28 Nov 2025.