Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo

NCT07253675 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SIBP-V08-02
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Monkeypox (Mpox)

Keywords

Monkeypox; vaccine; safety; immunogenicity

Outcome Measures

Primary Outcomes (7)

• Unsolicited adverse events

  An unsolicited AE is any AE reported in addition to those solicited during the clinical study.

  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.

  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.

  Day 8 after each dose

• Serious Adverse Events(SAEs)

  To evaluate the incidence of SAE after vaccination.

  Day 365 after the first dose

• Adverse Events of Special Interest(AESIs)

  To evaluate the incidence of AESI after vaccination.

  Day 365 after the first dose

• Medically Attended Adverse Events(MAAEs)

  To evaluate the incidence of MAAE after vaccination.

  Day 365 after the first dose

• Grade 3+ related adverse events

  Grade 3+ incidence of adverse events related to vaccination.

  Day 28 after each dose

Secondary Outcomes (4)

• Plaque Reduction Neutralization Test(PRNT) Geometric Mean Titers(GMT) of vaccinia

  Day 0, 28, 56, 181, 365

• PRNTest GMTof mpox

  Day 0, 28, 56, 181, 365

• Seroconversion rate of vaccinia

  Day 28, 56, 181, 365

• Seroconversion rate of mpox

  Day 28, 56, 181, 365

Study Arms (3)

Experimental group 1

EXPERIMENTAL

MVA-SIBP low dose: low dose monkeypox vaccine produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP)

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)

Biological: MVA-SIBP high dose

Control group

ACTIVE COMPARATOR

MVA-BN: monkeypox vaccine produced by Bavarian Nordic(BN)

Biological: MVA-BN

Interventions

MVA-SIBP low dose BIOLOGICAL

Participants received one subcutaneous dose of 0.5ml MVA-SIBP low dose on days 0 and 28, respectively, for a total of two doses.

Experimental group 1

MVA-SIBP high dose BIOLOGICAL

Participants received one subcutaneous dose of 0.5ml MVA-SIBP high dose on days 0 and 28, respectively, for a total of two doses.

Experimental group 2

MVA-BN BIOLOGICAL

Participants received one subcutaneous dose of 0.5ml MVA-BN low dose on days 0 and 28, respectively, for a total of two doses.

Control group

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Hypolite Muhindo Mavoko

  University of Kinshasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Chen

CONTACT

+862162800991; ddchen.sh@sinopharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share