A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine

NCT06771479 | Recruiting Phase 1 DMC

• 1 other identifier: SIBP-V08-Ⅰ
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Monkeypox

Keywords

Monkeypox vaccine; safety; vaccine; immunogenicity; Monkeypox

Outcome Measures

Primary Outcomes (6)

• Immediate adverse events

  The occurrence of any adverse events within 60 minutes after each dose of vaccine immunization.

  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.

  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.

  28 or 30 days after each dose of vaccination

• Abnormal incidence rate of electrocardiogram

  Abnormal electrocardiogram after 14 days of vaccination with each dose.

  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.

  12 months after the last dose

• Adverse Event of Special Interest (AESI)

  Adverse events that require special attention as specified in the experimental protocol.

  12 months after the last dose

Other Outcomes (7)

• Geometric Mean Titer (GMT) of neutralizing antibodies

  14 days after the first dose of vaccine, before the second dose of vaccine and14 days, 28 days, 6 months, and 12 months after the second dose

• Seroconversion rate of neutralizing antibodies

  14 days after the first dose of vaccine, before the second dose of vaccine and14 days, 28 days, 6 months, and 12 months after the second dose

• Seropositive rate of neutralizing antibodies

  14 days after the first dose of vaccine, before the second dose of vaccine and14 days, 28 days, 6 months, and 12 months after the second dose

Study Arms (6)

Experimental group 1

EXPERIMENTAL

Participants without a history of immunization against smallpox

Biological: MVA strain monkeypox attenuated live vaccine (low dose)

Experimental group 2

EXPERIMENTAL

Participants without a history of immunization against smallpox

Biological: MVA strain monkeypox attenuated live vaccine (high dose)

Experimental group 3

EXPERIMENTAL

Participants with a history of immunization against smallpox

Biological: MVA strain monkeypox attenuated live vaccine (low dose)

Experimental group 4

EXPERIMENTAL

Participants with a history of immunization against smallpox

Biological: MVA strain monkeypox attenuated live vaccine (high dose)

Control group 1

PLACEBO COMPARATOR

Participants without a history of immunization against smallpox

Other: Placebo

Control group 2

PLACEBO COMPARATOR

Participants with a history of immunization against smallpox

Other: Placebo

Interventions

MVA strain monkeypox attenuated live vaccine (low dose) BIOLOGICAL

Low dose MVA strain monkeypox attenuated live vaccine

Experimental group 1; Experimental group 3

MVA strain monkeypox attenuated live vaccine (high dose) BIOLOGICAL

High dose MVA strain monkeypox attenuated live vaccine

Experimental group 2; Experimental group 4

Placebo OTHER

Vaccine excipient

Control group 1; Control group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Henan Infectious Disease Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

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

Study Officials

• Shuang Li, Master

  Henan Infectious Disease Hospital

  PRINCIPAL INVESTIGATOR

• Qingxia zhao, Bachelor

  Henan Infectious Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Zhou, Bachelor

CONTACT

86-021-62800991; zhouhao5@sinopharm.com

Li

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 22, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)