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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Henan Infectious Disease Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Hao Zhou, Bachelor
zhouhao5@sinopharm.com
86-021-62800991
Backup
Li
Time Frame
Start Date: 2025-01-22
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 120
Treatments
Experimental: Experimental group 1
Participants without a history of immunization against smallpox
Experimental: Experimental group 2
Participants without a history of immunization against smallpox
Experimental: Experimental group 3
Participants with a history of immunization against smallpox
Experimental: Experimental group 4
Participants with a history of immunization against smallpox
Placebo_comparator: Control group 1
Participants without a history of immunization against smallpox
Placebo_comparator: Control group 2
Participants with a history of immunization against smallpox
Related Therapeutic Areas
Sponsors
Leads: Shanghai Institute Of Biological Products

This content was sourced from clinicaltrials.gov