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Tests treatment safety and results for Monkeypox
Official title A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine
ClinicalTrials.gov ID: NCT06771479
What this study is testing
What is MVA strain monkeypox attenuated live vaccine (low dose)?
MVA strain monkeypox attenuated live vaccine (low dose) is an investigational medicine, being studied as a potential treatment for monkeypox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature);
You likely can't join 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...
- 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...
- Administer inactivated vaccine within 14 days before administering the experimental vaccine or attenuated live vaccine within 30 days before...
See the full eligibility criteria
- 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.
- 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;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.