Bivalent Enterovirus Vaccine for Hand, Foot and Mouth Disease

Inactivated Bivalent Enterovirus Vaccine Phase I/II Clinical Trial: Open-Label Observation in Healthy Adults and Children, and Randomized, Double-Blind, Controlled Clinical Trial in Children

This study is testing a new vaccine for Hand, Foot and Mouth Disease to see if it is safe and effective for both healthy adults and children aged 6 months to 12 years.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 744 (estimated)
• Ages: 6 Months to 59 Years
• Sex: All
• Sponsor: Sinovac Biotech Co., Ltd (industry)
• Locations: 1 site (Chuxiong, Yunnan)
• Trial ID: NCT06063057 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of a bivalent inactivated enterovirus vaccine targeting Hand, Foot and Mouth Disease and Herpangina. It consists of two phases: the first part involves healthy adults and children aged 6-12 years receiving varying doses of the vaccine, while the second part focuses on younger children aged 6-71 months. Participants will receive two doses of the vaccine, and the study employs both open-label and randomized, double-blind methodologies to ensure robust data collection on safety and immunogenicity.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals aged 6 months to 59 years who meet the inclusion criteria.

Not a fit: Patients with a history of hand, foot, and mouth disease or those with severe allergies to vaccine components may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide effective protection against Hand, Foot and Mouth Disease and Herpangina in children and adults.

How similar studies have performed: Other studies on enterovirus vaccines have shown promise, but this specific bivalent approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Healthy participants aged 18-59 years, 6-12 years, and 6-71 months.
* Participants and/or their guardians can understand and voluntarily sign the informed consent form (participants aged 8-12 years require dual signatures from both participants and their guardians).
* Willing and able to comply with all visit schedules, sample collection, vaccine administration, and other trial procedures.
* Provide legal identification of the participants and/or their guardians.

Exclusion Criteria:

* History of hand, foot, and mouth disease or EV71 vaccination.
* Known severe allergy to the vaccine or vaccine components, such as urticaria, respiratory distress, and angioedema.
* Congenital abnormalities or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition, etc.
* Based on medical history and physical examination, the presence of severe chronic diseases, severe cardiovascular diseases, uncontrolled hypertension or diabetes, liver or kidney diseases, etc.
* Based on medical history and physical examination, the presence of autoimmune diseases, immunodeficiency diseases, and/or blood diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, thyroidectomy, autoimmune thyroid disease, any form of malignancy, asplenia, functional asplenia).
* Based on medical history and physical examination, abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or bleeding disorders.
* Based on medical history and physical examination, the presence of severe neurological diseases (epilepsy, convulsions, or seizures), mental illness, or corresponding family history.
* Long-term use (more than 14 days) of corticosteroids or other immunosuppressive agents (excluding corticosteroid sprays for allergic rhinitis and surface corticosteroid treatment for acute non-complicated dermatitis) or cytotoxic therapy or planning to receive such treatment during the trial.
* History of long-term alcohol abuse or drug abuse.
* Females who are breastfeeding, pregnant, or planning to become pregnant within 90 days, or females with positive pregnancy test results. Note: male participants whose spouse plans to become pregnant within 90 days are also included.
* Received immunoglobulin and/or other blood products in the past 3 months or planning to receive such treatment during the trial.
* Received other investigational drugs or vaccines within the past 30 days or planning to receive such drugs or vaccines during the trial.
* Vaccinated with attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days.
* Suspected or confirmed fever within 72 hours before vaccination or axillary temperature \>37.0℃ on the day of vaccination.
* Clinical laboratory testing shows laboratory abnormalities beyond the reference range and with clinical significance (applicable only to Phase I clinical trials for adults/6-12-year-old children/24-71-month-old children):

A. Complete blood count: white blood cell count, hemoglobin, platelet count.B. Blood biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose (Glu).C. Urine routine: urine protein (PRO).

* Any acute illness (with or without fever) or exacerbation of chronic illness within the past 7 days.
* According to the investigator's judgment, there are any other factors that make the participant unsuitable for participation in the clinical trial.

Where this trial is running

Chuxiong, Yunnan

• Dayao County Center for Disease Control and Prevention — Chuxiong, Yunnan, China (RECRUITING)

Study contacts

• Principal investigator: Zheng Yan — Yunnan Provincial Center for Disease Control and Prevention
• Study coordinator: Zeng Gang

Conditions: Hand, Foot and Mouth Disease, Herpangina, Inactivated enterovirus vaccine, Bivalent enterovirus vaccine