Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine

NCT07326878 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: EV71-CA16-101
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine in subjects ( aged 6 months to 59 years ).

Conditions

Hand, Foot and Mouth Disease (HFMD); HFMD; Hand, Foot and Mouth Disease

Outcome Measures

Primary Outcomes (1)

• Safety index - incidence of adverse events

  Incidence of adverse events after each dose vaccination

  0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after each dose

Secondary Outcomes (5)

• Safety index - incidence of serious adverse events

  From the beginning of the vaccination up to12 months after the last vaccination completed

• Immunogenicity index-Seroconversion rates

  Between baseline and Day 28 after full vaccination

• Immunogenicity index - Geometric mean titer (GMT)

  Day 28 after full vaccination

• Immunogenicity index - Geometric mean fold increases (GMFI)

  Between baseline and Day 28 after full vaccination

• Immunogenicity index-Seropositive rates

  Day 28 after full vaccination

Study Arms (4)

low-dose experimental group

EXPERIMENTAL

Participants aged 18\~59 years old, 6\~17years old, 6months old\~5 years old

Biological: Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)

medium-dose experimental group

EXPERIMENTAL

Participants aged 18\~59 years old, 6\~17years old, 6months old\~5 years old

Biological: Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)

high-dose experimental group

EXPERIMENTAL

Participants aged 18\~59 years old, 6\~17years old, 6months old\~5 years old

Biological: High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)

Placebo control group

PLACEBO COMPARATOR

Participants aged 18\~59 years old, 6\~17years old, 6months old\~5 years old

Biological: Placebo

Interventions

Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell) BIOLOGICAL

Low-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

low-dose experimental group

Placebo BIOLOGICAL

Placebo，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

Placebo control group

Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell) BIOLOGICAL

Medium-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

medium-dose experimental group

High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell) BIOLOGICAL

High-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

high-dose experimental group

Eligibility Criteria

• Age: 6 Months - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age Requirement: volunteers aged 6 months and 59 years.
• Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
• Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
• \~23months old: term delivery (gestational week 37 weeks \~ 42 weeks at birth), 2500g ≤ birth weight ≤ 4000g.
• Requirements for contraception: agree to take contraception actions in 12 months.
• Temperature Requirement: axillary body temperature is less than 37.3°C.

You may not qualify if:

• Subjects who have been allergic to any component of the vaccine in the past, or have any history of vaccine allergy or suspected allergy or other serious adverse reactions, such as urticaria, respiratory distress, and angioedema.
• History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment.
• Subjects with convulsion, epilepsy, encephalopathy, psychiatric history or family history.
• Known to have serious congenital malformations, developmental disorders, genetic defects or abnormal growth and development, or clinically diagnosed serious chronic diseases, including but not limited to neurological, cardiovascular, blood and lymphatic system, immune system, kidney, liver, gastrointestinal, respiratory system, metabolism and bone diseases and a history of malignant tumors.
• Subjects are acutely ill or in the acute phase of a chronic illness within 3 days before vaccination.
• Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.
• Subjects who intolerance to venipuncture and with a history of needle- or blood-induced syncope.
• History of surgical removal of the spleen or other vital organs for any reason.
• Donation or loss of blood (≥400 mL), receipt of blood products, or receipt of blood transfusion within the 3 months before enrollment.
• Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study.
• Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure.
• History of any EV71 antigen-containing vaccination, whether commercially available or investigational.
• Subjects with history of hand, foot, and mouth disease.
• Subjects with abnormal vital signs with clinical significance.
• Subjects who do not meet the criteria for good health based on comprehensive physical examination, including: (1) abnormal vital signs with clinical significance; (2) clinical laboratory testing shows laboratory abnormalities and with clinical significance (applicable only to subjects aged 2 years and above).

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• The Second Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xian Yu

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Longding Liu

CONTACT

0871-68334551; liuld@imbcams.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The dose escalation principle within each age group is from low to high doses, the sequential enrollment principle between different age groups is from adults to children.

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)