Hand, Foot and Mouth Disease (HFMD)Phase 1NCT07326878

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

A Phase 1 study testing Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell), Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell) and High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell) in people with Hand, Foot and Mouth Disease (HFMD) and HFMD, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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 ). Read more about this study

Who is it for?: Ages 6 months to 59 yearsHealthy volunteers can take part
Conditions the study is for: Hand, Foot and Mouth Disease (HFMD), HFMD, Hand, Foot and Mouth Disease
What is being tested?: Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell), Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell) and High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 1 siteChina
Study dates: 30 Dec 2025to 15 Aug 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 59 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.
6~23months 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.

Who cannot join

Subjects meeting any of the following exclusion criteria will be not eligible for enrollment.
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.

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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).
Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc.
Females with positive pregnancy test results.
Females who are lactating, or subjects who plan to conceive or to donate sperm or ova from the time of signing the informed consent form until 12 months after completion of the full vaccination schedule (applicable only to subjects aged 18 to 59 years).
Subjects with a history of abnormal birth delivery, birth asphyxia, neurological impairment, or clinically diagnosed pathological jaundice (applicable only to subjects aged 6 to 23 months).
Subjects deemed by the investigator to be unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Longding Liu contact

0871-68334551 ext. +86

liuld@imbcams.com.cn

China1 site

The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Xian Yu, 023-62888378 ext. +86, 22168398@qq.com

Other trials in China

About this study

Official title: A Single-center, Randomized, Double-blind, and Placebo Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine in People Aged 6 Months to 59 Years

Read the detailed description

This is a single-center, randomized, double-blinded, placebo-controlled phase I clinical trial in which three dose levels of the Enterovirus Type71 -Coxsackievirus Type A16 bivalent vaccine will be evaluated the safety and preliminary immunogenicity in subjects aged 6 months to 59 years. A total of 144 participants will be enrolled, including 48 adults (aged 18-59 years), 48 adolescents (aged 6-17 years), and 48 children (aged 6 months-5 years). Participants will be randomized into vaccine group and placebo group in a 3:1 ratio, and receive two doses of vaccine or placebo according to the 0- and 28-day immunization schedule.The dose escalation principle within each age group is from low to high doses, and the sequential enrollment principle between different age groups is from adults to children.

Primary endpoints are the occurrence of safety events after vaccination including the incidence of adverse events within 30 minutes/7 days/28 days after each dose, as well as the incidence of serious adverse events within 12 months after the final dose which will be defined as the secondary safety endpoint. Besides, the secondary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the final dose.

Conditions: Hand, Foot and Mouth Disease (HFMD), HFMD, Hand, Foot and Mouth Disease
Being tested: Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell), Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell), High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell), Placebo
Medical subject headings: Hand, Foot and Mouth Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07326878
Study group	Role	What they receive
low-dose experimental group	Experimental	Participants aged 18~59 years old, 6~17years old, 6months old~5 years old Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety index - incidence of adverse events
Incidence of adverse events after each dose vaccination
Measured: 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
Incidence of serious adverse events/adverse reactions after vaccination
Measured: From the beginning of the vaccination up to12 months after the last vaccination completed
Immunogenicity index-Seroconversion rates
The seroconversion rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies after the end of the entire vaccination course.
Measured: Between baseline and Day 28 after full vaccination
Immunogenicity index - Geometric mean titer (GMT)
The GMT of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the end of the entire vaccination course.
Measured: Day 28 after full vaccination
Immunogenicity index - Geometric mean fold increases (GMFI)
The GMFI of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies after the end of the entire vaccination course.
Measured: Between baseline and Day 28 after full vaccination
Immunogenicity index-Seropositive rates
The seropositive rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the end of the entire vaccination course.
Measured: Day 28 after full vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 202515 Aug 2027

First posted8 Jan 2026
Study start30 Dec 2025 (estimated)
Primary completion15 Aug 2026 (estimated)
Study completion15 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hand, Foot and Mouth Disease (HFMD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 144 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07326878
Sponsor's protocol ID: EV71-CA16-101
Status last verified: Dec 2025
First submitted: 26 Dec 2025
Last updated: 8 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Longding Liu

0871-68334551 ext. +86

liuld@imbcams.com.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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