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.
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
- Are there results?
- Not yet: the study is under way
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.
Show all 21Show fewer
- 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.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Xian Yu, 023-62888378 ext. +86, 22168398@qq.com
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
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 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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Responsible party
- Sponsor
- Investigators
- Xian Yu, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07326878
- Acronym / sponsor ID
- EV71-CA16-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| low-dose experimental group | Experimental | Biological: Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)Participants aged 18~59 years old, 6~17years old, 6months old~5 years old |
| medium-dose experimental group | Experimental | Biological: Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)Participants aged 18~59 years old, 6~17years old, 6months old~5 years old |
| high-dose experimental group | Experimental | Biological: High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)Participants aged 18~59 years old, 6~17years old, 6months old~5 years old |
| Placebo control group | Placebo comparator | Biological: PlaceboParticipants aged 18~59 years old, 6~17years old, 6months old~5 years old |
Who may qualify
- Ages
- 6 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)Low-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval | Biological | low-dose experimental group |
| Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)Medium-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval | Biological | medium-dose experimental group |
| High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)High-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval | Biological | high-dose experimental group |
| PlaceboPlacebo，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval | Biological | Placebo control group |
Primary outcome
Safety index - incidence of adverse events
Time frame: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after each dose
Incidence of adverse events after each dose vaccination
5 secondary outcomes
Safety index - incidence of serious adverse events
Time frame: From the beginning of the vaccination up to12 months after the last vaccination completed
Immunogenicity index-Seroconversion rates
Time frame: Between baseline and Day 28 after full vaccination
Immunogenicity index - Geometric mean titer (GMT)
Time frame: Day 28 after full vaccination
Immunogenicity index - Geometric mean fold increases (GMFI)
Time frame: Between baseline and Day 28 after full vaccination
Immunogenicity index-Seropositive rates
Time frame: Day 28 after full vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xian Yu principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longding Liu (0871-68334551 ext. +86, liuld@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety index - incidence of adverse events (time frame: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.