Hand, Foot and Mouth Disease, Hand, Foot and Mouth Disease (HFMD), HFMD
Conditions
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 ).
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.
Interventions
BIOLOGICALLow 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
BIOLOGICALMedium 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
BIOLOGICALHigh 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
BIOLOGICALPlacebo
Placebo，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Institute of Medical Biology, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety index - incidence of adverse events | 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after each dose | Incidence of adverse events after each dose vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety index - incidence of serious adverse events | From the beginning of the vaccination up to12 months after the last vaccination completed | Incidence of serious adverse events/adverse reactions after vaccination |
| Immunogenicity index-Seroconversion rates | Between baseline and Day 28 after full vaccination | The seroconversion rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies after the end of the entire vaccination course. |
| Immunogenicity index - Geometric mean titer (GMT) | Day 28 after full vaccination | The GMT of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the end of the entire vaccination course. |
| Immunogenicity index - Geometric mean fold increases (GMFI) | Between baseline and Day 28 after full vaccination | The GMFI of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies after the end of the entire vaccination course. |
| Immunogenicity index-Seropositive rates | Day 28 after full vaccination | The seropositive rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the end of the entire vaccination course. |
Countries
China
Contacts
Primary ContactLongding Liu
Outcome results
None listed