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

ConditionsHand, Foot and Mouth Disease (HFMD)HFMDHand, Foot and Mouth Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-59
SponsorInstitute of Medical Biology, Chinese Academy of Medical Sciences

About this trial

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 ).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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

    Biological/Vaccine

    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/Vaccine

    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/Vaccine

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

  • Placebo

    Biological/Vaccine

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

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: low-dose experimental groupExperimental treatment 1 intervention
Group B: medium-dose experimental groupExperimental treatment 1 intervention
Group C: high-dose experimental groupExperimental treatment 1 intervention
Group D: Placebo control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety index - incidence of adverse events

Incidence of adverse events after each dose vaccination

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

Secondary outcomes

1

Safety index - incidence of serious adverse events

Incidence of serious adverse events/adverse reactions after vaccination

Time frame
From the beginning of the vaccination up to12 months after the last vaccination completed
2

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.

Time frame
Between baseline and Day 28 after full vaccination
3

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.

Time frame
Day 28 after full vaccination
4

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.

Time frame
Between baseline and Day 28 after full vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Medical Biology, Chinese Academy of Medical Sciences

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: