Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine(Hansenula Polymorpha) in Healthy People Aged Aged From 6 Months to 59 Years
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Norovirus Infections
- Sponsor
- National Vaccine and Serum Institute, China
- Enrollment
- 1716
- Locations
- 1
- Primary Endpoint
- the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
- Last Updated
- 3 years ago
Overview
Brief Summary
Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age range: healthy people aged 6 months -59 years and and older who can provide legal identification;
- •Inquired about medical history and physical examination, the investigator judged that the health condition is good;
- •The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
- •Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;
Exclusion Criteria
- •First Dose Exclusion Criteria：
- •Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- •Have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days);
- •Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- •Having serious congenital malformations or chronic diseases (including but not limited to:Down syndrome, thalassemia, heart disease, kidney disease, diabetes, autoimmune disease, genetic allergies, Guillain Barre syndrome, etc.);
- •Asthenia or splenectomy, functional asthenia caused by any situation;
- •Severe liver and kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension (systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors, various acute diseases or acute attacks of chronic diseases;
- •Have a history of chronic gastrointestinal disease, current diarrhea or other digestive system diseases, gastroenteritis requiring treatment in the past 7 days;
- •Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
Outcomes
Primary Outcomes
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Time Frame: through 30 minutes after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Time Frame: through 30 days after each dose
If there is still next vaccination ，collect the incidence and severity of non-collective adverse reactions/events within vaccination interval（28 days） after vaccination
Antibody titer of HBGA-blocking antibody on the 14th day after the full course of vaccination
Time Frame: 14th day after the full course of vaccination
Antibody titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination
Time Frame: 14th day after the full course of vaccination
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Time Frame: through 7 days after each dose
the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination
Time Frame: up to 6 months after the full course of vaccination
4-fold Seroconversion rate on the 14th day after the full course of vaccination
Time Frame: 14th day after the full course of vaccination
Secondary Outcomes
- Immune response（compared with before vaccination, the antibody increased by 4 times or more） rate of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination(14th day after the full course of vaccination)
- Antibody titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on 90th,180th,270th,360th,540th,720th day after the full course of vaccination(90th,180th,270th,360th,540th,720th day after the full course of vaccination)
- Binding Antibody (IgG) on 90th,180th,270th,360th,540th,720th day after the full course of vaccination(90th,180th,270th,360th,540th,720th day after the full course of vaccination)
- Geometric mean Titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination(14th day after the full course of vaccination)