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A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188691
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 6, 2019
Sponsor:
Collaborators:
Lanzhou Institute of Biological Products Co., Ltd
Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.
Zhengzhou University
Information provided by (Responsible Party):
National Vaccine and Serum Institute, China

Brief Summary:

A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.

The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.


Condition or disease Intervention/treatment Phase
Norwalk Gastroenteritis Norovirus Infections Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(low) Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle) Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(high) Biological: Normal saline Biological: Aluminum adjuvant Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years
Actual Study Start Date : November 28, 2019
Estimated Primary Completion Date : September 13, 2020
Estimated Study Completion Date : September 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vaccine group 1
vaccine produced by NVSI , Specification: GI.1 / GII.4 (low), 0.5ml / dose
Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(low)
Norovirus Bivalent (GI.1 / GII.4) Vaccine(low)administered intramuscularly according to a 0, 28,(56) day vaccination schedule

Experimental: vaccine group 2
vaccine produced by NVSI , Specification: GI.1 / GII.4 (middle), 0.5ml / dose
Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle)
Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle)administered intramuscularly according to a 0, 28,(56) day vaccination schedule

Experimental: vaccine group 3
vaccine produced by NVSI , Specification: GI.1 / GII.4 (high), 0.5ml / dose
Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(high)
Norovirus Bivalent (GI.1 / GII.4) Vaccine(high)administered intramuscularly according to a 0, 28,(56)day vaccination schedule

Placebo Comparator: Normal saline
(0.5ml / dose)produced by NVSI
Biological: Normal saline
Normal saline administered intramuscularly according to a 0, 28 ,(56)day vaccination schedule

Placebo Comparator: Aluminum adjuvant
(0.5ml / dose)produced by NVSI
Biological: Aluminum adjuvant
Aluminum adjuvant administered intramuscularly according to a 0, 28,(56) day vaccination schedule




Primary Outcome Measures :
  1. AE of local and systemic reactions within 30 minutes after each dose [ Time Frame: 30 minutes ]
  2. All active AEs within 0-7 days after each dose [ Time Frame: 7 days ]
    Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination

  3. All non-active collection AEs within 0-28(30) days after each dose [ Time Frame: 28(30) days ]
    Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window

  4. All SAEs within 6 months after the last dose is vaccinated [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies [ Time Frame: 28 days after the full vaccination ]
  2. Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies [ Time Frame: 28 days after the full vaccination ]
  3. Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers [ Time Frame: 28 days after the full vaccination ]
  4. Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates [ Time Frame: 28 days after the full vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 6 months to 59 years old, can provide legal identification of Chinese population;
  • Based on medical history and physical examination, determined by the researcher as healthy;
  • Volunteer legal guardians or trustees have the ability to understand (non-illiterate) research procedures, sign informed consent voluntarily with informed consent, and be able to comply with the requirements of clinical research protocols;
  • Female subjects of childbearing age were not pregnant at the time of enrollment (negative urine pregnancy test), were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures were taken within 2 weeks before enrollment.

Exclusion Criteria:

  • Axillary body temperature before inoculation on the day of entry> 37.0 ℃;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc .;
  • Have a history of epilepsy, convulsions or convulsions, or a family history of mental illness;
  • Those who received immunoenhancement or inhibitor therapy within 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;
  • No spleen or spleen function defect caused by any situation;
  • Severe liver and kidney disease, drug-uncontrollable hypertension (systolic blood pressure> 140mmHg, diastolic blood pressure> 90mmHg), diabetic complications, malignant tumors, various acute diseases or chronic attacks of acute diseases;
  • Have a history of chronic gastrointestinal diseases, diarrhea or other digestive system diseases, and have had gastroenteritis requiring treatment in the past 7 days;.
  • Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
  • Have a history of severe allergic reactions to vaccination; are allergic to any component of the test vaccine;
  • Live attenuated vaccine within14 days; other vaccines received within 7 days;
  • Participating in other clinical trials in the near future;
  • The investigator judges other circumstances that are not suitable for participation in this clinical trial.

In addition to the general exclusion criteria, specific populations should also adhere to the following exclusion criteria:

  • Premature birth (delivery before the 37th week of pregnancy), low weight (birth <2300g) infants under 24 months of age;
  • History of salvage, birth apnea, or other causes of salvage, neurological damage, severe chronic disease (such as Down syndrome, sickle cell anemia, or neurological disorders) in children under 24 months of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188691


Contacts
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Contact: Xia shengli, bachelor (+86)13592610137 1792865518@qq.com

Locations
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China, Henan
qixian Center for Disease Control and Prevention Recruiting
Hebi, Henan, China
Contact: dacheng zhan    15803925825      
Sponsors and Collaborators
National Vaccine and Serum Institute, China
Lanzhou Institute of Biological Products Co., Ltd
Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.
Zhengzhou University

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Responsible Party: National Vaccine and Serum Institute, China
ClinicalTrials.gov Identifier: NCT04188691    
Other Study ID Numbers: CXSL1700011-I
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caliciviridae Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs