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A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants

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ClinicalTrials.gov Identifier: NCT02367664
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Shandong Hengye Biotech Co., Ltd.
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Brief Summary:
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.

Condition or disease Intervention/treatment Phase
Encephalitis Biological: 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine Biological: 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine Biological: 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) Phase 3

Detailed Description:

Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days. In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.

In order to evaluate immunogenicity and safety of Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd. a single-centre phase III clinical trial is planned to conduct in healthy infants aged 6-11 months in China.

There will be two immunization programs. 600 healthy infants aged 6-11 months will be randomly assigned (1:1) to receive an experimental vaccine or a positive control vaccine at day 0,7. Another 300 healthy infants aged 6-11 months will be recruited to receive an experimental vaccine at day 0,28. All of them will be received a third dose as booster vaccination 12 months later.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Single-centre Phase III Clinical Trial for Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Produced by Shandong Hengye Biotech Co., Ltd. in Healthy Chinese Infants Aged 6-11 Months, Aimed to Evaluate Immunogenicity and Safety
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Experimental: 0.5ml experimental vaccine on day 0,7
0.5ml experimental vaccine on day 0,7 and a booster dose 12 months later
Biological: 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine
Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose

Experimental: 0.5ml experimental vaccine on day 0,28
0.5ml experimental vaccine on day 0,28 and a booster dose 12 months later
Biological: 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine
Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 28 days interval, a booster dose 12 months after the first dose

Active Comparator: 0.5ml active comparator vaccine on day 0,7
0.5ml active comparator vaccine on day 0,7 and a booster dose 12 months later
Biological: 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)
inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) produced by Beijing Tiantan Biological Products Co., Ltd. /0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose




Primary Outcome Measures :
  1. positive seroconversion rate of JE neutralizing antibody following primary vaccination [ Time Frame: 28 days after primary vaccination ]
    to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after primary vaccination

  2. incidence of solicited adverse reactions (including systemic and local adverse reactions) following primary vaccination [ Time Frame: 0-7 days after primary vaccination ]
    to evaluate incidence of solicited adverse reactions (including systemic and local adverse reactions) within 0-7 days after primary vaccination


Secondary Outcome Measures :
  1. GMT of JE neutralizing antibody following primary vaccination [ Time Frame: 28 days after primary vaccination ]
    to evaluate the GMT of JE neutralizing antibody 28 days after primary vaccination

  2. positive seroconversion rate of JE neutralizing antibody following booster vaccination [ Time Frame: 28 days after booster vaccination ]
    to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after booster vaccination

  3. positive seroconversion rate of JE neutralizing antibody following primary vaccination [ Time Frame: 12 months after primary vaccination ]
    to evaluate the positive seroconversion rate of JE neutralizing antibody 12 months after primary vaccination

  4. incidence of unsolicited adverse reactions (including systemic and local adverse reactions) following primary vaccination [ Time Frame: 0-28 days after primary vaccination ]
    to evaluate incidence of unsolicited adverse reactions (including systemic and local adverse reactions) within 0-28 days after primary vaccination

  5. incidence of adverse event (AE) following booster vaccination [ Time Frame: 0-28 days after booster vaccination ]
    to evaluate incidence of adverse event (AE) within 0-28 days after booster vaccination

  6. incidence of serious adverse event (SAE) during the whole study period [ Time Frame: Day 0 of the first dose up to Day 28 of the third dose ]
    to evaluate incidence of serious adverse event (SAE) during the whole study period

  7. GMT of JE neutralizing antibody following booster vaccination [ Time Frame: 28 days after booster vaccination ]
    to evaluate the GMT and GMI of JE neutralizing antibody 28 days after booster vaccination

  8. GMT of JE neutralizing antibody following primary vaccination [ Time Frame: 12 months after primary vaccination ]
    to evaluate the GMT of JE neutralizing antibody 12 months after primary vaccination



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged from 6 to 11 months old on the day of inclusion
  • Had never received any Japanese Encephalitis vaccine
  • Subjects' legal guardians are able to understand and sign the informed consent
  • In good general health judged from medical history and clinical examination at the time of inclusion
  • Subjects and legal guardians can and will comply with the requirements of the protocol
  • Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

  • Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
  • Subject who is allergic to any ingredient of the vaccine
  • Family history of congenital or hereditary immunodeficiency
  • Subject with damaged or low immune function which has already been known
  • Subject who had a Japanese Encephalitis medical history
  • Subject with acute febrile illness or infectious disease
  • Major congenital defects or serious chronic illness, including perinatal brain damage
  • Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
  • Subject who has serious allergic history
  • Subject with other medical history not suitable for vaccination such as fainting during injection or acupuncture treatment
  • Any prior administration of immunodepressant or corticosteroids in last 6 months
  • Any prior administration of blood products in last 3 months
  • Any prior administration of other research medicine/vaccine in last 30 days
  • Any prior administration of any attenuated live vaccine in last 30 days
  • Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
  • Any acute infection or serious infection needing systemic antibiotics or antiviral treatment in last 7 days
  • Any fever with temperature >=38.0°C on axillary setting in last 3 days
  • Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

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): NCT02367664


Locations
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China, Jiangsu
Pizhou Center for Disease Control and Prevention
Xuzhou, Jiangsu, China, 221300
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Shandong Hengye Biotech Co., Ltd.

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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02367664     History of Changes
Other Study ID Numbers: JSVCT015
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2015
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Japanese encephalitis
immunogenicity
safety
vaccine
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs