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Safety & Immunogenicity of Enterovirus Type 71 Vaccine in Healthy Adults and Children 6-71months

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467541
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE June 25, 2020
First Posted Date  ICMJE July 13, 2020
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE December 24, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
Neutralizing Antibody responses for evaluation of enterovirus 71( EV71) vaccines [ Time Frame: before immunization, 7, 15, 30 days after the first inoculation, 7, 15, 30 days after the second inoculation ]
Testing the neutralization antibody levels before immunization, 7, 15, 30 days after Ist inoculation, 7, 15, 30 days after the 2nd inoculation, calculate the positive seroconversion rate, the positive rate and geometric mean titre of neutralization antibody. Vaccine recipients will have greater increase in neutralization antibody titers (NT) after the first dose, without a further increase in NT after the second dose. The seroconversion rate will be increased after Ist & second inoculation Detection Method of the Anti-EV71 Neutralizing Antibody
  • Sample collection and processing
  • Serum will be examined to determine the potency of the neutralizing antibody
  • Treatment of the serum to be examined
  • Dilution of the serum to be examined and virus used for neutralization:
  • Serum and virus neutralizing and virus culture
  • Observation of the cytopathic change and judgment results
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
Safety Outcome [ Time Frame: After Ist vacctination (0 day) & 30 days after 2nd vaccination ]
Solicited AE's (Local) e.g. Tenderness, Indurations, Redness, swelling Rash (Injection site), Pruritus with Grading & Solicited AE's (Systemic) e.g. Allergic Reaction, Fatigue, Asthenia, Dysphoria, Loss of Appetite Nausea, Vomiting, Diarrhea Fever (Axillary Temp)with Grading will be assessed. If any solicited or unsolicited AE's following vaccination in this study and will record adverse events at home in diary card.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety & Immunogenicity of Enterovirus Type 71 Vaccine in Healthy Adults and Children 6-71months
Official Title  ICMJE A Randomized, Open, Phase I/II to Evaluate the Inactivated EV 71 Vaccine Safety in Healthy Adults Followed by Safety and Immunogenicity Administered in 2 Consecutive Doses, 1 Month Apart Among Child Aged 6 to 71 Months.
Brief Summary
  1. Burden: Hand-foot-and-mouth disease (HFMD) characterized by skin rash in extremities, mouth ulcer and fever among <5 years children.Primarily caused by Enterovirus- predominantly human Enterovirus (EV) 71 and Coxsackie virus (CoxA). Several large epidemics have been reported worldwide.Large Asia-Pacific epidemic-in China in 2008, approximately 490,000 infections and 126 deaths of children. EV71 contributes severe and fatal cases e.g. encephalitis.A recent outbreak of HFMD in Bhubaneswar, Odisha in India indicates there is a chance of HFMD outbreaks in Bangladesh. However there is not much report of HFMD from Bangladesh.
  2. Knowledge gap: EV71 is most commonly transmitted via close person-to-person contact. Since there is no known effective treatment for HFMD and as the causative virus is highly contagious, hand washing is the best defense for prevention. However, asymptomatic or mild nature of the infection leads to ineffectiveness of public health interventions like hand washing. Thus the symptomatic management remains the mainstay of treatment strategy for HFMD as of now. EV71 vaccine, an inactivated vaccine, developed by Sinovac Biotech Ltd has shown satisfactory safety and effectiveness through Phase III trials conducted in various regions of mainland China, This new vaccine has the potential to significantly reduce suffering and death from EV71 disease in China. However, it is not assessed on Bangladeshi child.
  3. Relevance: Due to the absence of effective public health strategy and proper treatment, the development of an effective vaccine may be the best way to control EV71 infection.
Detailed Description

General objective:

  1. To evaluate the safety of EV71 vaccine in adults and in children age 6-71 months
  2. To evaluate the immunogenicity of the vaccine in children by assessing the neutralization antibody levels before immunization; then 7, 15, 30 days after the first inoculation; and also 7, 15, 30 days after the second inoculation.
  3. To assess the incidence rate of adverse reactions/events

Specific objective: To find out:

  1. Seroconversion rate of neutralization antibody on the day 30 after the whole-range immunization (i.e. after 2nd dose of vaccination);
  2. Positive rate and Geometric Mean Titer of neutralization antibody on the day 30 after the whole-range immunization;
  3. Seroconversion rate, positive rate and Geometric Mean Titer of serum neutralization antibody on the day 7, day 15, day 30 after the first inoculation;
  4. Seroconversion rate,positive rate and Geometric Mean Titer of serum neutralization antibody on the day 7, day 15 after the second inoculation;
  5. The incidence rate of adverse reactions & serious adverse events during the observation period of safety;
  6. The incidence rate of adverse reactions 0-30 days after each inoculation of vaccine;
  7. The incidence rate of adverse events 0-7 days after each inoculation of vaccine;
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hand Foot & Mouth Disease
Intervention  ICMJE Biological: Inactivated Enterovirus Type 71 (EV71) Vaccine (Vero Cell)
Inactivated Enterovirus Type 71 (EV71) Vaccine safety in healthy adults followed by safety and immunogenicity administered in two consecutive doses, one-month apart among children aged 6 to 71 months
Other Name: Inlive
Study Arms  ICMJE Experimental: Inactivated enterovirus type 71 vaccine
Inactivated enterovirus type 71 vaccine safety in healthy adults followed by safety and immunogenicity administered in two consecutive doses, one-month apart among children aged 6 to 71 months
Intervention: Biological: Inactivated Enterovirus Type 71 (EV71) Vaccine (Vero Cell)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 7, 2020)
430
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Bangladeshi healthy adults 18-45yrs and children aged 6-71 months on the day of screening;
  • Either sex;
  • The participant /parents or guardian of the participant properly informed about the study and having signed the informed consent form (ICF);
  • Participant/Parents' or guardian's availability for the entire period of the study and reachability by study staff for post-vaccination follow-up

Exclusion Criteria:

Exclusion Criteria for Inoculation of the First Dose:

Whether the participant should be enrolled should be judged according to the following criteria. The participant cannot participate in the study if any of the following circumstances exists:

  1. Previous history of hand, foot and mouth disease;
  2. Allergy history to vaccine or components of the vaccine, previous history of asthma, serious adverse effects of the vaccine such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
  3. Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc;
  4. Autoimmune disease or immunodeficiency or immunosuppression;
  5. Severe neurological disorders (epilepsy, convulsion or tic) or family history of mental disease;
  6. History of thyroidectomy, or asplenia or functional asplenia;
  7. Severely malnourished children
  8. Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
  9. Received immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;
  10. Received blood products within 3 months before receiving the investigational vaccine;
  11. Received other study drugs or vaccines within 30 days before receiving the investigational vaccine;
  12. Received live attenuated vaccines within 14 days before receiving the investigational vaccine;
  13. Received subunit or inactivated vaccines within 7 days before receiving the investigational vaccine;
  14. Various acute diseases or acute exacerbation of chronic diseases within 7 days;
  15. Fever before vaccine inoculation, axillary temperature >37.5°C;
  16. Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

Exclusion Criteria for Inoculation of the Second Dose of Vaccine:

  1. Any serious adverse event related to the inoculation of the investigational product;
  2. Hypersensitivity after vaccine inoculation (including urticaria/rash appeared within 30 minutes after inoculation);
  3. Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
  4. If acute or newly onset chronic disease occurs during vaccine inoculation;
  5. The investigator judged that other significant reactions occur (including serious pain, serious swelling, serious activity limitation, continuous hyperthermia, serious headache or other systemic or local reactions);
  6. The patient develops acute disease when vaccine is inoculated (acute diseases means the moderate or severe disease with or without fever);
  7. Axillary temperature >37.5°C when vaccine is inoculated;
  8. The patient has received subunit inactivated vaccine within 7 days or live attenuated vaccines within 14 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04467541
Other Study ID Numbers  ICMJE PR-19055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wasif Ali Khan, MBBS, MHS International Centre for Diarrhoeal Disease Research, Bangladesh
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP