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
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Hand Foot & Mouth Disease||Biological: Inactivated Enterovirus Type 71 (EV71) Vaccine (Vero Cell)||Phase 1 Phase 2|
- To evaluate the safety of EV71 vaccine in adults and in children age 6-71 months
- 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.
- To assess the incidence rate of adverse reactions/events
Specific objective: To find out:
- Seroconversion rate of neutralization antibody on the day 30 after the whole-range immunization (i.e. after 2nd dose of vaccination);
- Positive rate and Geometric Mean Titer of neutralization antibody on the day 30 after the whole-range immunization;
- Seroconversion rate, positive rate and Geometric Mean Titer of serum neutralization antibody on the day 7, day 15, day 30 after the first inoculation;
- Seroconversion rate,positive rate and Geometric Mean Titer of serum neutralization antibody on the day 7, day 15 after the second inoculation;
- The incidence rate of adverse reactions & serious adverse events during the observation period of safety;
- The incidence rate of adverse reactions 0-30 days after each inoculation of vaccine;
- The incidence rate of adverse events 0-7 days after each inoculation of vaccine;
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||430 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||December 24, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
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
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
- 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
- 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.
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): NCT04467541
|Dhaka, Bangladesh, 1000|
|Principal Investigator:||Wasif Ali Khan, MBBS, MHS||International Centre for Diarrhoeal Disease Research, Bangladesh|