Hand Foot & Mouth Disease Clinical Trial
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.
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.
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; ;