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

Hand Foot & Mouth Disease

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

Inactivated Enterovirus Type 71 (EV71) Vaccine (Vero Cell)

Icddr,B

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

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.

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

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.

International Centre for Diarrhoeal Disease Research, Bangladesh

The CSF samples will be stored at -80°C until testing . CSF specimens will be prepared for GS and culture examinations by centrifugation at 3,000 rpm for 10 minutes at room temperaturetemperature.Culture will be performed by inoculating 1-2 drops of CSF sediment directly onto each of the following agar plates: horse-blood agar, Thayer-Martin agar, choc- olate agar and Sabouraud agar. Moreover, a broth tube (brain-heart infusion, BHI) will be inoculated with one drop of the sediment. Agar plates and broth will be incubated for 1 to 5 days at 35-37°C (with ~5% CO2, or in a candle-jar, for Thayer-Martin and chocolate agar) .
In addition to GS and culture method , India ink test and culture and latex agglutination test (LAT). LAT assay will be performed on CSF samples using Latex-antigen detection system kit..

Diagnoses Disease

The CSF samples will be stored at -80°C until testing . CSF specimens will be prepared for GS and culture examinations by centrifugation at 3,000 rpm for 10 minutes at room temperature. Culture will be performed by inoculating 1-2 drops of CSF sediment directly onto each of the following agar plates: horse-blood agar, Thayer-Martin agar, choc- olate agar and Sabouraud agar. Moreover, a broth tube (brain-heart infusion, BHI) will be inoculated with one drop of the sediment. Agar plates and broth will be incubated for 1 to 5 days at 35-37°C (with ~5% CO2, or in a candle-jar, for Thayer-Martin and chocolate agar) .
In addition to GS and culture method , India ink test and culture and latex agglutination test (LAT). LAT assay will be performed on CSF samples using Latex-antigen detection system kit.

CSF examination

Evaluation of Different Methods for Diagnosis of ME

Evaluation of Different Methods for Rapid Diagnosis of Meningitis in Assiut University Hospital

The CSF samples will be stored at -80°C until testing . CSF specimens will be prepared for GS and culture examinations by centrifugation at 3,000 rpm for 10 minutes at room temperature. When dry, the smear will be fixed stained and finally observed by light microscopy with a 100X objective. Culture will be performed by inoculating 1-2 drops of CSF sediment directly onto each of the following agar plates: horse-blood agar, Thayer-Martin agar, choc- olate agar and Sabouraud agar. Moreover, a broth tube (brain-heart infusion, BHI) will be inoculated with one drop of the sediment. Agar plates and broth will be incubated for 1 to 5 days at 35-37°C (with ~5% CO2, or in a candle-jar, for Thayer-Martin and chocolate agar) .
In addition to GS and culture method , India ink test and culture and latex agglutination test (LAT). LAT assay will be performed on CSF samples using Latex-antigen detection system kit.

Doha Fahmy

Principal investigator

Assiut University

The posterior oropharynx exam was performed with a traditional, unflavored Puritan Regular tongue depressor.

The posterior oropharynx exam was performed with a grape flavored, commercially available, Puritan Junior tongue depressor.

Oropharynx

Grape flavored Puritan Junior tongue depressor

Traditional unflavored Puritan Regular Tongue Depressor

Do Traditional or Flavored Tongue Depressors Make for Easier Posterior Oropharynx Exams in Pediatric Patients

Do Traditional or Flavored Tongue Depressors Make for Easier Posterior

Brian P. Murray, DO

Senior Resident, Emergency Medicine

Brooke Army Medical Center

All patients registered for evaluation in the Brooke Army Medical Center Pediatric Emergency Department will be screened by evaluation of age, mental status, physical features and history of immunocompromised by the PI or AI as part of their standard triage and care procedures for their evaluation and treatment in the Emergency Department. Potential participants will be identified by the PI and AI from patients who are registered to be seen by the PI or AI. Potential participants who meet the inclusion criteria and who have none of the exclusion criteria will be approached prior to completion of the posterior oropharynx exam for permission to enroll them in this study.

Using a computer-generated simple randomization sequence in permuted blocks of 10, numbered study packets that include the surveys and tongue depressor will be prepared in advance. The packets, which will be prepared by a third party not participating in this research study, will include the information sheet, surveys for the investigator, participant and parent, all labeled with the sample number, and a tongue depressor within original packaging. The randomization key will be kept by the third party until the completion of data collection, at which time it will be given to the PI.

These children will be recruited from district 8, Ho Chi Minh City where most HFMD admissions to the Hospital for Tropical Diseases occur. We wil recruit healthy children from three kindergartens and ask for volunteers from participants enrolled in an Oxford University Clinical Research Unit Dengue birth cohort study (OXTREC approval 02-09) in District 8, HCMC. This birth cohort is an observational study.

The Vietnamese Ministry of Health has a clinical grading system. Grade 1 disease is uncomplicated and are not admitted to hospital. Grade 2 and above are admitted to hospital with clinical features of neurological or systemic involvement. Grade 2 is split into Grade 2a and 2b depending if neurological manifestations such as myoclonus have been witnessed by the parents or by a health professional. In total, it is anticipated that 125 Grade 2a and 125 Grade 2b and 100 more severe Grade 3 and 4 will be recruited over one year. A subset who agree for brain magnetic resonance imaging (MRI) will also have a scan done during their hospital admission.