Patients developing clinical autoimmune encephalitis or meningoencephalomyelitis with anti-GFAP antibodies, managed by the National Reference Center for Paraneoplastic Syndromes and Autoimmune Encephalitis or the National Reference Center for Centre de référence for Neuro-inflammatory diseases of the brain and the spinal cord at the Neurological Hospital of Bron.

Autoimmune GFAP Astrocytopathy

Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.

Description and analysis

Hospices Civils de Lyon

GFAP Auto-immunity : a French Cohort Study

Describe prodromes (yes or no), neurologic signs and clinical course (acute/subacute - yes or
no - or progressive onset - yes or no), if admitted in intensive care units (yes or no), retrospectively provided by
the treating physicians using a structured questionnaire.or progressive onset), if admitted in intensive care units, neoplastic and dysimmune associated diseases and T cell dysregulation condition .

positivity of GFAP α -IgG in cerebrospinal fluid, in serum and isoform type at diagnostic and follow up.
positivity of GFAP α -IgG in cerebrospinal fluid, in serum and isoform type at diagnostic and follow up.

age at onset (years) retrospectively provided by the treating
physicians using a structured questionnaire

Report if caucasian (yes or no) retrospectively provided by the treating
physicians using a structured questionnaire

Report if female sex (yes or no) retrospectively provided by the treating
physicians using a structured questionnaire
physicians using a structured questionnaire

Report if neoplastic and dysimmune associated diseases and T cell dysregulation condition (yes or no)
physicians using a structured questionnaire
physicians using a structured questionnaire

Head and medullar MRI at diagnostic and follow up were reviewed by a neuroradiologist. scale) at each relapse and last follow up.

Describe electroencephalographic results at diagnostic and follow up when done .

Describe electromyographic results at diagnostic and follow up when done .

Describe visual acuity (/10) at diagnostic and follow up when done .

Describe ocular fundus at diagnostic and follow up results when done .

Describe visual field at diagnostic and follow up when done .

Describe optical coherence tomography (RNFL thickness) at diagnostic and follow up when done .

Describe histologic results at diagnostic and follow up when done .

Describe acute and long-term treatments administered and response.

Describe outcome (modified Rankin scale) at each relapse and last follow up.

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 6-11 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 12-23 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1500 children aged 24-35 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1000 children aged 36-71 months old on day 0, 28

0U/0.5ml (0Eu/0.5ml) placebo in 1750 infants aged 6-11 months old on day 0, 28

0U/0.5ml (0Eu/0.5ml) placebo in 1750 infants aged 12-23 months old on day 0, 28

0U/0.5ml (0Eu/0.5ml) placebo in 1500 children aged 24-35 months old on day 0, 28

0U/0.5ml (0Eu/0.5ml) placebo in 1000 children aged 36-71 months old on day 0, 28

The Efficacy of Inactivated EV71 Vaccine (KMB17) Against HFMD in Chinese Children and Infants

100U/0.5ml in 6-11 months old infants

100U/0.5ml in 12-23 months old infants

100U/0.5ml in 24-35 months old children

100U/0.5ml in 36-71 months old children

Guangxi Provincial Center for Diseases Control and Prevention

A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children

A Phase III Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Infants and Children

Adverse reactions associated with vaccine and protection efficiency were observed in Chinese Infants and children (from 6 to 71 months old) after the first vaccination.

Adverse reactions associated with vaccine were observed in Chinese Infants and children (from 6 to 71 months old) after the first vaccination.

The preventive efficacy were observed in Chinese Infants and children (from 6 to 71 months old) after the second vaccination

The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children and infant, at the 28 day after the first vaccination

The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children and infant, at the 28 or 56 days after the second vaccination

Longding Liu

Professor

Chinese Academy of Medical Sciences

Guangxi Center for Disease Control and Prevention

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 6-11 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 6-11 months old on day 0, 28

0Eu/0.5ml placebo in 80 infants aged 6-11 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 12-23 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 12-23 months old on day 0, 28

0Eu/0.5ml placebo in 50 infants aged 12-23 months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 children aged 24 months-5 years months old on day 0, 28

0Eu/0.5ml placebo in 50 children aged 24 months-5 years old on day 0, 28

The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and Infants

160Eu/0.5ml in infants (6-11 months old)

320Eu/0.5ml in infants (6-11 months old)

640Eu/0.5ml in infants (6-11 months old)

1280Eu/0.5ml (without adjuvant) in infants (6-11 months old)

0Eu/0.5ml in infants (6-11 months old)

160Eu/0.5ml in infants (12-23 months old)

320Eu/0.5ml in infants (12-23 months old)

640Eu/0.5ml in infants (12-23 months old)

1280Eu/0.5ml (without adjuvant) in infants (12-23 months old)

0Eu/0.5ml in infants (12-23 months old)

160Eu/0.5ml in children (24 months-5 years old)

320Eu/0.5ml in children (24 months-5 years old)

640Eu/0.5ml in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28

1280Eu/0.5ml (without adjuvant) in children (24 months-5 years old)

0Eu/0.5ml in children (24 months-5 years old)

A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants

A Phase II Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Infants

Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 11 months old) after the first vaccination.

Adverse reactions associated with vaccine were observed in Chinese Infants (from 12 to 23 months old) after the first vaccination

Adverse reactions associated with vaccine were observed in Chinese children (from 24 months to 5 years old) after the first vaccination

Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 11 months old) after the second vaccination

Adverse reactions associated with vaccine were observed in Chinese Infants (from 12 to 23 months old) after the second vaccination

Adverse reactions associated with vaccine were observed in Chinese children (from 24 months to 5 years old) after the second vaccination

The seroconversion rate of antinuclear antibodies was evaluated in serum of children and infant, at the 28 day after the first vaccination

The seroconversion rate of antinuclear antibodies was evaluated in serum of children and infant, the 28 or 56 days after the second vaccination

The abnormity change of live and kidney function indexes were evaluated in serum of children and infant, at the 28 days after the first vaccination

The abnormity change of live and kidney function indexes were evaluated in serum of children and infant, the 28 or 56 days after the second vaccination

The abnormity change of body temperature of children and infant were evaluated, at the 28 days after the first vaccination

The abnormity change of body temperature of children and infant were evaluated, within the first 56 days after the second vaccination

The vaccine-induced cellular immune responses were evaluated in serum of children and infant, at the 28 day after the first vaccination

The vaccine-induced cellular immune responses were evaluated in serum of children and infant, at the 28 or 56 days after the second vaccination

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 adults aged 18-49 years old on day 0, 14.

0Eu/0.5ml placebo in 24 adults aged 18-49 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 children aged 3-11 years old on day 0, 14.

0Eu/0.5ml placebo in 24 children aged 3-11 years old on day 0, 14.

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 24 infants aged 6-35 months old on day 0, 28.

0Eu/0.5ml placebo in 48 infants aged 6-35 months old on day 0, 28.

The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Adults, Children and Infants.

160Eu/0.5ml in adults

320Eu/0.5ml in adults

640Eu/0.5ml in adults

1280Eu/0.5ml (without adjuvant) in 12 adults

0Eu/0.5ml in adults

160Eu/0.5ml in children

320Eu/0.5ml in children

640Eu/0.5ml in children

1280Eu/0.5ml (without adjuvant) in children

0Eu/0.5ml in children

160Eu/0.5ml in infants

320Eu/0.5ml in infants

640Eu/0.5ml in infants

1280Eu/0.5ml (without adjuvant) in infants

0Eu/0.5ml in infants

The neonatal rhesus monkey model could shed light on EV71 infection process and pathogenesis. The effects of EV71 vaccines could be evaluated by this animal model.

The rhesus monkey model may be used to study not only the basic pathogenesis of EV71 viral infections, but also to examine clinical features, such as neurological lesions, in the CNS and pathological changes in associated organs.

The significance and value of assessing the immunogenicity and immunoprotection of vaccine candidates were elucidated in rhesus monkeys by relying on a range of analyses, including pathological, etiological and lethal challenge analyses.

A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants

A Phase I Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Adults, Children and Infants

Adverse reactions associated with vaccine were observed in Chinese Adults (from 18 to 49 years old) after the first vaccination.

Adverse reactions associated with vaccine were observed in Chinese Adults (from 18 to 49 years old) after the second vaccination.

Adverse reactions associated with vaccine were observed in Chinese Children (from 3 to 11 years old) after the first vaccination.

Adverse reactions associated with vaccine were observed in Chinese Children (from 3 to 11 years old) after the second vaccination.

Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 35 months old) after the first vaccination.

Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 35 months old) after the second vaccination.

The seroconversion rate of anti-EV71 antibodies was evaluated in serum of adults within the first 14 days after first vaccination.
The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children within the first 14 days after first vaccination.
The seroconversion rate of anti-EV71 antibodies was evaluated in serum of infant, within the first 28 days after first vaccination.

The seroconversion rate of anti-EV71 antibodies was evaluated in serum of adults within the first 4 days after second vaccination.
The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children within the first 4 days after second vaccination.
The seroconversion rate of anti-EV71 antibodies was evaluated in serum of infant, within the first 28 days after second vaccination.

The seroconversion rate of antinuclear antibodies was evaluated in serum of adults within the first 14 days after first vaccination.
The seroconversion rate of antinuclear antibodies was evaluated in serum of children within the first 14 days after first vaccination.
The seroconversion rate of antinuclear antibodies was evaluated in serum of infant, within the first 28 days after first vaccination.

The seroconversion rate of antinuclear antibodies was evaluated in serum of adults within the first 4 days after the second vaccination.
The seroconversion rate of antinuclear antibodies was evaluated in serum of children within the first 4 days after the second vaccination.
The seroconversion rate of antinuclear antibodies was evaluated in serum of infant, within the first 28 days after the second vaccination.

The abnormity change of live and kidney function indexes were evaluated in serum of adults within the first 14 days after first vaccination.
The abnormity change of live and kidney function indexes were evaluated in serum of children within the first 14 days after first vaccination.
The abnormity change of live and kidney function indexes were evaluated in serum of infant, within the first 28 days after first vaccination.

The abnormity change of live and kidney function indexes were evaluated in serum of adults within the first 4 days after the second vaccination.
The abnormity change of live and kidney function indexes were evaluated in serum of children within the first 4 days after the second vaccination.
The abnormity change of live and kidney function indexes were evaluated in serum of infant, within the first 28 days after the second vaccination.

The vaccine-induced cellular immune responses were evaluated in serum of infant, within the first 28 days after the first vaccination.

The vaccine-induced cellular immune responses were evaluated in serum of infant, within the first 28 days after the second vaccination.

myelitis/edema

GFAP Auto-immunity : a French Cohort Study

A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children

A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants

A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants

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