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

NmVac4-A/C/Y/W-135-DT™ conjugate vaccine

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Test Vaccine

US Licensed Vaccine

Total

Sex: Female, Male

Race/Ethnicity, Customized

Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a 4-fold rise in antibody levels.

NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.

Seroresponse (Percent Seroconversion).

Local and systemic rates from Diary Cards filled by the participants.

Test Vaccine - Male

Test Vaccine - Female

US Licensed Vaccine - Male

US Licensed Vaccine - Female

Solicited Adverse Events From Diary Cards

Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.

Non Solicited Adverse Events

Overall Study

Regulatory Affairs Director

Meningococcal Meningitis

Meningococcal Infections

NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.

Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.

Mid Atlantic Urology Associates LLC

Chesapeake Research Group

IRC Clinics

Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

A Phase 2 Double Blind Study to Evaluate Safety and Immunogenicity of Meningococcal Meningitis Serogroups A, C, Y & W-135 Polysaccharide Diphtheria Toxoid Conjugate Vaccine (NmVac4-A/C/Y/W-135-DT™) Compared With a Licensed Vaccine

JN-International Medical Corporation

NmVac4-A/C/Y/W-135-DT™conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 16 µg total diphtheria toxoid.

meningococcal meningitis conjugate vaccine, quadrivalent

Meningococcal (Groups A,C,Y and W-135-DT) Polysaccharide Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 48 µg total diphtheria toxoid.

Kings Cardiology Group

Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis

A Double-Blind, Randomized, Controlled, Two Arm Phase 1 Clinical Trial of the Safety and Immunogenicity of Group A, C, Y & W-135 Meningococcal Polysaccharide DT Conjugate Vaccine: NmVac4-A/C/Y/W-135-DT™

local and systemic rates throughout the course of the study

meningococcal infections/qusma

Evaluation of Different Methods for Diagnosis of ME

Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis

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