The influenza virus strain a/47/sydney/97/14(h3n2) for production of live intranasal influenza vaccine for children

 

(57) Abstract:

Vaccine strain a/47/Sydney/97/14 (H3N2) is reassortants. It was obtained by crossing epidemic virus A/Sydney/5/97/ (H3N2) with holodnodeformirovannym temperaturecontrolled virus A/Leningrad/134/47/57 (H2N2) - donor attenuatio. Strain a/47/Sydney/97/14 (H3N2) reproduces actively in developing chicken embryos at the optimum temperature of 34°C. is Characterized by temperaturesalinity and holidaytravelwatch. Reassortant inherited from epidemic virus has two genes encoding surface proteins (hemagglutinin and neuraminidase). Reassortant also received six genes encoding deglycosylated proteins from the donor to attenuate. Strain a/47/Sydney/97/14 (H3N2) reactogenic for children by intra. Vaccine strain a/47/Sydney/97/14 (H3N2) biological properties and indicators of reactogenicity meets the requirements of the vaccine strains. The invention enables the prevention of epidemic influenza relevant antigenic variants. table 1.

The invention relates to medical Virology and can be used in health care for the prevention of EP is hydrated strain a/47/Shangdong/93/1 (H3N2) - prototype [1] - lost antigenic relevance and consequently will not be able to induce a protective response during a flu epidemic, caused by a strain of influenza virus, the same virus A/Sydney/5/97 (H3N2).

The task, which is aimed by the invention, is getting the vaccine strain relevant antigenic variants based on epidemic virus A/Sydney/5/97 (H3N2).

Vaccine strain a/47/Sydney/97/14 (H3N2) obtained by the method of genetic reasontly epidemic virus A/Sydney/5/97 (H3N2) with holodnodeformirovannym strain A/Leningrad/134/47/57 (H2N2) - donor attenuatio - followed by selection in the presence of antisera to the virus A/Leningrad/134/47/57 (H2N2). Donor of attenuation - holodnodeformirovannye temperaturesalinity strain of influenza virus A/Leningrad/134/47/57 (H2N2), allowed to obtain harmless live intranasal vaccines for children [2].

By using restriction analysis of DNA gene copies vaccine and parental strains, the vaccine strain a/47/Sydney/97/14 (H3N2) inherited 6 genes encoding internal proteins (RW, RV, PA, NP, M, NS), from a donor of attenuation A/Leningrad/134/47/57 (H2N2) and 2 gene encoding surface proteins (hemagglutinin) and NA (laramiecigarettes which completely neutralized. The strain is temperaturecontrolled (difference in rates of infectious activity 33oC and 40oC is 7.0 lg EID50/0.2 ml) and holodnodeformirovannym (difference in rates of infectious activity 33oC and 25oC - 3.0 lg EID50/0.2 ml).

Accordingly, the vaccine strain a/47/Sydney/97/14 (H3N2) is characterized by a combination of useful features, required vaccine strain: antigenic specificity of surface proteins epidemic virus A/Sydney/5/97 (H3N2), genome structure, optimal for reassortant vaccine strains, temperaturesalinity and holidaytravelwatch that correlates with the attenuation for a man, characteristic of the donor attenuatio.

Morphology of strain - polymorphic typical of influenza virus.

CHARACTERISTICS OF THE STRAIN

Infectious activity of reproduction in developing chicken embryos at 33-34oC within 48 hours - 8,5-9,0 lg EID50/0,2 ml

Hemagglutinin activity -1:512.

The strain exhibits genetic stability of the biological signs after 5 passages in chicken embryos (when using large infecting doses).

Oberservation the INTRODUCTION of CHILDREN 3-14 YEARS.

Example. A group of 108 children aged 3-14 years were vaccinated intranasally in a volume of 0.5 ml recombinant vaccine strain a/47/Sydney/97/14 (H3N2) infectious activity of 8.5 Ig EID50/0,2 ml of a Group of children of the same age of 101 people received a placebo.

Strong temperature of the reaction with increasing temperature over 38,5oC and average reaction with short-term increasing temperature in the range of 37.6-38,5oC was not observed. Weak reaction temperature (up to 37.5oC) the graft was observed in 9 people (8.3% of cases). Weak reaction temperature (up to 37.5oC) in the placebo group was observed in 15 (14.9% of the cases). The rate of reactogenicity (the difference in the percentage of secondary reactions in vaccinated with the vaccine and who received placebo) was 0% (see table).

Thus, the vaccine strain a/47/Sydney/97/14 (H3N2) in terms of reactogenicity meets the requirements of vaccine strains of Pharmacopoeial article FS 42-3353-97 on live influenza vaccine for intranasal use children 3-14 years.

PASSPORT STRAIN

1. The name of the strain a/47/Sydney/97/14 (H3N2).

2. Series - series 1.

3. Method get - recombination; the characteristics of the parent viruses:esto passages - 6 in the recombination process.

5. Characterization of strain prior to lyophilization:

a). optimal conditions for reproduction - 33oC, 48 hours;

b). hemagglutinin activity - 1:512;

in). contagious - 8.5 lg EID50/0.2 ml;

g). sensitivity to inhibitors - inhibitorcontaining;

d). the difference in rates of infectious activity 33oC and 40oC - 7.0 lg EID50/0.2 ml;

e). the difference in rates of infectious activity 33oC and 25oC - 3.0 lg EID50/0.2 ml;

W). the structure of the genome of the recombinant:

- genes from epidemic virus, NA

- genes from the donor to attenuate - RA, RV, RV, NP, M, NS.

6. The characteristic strain after lyophilization:

a). date lyophilization - September 14, 1998;

b). the volume of material in the ampoule 1 ml;

in). the number of doses in the series - 3;

g). contagious - 7.5 lg EID50/0.2 ml;

d). hemagglutinin activity - 1:256.

7. Recommended dilutions when vaccination is 1:3.

8. Antigenic specificity

a). hemagglutinin in RTG - identical virus A/Sydney/5/97 (H3N2), anticorodal which completely neutralized;

b). neuraminidase is identical to the virus And/Seidkona and intraperitoneal administration - harmless.

10. Bacteriological control of lyophilized material: date - September 14, 1998 the result is sterile.

11. The control in the absence of extraneous viruses extraneous viruses are missing.

LITERATURE

1. Strain a/47/Shangdong/93/1 (H3N2) for production of live intranasal influenza vaccine for children. RF patent N 2065498, 20.08.1996, BI N 23.

2. Alexandrov, I., Klimov, A. I. Live influenza vaccine. - SPb.: Science.- 1994,- 151 C.

The influenza virus strain a/47/Sydney/97/14 (H3N2) risk N 392/3 (State Institute of standardization and control them.L.A. Tarasevich) used to get the live intranasal influenza vaccine for children.

 

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