The influenza virus strain a/47/beijing/95/35(h1n1) for production of live intranasal influenza vaccine for children

 

(57) Abstract:

Vaccine strain a/47/Beijing/95/35(H1N1) is reassortants. Obtained by crossing epidemic virus A/Beijing/262/95 (H1N1) holodnodeformirovannym temperaturecontrolled virus A/Leningrad/134/47/57 (H2N2) - donor attenuatio. Strain harmless for children. Strain A/47/Beijing/95/35(H1N1) virus actively replicates in developing chicken embryos at the optimum temperature of 33 - 34oWith, characterized by temperaturesalinity and holidaytravelwatch. Reassortant inherited from epidemic virus has two genes encoding surface proteins (hemagglutinin and neuraminidase), and six genes encoding deglycosylated proteins from the donor to attenuate. Strain a/47/Beijing/95/35(H1N1) reactogenic for children by intra. The properties of the strain enable guaranteed to get reassortant vaccine strains from emerging epidemic viruses. table 1.

The invention relates to medical Virology and can be used in health care for the prevention of epidemic influenza among children live intranasal influenza vaccine from strain A/47/Beijing/95/35(H1N1). A known strain a/47/Texas/91/2/6 (H1N1) prototype [rippa, caused by a strain of influenza virus, the same virus A/Beijing/262/95 (H1N1).

The task, which is aimed by the invention, is getting the vaccine strain relevant antigenic variants based on epidemic virus A/Beijing/262/95 (H1N1).

Vaccine strain a/47/Beijing/95/35(H1N1) obtained by the method of genetic reasontly epidemic virus A/Beijing/262/95 (H1N1) 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 copies of the genes of the parent viruses and reassortant vaccine strain is established that the vaccine strain A/47/Beijing/95/35(H1N1) inherited 6 genes encoding internal proteins (RW, RV, PA, NP, M, NS) from the donor to attenuate A/Leningrad/134/47/57 (H2N2), and 2 gene encoding surface proteins (hemagglutinin) and NA (neuraminidase) from epidemic virus A/Beijing/262/95 (H1N1). Hemagglutinin in rtga identical to the virus A/Beijing/262/95 (H1N1), ukazatelej 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/Beijing/95/35(H1N1) is characterized by a combination of useful features, required vaccine strain: antigenic specificity of surface proteins epidemic virus A/Beijing/262/95 (H1N1), the structure of the genome that is 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).

Sample passport to the vaccine strain A/47/Beijing/95/35 (H1N1) is attached.

STRAIN a/47/BEIJING/95/35 (H1N1) REACTOR is coordinated intranasally in a volume of 0.5 ml recombinant vaccine strain a/47/Beijing/95/35 (H1N1) infectious activity of 8.5 1g 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 11 people (10.9% 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% (table 1).

Thus, the vaccine strain a/47/Beijing/95/35 (H1N1) 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/Beijing/95/35 (H1N1).

2. Series - series 1.

3. Method get - recombination; the characteristics of the parent viruses:

a) epidemic virus - A/Beijing/262/95 (H1N1);

b) the donor of attenuation - A/Leningrad/134/47/57 (H2N2).

4. The number of passages 6 in the recombination process.

5. Characterisa activity - 1:512;

C) infectious activity - 8.5 lg EID50/0.2 ml;

g) sensitivity to inhibitors - inhibitorresistant;

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) the date of lyophilization - September 14, 1998;

b) amount of material in the ampoule 1 ml;

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

g) infectious activity - 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/Beijing/262/95 (H1N1), anticorodal which completely neutralized;

b) neuraminidase is identical to the virus A/Beijing/262/95 (H1N1) according to PCR-restriction analysis of DNA-gene copies.

9. Harmless to mice by subcutaneous and intraperitoneal administration is harmless.

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

LITERATURE

1. Strain A/47/Texac/91/2/6 (H1N1) for production of live intranasal influenza vaccine for children. RF patent 2077581 from 20.04.97. Published in Bulletin of inventions No. 11 from 20.04.97.

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

The influenza virus strain a/47/Beijing/95/35 (H1N1) risk N 394/5 (State Institute of standardization and control them.L.A. Tarasevich) used to get the live intranasal influenza vaccine for children.

 

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