The influenza virus strain a/17/sydney/97/76(h3n2) for production of live intranasal influenza vaccine for adults

 

(57) Abstract:

Vaccine strain a/17/Sydney/97/76 (H3N2) is reassortants. It was obtained by crossing epidemic virus A/Sydney/5/97 (H3N2) with holodnodeformirovannym temperaturecontrolled virus A/Leningrad/134/17/57 (H2N2) - donor attenuatio. Strain a/17/Sydney/97/76 (H3N2) reproduces actively in developing chicken embryos at the optimum temperature of 33-34C. is Characterized by temperaturesalinity and holidaytravelwatch. Reassortant inherited from epidemic virus has two genes encoding surface proteins (hemagglutinin and neuraminidase). The strain also inherited six genes encoding deglycosylated proteins from the donor to attenuate. Strain a/17/Sydney/97/76 (H3N2) in terms of reactogenicity meets the requirements of vaccine strains for live influenza vaccine for intranasal use for adults. 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 epidemic influenza in adults alive is A (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 similar to the influenza 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/17/Sydney/97/76 (H3N2) obtained by the method of genetic reasontly epidemic virus A/Sydney/5/97 (H3N2) with holodnodeformirovannym strain A/Leningrad/134/17/57 (H2N2) - donor attenuatio - followed by selection in the presence of antisera to the virus A/Leningrad/134/17/57 (H2N2). Donor of attenuation - holodnodeformirovannye temperaturesalinity strain of influenza virus A/Leningrad/134/17/57 (H2N2), allowed to obtain harmless live intranasal vaccine for adults [2].

By using restriction analysis of DNA gene copies vaccine and parental strains, the vaccine strain A/17/Sydney/97/76 (H3N2) inherited 6 genes encoding internal proteins (RW, RV, PA, NP, M, NS) from the donor to attenuate A/Leningrad/134/17/57 (H2N2) and 2 gene encoding surface proteins (hemagglutinin) and NA (neuraminidase which completely neutralized. The strain is temperaturecontrolled (difference in rates of infectious activity 33oC and 40oC is 7.0 lg EID50/Oh,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/17/Sydney/97/76 (3N2) 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 of 8.5 lg EID50/0,2 ml

Hemagglutinin activity - 1:256-1:512.

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

OBrien for adult contingent

Example. When vaccination 89 adults intranasal recombinant vaccine strain A/17/Sydney/97/76 (H3N2) infectious activity of 8.5 1D EID50/0.2 ml in dilution of 1:2 in volume of 0.5 ml of strong temperature reactions with increasing temperature over 38,5oC and secondary reactions with short-term increasing temperature in the range of 37.6-38,5oC was not observed. Weak reaction temperature (up to 37.5oC) were observed in one (1.1 %).

In the control group of 52 persons who received placebo, a strong temperature reactions with increasing temperature over 38,5oC, secondary reactions with increasing temperature in the range of 37.6-38,5oC and a weak temperature reactions to 37.5oC was not observed (see table).

Thus, the vaccine strain a/17/Sydney/97/76 (H3N2) in terms of reactogenicity complies with the requirements of Pharmacopoeia article FS 42-3569-98 to vaccine strains for live influenza vaccine for intranasal use for adults.

Passport strain

1. The name of the strain - A/17/Sydney/97/76 (H3N2)

2. Series - series 1

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

a) epidemic virus - A/Sydney/5/97 (H3N2);

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

b) hemagglutinin activity -1:512;

C) infectious activity - 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 EID50/0,02 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. The recommended dilution in vaccination - 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 A/Sydney/5/97 (H3N2) according to PCR-restriction analysis of DNA - gene copies.

9. Harmlessness on fileserving 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 17/f of influenza A (H3N2) used to get the live intranasal vaccine for adults. Author's certificate N 1222276. Published 07.04.86, BI N13 for 1986

2. Alexandrov, I., Klimov, A. I. Live influenza vaccine. -SPb.: Science.- 1994.151 polyurthane C.

The influenza virus strain A/17/Sydney/97/76 (H3N2) risk N 395/6 (State Institute of standardization and control them.L.A. Tarasevich) used to get the live intranasal influenza vaccine for adults.

 

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