[Field trial with a new type of influenza subunit vaccine (author's transl)].

Abstract

In a field trial a new influenza subunit vaccine was tested in parallel with a vaccine prepared from the whole virus. The subunit vaccine essentially contained only the proteins of the viral envelope, haemagglutinin and neuraminidase, which had been selectively solubilized by treatment with cetyl trimethylammonium bromide. Both vaccines contained 700 IU of strain A/Port Chalmers/73 in 0.5 ml. They were given to volunteers by the subcutaneous route with and without the addition of Al (OH)3 as adjuvant. Blood samples were taken on days 0, 28 and 90. Development of antibodies was assayed in the haemagglutination-inhibition (HI) and neuraminidase-inhibition (NI) test. All vaccines exhibited a very good immunogenic effect as judged from the number of volunteers with at least a four-fold rise in antibodies in the HI-test and those reaching titres that are considered to be sufficiently high for protection against disease. The best results were obtained with the aqueous subunit vaccine. All four vaccines also stimulated the formation of neuraminidase-inhibiting antibodies. The vaccines were well tolerated by the volunteers. The incidence of minor local reactions such as redness, swelling and pain varied according to the vaccine used, as shown on statistical evaluation. The aqueous subunit vaccine clearly proved to be superior in this respect.

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