Závadová H, Domorázková E, Skovránková J, Vodicková M, Ragac P, Vonka V
Ustav sér a ockovacích látek, Praha.
Cesk Pediatr. 1990 Jun;45(6):344-6.
In a group of 144 children (six months to 15 years) three doses vaccine were administered. The latter contains the main strains of the influenza type A and strain type B. From the clinical evaluation ensued that this vaccine in children is areactogenic even after repeated doses. The morbidity was followed up for 18 months and during this period in the immunized communities no case of influenza was recorded. The antibody levels were assessed by the haemagglutination-inhibition test (HIT) and the enzyme test (NIT) The assessed HI titres were high after the second and third dose, in particular as regard subtype H3N2 and H1N1. The titres against subtype H2N2 and type B were markedly lower. Antibodies against neuraminidase were highest against subtype N1 and type B, lowest against N2. The dynamics of the formation of antineuraminidase antibodies was similar as that of haemagglutination-inhibition antibodies. Based on these results the vaccine is evaluated as very satisfactory and after approval by the Ministry of Health and Social Affairs this vaccine will be used for a field trial in 1-2 thousand children where above all the protective effect of the vaccine will be investigated. This vaccine is intended for children, with the aim to induce complex immunity against influenza.
在一组144名6个月至15岁的儿童中接种了三剂疫苗。该疫苗包含甲型流感和乙型流感的主要毒株。临床评估结果显示,这种疫苗即使在儿童重复接种后也会产生反应原性。对发病率进行了18个月的随访,在此期间,在接种疫苗的社区未记录到流感病例。通过血凝抑制试验(HIT)和酶试验(NIT)评估抗体水平。在接种第二剂和第三剂后,尤其是针对H3N2和H1N1亚型,评估的血凝抑制效价较高。针对H2N2亚型和乙型流感的效价明显较低。针对神经氨酸酶的抗体,针对N1亚型和乙型流感最高,针对N2最低。抗神经氨酸酶抗体的形成动态与血凝抑制抗体相似。基于这些结果,该疫苗被评估为非常令人满意,经卫生和社会事务部批准后,这种疫苗将在1000至2000名儿童中进行现场试验,其中首要目的是研究该疫苗的保护效果。这种疫苗适用于儿童,旨在诱导针对流感的综合免疫力。