Tanaka Y, Ueda K, Miyazaki C, Nakayama M, Kusuhara K, Okada K, Tokugawa K, Shibata R, Nishima S, Yamane N
Department of Pediatrics, Faculty of Medicine, Kyushu University, Fukuoka, Japan.
Pediatr Infect Dis J. 1993 Jul;12(7):600-5. doi: 10.1097/00006454-199307000-00011.
Twenty asthmatic children and 48 patients with severe psychomotor retardation were inoculated intranasally with trivalent cold-adapted recombinant (CR) influenza vaccine containing CR-125 (H1N1), CR-159 (H3N2) and CRB-117 (B). The vaccinees were mostly seropositive. Severe adverse reactions or asthmatic attacks were not observed, but 7 (15%) of 48 vaccinees with severe psychomotor retardation developed mild to moderate fever. Significant antibody responses in hemagglutination-inhibition tests were demonstrated in 33 (49%) vaccinees to CR-125, 20 (29%) to CR-159 and 8 (12%) to CRB-117. Two nosocomial outbreaks of influenza were observed in the subsequent winter. During an outbreak with H3N2 in one ward of severe psychomotor retardation patients, 2 (11%) of 18 vaccinees became infected compared with 10 (48%) of 21 placebo controls in the same ward (P < 0.05). In the other outbreak, with influenza B virus, 2 (14%) of 14 vaccinees and 13 (52%) of 25 controls in the ward for asthmatic children were infected (P < 0.05). The results indicate that trivalent CR vaccine is safe and effective against nosocomial outbreaks of influenza.
20名哮喘儿童和48名严重精神运动发育迟缓患者经鼻接种了含有CR-125(H1N1)、CR-159(H3N2)和CRB-117(B)的三价冷适应重组(CR)流感疫苗。接种疫苗者大多血清反应呈阳性。未观察到严重不良反应或哮喘发作,但48名严重精神运动发育迟缓的接种疫苗者中有7人(15%)出现了轻至中度发热。在血凝抑制试验中,33名(49%)接种疫苗者对CR-125、20名(29%)对CR-159、8名(12%)对CRB-117产生了显著的抗体反应。在随后的冬季观察到两起医院内流感暴发。在一个严重精神运动发育迟缓患者病房发生H3N2暴发期间,该病房18名接种疫苗者中有2人(11%)感染,而21名安慰剂对照者中有10人(48%)感染(P<0.05)。在另一起由乙型流感病毒引起的暴发中,哮喘儿童病房的14名接种疫苗者中有2人(14%)感染,25名对照者中有13人(52%)感染(P<0.05)。结果表明,三价CR疫苗对医院内流感暴发安全有效。