Lin D B, Kao C L, Lee C Y
School of Medical Technology, Chung Shan Medical and Dental College, Taichung, Taiwan, ROC.
Southeast Asian J Trop Med Public Health. 1996 Dec;27(4):707-14.
Since the licensing of the rubella virus vaccine (RA 27/3 strain) in 1979, clinical studies on the RA 27/3 strain vaccine, which gives rise to high titer antibody, have been reported. In the present study, this vaccine was used to examine the immune response in young women. Volunteers without the previous immunity to rubella virus screened by hemagglutination inhibition (HAI), latex agglutination (LA), fluorescence immunoassay (FIA) and solid-phase immunoassay (SPIA) tests were injected with Rudivax vaccine or Meruvax II vaccine. Adverse reactions occurred between 10 and 20 days after vaccination in 30% of the volunteers. After 28-35 days, vaccinees developed antibodies against rubella virus. The titer of rubella antibody reached it's peak from the 40th day through the 100th day. One year after vaccination, the geometric mean titer (GMT) of rubella virus antibody still remained over 1 : 64 (HAI) and 1 : 38.2 (FIA), and SPIA IgG RI mean was 2.80. Two years later, the antibody titers were 1 : 52 by HAI and 1 : 32.1 by FIA, and SPIA IgG RI mean was 2.75. After 5 years, the antibody titers were 1 : 48.6 (HAI) and 1 : 28.2 (FIA), and SPIA IgG RI mean was 2.74. After 10 years, the anti-rubella virus antibody titers were 1 : 38.9 (HAI) and 1 : 25.1 (FIA), and SPIA IgG RI mean was 2.42. LA antibody still remained seropositive. In conclusion, the rubella vaccine RA 27/3 is safe and efficient, and it is applicable for the control of the rubella in Taiwan.
自1979年风疹病毒疫苗(RA 27/3株)获得许可以来,已有关于产生高滴度抗体的RA 27/3株疫苗的临床研究报道。在本研究中,使用该疫苗检测年轻女性的免疫反应。通过血凝抑制(HAI)、乳胶凝集(LA)、荧光免疫测定(FIA)和固相免疫测定(SPIA)试验筛选出的对风疹病毒无既往免疫力的志愿者,接种了鲁迪瓦克斯疫苗或默鲁瓦克斯II疫苗。30%的志愿者在接种疫苗后10至20天出现不良反应。28至35天后,接种者产生了抗风疹病毒抗体。风疹抗体滴度在第40天至第100天达到峰值。接种疫苗一年后,风疹病毒抗体的几何平均滴度(GMT)仍超过1:64(HAI)和1:38.2(FIA),SPIA IgG RI平均值为2.80。两年后,HAI抗体滴度为1:52,FIA为1:32.1,SPIA IgG RI平均值为2.75。5年后,抗体滴度为1:48.6(HAI)和1:28.2(FIA),SPIA IgG RI平均值为2.74。10年后,抗风疹病毒抗体滴度为1:38.9(HAI)和1:25.1(FIA),SPIA IgG RI平均值为2.42。LA抗体仍保持血清阳性。总之,风疹疫苗RA 27/3安全有效,适用于台湾地区风疹的防控。