Narayana Ashwath, Manoharan Aravind, Narayan Madhusudana Shampur, Kalappa Sudarshan Mysore, Biligumba Gangaboraiah, Haradanahalli Ravish, Anand Ashwini Manoor
a Community Medicine; Kempegowda Institute of Medical Sciences ; Bangalore , Karnataka , India.
Hum Vaccin Immunother. 2015;11(7):1748-53. doi: 10.1080/21645515.2015.1048938.
The currently advocated rabies post-exposure prophylaxis regimens are of one month duration with reduced patient compliance. WHO recommended research on shortened vaccination regimens which have a practical and economic advantage over the existing regimens. Hence, the present study was undertaken to assess the safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases. This study was a comparative, open label, phase III, randomized clinical trial conducted at Anti rabies clinic, KIMS Hospital, Bangalore, India. The study was registered in Clinical Trials Registry of India (CTRI) bearing the registration number CTRI/2012/12/003230. Ninety subjects with category II/III animal bites/exposures were enrolled. Equine rabies immunoglobulin was administered to all category III exposures. 0.1 mL of either purified chick embryo cell vaccine (Rabipur) or purified verocell rabies vaccine (Verorab) was administered intradermally into 4 sites on days 0, 3 and 7 to all the study subjects. Serum of subjects collected on day 0, 14, 90 and 365 were analyzed for rabies virus neutralizing antibody (RVNA) concentration. The incidence of ADR in Rabipur and Verorab group was 2.96% and 1.14% respectively. In Rabipur group, geometric mean concentration (95% confidence interval) of RVNA was 14.5 (13.50, 15.57), 11.78 (11.27, 12.31) and 5.95 (5.50, 6.44) IU/mL on days 14, 90 and 365 respectively; In Verorab group geometric mean concentration (95% confidence interval) of RVNA was 14.43 (13.41, 15.53), 11.93 (11.47, 12.40) and 5.67 (5.29, 6.08) IU/mL on days 14, 90 and 365 respectively. In conclusion, Rabipur and Verorab were found to be safe, immunogenic and comparable with each other, when administered using one week, 4 site intradermal regimen (4-4-4-0-0) in animal bite cases.
目前所倡导的狂犬病暴露后预防方案疗程为一个月，但患者依从性较低。世界卫生组织建议开展关于缩短疫苗接种疗程的研究，这类缩短疗程方案相对于现有方案具有实际和经济优势。因此，本研究旨在评估在动物咬伤病例中采用一周4部位皮内接种方案（4-4-4-0-0）接种两种世界卫生组织预认证狂犬病疫苗的安全性和免疫原性。本研究是在印度班加罗尔KIMS医院抗狂犬病诊所进行的一项比较性、开放标签、III期随机临床试验。该研究已在印度临床试验注册中心（CTRI）注册，注册号为CTRI/2012/12/003230。招募了90名II/III级动物咬伤/暴露者。所有III级暴露者均注射了马狂犬病免疫球蛋白。在第0、3和7天，给所有研究对象在4个部位皮内注射0.1 mL纯化鸡胚细胞疫苗（瑞必补尔）或纯化vero细胞狂犬病疫苗（威博瑞）。对在第0、14、90和365天采集的研究对象血清进行狂犬病病毒中和抗体（RVNA）浓度分析。瑞必补尔组和威博瑞组的不良事件发生率分别为2.96%和1.14%。在瑞必补尔组，第14、90和365天RVNA的几何平均浓度（95%置信区间）分别为14.5（13.50, 15.57）、11.78（11.27, 12.31）和5.95（5.50, 6.44）IU/mL；在威博瑞组，第14、90和365天RVNA的几何平均浓度（95%置信区间）分别为14.43（13.41, 15.53）、11.93（11.47, 12.40）和5.67（5.29, 6.08）IU/mL。总之，在动物咬伤病例中采用一周4部位皮内接种方案（4-4-4-0-0）接种时，发现瑞必补尔和威博瑞安全、具有免疫原性且相互可比。
