Kulkarni P S, Raut S K, Patki P S, Phadke M A, Jadhav S S, Kapre S V, Dhorje S P, Godse S R
Serum Institute of India Ltd., 212/2, Hadapsar, Pune 411028, India.
Vaccine. 2006 Apr 24;24(17):3457-60. doi: 10.1016/j.vaccine.2006.02.008. Epub 2006 Feb 21.
Hepatitis B virus (HBV) infection is highly prevalent world over, especially in developing countries. A new recombinant hepatitis B virus (GeneVac-B; Serum Institute of India Ltd.) vaccine is developed using Hansenula polymorpha yeast. We decided to assess the immunogenicity, and reactogenicity of this vaccine in a large adult population.
Seven hundred eighty-eight adults subjects (age: 19-57 years, male:female ratio 35:1) received three 20 microg doses of a H. polymorpha-derived recombinant hepatitis B vaccine in months 0, 1, and 6. All the eligible subjects had negative baseline serum HBs Ag, and anti-HBs. The anti-HBs titer was obtained 1 month after the last dose of vaccine and was considered seroconverted if more than 1 mIU/ml, and seroprotective if more than 10 mIU/ml.
The seroprotection rate was 96% and seroconversion rate was 97%. Seroconversion and seroprotection rates declined with increasing age. The minimum geometric mean titre of anti HBs was 443 mIU/ml (95% CI 407-482). Seroprotection was 96% in age group<40 years, while the same was 91% in >40 years group (Odd's ratio-2.9100, Z value-2.6183, highly significant). No other factor like smoking, tobacco-chewing, alcohol consumption, chronic diseases, and obesity, affected the immune response. No significant adverse reactions were reported in any of the subjects.
Three standard doses of the H. polymorpha-derived recombinant HBV vaccine are highly immunogenic and safe in a predominantly male adult population. Young adults respond better with this vaccine. Because of its low cost, the vaccine may be a good choice in prevention of hepatitis B infection.
乙肝病毒（HBV）感染在全球高度流行，尤其是在发展中国家。一种新的重组乙肝病毒（GeneVac - B；印度血清研究所）疫苗是利用多形汉逊酵母研发的。我们决定在大量成年人群中评估该疫苗的免疫原性和反应原性。
788名成年受试者（年龄：19 - 57岁，男女比例35:1）在第0、1和6个月接受了三剂20微克的多形汉逊酵母衍生重组乙肝疫苗。所有符合条件的受试者基线血清乙肝表面抗原（HBs Ag）和抗 - HBs均为阴性。在最后一剂疫苗接种后1个月检测抗 - HBs滴度，若大于1 mIU/ml则视为血清学转换，若大于10 mIU/ml则视为具有血清保护作用。
血清保护率为96%，血清学转换率为97%。血清学转换率和血清保护率随年龄增长而下降。抗 - HBs的最低几何平均滴度为443 mIU/ml（95%可信区间407 - 482）。年龄<40岁组的血清保护率为96%，而>40岁组为91%（优势比 - 2.9100，Z值 - 2.6183，高度显著）。吸烟、嚼烟、饮酒、慢性病和肥胖等其他因素均未影响免疫反应。所有受试者均未报告明显不良反应。
三剂标准剂量的多形汉逊酵母衍生重组乙肝疫苗在以男性为主的成年人群中具有高度免疫原性且安全。年轻人对该疫苗反应更佳。由于其成本低廉，该疫苗可能是预防乙肝感染的良好选择。
