Evaluation of a new recombinant DNA hepatitis B vaccine (Shanvac-B)

被引：14

作者：

Abraham, P ^{[1
]}

Mistry, FP

Bapat, MR

Sharma, G

Reddy, GR

Prasad, KSN

Ramanna, T

机构：

[1] King Edward Mem Hosp, Dept Gastroenterol, Mumbai 400012, India

[2] Shantha Biotech, Medchal, AP, India

来源：

VACCINE | 1999年 / 17卷 / 9-10期

关键词：

yeast-derived vaccine;

D O I：

10.1016/S0264-410X(98)00331-4

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

We assessed the efficacy and safety of Shanvac-B, a new recombinant hepatitis B vaccine developed in India. Eighty-one healthy volunteers (75 women, 6 men; aged 18-40 yr), negative for markers for,hepatitis B and HIV, received 20 mu g of the vaccine intramuscularly at 0, 1 and 2 months. Forty-three (53%) seroconverted at one month after dose 1; of these, 26% were seroprotected (anti-HBs > 10 mIU/mL). Seroprotection at one month after doses 2 and 3 was 99% and 100%, respectively. Geometric mean titres of anti-HBs in subjects who seroconverted were 11 (range 2-366), 266 (8-7469) and 2246 (102-23680) mIU/mL, respectively. One subject developed urticarial rash after the second dose; there was no other adverse event. We conclude that this vaccine is safe and efficacious, providing significant protection even after two doses. (C) 1999 Elsevier Science Ltd. All rights reserved.

引用

页码：1125 / 1129

页数：5

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