Bobadilla (ed

Bobadilla (ed.), Disease control priorities in developing countries. than for Engerix-B (167 10?3 IU/ml), but the difference was not significant. The seroprotection rates NOS3 were related for both vaccines (96% and 95%, respectively). The most common systemic reaction events were slight to moderate fever, excessive crying, local swelling, rash, and irritability, Nepicastat (free base) (SYN-117) and the local reactions were redness, induration, and edema, which most probably were caused by Nepicastat (free base) (SYN-117) the simultaneously given DTPw vaccine. All events were transient and resolved without sequelae. Reactogenicity was related for the two vaccines. The present study demonstrates GeneVac-B is as immunogenic and as well tolerated as Engerix-B when given with DTPw vaccine at 6, 10, and 14 weeks of age. Hepatitis B is one of the world’s major health problems (9). By recent estimates, more than 2 billion people are infected with hepatitis B disease (HBV) globally. This includes 350 million chronic service providers of the disease. The infection is supposed to be causally related to 1 to 2 2 million deaths per year worldwide (11). In India, too, hepatitis B is definitely a major general public health problem. India comes under the intermediate zone (2 to 7%) of HBV prevalence, the carrier rate being approximately 5%. The HBV carrier weight is around 38 to 43 million (12). The WHO Assembly endorsed the recommendation of its Global Advisory Group that all countries should implement a hepatitis B immunization system (15). According to the WHO statement of March 1994, 72 countries have used hepatitis B vaccine in their common system of immunization (12). However, HBV vaccine has not been included in the national immunization system in India, and cost is one of the limiting factors. The page may be turning, however, because recombinant HBV vaccines are now manufactured locally and the price of the vaccine is much less than that of imported vaccine(s). A recombinant hepatitis B vaccine (GeneVac-B) is definitely manufactured by the Serum Institute of India Ltd., Pune, India. The vaccine is definitely authorized in India, and several hundred thousand doses have been used in this country and abroad. The immunogenicity and security of GeneVac-B have been verified for adults (13) and adolescents (8, 14). A rival vaccine (Engerix-B) built by GlaxoSmithKline, Rixensart, Belgium, has also been promoted in India for several years. The present study wanted to compare the reactogenicity and immunogenicity of these two vaccines in normal healthy babies. MATERIALS AND METHODS Vaccines. GeneVac-B (test vaccine) consists of purified surface antigen (Ag) of HBV acquired by culturing genetically manufactured candida cells expressing the surface Ag gene of the virus. There is no material of human being or animal source. Each pediatric dose of 0.5 ml consists of 10 g of surface Ag adsorbed on 1.25 mg of aluminum hydroxide, with 0.01% thimerosal added like a preservative. The commercial batch quantity was S-50304, and the manufacture and expiration times were January 2003 and December 2004, respectively. Also, Engerix-B (comparator vaccine) is definitely a noninfectious recombinant DNA hepatitis B vaccine. It contains purified surface Ag from genetically manufactured cells, which carry the surface Ag gene of HBV. Each pediatric dose of 0.5 ml has 10 g of Ag protein adsorbed on 0.25 mg of aluminum hydroxide with 1:20,000 thimerosal added like a preservative. The commercial batch quantity was ENG-3445A1, and the manufacture and expiration times were February 2002 and January 2005, respectively. The vaccines were stored at 2 to 8C inside a refrigerator. Use and Nepicastat (free base) (SYN-117) storage of the vaccine were under the supervision of a responsible staff member participating Nepicastat (free base) (SYN-117) in the study. Setup. An open, randomized, comparative postmarketing trial was carried out among 173 babies meeting the eligibility criteria. The study center was the Indira Gandhi Institute of Child Health, Bangalore, India, and serology screening was done from the Division of Microbiology, Indira Gandhi Institute of Child Health. This study was authorized by the Institutional Ethics Committee of Indira Gandhi Institute, and it was carried out between October 2003 and September 2004..