Comparison of Two Hepatitis B Vaccines (GeneVac-B and Engerix-B) in Healthy Infants in India

Abstract

Hepatitis B is a major problem in many parts of the world. The WHO has recommended the inclusion of hepatitis B vaccines in routine immunization schedules. We wanted to compare two recombinant hepatitis B vaccines in an infant population for immunogenicity and reactogenicity when given at 6, 10, and 14 weeks of age. One hundred seventy-three infants meeting eligibility criteria were given either GeneVac-B (Serum Institute of India Ltd.) or Engerix-B (GlaxoSmithKline Beecham) in a random fashion. Three 0.5-ml (10-g) doses of the vaccines were given at 6, 10, and 14 weeks of age along with diphtheria-pertussis (whole cell)-tetanus (DTPw) vaccine. Blood samples were collected at baseline and 1 month after administration of the third dose of the vaccines to measure anti-HBs antibody levels. Seroconversion was defined as a titer of more than 1 ؋ 10 ؊3 IU/ml, while seroprotection was defined as a titer of more than 10 ؋ 10 ؊3 IU/ml. Of the GeneVac-B recipients, 98% seroconverted versus 99% of the Engerix-B group. The anti-HBs geometric mean titer was slightly greater for GeneVac-B (229 ؋ 10 ؊3 IU/ml) than for Engerix-B (167 ؋ 10 ؊3 IU/ml), but the difference was not significant. The seroprotection rates were similar for both vaccines (96% and 95%, respectively). The most common systemic reaction events were mild to moderate fever, excessive crying, local swelling, rash, and irritability, and the local reactions were redness, induration, and edema, which most probably were caused by the simultaneously administered DTPw vaccine. All events were transient and resolved without sequelae. Reactogenicity was similar for the two vaccines. The present study shows that GeneVac-B is as immunogenic and as well tolerated as Engerix-B when administered 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 virus (HBV) globally. This includes 350 million chronic carriers of the virus. The infection is supposed to be causally related to 1 to 2 million deaths per year worldwide (11).In India, too, hepatitis B is a major public health problem. India comes under the intermediate zone (2 to 7%) of HBV prevalence, the carrier rate being approximately 5%. The HBV carrier load 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 program (15). According to the WHO report of March 1994, 72 countries have adopted hepatitis B vaccine in their universal program of immunization (12). However, HBV vaccine has not been included in the national immunization program 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 manufactured by the Serum Institute of India Ltd., Pune, India. The vaccine ...

Hepatitis B immunization at the University College Hospital, Ibadan: an eight year review of vaccine administration records

“…The prescreening for both HBsAg and anti-HBc carried out in 1999 follows acceptable norm [2,18,19] especially in HBV hyper-endemic areas [1]. The use of either Engerix -or Genevac -B vaccine at any of the dose of the HBV vaccination schedule observed from the study follows previous reports [8][9][10]20]; hence any available recombinant DNA technology type of HBV vaccines could be administered. This will enhance compliance of the subjects to the vaccination schedule.…”

Effect of Revaccination Using Different Schemes among Adults with Low or Undetectable Anti-HBs Titers after Hepatitis B Virus Vaccination

“…The current chief countermeasures include using more-immunogenic epitopes (24) or replacement vaccines (18,22), increasing the number of vaccinations and doses, changing the method of vaccination, and combining the vaccine with an adjuvant or immunoregulant (14,16,25,27). The addition of preS2 antigen or core antigens (HBcAg) to the HBV surface antigen (HBsAg) provides additional protective immunity.…”

Viral hepatitis vaccination during pregnancy

“…Recombinant HB vaccines with 3-or 4-dose schedules, such as Engerix-B, are effective and safe for infants 67,68 and adults. [69][70][71] To our knowledge, no large-scale randomized controlled trials (RCTs) have yet assessed the efficacy and safety of HB vaccines in pregnant women, 72 likely due to ethical issues.…”