Comparison of two hepatitis B vaccines (GeneVac-B and Engerix-B) in healthy infants in India.

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-mug) 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 x 10(-3) IU/ml, while seroprotection was defined as a titer of more than 10 x 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 x 10(-3) IU/ml) than for Engerix-B (167 x 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.