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Persistence of anti-HBs titers after two different doses of Genevac B,
a recombinant hepatitis B vaccine,
in healthy adolescents
We compared the immunogenicity, safety and persistence of anti-HBs titers after two different doses of a new recombinant hepatitis B vaccine, Genevac B (Serum Institute of India), in healthy adolescents. School children studying at the Corporation Higher Secondary School, Adyar, Chennai were recruited after obtaining written informed consent from their parents. Healthy adolescents aged 11-19 years of either sex; tested negative for HBsAg, anti-HBs, antiHBc IgM; and with no history of previous vaccina tion against hepatitis B were included in the trial. The exclusion criteria were: active moderate or se vere illness; previously diagnosed hepatitis B posi tivity; hepatomegaly and/or splenomegaly; uncontrolled coagulopathy; known immunological deficiency in cluding HIV infection; treatment with immunosuppressors including corticosteroids; chronic illness like epilepsy; evidence of skin diseases or infection at any site. Two hundred healthy adolescents were recruited and randomly allocated as 100 subjects each to re ceive 1 mL doses (20 µg) and 0.5 mL doses (10 µg) of Genevac B vaccine. The vaccine was adminis tered in the deltoid region at 0, 1 and 6 months. Following administration of each dose, the subjects were observed for adverse events. Blood samples collected one month after each dose were assayed for quantitative levels of anti-HBs (Monolisa AntiHBs [BIORAD] 3.0; Sanafi Pastuer). Seroconversion and seroprotection rates were defined as anti-HBs titer 10 mIU/mL levels, respec tively. On completion of the seventh month and after one year, 94 children receiving the 20 µg dose and 96 receiving the 10 µg dose followed up. The seroconversion rates on completion of the vaccina tion were 100% in both groups (Table). The antiHBs levels achieved (GMT) were 2628.98 mIU/mL and 1372.80 mIU/mL, respectively (p>0.05). The GMT dropped at one year after vaccination to 2261.7 mIU/mL and 1038.5 mIU/mL, respectively. Pain at the site of injection and fever were the only symp toms, seen in equal numbers in both the groups. We conclude that Genevac B boosts good im mune response even with 10 µg dose in healthy adolescents. Vaccination with 10 µg of this lost-cost vaccine 1 can provide an effectve, economical alter-
Letters
Table: Seroconversion and seroprotection rates after hepatitis B vaccination
One month after One year after 1st dose 2nd dose 3rd dose 3rd dose 20 µg Seroconversion Seroprotection Anti-HBs GMT (mIU/mL) 10 µg Seroconversion Seroprotection Anti-HBs GMT (mIU/mL)
46.8% 19.1%
94.6% 86.1%
100% 100%
100% 100%
14.47
94.30
26.28.9
2261.7
37.5% 10.4%
92.7% 70.8%
100% 100%
100% 100%
13.8
48.3
1372.8
1038.5
native to the 20 µg dose normally recommended for healthy adolescents. Vijayakumar Velu, Subhadra Nandakumar,
Saravanan Shanmugam,
Sadras Panchatcharam Thyagarajan
Department of Microbiology, Dr A L M Post
Graduate Institute of Basic Medical Sciences,
University of Madras, Taramani,
Tamil Nadu 600 113
Reference 1. Kulkarni PS, Raul SK, Patki PS, Phadke MA, Jadhav SS, Kape SV, et al. Immunogenicity of a new, low-cost recom binant hepatitis B vaccine derived from Hansenula polymorpha in adults. Vaccine 2006;24:3457-60. Acknowledgement: We thank M/s Serum Institute of India, Pune, for financial assistance to conduct this study Correspondence to: Dr Thyagarajan, Vice-Chancellor, Uni versity of Madras, Chennai 600 005. Fax: (44) 2536 7654, 2445 3706. E-mail:
[email protected]
Randomized, comparative study of cefotaxime 2 versus 4 grams in spontaneous bacterial peritonitis
The bacterial load in spontaneous bacterial peritonitis (SBP) is low when compared with other infections. The MIC values of commonly used antibiotics are lower than those for other infections. 1 The elimination of cefotaxime and its active metabolites decreases in cirrhotic patients, due to functional renal failure. 2 We conducted a randomized, prospective trial, from June 2003 to July 2004 comparing two dose schedules of cefotaxime. Thirty-six episodes of SBP were diagnosed on hospital admission in 36 cirrhotic patients. SBP was diagnosed on the basis of ascitic fluid polymorphonuclear leukocytes (PMN) count over 250/mm 3 in the absence of features suggesting sec ondary peritonitis. Patients taking antibiotics within
48 Indian Journal of Gastroenterology 2007 Vol 26 January - February
