Immune response to an indigenously developed r-hepatitis B vaccine in mixed population: study of an accelerated vaccination schedule.
OBJECTIVE
To establish the safety and efficacy of an indigenously developed r-hepatitis B vaccine using an accelerated schedule and to highlight the social awareness and commitment in preventing the spreading of hepatitis B virus infection.


METHODS
The study was a multicentric, double blind, randomized (3:1) study using three doses of vaccine immunization schedule (20 mug for those above 10 years old and 10 mug for those below 10 years old) on d 0, 30 and 60. One hundred and sixty-six subjects were enrolled (87 males and 76 females aged 5-35 years). The main outcome measure was assessment of immunogenicity and safety.


RESULTS
A 100% seroconversion response was observed on the 30(th) d after the 1(st) injection in both the experimental groups. The sero-protection data reported a 41.2-65.6% response on the 30(th) d after the 1(st) injection and reached 100% on the 60(th) d. Descriptive statistical analysis showed a geometric mean titer value of 13.77 mIU/mL in the test (BEVAC) group and 10.95 mIU/mL in the commercial control (ENGERIX-B) group on the 30(th) d after the 1(st) injection. The response on the 60(th) d showed a geometric mean titre value (GMT) of 519.84 mIU/mL in the BEVAC group and 475.46 mIU/mL in the ENGERIX-B group. On the 90(th) d, the antibody titer response was observed to be 2627.58 mIU/mL in the BEVAC group and 2272.72 mIU/mL in the ENGERIX-B group. Two subjects in each group experienced pains at injection site after the first vaccination. A total of six subjects in both groups experienced a solicited adverse reaction, which included pains, swelling and redness at the injection site, three subjects in the group-B had a pain at the injection site after the third dose. No other serious adverse events occurred and no dose-related local or general symptoms were observed during the study.


CONCLUSIONS
The vaccine is safe, efficacious and immunogenic in comparison with the well documented ENGERIX-B.
Chowdhury
A
A
Department of Clinical and Regulatory Affairs, Biological E.Limited, 18/1 and 3 Azamabad, Hyderabad, Zip-500020, India.
Santra
A
A
Habibullah
C-M
CM
Khan
A-A
AA
Karunakaramaiah
J
J
Kishore
T-S-A
TS
Raju
A-V-R
AV
Lahiri
S
S
D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male
D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines
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