Safety and immunogenicity of indigenous recombinant hepatitis B vaccine (Shanvac-B) in comparison with commercially available vaccine.
Article
in English
| IMSEAR
| ID: sea-65759
ABSTRACT
AIM:
To assess the clinical safety, reactogenicity and immunogenicity of an indigenously developed recombinant hepatitis B vaccine (Shanvac-B; Shantha Biotechnics) and to compare it with another commercially available vaccine (Engerix-B, SmithKline Beecham) in healthy adults.METHODS:
120 healthy adults randomLy received 20 micrograms of either Engerix-B (Group A; n = 61) or Shanvac-B (Group B; n = 59) in 0, 1, 2 months schedule. Anti HBs was assessed using commercially available AUSAB kits (Abbott Laboratories) one month after each dose.RESULTS:
Protective seroconversion rates after first, second and third dose were 10%, 62.7% and 91.4%, respectively in Group A and 22.4%, 68.9% and 96.4% in Group B, respectively. The geometric mean titer (GMT) after the third dose was significantly high in Group B (419 mIU/mL) than in Group A (140 mIU/mL; p < 0.001). The GMT was significantly higher in women in both the groups. The indigenous vaccine was found to be clinically safe and well tolerated without significant side effects.CONCLUSION:
The recombinant hepatitis B vaccine (Shanvac-B) developed in India is safe, well tolerated, and highly immunogenic, with high seroconversion and GMT response.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Main subject:
Recombinant Proteins
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Female
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Humans
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Male
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Enzyme-Linked Immunosorbent Assay
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Hepatitis Antibodies
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Chi-Square Distribution
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Hepatitis B Vaccines
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Vaccines, DNA
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Adult
Type of study:
Controlled clinical trial
Language:
English
Year:
2000
Type:
Article
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