Efficacy of Shanvac-B recombinant DNA hepatitis B vaccine in health care workers of Northern India.
BACKGROUND
Health care workers (HCWs) constitute a high-risk population of HBV infection. There are limited data on the efficacy of vaccination in HCWs in India. This study was to evaluate the efficacy of indigenous recombinant hepatitis B vaccine, Shanvac-B, in HCWs.


METHODS
In 597 HCWs screened before the vaccination, 216 (36.2%) showed the presence of at least one of the markers of HBV/HCV infection. Of the remaining 381 (63.8%) HCWs who were considered for vaccination, only 153 (age 18-45 years; 48 males and 105 females) were available for final assessment. These HCWs received 20 microg of vaccine at 0, 1 and 6 months. They were asked for the reactogenicity and monitored for the seroprotective efficacy of the vaccination. Anti-HBs titres were measured after vaccination at 1, 2 and 7 months. The presence of anti-HBs titers equal to 1 MIU/ml was considered as seroconversion and that of titres greater than 10 MIU/ml as seroprotection.


RESULTS
After vaccination, 32 males (67%) and 76 females (72%) showed seroconvertion; finally 12 (25%) of the males and 47 (45%) of the females were seroprotected. Seroprotection at 2 and 7 months was more dominant in the females than in the males (96% vs. 56%, P=0.001, 100% vs. 85%, P=0.0001), respectively. Geometric mean titres of anti-HBs after vaccination were also higher in the females than in the males (257+/-19.7 vs. 29+/-1.88 MIU/ml, P=0.01, 1802+/-35.2 vs. 306+/-13.6 MIU/ml, P< or =0.05, 6465+/-72 vs. 2142+/-73.6 MIU/ml, P<0.05). Seven male HCWs showed unsatisfactory response, non-response (n=3, 6%) and hypo-response (< or =10 MIU/ml, n=4, 8%) at the end of vaccination. Smoking and alcoholism were significantly correlated with unsatisfactory response. No significant adverse effects of vaccination were observed in any HCW.


CONCLUSIONS
The presence of HBsAg in HCWs indicates that a high proportion of HCWs are infected with HBV and HCV in India. Recombinant indigenous vaccine Shanvac-B is highly efficacious in HCWs, and its immunogenicity is significantly higher in females than in males. However, pre-vaccination screening of HCWs is strongly recommended in India.
Thakur
Varsha
V
Department of Gastroenterology, GB Pant Hospital, New Delhi, India.
Pati
Nirupma T
NT
Gupta
Rajkumar C
RC
Sarin
Shiv K
SK
D000293:Adolescent; D000328:Adult; D005260:Female; D006509:Hepatitis B / Q000097:blood / Q000453:epidemiology / Q000635:transmission*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D006801:Humans; D007194:India / Q000453:epidemiology; D017757:Infectious Disease Transmission, Professional-to-Patient / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D012189:Retrospective Studies; D016896:Treatment Outcome; D019444:Vaccines, DNA / Q000627:therapeutic use*; D055815:Young Adult
D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; C522543:Shanvac B; D019444:Vaccines, DNA