Efficacy of low dose intradermal hepatitis B vaccine: results of a randomized trial among health care workers. 2002

H S Das, and P Sawant, and R G Shirhatti, and K Vyas, and S Vispute, and S Dhadphale, and V Patrawalla, and N Desai
Department of Gastroenterology, LTMMC and LTMGH, Sion, Mumbai.

BACKGROUND Hepatitis B virus (HBV) infection is an occupational health hazard among the healthcare workers. Vaccination against HBV has been established to be the most effective preventive strategy. The present study was designed to assess the efficacy of low dose intradermal HBV vaccine among the nursing staff in a tertiary care hospital setting. METHODS Staff nurses working in our hospital were included in the study as vaccine recipients. Each staff nurse was tested for HBsAg and anti-HBs (commercial ELISA). Those who tested negative for both the above markers were randomized to receive either three doses of intramuscular (i.m.) HBV vaccine (20 micrograms m each dose) at 0, 1 and 6 month interval or three doses of intradermal HBV vaccine (2 micrograms m each dose) at similar intervals. Each vaccine recipient was tested for the presence of anti HBs (commercial ELISA) at the end of 1 month and 1 year after the last dose of the vaccine. The anti-HBs titres were also estimated simultaneously in them. RESULTS Out of 153 staff nurses screened, 19 were either positive for HBsAg (n = 1) or anti HBs (n = 18). 96(72%) of the remaining 134 nurses agreed to receive HBV vaccine (i.m.--48, intradermal--48). At the end of 1 month after last dose of the vaccine, all vaccinees in both the group tested positive for anti-HBs. However the anti-HBs titres at 1 month were significantly higher among intramuscular vaccinees than the nurses receiving the vaccine through intra-dermal route (253 +/- 127.7 mIU/ml vs 151.3 +/- 92.8 mIU/ml, P < 0.001). Eighty four (85.5%) of these 96 vaccine recipient were available for evaluation of anti-HBs titre at the end of 1 year after the last dose of vaccine (1M group = 40, Intradermal group = 44). All the nurses continued to be positive for anti-HBs at the end of 1 year but the anti HBs-titre among i.m. vaccine recipient continued to remain at a significantly higher level than the similar titre among the intradermal vaccine recipients (256.4 +/- 124.7 mIU/ml vs 121.6 +/- 122.4 mIU/ml p < 0.001). CONCLUSIONS Intradermal route for HBV vaccine had similar immunogenic efficacy as the conventional intramuscular route, but the dose required in the former route is one tenth of the intramuscular route. Therefore intradermal route may reduce the cost of HBV vaccine markedly.

UI MeSH Term Description Entries
D007271 Injections, Intradermal The forcing into the skin of liquid medication, nutrient, or other fluid through a hollow needle, piercing the top skin layer. Intradermal Injections,Injection, Intradermal,Intradermal Injection
D008297 Male Males
D009741 Nursing Staff, Hospital Personnel who provide nursing service to patients in a hospital. Hospital Nursing Staff,Hospital Nursing Staffs,Nursing Staffs, Hospital,Staff, Hospital Nursing,Staffs, Hospital Nursing
D005260 Female Females
D006509 Hepatitis B INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact. Hepatitis B Virus Infection
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D016009 Chi-Square Distribution A distribution in which a variable is distributed like the sum of the squares of any given independent random variable, each of which has a normal distribution with mean of zero and variance of one. The chi-square test is a statistical test based on comparison of a test statistic to a chi-square distribution. The oldest of these tests are used to detect whether two or more population distributions differ from one another. Chi-Square Test,Chi Square Distribution,Chi Square Test,Chi-Square Distributions,Chi-Square Tests,Distribution, Chi-Square,Distributions, Chi-Square,Test, Chi-Square,Tests, Chi-Square
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes

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