An estimated 1.5 million
clinical cases of hepatitis A occur each year, majority of which are
reported from developing countries. Hepatitis A vaccine in most developing
countries is recommended only for travellers to endemic areas. This is the
reason why the immunization coverage for hepatitis A is relatively low and
the risk of hepatitis A infection is not perceived as a serious health
problem(2). However, recently a substantial number of hepatitis A cases
have been reported from developed countries. The ongoing outbreak of
hepatitis A in the Czech Republic, a country with a very low incidence (2
per 100,000 population) and having a consistent decline in number of cases
since the last outbreak in 1979-1980, clearly illustrates this scenario. A
very low seroprevalence of HAV facilitated its spread, and hundreds of new
cases in a short time led to an escalated demand of the HAV vaccine. The
current outbreak was imported from the Mediterranean region highlighting
an important epidemiological aspect of hepatitis A infection in
travellers(3).
HAV immunization in
infants was not recommended due to the possible interference by the
passively-acquired maternal antibodies which would lower the vaccine
efficacy(1). Studies, where HAV vaccine was administered at 2, 4, and, 6
months of age with a booster at 12-15 months of age have been carried out
to resolve this issue.
Four comparable
hepatitis A vaccines are available (Havrix, Vaqta, Avaxim and Epaxal).
Epaxal differs from the others in using a liposome adjuvant. Live
attenuated hepatitis A vaccines have been tested in humans and are shown
to be safe. Unfortunately, the vaccines studied to date replicate poorly
in humans and do not induce a satisfactory immune response when given
orally. This can limit another major advantage of live attenuated vaccine
of only a single dose regimen. Live attenuated vaccine developed using the
H2 strain is licensed for use in China. After subcutaneous or
intramuscular administration the vaccine appears to be immunogenic and
effective in protecting individuals and preventing outbreaks. Data show
protective antibody levels of 98.6% two months after inoculation and 80.2%
after ten years(4-6). Live attenuated H2 strain Hepatitis A vaccine in a
single dose was also found to be immunogenic and safe in Indian
children(7). Current study of Faridi, et al.(8) proved a similar
concept in four municipal areas in India and confirmed the immunogenicity
and safety of single dose injectable live attenuated hepatitis A vaccine
in children 18– 60 months. It raises an important question of how to
design studies in areas with higher prevalence of antibody on the
baseline. Methodologically it would be better to screen all the subjects
at entry, and to enroll only those who are seronegative. However, an
additional visit may increase the number of drop-outs and decrease the
compliance. This study follows a more practical approach where children
were not tested prior to immunization. Nevertheless it would be
interesting to study if the reactogenicity is higher in seropositives on
baseline.
1. WHO. Position paper on Hepatitis A vaccines. Wkly
Epidemiol Rec 2000; 75, 5: 38-42.
2. Fiore AE, Feinstone SM, Bell BP. Hepatitis A
vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th
ed. Philadelphia: Saunders; 2008. p. 177-203.
3. Dlhy J, Benes C. Imported viral hepatitis in the
Czech republic. Klin Mikrobiol Infekc Lek 2007; 13: 48-53.
4. Zhuang F, Jiang Q, Gong Y. Epidemiological effects
of live attenuated hepatitis A vaccine (H2-strain): results of a 10-year
observation. Zhonghua Liu Xing Bing Xue Za Zhi 2001; 22: 188-190.
5. Wang XY, Xu ZY, Ma JC, von Seidlein L, Zhang Y, Hao
ZY, et al. Long-term immunogenicity after single and booster dose
of a live attenuated hepatitis vaccine: results from 8-year follow-up.
Vaccine 2007; 25: 446-449.
6. Zhuang FC, Qian W, Mao ZA, Gong YP, Jiang Q, Jiang
LM, et al. Persistent efficacy of live attenuated hepatitis A
vaccine (H2-strain) after a mass vaccination program. Chin Med J 2005;
118: 1851-1856.
7. Bhave S, Bavdekar A, Madan Z, Jha R, Bhure S,
Chaudhari J, et al. Evaluation of immunogenicity and tolerability
of a live attenuated hepatitis A vaccine in Indian children. Indian
Pediatr 2006; 43: 983-987.
8. Faridi MMA, Shah N, Ghosh TK, Sankaranarayanan VS,
Arankalle V, Aggarwal A, et al. Immunogenicity and safety of live
attenuated hepatitis A vaccine: A multicentric study. Indian Pediatr 2009;
46: 29-34.