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Year : 2004  |  Volume : 1  |  Issue : 1  |  Page : 240-248
Hepatitis B Immunization: FAQs

Dept. of Gastroenterology, S.C.B. Medical College, Cuttack 753 007, India

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How to cite this article:
Singh SP. Hepatitis B Immunization: FAQs. Hep B Annual 2004;1:240-8

How to cite this URL:
Singh SP. Hepatitis B Immunization: FAQs. Hep B Annual [serial online] 2004 [cited 2024 Feb 21];1:240-8. Available from: https://www.hepatitisbannual.org/text.asp?2004/1/1/240/27929

Q. Does breastfeeding pose any additional risk of immunoprophylaxis failure to infants of HBV carrier mothers ?

A. No breastfeeding does not have a negative influence on the response of anti-HBs and on the failure rates of immunoprophylaxis in the infants born to HBV carrier mothers.

A total of 230 such babies were followed up for one year to assess the influence of feeding methods on the efficacy of HB immunoprophylaxis. The positive rates of anti-HBs at different ages were not statistically different between the breastfed group and the bottle-fed group. At 1 year, the rate was 80.9% in the breastfed group and 73.2% in the bottle-fed group in infants with HB vaccine alone, and 90.9% in the breastfed group and 90.3% in the bottle-fed group in infants with HBIG plus HB vaccine. There were no significant differences in the incidence of immunoprophylaxis failure between breastfed and bottle-fed babies.[1]

Q. Is there increased risk of hepatitis B transmission in breast-fed infants of chronic hepatitis B carriers?

A. With appropriate immunoprophylaxis, including hepatitis B immune globulin and hepatitis B vaccine, breast-feeding of infants of chronic HBV carriers poses no additional risk for the transmission of the hepatitis B virus.

A study was carried out in Texas[2] to measure the rate of hepatitis B (HBV) transmission from chronic HBV carriers to breast-fed infants after immunoprophylaxis. A total of 369 infants born to women with chronic HBV were studied. 101 breast-fed infants were compared with 268 formula-fed infants. The mean length of time for breast-feeding was 4.9 months (range 2 weeks to 1 year). Overall, there were nine cases of HBV infection transmission (2.4%). None of the 101 breast-fed infants and nine formula-fed infants (3%) were positive for HBsAg after the initial vaccination series (p = .063). The researchers concluded that with appropriate immunoprophylaxis, including hepatitis P immune globulin and hepatitis B vaccine, breast-feeding of infants did not pose any additional risk for the transmission of the hepatitis B virus.

Q. Intrauterine infection of hepatitis B virus (HBV) can occur despite combined passive and active immunizations in 10%-16% neonates born to HBV carrier mothers. Does HBV specific immunoglobulin (HBIG) before delivery have any role in interrupting intrauterine transmission of HBV?

A. HBV infection in the uterus may be interrupted by injecting multiple intramuscular HBIG injections before delivery without causing any side-effects.

There are about 400 million hepatitis B virus carriers in the world. Mother to infant transmission is usually the reason for high carrier rates. HBIG plus hepatitis B vaccine (HB Vac) has been proven highly effective in preventing perinatal transmission of HBV infection. Unfortunately, approximately 10%-20% of infants undergoing this treatment still become carriers in their early life. Intrauterine HBV infection is the major cause of the failure of vaccination against hepatitis B in neonates born to HBV carrier mothers.

A Chinese study[3] in Shanghai evaluating the interruptive effect of HBIG in the prevention of intrauterine transmission of HBV- randomly divided nine hundred and eighty HBsAg carrier pregnant women into HBIG group and control group. Each subject in the HBIG group received 200 IU or 400 IU of HBIG intramuscularly at 3, 2 and 1 month before delivery. All newborn infants received 100 IU of HBIG intramascularly at birth and 2 weeks after birth, followed by 30 microg plasma-derived HB vaccine or 5 micro g recombinant yeast-derived hepatitis B vaccine at 1, 2 and 7 months of age. The rates of intrauterine transmission in the HBIG group and the control group were 14.3% and 5.7% respectively, and were significantly different (chi2 =20.28, p<0.001).

Q . Can a hepatitis B vaccination schedule initiated with one brand of vaccine be completed with another?

A. Yes, a hepatitis B vaccination schedule initiated with one recombinant DNA vaccine can be completed with another.

A study[4] was conducted to determine if a hepatitis B vaccination schedule initiated with one recombinant DNA vaccine could be completed with another. Forty-eight adults on a hepatitis B vaccination schedule of 0, 1 and 6 months had received their first two doses 10 micrograms with Merck Sharpe and Dohme's recombinant DNA (MSD rDNA) vaccine (Recombivax HB). At month 6, the subjects were randomized to receive SmithKline Beecham's recombinant DNA (SB rDNA) vaccine (Engerix-B) at its adult dose of 20 micrograms or MSD rDNA vaccine. Just prior to the third dose of SB rDNA or MSD rDNA vaccine, the geometric mean anti-HBs titres (GMT) were 161 and 168 mIU ml-1 for the two groups, respectively. The GMT at month 7 were 4077 and 2654 mIU m -1sub for those who had received SB rDNA or MSD rDNA vaccine, respectively. This study conclusively demonstrated that a hepatitis B vaccination schedule initiated with MSD rDNA vaccine could be completed with SB rDNA vaccine.

Q. Can hepatitis B vaccine be administered during pregnancy?

A. Yes hepatitis B vaccine can be safely administered during pregnancy.

Hepatitis in pregnancy is not associated with increased abortion rate, stillbirth, or congenital malformation. However, prematurity seems to be increased if hepatitis is acquired in the last trimester. Sixty percent of pregnant women who acquire acute HB infections at or near delivery will transmit the HB virus to their offspring. Although infection is rarely symptomatic, 70 to 90% of the babies will remain chronically infected into adult life and be prone to cirrhosis and hepatocellular carcinoma. Because of such high risks and the safety and efficacy (seroconversion 90 to 100%) of HB vaccine in preventing HB infection, it is recommended that HB vaccine be given to pregnant women at high risk.[5]

Adult immunization rates have fallen short of national goals partly because of misconceptions about the safety and benefits of current vaccines. The danger of these misconceptions is magnified during pregnancy, when concerned physicians are hesitant to administer vaccines and patients are reluctant to accept them. Routine vaccines that generally are safe to administer during pregnancy include diphtheria, tetanus, influenza, and hepatitis B.

Gupta and Ratho[6] tested the immunogenicity and safety of Hepatitis B (HB) vaccination in ninety-nine HBsAg-negative pregnant women during pregnancy, and also the passive transfer of antibodies to the newborn. They concluded that Hepatitis B vaccination during pregnancy is safe and highly immunogenic, and there is passive transfer of antibodies to the newborns. Levy and Koren[7] too reported pregnancy outcome in ten women. No congenital abnormalities were observed and all the infants were physically and developmentally normal for their ages at 2 to 12 months. Although small, this cohort suggests safe use of the vaccine in early pregnancy.

Reddy et al[8] too studied 15 pregnant HBsAg negative women after 3 doses of hepatitis B vaccine. No untoward effects of vaccine were observed and a good immunogenic response with very high antibody titres 178 IU/l and 184 IU/l at delivery and 3 months post delivery respectively were noted. Passive transfer of antibodies to the neonates was 100% at birth but these levels declined rapidly. They concluded that hepatitis B vaccine is safe and immunogenic in pregnant women and protects their babies in the immediate neonatal period.

Some more data on the subject is provided by Grosheide et al[9] from the Netherlands. Hepatitis B immunoglobulin and vaccine were given as post-exposure prophylaxis to 73 women after an outbreak of hepatitis B due to in vitro fertilization treatment. The safety and immunogenicity of hepatitis B vaccine were studied in 16 women who became pregnant after in vitro fertilization; 57 non-pregnant women receiving the same treatment served as controls. One patient had a clinical abortion 2 days after initial immunization; other side effects of vaccination were not found in vaccinees or in their offspring. The authors concluded that when post-exposure prophylaxis for hepatitis B infection is indicated, passive active immunization can be started safely during pregnancy.

Q. Are booster immunisations needed for lifelong hepatitis B immunity?

A. Available data suggest that booster immunisations are not needed for lifelong hepatitis B immunity.

Analyses of cumulated data[10] from a number of long-term follow-up studies among infants, children and adults vaccinated against hepatitis B in industrialised and developing countries showed that despite low or undetectable antibody responses years after vaccination, the development of HBsAg was a rarity and, if present, only transient. Some vaccinees developed anti-HBc responses but none developed an HB carrier state or clinical manifestations of disease. Studies demonstrating anamnestic responses among those with low or undetectable anti-HBs levels following challenge with HB vaccine, together with the production of anti-HBs in circulating B-cells by spot ELISA, confirmed the presence of immune memory among vaccinees. Anamnestic anti-HBs responses correlate closely in kinetics and magnitude with proliferative T-cell responses. The accumulated data from studies assessed in this review indicate that protection is dependent on immune memory, rather than declining anti-HBs responses, and add additional weight to the European Consensus recommendations that following a complete course of vaccination, booster doses are unnecessary in immunocompetent persons. CDC[11] also does not recommend booster doses of vaccination since even persons with declining antibody levels are still protected against clinical illness and chronic disease. For health care workers with normal immune status who have demonstrated an anti-HBs response following vaccination, booster doses of vaccine are not recommended nor is periodic anti-HBs testing.

A study by Williams et al[12] evaluated the response to a booster dose of hepatitis B vaccine in previously immunized healthcare workers, and concluded that their data supported current recommendations that immunized HCW do not require periodic antibody testing or vaccine boosters. European Consensus Group on Hepatitis B Immunity[13] also concluded that there was no data to support the need for booster doses of HB vaccine in immunocompetent individuals who have responded to a primary course. However, for immunocompromised patients, the Group recommends regular testing for anti-HBs, a booster injection when the titer falls below 10 mIU/mL, continuing long-term monitoring to confirm the absence of clinically significant breakthrough episodes of hepatitis B and to find out if a carrier state develops after 15 years. Also, the Group recommends that non-responders to a primary course should continue to be studied.

Q. If a vial of hepatitis B vaccine has been kept out of the refrigerator for a few days, should it be discarded?

A. No it should not be discarded. Few days' stay outside the refrigerator is not going to influence the immunogenicity of Hepatitis B vaccine.

Just and Berger[14] in Switzerland studied the effect of heating on the reactogenicity and the immunogenicity of a recombinant DNA hepatitis B vaccine. Treatment of this vaccine for one week at 37 degrees C did not significantly alter these properties when compared to vaccine stored at 4 degrees C. Similar results were also obtained by Wiedermann and Ambrosch[15] with inactivated hepatitis A vaccine (Havrix). The reactogenicity and immunogenicity of the vaccine were compared after storage at 37 degrees C for 1 week and at the recommended storage temperature of 2-8 degrees C, in two groups of healthy adults in a randomized, double-blind controlled study. The reactogenicity, geometric mean concentrations and seroconversion rates were all similar in both groups, confirming the good thermal stability of the vaccine. Another study by Van Damme[16] et al in 1992 evaluated the heat stability of a recombinant DNA hepatitis B vaccine in healthy adult volunteers. When compared with vaccine stored at 4 degrees C, heating of the vaccine for 1 week at 45 degrees C or for 1 month at 37 degrees C did not alter the reactogenicity or the ability of the vaccine to elicit antibody titres considered to be protective. These results have important implications in situations where the cold chain is broken, as can happen in developing countries where facilities for proper storage and transport facilities are are often inadequate.

   References Top

1.Wang JS, Zhu QR, Wang XH. Breastfeeding does not pose any additional risk of immunoprophylaxis failure on infants of HBV carrier mothers. Int J Clin Pract. 2003;57:100-2.  Back to cited text no. 1  [PUBMED]  
2.Hill JB, Sheffield JS, Kim MJ, et al. Risk of hepatitis B transmission in breast-fed infants of chronic hepatitis B carriers. Obstet Gynecol 2002;99:1049-52.  Back to cited text no. 2  [PUBMED]  [FULLTEXT]
3.Zhu Q, Yu G, Yu H, et al. A randomized control trial on interruption of HBV transmission in uterus. Chin Med J 2003;116:685-7.   Back to cited text no. 3  [PUBMED]  [FULLTEXT]
4.Bush LM, Moonsammy GI, Boscia JA. Evaluation of initiating a hepatitis B vaccination schedule with one vaccine and completing it with another. Vaccine 1991;9:807-9.  Back to cited text no. 4  [PUBMED]  
5.Sur DK, Wallis DH, O'Connell TX. Vaccinations in pregnancy. Am Fam Physician 2003;68:299-304.  Back to cited text no. 5  [PUBMED]  [FULLTEXT]
6.Gupta I, Ratho RK. Immunogenicity and safety of two schedules of Hepatitis B vaccination during pregnancy. J Obstet Gynaecol Res 2003;29:84-6.  Back to cited text no. 6  [PUBMED]  [FULLTEXT]
7.Levy M, Koren G. Hepatitis B vaccine in pregnancy: maternal and fetal safety. Am J Perinatol 1991;8:227-32.  Back to cited text no. 7  [PUBMED]  
8.Reddy PA, Gupta I, Ganguly NK. Hepatitis-B vaccination in pregnancy: safety and immunogenic response in mothers and antibody transfer to neonates. Asia Oceania J Obstet Gynaecol 1994;20:361-5.  Back to cited text no. 8  [PUBMED]  
9.Grosheide PM, Schalm SW, van Os HC, et al. Immune response to hepatitis B vaccine in pregnant women receiving post-exposure prophylaxis. Eur J Obstet Gynecol Reprod Biol 1993;50:53-8.  Back to cited text no. 9  [PUBMED]  
10.Banatvala JE, Van Damme P. Hepatitis B vaccine - do we need boosters? J Viral Hepat 2003;10:1-6.  Back to cited text no. 10  [PUBMED]  [FULLTEXT]
11.CDC. Hepatitis B Vaccine: Fact Sheet. Available : http://www.cdc.gov/ncidod/diseases/hepatitis/b/factvax.htm (accessed 12.05.04)  Back to cited text no. 11    
12.Williams JL, Christensen CJ, McMahon BJ, et al. Evaluation of the response to a booster dose of hepatitis B vaccine in previously immunized healthcare workers. Vaccine 2001;19:4081-5.  Back to cited text no. 12  [PUBMED]  [FULLTEXT]
13.European Consensus Group on Hepatitis B Immunity. Are booster immunisations needed for lifelong hepatitis B immunity? Lancet 2000;355:561-5.  Back to cited text no. 13  [PUBMED]  [FULLTEXT]
14.Just M, Berger R. Immunogenicity of a heat-treated recombinant DNA hepatitis B vaccine. Vaccine 1988;6:399-400.  Back to cited text no. 14  [PUBMED]  [FULLTEXT]
15.Wiedermann G, Ambrosch F. Immunogenicity of an inactivated hepatitis A vaccine after exposure at 37 degrees C for 1 week. Vaccine 1994;12:401-2.  Back to cited text no. 15  [PUBMED]  
16.Van Damme P, Cramm M, Safary A, et al. Heat stability of a recombinant DNA hepatitis B vaccine.Vaccine 1992;10:366-7.  Back to cited text no. 16  [PUBMED]  

Correspondence Address:
Shivaram Prasad Singh
Dept. of Gastroenterology, S.C.B. Medical College, Cuttack 753 007
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