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Year : 2007  |  Volume : 4  |  Issue : 1  |  Page : 55-60
Hepatitis B vaccine induced HBsAg positivity


Department of Gastroenterology, SCB Medical College, Cuttack-753 007, India

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   Abstract 

Hepatitis B vaccine can induce transient hepatitis B surface antigen positivity not only in adult hemodialysis patients but also in normal adults and children. Hence hepatitis B vaccinees may be mistaken for confirmed hepatitis B surface antigen-positive carrier. Hence blood donors should not donate blood in this early post-vaccination period and renal dialysis patients should not be screened for hepatitis B surface antigen for at least 21 to 28 days after hepatitis B vaccination. These guidelines could prevent individuals in the early post-inoculation period from being erroneously labeled as having hepatitis B viral infection.

Keywords: Hepatitis B virus, hepatitis B vaccine, hepatitis B antigen, HBsAg, hemodialysis

How to cite this article:
Singh SP. Hepatitis B vaccine induced HBsAg positivity. Hep B Annual 2007;4:55-60

How to cite this URL:
Singh SP. Hepatitis B vaccine induced HBsAg positivity. Hep B Annual [serial online] 2007 [cited 2014 Apr 24];4:55-60. Available from: http://www.hepatitisbannual.org/text.asp?2007/4/1/55/45089



   Introduction Top


Hepatitis B vaccinees may be mistaken for confirmed hepatitis B surface antigen-positive blood donors. Hepatitis B vaccine induces transient hepatitis B surface antigen positivity not only in adult hemodialysis patients but also in normal adults and children. The frequency of its occurrence is largely unknown but its duration does not exceed 28 days. There are by now over a hundred reported cases of hepatitis B antigenemia after vaccination. It is caused by a passive transfer of antigen by vaccination and not by viral replication; hence there is no risk for vaccination-induced infection. An important implication of this phenomenon is that the results of HBsAg assays should be interpreted according to the time elapsed since the last administration of a vaccine against hepatitis B. Blood donors should not donate blood in this early post-vaccination period and renal dialysis patients should not be screened for hepatitis B surface antigen for at least 21 to 28 days after hepatitis B vaccination. These guidelines would incorporate a measure of safety to prevent individuals in the early post-inoculation period from being erroneously labeled as having hepatitis B viral infections. [1]


   Hepatitis B Antigenemia in Hemodialysis Patients Top


Transient hepatitis B antigenemia in hemodialysis patients following hepatitis B vaccination was reported by Janzen et al[1] and Kear et al, [2] way back in 1996. Soon after, a prospective study was undertaken by Spanish workers [3] to verify the presence and duration of post-vaccinal antigenemia in patients on hemodialysis. They found that after the administration of one vaccine dose, 31.5% of patients were HBsAg positive at least once. Antigenemia was identified more frequently 2 to 4 days (83.3%) after immunization and in all cases antigenemia was transient and had cleared after 11 days of vaccination. The follow-up of serologic markers revealed the absence of infection with virus B. Only 16.6% of patients with transient antigenemia responded to vaccination (titer of anti-HBs > or = 10 mIU/ml), while the corresponding percentage in the group of HBsAg-negative patients was 69.2% (P < 0.05). They concluded that there is high frequency of post-vaccinal antigenemia in patients on hemodialysis, in absence of virus B infection and suggested that there existed a possible relationship between the presence of transient antigenemia and the non-responder status.

Ly et al, [4] performed a prospective study of de novo HBV infection in over 2400 hemodialysis patients who were screened monthly for HBsAg using a standard enzyme immunoassay. They concluded that HBV immunization was the most common cause of detectable HBsAg in hemodialysis patients. In their opinion, hemodialysis patients should not be screened for HBV within a week of immunization and caution should be exercised when interpreting HBsAg seropositivity within 4 weeks of HBV immunization.


   Hepatitis B Antigenemia in Healthy Individuals Top


Kloster et al, [5] reported a total of nine cases of transient, confirmed (neutralizable) antigenemia in healthy individuals who donated blood 1 to 3 days following vaccination with a recombinant hepatitis B vaccine. Follow-up testing showed no evidence of infection by hepatitis B virus. They concluded that individuals recently vaccinated for hepatitis B may test positive for HBsAg and become permanently disqualified as blood donors. Therefore, blood collection centers should consider temporary deferral of potential donors who recently received hepatitis B vaccine. Another study found that the incidence of false positive HBsAg was 50% and the duration of the vaccine-induced positive HBsAg lasted no more than two weeks. [6]

Lunn et al, [7] reported a case of prolonged hepatitis B antigenemia after routine vaccination with Engerix B. A positive hepatitis B surface antigen was found when the individual donated blood 18 days after vaccination. This resulted in rejection of the donated blood and permanent deferral from further donation. It also led to referral to a physician, creating anxiety in the individual and additional unnecessary testing.

Dow et al, [8] tested 8 volunteers using three HBsAg assays (Abbott Auszyme ortho HBsAg-3 and Abbott/Murex GE34/36) on days 0, 3, 5, 7 and 10 after administration of hepatitis B vaccine. Two HBsAg tests (Abbott Auszyme and Ortho HBsAg-3) did not detect HBsAg reactivity amongst the volunteers, although the Abbott Auszyme test results reached 70-80% of the manufacturer's cut-off at day 3 in two volunteers. The most recently launched assay (Abbott/Murex GE 34/36) detected seven (87%) of the eight volunteers as HBsAg reactive on day 3 and two (25%) volunteers were still reactive on day 5. Thus the Abbott/Murex GE 34/36 assay demonstrated HBsAg reactivity in most volunteers on day 3 and in some on day 5 after vaccination. Dow et al, recommended that individuals who have recently been vaccinated with hepatitis B be deferred from blood donation for at least 7 days.

Koksal et al, [9] followed 39 infants prospectively for hepatitis B surface antigen (HBsAg) following immunization with hepatitis B vaccine. A total of 69.2% of the infants tested positive for antigenemia at least once. Antigenemia was identified most often at 2-3 days (43.5%) and 5-6 days (43.5%) after immunization. The longest documented duration of antigenemia was 21 days. In all cases the antigenemia was transient and cleared by 28th day post-vaccination.

Otag et al, [10] studied the phenomenon with three different vaccines (i.e. Engerix B, Hepavax Gene and Gen Hevac B) which were administered to 44 healthy adult subjects divided randomly into three groups. Blood samples were drawn at 1, 24h and 3 days after vaccination and tested for the presence of Hepatitis B surface antigen (HBsAg) by enzyme immunoassay (EIA). Each groups, receiving different vaccine produced one "false positive" result in blood samples drawn at 24h after vaccination. These transient antigenemia were cleared within 3 days in three subjects with "false positive" results. The researchers concluded that the "false positive" results can be observed with the different recombinant Hepatitis B vaccines. Subsequently, De Schryver et al, [11] have reported a case of transient hepatitis B surface antigenaemia (HBsAg) following vaccination with a combined vaccine against hepatitis A and B in a healthy adult.

Rodriguez et al, [12] undertook a prospective study to verify the presence and duration of post-vaccinal antigenemia. They observed that after the administration of one vaccine dose, 31.5% of patients were HBsAg positive at least once and antigenemia was identified more frequently 2 to 4 days (83.3%) after immunization. In all their cases, antigenemia was transient and cleared after 11 days of vaccination. Follow-up of these cases showed the absence of infection with virus B. They also observed that while only 16.6% of patients with transient antigenemia responded to vaccination, the corresponding percentage in the group of HBsAg-negative patients was 69.2% (p < 0.05). They concluded that a high frequency of post-vaccinal antigenemia occurs in patients on hemodialysis, in absence of virus B infection. They also proposed a possible relationship between the presence of transient antigenemia and the non-responder status.


   Conclusions Top


Caution should be exercised when interpreting HBsAg seropositivity within 4 weeks of HBV immunization. Individuals recently vaccinated for hepatitis B may test positive for HBsAg and become permanently disqualified as blood donors. Therefore blood collection centers should consider temporary deferral of potential donors who recently received hepatitis B vaccine and renal dialysis patients should not be screened for hepatitis B surface antigen for at least 21 to 28 days after hepatitis B vaccination. These guidelines could prevent individuals in the early post-inoculation period from being erroneously labeled as having hepatitis B viral infection. Besides, there is some data to suggest that presence of transient antigenemia is associated with non-responder status in hemodialysis patients.

 
   References Top

1.Janzen L, Minuk GY, Fast M, Bernstein KN. Vaccine-induced hepatitis B surface antigen positivity in adult hemodialysis patients: Incidental and surveillance data. J Am Soc Nephrol 1996;7:1228-34.   Back to cited text no. 1  [PUBMED]  [FULLTEXT]
2.Kear TM, Wright LS. Transient hepatitis B antigenemia in hemodialysis patients following hepatitis B vaccination. ANNA J 1996;23:331-7.  Back to cited text no. 2  [PUBMED]  
3.Santana Rodriguez OE, Morillas Jarillo C, Esparza Martin N, Toledo Gonzalez A, Checa Andres MD, Martin Sanchez AM. Transient blood surface antigens of hepatitis B in patients on hemodialysis. J Am Soc Nephrol 1996;7:1228-34.  Back to cited text no. 3    
4.Ly D, Yee HF Jr, Brezina M, Martin P, Gitnick G, Saab S. Hepatitis B surface antigenemia in chronic hemodialysis patients: Effect of hepatitis B immunization. Am J Gastroenterol 2002;97:138-41.  Back to cited text no. 4  [PUBMED]  
5.Kloster B, Kramer R, Eastlund T, Grossman B, Zarvan B. Hepatitis B surface antigenemia in blood donors following vaccination. Transfusion 1995;35:475-7.  Back to cited text no. 5  [PUBMED]  
6.Olde C, Garcia M. Hepatitis B vaccine as a cause of false positive hepatitis B surface antigen. J CANNT 1998;8:20-1.  Back to cited text no. 6  [PUBMED]  
7.Lunn ER, Hoggarth BJ, Cook WJ. Prolonged hepatitis B surface antigenemia after vaccination. Pediatrics 2000;105:E81.  Back to cited text no. 7  [PUBMED]  [FULLTEXT]
8.Dow BC, Yates P, Galea G, Munro H, Buchanan I, Ferguson K. Hepatitis B vaccinees may be mistaken for confirmed hepatitis B surface antigen-positive blood donors. Vox Sang 2002;82:15-7.  Back to cited text no. 8  [PUBMED]  [FULLTEXT]
9.Koksal N, Altinkaya N, Perk Y. Transient hepatitis B surface antigenemia after neonatal hepatitis B immunization. Acta Paediatr 1996;85:1501-2.  Back to cited text no. 9    
10.Otag F, Mert A, Yilmaz G. Temporary deferral of blood donors after administration of hepatitis B vaccine. Transfusion 1997;37:880.  Back to cited text no. 10    
11.De Schryver A, De Gendt K, Francois G, Van Damme P, Meheus A. Hepatitis B surface antigenaemia following vaccination with a combined vaccine against hepatitis A and B. J Viral Hepat 2004;11:88-90.   Back to cited text no. 11    
12.Santana Rodriguez OE, Morillas Jarillo C, Esparza Martin N, Toledo Gonzalez A, Checa Andres MD, Martin Sanchez AM. Transient blood surface antigens of hepatitis B in patients on hemodialysis. Rev Clin Esp 1999;199:198-201.  Back to cited text no. 12    

Top
Correspondence Address:
Shivaram Prasad Singh
Department of Gastroenterology, SCB Medical College, Cuttack-753 007
India
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DOI: 10.4103/0972-9747.45089

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