Worldwide experience with the CR326F-derived inactivated hepatitis A virus vaccine in pediatric and adult populations: an overview

Nalin, David R.; Kuter, Barbara J.; Brown, Leora; C, Patterson; Calandra, Gary B.; Werzberger, Alan; Shouval, Daniel; Ellerbeck, Edward F.; Block, S.; Bishop, R. P.; Wiens, Brian L.; Schwartz, Skai W.; Lewis, John A.; Sitrin, Robert D.; Provost, Philip J.; Miller, William J.; Ryan, John L.

doi:10.1016/s0168-8278(05)80379-4

Cited by 73 publications

(18 citation statements)

References 6 publications

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“…The results of the present study confirm the observation from other studies that although lower prebooster seroprotection rates are found in older subjects (Ͼ40 years old) than in younger subjects, the postbooster immune responses are comparable between the different age groups (7,10,11).…”

supporting

confidence: 92%

Successful Memory Response following a Booster Dose with a Virosome-Formulated Hepatitis A Vaccine Delayed Up to 11 Years

Hatz

Ploeg

Beck

et al. 2011

Clin. Vaccine Immunol.

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Boosting adult travelers with the virosome-formulated, aluminum-free hepatitis A vaccine Epaxal up to 128 months after a single primary dose confers full protection against hepatitis A, even in travelers aged 50 years and above. Delaying the booster dose did not influence the immune memory response to Epaxal.Adults traveling from regions where the prevalence of hepatitis A is low to regions where it is high are at risk of acquiring symptomatic hepatitis A virus (HAV) infection (1). Long-lasting protection against HAV is, by recommendation, achieved with administration of 2 vaccine doses 6 to 18 months apart (12). In practice, many travelers do not return to see their doctors within the recommended time for the second (booster) dose, and therefore, defining the maximum interval between the two doses still conveying long-term seroprotection is of importance. Several studies using an aluminum-absorbed HAV vaccine (Havrix) and comparing various lengths of delay of the second dose (Ն24 months [9] or up to 8 years [8] after a single primary dose) have shown comparable memory responses irrespective of the interval between the two doses. A single dose of Epaxal, the only aluminum-free virosomal HAV vaccine currently available, is highly immunogenic (3). Two doses of Epaxal administered 12 months apart give adults a real-time protection of at least 9 to 11 years, which is predicted to last for at least 30 years in Ն95% of individuals (4).A study in 1999 showed that Epaxal is highly immunogenic when a booster is given 18 to 54 months after the primary dose, indicating that a delay in the administration of the booster of up to 54 months does not lead to loss of immunogenicity (2). A subsequent study in 2006 investigated the immunogenicity of an Epaxal booster administered Ն5 years after the primary immunization. This report presents the results from that 2006 study but as a combined analysis of both the 1999 and 2006 studies and evaluates the level of memory response to Epaxal when given as a booster dose 9 to 128 months (0.8 to 10.7 years) after the primary dose. Previously unpublished results from the 1999 study evaluating the postbooster immune response in a subgroup 9 to 17 months after the primary immunization are also included.Both studies were noncomparative, open-label, and singlecenter studies and were performed at the Swiss Tropical and Public Health Institute (STPH) in Basel, Switzerland; they were approved by the Ethics Committee of Basel EKBB (Basel, Switzerland) and conducted in compliance with the Declaration of Helsinki. All subjects provided informed consent before study entry.The study population included subjects who had received Epaxal primary immunization at the STPH travel clinic but had not received a booster dose for Ն9 months (in the case of the 1999 study) or Ն5 years (in the case of the 2006 study). The exclusion criteria were as previously described (2). All participants received a booster dose of 0.5 ml Epaxal (containing Ն24 IU of HAV antigen; Crucell Switzerland AG) supplied in ready-to-use s...

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supporting

confidence: 92%

Successful Memory Response following a Booster Dose with a Virosome-Formulated Hepatitis A Vaccine Delayed Up to 11 Years

Hatz

Ploeg

Beck

et al. 2011

Clin. Vaccine Immunol.

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“…That concentration is ϳ10 mIU/ml if maintained over a 2-month period, although some individuals may be protected at much lower concentrations (29). The inactivated hepatitis A virus vaccines generate an average concentration 1,000-fold higher than the protective concentrations and also induce immunologic memory (29,45,110,163,172,192).…”

Section: Hepatitis Virusesmentioning

confidence: 99%

Correlates of Protection Induced by Vaccination

Plotkin

2010

Clin Vaccine Immunol

1,403

1,128

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This paper attempts to summarize current knowledge about immune responses to vaccines that correlate with protection. Although the immune system is redundant, almost all current vaccines work through antibodies in serum or on mucosa that block infection or bacteremia/viremia and thus provide a correlate of protection. The functional characteristics of antibodies, as well as quantity, are important. Antibody may be highly correlated with protection or synergistic with other functions. Immune memory is a critical correlate: effector memory for short-incubation diseases and central memory for long-incubation diseases. Cellular immunity acts to kill or suppress intracellular pathogens and may also synergize with antibody. For some vaccines, we have no true correlates, but only useful surrogates, for an unknown protective response.

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“…Individuals infected by HAV in one part of the world are protected from reinfection by HAV from other parts of the world. Immune globulin preparations containing anti-HAV, irrespective of their geographic origin, appear to provide protection from disease, and vaccines prepared from virus isolates originating in Australia or Costa Rica protect from infection worldwide (113,172). The antigenic structure of the virus is relatively simple, with a restricted number of overlapping epitopes combining to form a single dominant antigenic site that interacts with virus-neutralizing antibodies.…”

Section: Antigenicity and Serotypementioning

confidence: 99%

Diagnosis of Hepatitis A Virus Infection: a Molecular Approach

et al. 2006

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SUMMARY Current serologic tests provide the foundation for diagnosis of hepatitis A and hepatitis A virus (HAV) infection. Recent advances in methods to identify and characterize nucleic acid markers of viral infections have provided the foundation for the field of molecular epidemiology and increased our knowledge of the molecular biology and epidemiology of HAV. Although HAV is primarily shed in feces, there is a strong viremic phase during infection which has allowed easy access to virus isolates and the use of molecular markers to determine their genetic relatedness. Molecular epidemiologic studies have provided new information on the types and extent of HAV infection and transmission in the United States. In addition, these new diagnostic methods have provided tools for the rapid detection of food-borne HAV transmission and identification of the potential source of the food contamination.

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Worldwide experience with the CR326F-derived inactivated hepatitis A virus vaccine in pediatric and adult populations: an overview

Cited by 73 publications

References 6 publications

Successful Memory Response following a Booster Dose with a Virosome-Formulated Hepatitis A Vaccine Delayed Up to 11 Years

Successful Memory Response following a Booster Dose with a Virosome-Formulated Hepatitis A Vaccine Delayed Up to 11 Years

Correlates of Protection Induced by Vaccination

Diagnosis of Hepatitis A Virus Infection: a Molecular Approach

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