Clinical experience with an inactivated hepatitis A vaccine.

Clemens, R.; Safary, A.; Hepburn, A.; Roche, C.; Stanbury, W. J.; Andre, F. E.

doi:10.1093/infdis/171.supplement_1.s44

Cited by 224Hepatitis Viruses Studies and EpidemiologyHepatitis B Virus StudiesTravel-related health issues

The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.

Clinical experience with an inactivated hepatitis A vaccine.

Clemens, R., Safary, A., Hepburn, A., Roche, C., Stanbury, W. J., Andre, F. E.·1995·Journal of Infectious Diseases

DOI 10.1093/infdis/171.supplement_1.s44

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Abstract

Clinical trials of an inactivated hepatitis A vaccine have encompassed 104 studies completed by December 1993 in 27 countries. Studies involved 50,677 subjects and administration of > 120,000 vaccine doses. Results show that the vaccine is safe, clinically well-tolerated, and highly immunogenic in all age groups. A seroconversion rate of 100% is achieved 1 month after primary vaccination. Vaccine-induced antibody titers persist after a primary vaccination course for > or = 1 year with a single dose of 1440 ELISA units (EL.U.) in adults and after two doses of 360 EL.U. in children. A booster dose 6-12 months after the first vaccine dose induces very high antibody titers, which according to a mathematical model, are expected to protect against hepatitis A for > 20 years. The vaccine is equally immunogenic when administered simultaneously with other traveler vaccines, therefore enabling flexible and convenient vaccination against hepatitis A.

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By 1 month after the first dose, 94%-100% of adults have protective antibody levels, and after a second dose, 100% achieve protective levels.
“By 1 month after the first dose, 94%–100% of adults have protective antibody levels, and after a second dose, 100% achieve protective levels (1297,1300,1301).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [1300]

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Jacobs, R. J., Saab, S., & Meyerhoff, A. S. (2003) · Journal of American College Health · doi:10.1080/07448480309596355 · Cited by 40
Hepatitis A antibodies in liver transplant recipients: Evidence for loss of immunity posttransplantation
Arslan, M., Wiesner, R. H., Poterucha, J. J., Gross, J. B., & Zein, N. N. (2000) · Liver Transplantation · doi:10.1002/lt.500060216 · Cited by 39
“Viral hepatitis B or C 5 (21) 8 (11) 13 (13)”
Safety and Immunogenicity of a Combined Hepatitis A and Hepatitis B Vaccine in Young Healthy Adults
Leroux-Roels, G. G., Moreau, E., Desombere, I., & Safary, A. (1996) · Scandinavian Journal of Gastroenterology · doi:10.3109/00365529609003124 · Cited by 39
Hepatitis A vaccine
Bell, B. P. (2002) · Seminars in Pediatric Infectious Diseases · doi:10.1053/spid.2002.125859 · Cited by 38
Hepatitis A vaccine response in HIV-infected patients: Are TWINRIX® and HAVRIX® interchangeable?
Jimenez, H. R., Hallit, R. R., DeBari, V. A., & Slim, J. (2012) · Vaccine · doi:10.1016/j.vaccine.2012.12.045 · Cited by 36
Hazards of hepatitis at the Hajj
Rafiq, S. M., Rashid, H., Haworth, E., & Booy, R. (2008) · Travel Medicine and Infectious Disease · doi:10.1016/j.tmaid.2008.09.008 · Cited by 36
AN OVERVIEW OF RECOMBINANT VACCINE TECHNOLOGY, ADJUVANTS AND VACCINE DELIVERY METHODS
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“Hepatitis A Inactivated or killed 1995 [20] *”
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Sexual Transmission of Viral Hepatitis
Gorgos, L. M. (2013) · Infectious Disease Clinics of North America · doi:10.1016/j.idc.2013.08.002 · Cited by 34
Inactivation of respiratory syncytial virus by zinc finger reactive compounds
Boukhvalova, M. S., Prince, G. A., & Blanco, J. C. G. (2010) · Virology Journal · doi:10.1186/1743-422x-7-20 · Cited by 32
“Some of the successful examples include inactivated hepatitis A vaccine [1], poliovirus vaccine [2], and SIV vaccine [3].”
Background
Persistence of hepatitis A vaccine induced seropositivity in infants and young children by maternal antibody status: 10-year follow-up.
Sharapov, U. M., Bulkow, L. R., Negus, S. E., Spradling, P. R., Homan, C., Drobeniuc, J., Bruce, M., Kamili, S., Hu, D. J., & McMahon, B. J. (2012) · Hepatology · doi:10.1002/hep.25687 · Cited by 32
“In other studies, lower limit of detection of antiHAV (as prescribed by the assays used) is used to define seroprotection which varied from >10 to >33 mIU/mL.(24,25) We used the assay with a lower limit of detection of 10 mIU/mL, which might have resulted in higher yield of seroprotected children in our study.”
Method
Immune response to hepatitis A vaccine in patients with HIV
Fritzsche, C., Bergmann, L., Loebermann, M., Glass, Ä., & Reisinger, E. C. (2019) · Vaccine · doi:10.1016/j.vaccine.2019.02.064 · Cited by 32
Immune memory at 17-years of follow-up of a single dose of live attenuated hepatitis A vaccine
Chen, Y., Zhou, C., Zhang, X., Hao, Z.-Y., Zhang, Y.-H., Wang, S., Ma, J., Zhao, G., Qiu, C., Zhao, Y., et al. (2017) · Vaccine · doi:10.1016/j.vaccine.2017.11.036 · Cited by 31
Factors associated with the immune response to hepatitis A vaccination in HIV-infected patients in the era of highly active antiretroviral therapy
Mena, G., García‐Basteiro, A. L., Llupià, A., Díez, C., Costa, J. M., Gatell, J.-M., García, F., & Bayas, J. M. (2013) · Vaccine · doi:10.1016/j.vaccine.2013.06.012 · Cited by 31
Hepatitis A Virus
Spradling, P. R., Martin, A., & Feinstone, S. M. (2009) · doi:10.1128/9781555815981.ch47 · Cited by 31
Evidence for positive selection of hepatitis A virus antigenic variants in vaccinated men-having-sex-with men patients: Implications for immunization policies
Sabrià, A., Gregori, J., García‐Cehic, D., Guix, S., Pumarola, T., Manzanares-Laya, S., Caylà, J. A., Bosch, A., Quer, J., & Pintó, R. M. (2018) · EBioMedicine · doi:10.1016/j.ebiom.2018.11.023 · Cited by 30
“HAV vaccination is estimated to provide immunity up to twenty years in the general population [30], and at least up to ten years in the HIV-infected patients with high seropositivity rates [31].”
Background
Seroprotection After Hepatitis A Vaccination in Patients With Drug‐Induced Immunosuppression
van den Bijllaardt, W., Siers, H. M., Timmerman‐Kok, C., Pessers, F. G., Natrop, G., van Baars, J. F., Nutma, N., van der Werf, D., & Gisolf, E. H. (2013) · Journal of Travel Medicine · doi:10.1111/jtm.12050 · Cited by 30
Approaches To A Vaccine Against Hepatitis A: Development And Manufacture Of An Inactivated Vaccine
Andre, F. E. (1995) · The Journal of Infectious Diseases · doi:10.1093/infdis/171.supplement_1.s33 · Cited by 30
Hepatitis A: post-exposure prophylaxis
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Safety and immunogenicity of a new formulation of an inactivated hepatitis A vaccine
Dagan, R. (1999) · Vaccine · doi:10.1016/s0264-410x(98)00461-7 · Cited by 29
Seroprevalence of hepatitis A virus infection in persons with HIV infection in Taiwan: implications for hepatitis A vaccination
Sun, H., Kung, H., Ho, Y., Chien, Y.-F., Chen, M.-Y., Sheng, W., Hsieh, S., Wu, C.-H., Liu, W., Hung, C., et al. (2009) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2008.12.009 · Cited by 28
“In immunocompetent persons, the seroconversion rate after a single dose of HAV vaccination is as high as 95%.(43) However, seroconversion after a single-dose immunization was found to be only 37—44% in IDU and 44.”
Viral hepatitis prevention by immunization
Ferreira, C. T., & da Silveira, T. R. (2006) · Jornal de Pediatria · doi:10.2223/jped.1500 · Cited by 28
A simple cost-decision analysis model comparing two strategies for hepatitis A vaccination
Saab, S., Martin, P. B., & Yee, H. F. (2000) · The American Journal of Medicine · doi:10.1016/s0002-9343(00)00469-1 · Cited by 28
Critical prevalence of antibodies minimizing vaccination costs for hepatitis A, hepatitis B, varicella, measles and tetanus in adults and adolescents in Catalonia, Spain
Plans-Rubió, P. (2004) · Vaccine · doi:10.1016/j.vaccine.2004.03.048 · Cited by 26
Immunogenicity and reactogenicity of the combined hepatitis A and B vaccine in young adults
Tsai, I., Chang, M., Chen, H., Ni, Y., Lee, P., Chiu, T.-Y., & Safary, A. (2000) · Vaccine · doi:10.1016/s0264-410x(00)00205-x · Cited by 26
Vaccines and immunotherapies for the prevention of infectious diseases having cutaneous manifestations
Wu, J. J., Huang, D. B., Pang, K. R., & Tyring, S. K. (2004) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2003.12.003 · Cited by 25
Immunological priming of one dose of inactivated hepatitis A vaccine given during the first year of life in presence of maternal antibodies
Lagos, R., Muñoz, A., Dumas, R., Pichon, S., Zambrano, B., Levine, M. M., & Vidor, E. J. (2003) · Vaccine · doi:10.1016/s0264-410x(03)00385-2 · Cited by 26
Synthesis, lipophilic derivatization and interaction with liposomes of HAV–VP3 (102–121) sequence by using spectroscopic techniques
Garcı́a, M., Pujol, M., Reig, F., Alsina, M. A., & Haro, I. (1996) · The Analyst · doi:10.1039/an9962101583 · Cited by 26
VIRAL INFECTIONS OF THE FETUS AND NEONATE
Sánchez, P. J., & Demmler‐Harrison, G. J. (2009) · Elsevier eBooks · doi:10.1016/b978-1-4160-4044-6.50078-9 · Cited by 23
Hepatitis a vaccine: Ready for prime time
DUFF, B. (1998) · Obstetrics and Gynecology · doi:10.1016/s0029-7844(97)00669-8 · Cited by 25
LONG-TERM MANAGEMENT OF THE LIVER TRANSPLANT RECIPIENT
Muñoz, S. J. (1996) · Medical Clinics of North America · doi:10.1016/s0025-7125(05)70481-8 · Cited by 25
Sexual transmission and prevention of the hepatitis viruses A-E and G
Brook, M. G. (1998) · Sexually Transmitted Infections · doi:10.1136/sti.74.6.395 · Cited by 24
Immunogenicity and safety of three consecutive lots of a new preservative-free inactivated hepatitis A vaccine (Healive®): A double-blind, randomized and controlled trial
Jiang, W., Chen, J.-T., Wang, X., Wang, Y., Liu, Y., Chen, W., Xu, W.-G., Qiu, Y., & Yin, W. (2007) · Vaccine · doi:10.1016/j.vaccine.2007.11.008 · Cited by 23
Business travelers: vaccination considerations for this population
Chen, L. H., Leder, K. S., & Wilson, M. E. (2013) · Expert Review of Vaccines · doi:10.1586/erv.13.16 · Cited by 23
Randomized, Double-Blind Study in Healthy Adults to Assess the Boosting Effect of Vaqta or Havrix after a Single Dose of Havrix
Connor, B. A., Phair, J., Sack, D. A., McEniry, D., Hornick, R. B., Banerjee, D., Jensen, E., & Kuter, B. J. (2001) · Clinical Infectious Diseases · doi:10.1086/318522 · Cited by 23
A survey on hepatitis A in Portuguese children and adolescents
Barros, H., Oliveira, F., & Miranda, H. (1999) · Journal of Viral Hepatitis · doi:10.1046/j.1365-2893.1999.00144.x · Cited by 23
Durability of response to vaccination against viral hepatitis A in HIV-infected patients: a 5-year observation
Jabłonowska, E., & Kuydowicz, J. (2014) · International Journal of STD & AIDS · doi:10.1177/0956462413518902 · Cited by 22
Prevenção das hepatites virais através de imunização
Ferreira, C. T., & da Silveira, T. R. (2006) · Jornal de Pediatria · doi:10.1590/s0021-75572006000400007 · Cited by 21
Does the Concurrent Administration of an Inactivated Hepatitis A Vaccine Influence the Immune Response to Other Travelers Vaccines?
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Travel-Related Vaccines
Wilson, M. E. (2001) · Infectious Disease Clinics of North America · doi:10.1016/s0891-5520(05)70277-4 · Cited by 20
Immunogenicity, reactogenicity and adherence with hepatitis A vaccination among drug users
Quaglio, G., Pajusco, B., Civitelli, P., Migliozzi, S., Jarlais, D. C. D., Romanò, L., Lechi, A., Mezzelani, P., & Lugoboni, F. (2004) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2003.12.001 · Cited by 19
“Lower GMTs of anti-HAV were observed in this cohort of DUs compared with healthy subjects (Van Damme et al., 1994; Clemens et al., 1995; Lemon and Thomas, 1997).”
BackgroundResult
Hepatitis A vaccines
Fiore, A. E., Feinstone, S. M., & Bell, B. P. (2008) · Elsevier eBooks · doi:10.1016/b978-1-4160-3611-1.50016-7 · Cited by 19
Preventing acute liver disease in patients with chronic liver disease† ‡
Sjögren, M. H. (1998) · Hepatology · doi:10.1002/hep.510270337 · Cited by 19
Response to Hepatitis A Vaccine in Children after a Single Dose with a Booster Administration 6 Months Later
Findor, J., Velasco, M., Mutti, J., & Safary, A. (1996) · Journal of Travel Medicine · doi:10.1111/j.1708-8305.1996.tb00730.x · Cited by 18

Authors: Clemens, R., Safary, A., Hepburn, A., Roche, C., Stanbury, W. J., & Andre, F. E.
Corresponding author: Clemens, R.
ORCID: Clemens, R.
Venue: Journal of Infectious Diseases
Publisher: Oxford University Press (OUP)
Published: 1995-03-01
Volume: 171
Issue: Supplement 1
Pages: S44-S49
ISSN: 0022-1899 (ISSN-L)
1537-6613
DOI: 10.1093/infdis/171.supplement_1.s44
OpenAlex: W2077738168
Cited by: 223
References: 23
Citations by year: 2025: 3 · 2023: 3 · 2022: 2 · 2021: 2 · 2020: 1 · 2019: 2 · 2018: 5 · 2017: 6 · 2016: 3 · 2015: 3 · 2014: 5 · 2013: 10 · 2012: 8
FWCI: 13.72
Type: journal article
Language: en
Open access: closed
Locations: The Journal of Infectious Diseases (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Hepatology › Hepatitis Viruses Studies and Epidemiology
Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Travel-related health issues
Keywords: inactivated hepatitis A vaccine, vaccine safety, immunogenicity, seroconversion, antibody persistence, booster vaccination, vaccine-induced antibodies, hepatitis A prevention
MeSH terms: Adult, Child, Clinical Trials as Topic, Hepatitis A, Hepatitis Antibodies, Humans, Pilot Projects, Travel, Vaccines, Viral Hepatitis Vaccines, Vaccines, Inactivated, HIV Infections, Hepatitis A Virus, Human, Hepatitis A Vaccines, Hepatitis A Antibodies

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Clinical experience with an inactivated hepatitis A vaccine.

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