Safety and immunogenicity of hepatitis A vaccine in healthy adult volunteers. 1993

Y C Horng, and M H Chang, and C Y Lee, and A Safary, and F E Andre, and D S Chen
Department of Pediatrics, College of Medicine, National Taiwan University Hospital, Taipei, Republic of China.

The immunogenicity and adverse reaction of an inactivated hepatitis A (HA) vaccine were investigated. Sixty healthy adult volunteers who lacked antibody to HA virus (anti-HAV) received three doses of vaccine containing 720 enzyme-linked immunosorbent assay (ELISA) units (EL.U) according to a 0, 1 and 6 month schedule. Blood tests for serum liver enzymes and anti-HAV were performed at screening 7 days prior to, and 1, 6 and 7 months after the first dose. Anti-HAV was tested by radio immunoassay and ELISA for titre determination. The seroconversion rates measured by ELISA were 98.3% (59/60) at months 1 and 6 and 100% at month 7. Sixty-one per cent (109/180) of the documented injections were followed by local symptoms, essentially mild soreness at the site of injection; and 22.2% (40/180) by minor general symptoms including malaise, fatigue and lethargy. It is concluded that HA vaccine is highly immunogenic and safe. It may replace immunoglobulin as an effective method of preventing HA virus infection in adults.

UI MeSH Term Description Entries
D008099 Liver A large lobed glandular organ in the abdomen of vertebrates that is responsible for detoxification, metabolism, synthesis and storage of various substances. Livers
D004797 Enzyme-Linked Immunosorbent Assay An immunoassay utilizing an antibody labeled with an enzyme marker such as horseradish peroxidase. While either the enzyme or the antibody is bound to an immunosorbent substrate, they both retain their biologic activity; the change in enzyme activity as a result of the enzyme-antibody-antigen reaction is proportional to the concentration of the antigen and can be measured spectrophotometrically or with the naked eye. Many variations of the method have been developed. ELISA,Assay, Enzyme-Linked Immunosorbent,Assays, Enzyme-Linked Immunosorbent,Enzyme Linked Immunosorbent Assay,Enzyme-Linked Immunosorbent Assays,Immunosorbent Assay, Enzyme-Linked,Immunosorbent Assays, Enzyme-Linked
D006507 Hepatovirus A genus of PICORNAVIRIDAE causing infectious hepatitis naturally in humans and experimentally in other primates. It is transmitted through fecal contamination of food or water. HEPATITIS A VIRUS is the type species. Hepatitis Virus, Infectious,Infectious Hepatitis Virus,Hepatitis Viruses, Infectious,Hepatoviruses,Infectious Hepatitis Viruses
D006508 Hepatitis Antibodies Immunoglobulins raised by any form of viral hepatitis; some of these antibodies are used to diagnose the specific kind of hepatitis. Antibodies, Hepatitis
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D014761 Viral Hepatitis Vaccines Any vaccine raised against any virus or viral derivative that causes hepatitis. Hepatitis, Viral, Vaccines,Hepatitis Vaccines, Viral,Vaccines, Viral Hepatitis
D015164 Vaccines, Inactivated Vaccines in which the infectious microbial nucleic acid components have been destroyed by chemical or physical treatment (e.g., formalin, beta-propiolactone, gamma radiation) without affecting the antigenicity or immunogenicity of the viral coat or bacterial outer membrane proteins. Inactivated Vaccine,Killed Vaccine,Killed Vaccines,Vaccines, Killed,Inactivated Vaccines,Vaccine, Inactivated,Vaccine, Killed
D022362 Hepatitis A Vaccines Vaccines or candidate vaccines used to prevent infection with hepatitis A virus (HEPATOVIRUS). Havrix,Hepatitis A Vaccine,Hepatovirus Vaccines,Vaqta,Vaccine, Hepatitis A,Vaccines, Hepatitis A,Vaccines, Hepatovirus
D035922 Hepatitis A Antibodies Antibodies to the HEPATITIS A ANTIGENS including antibodies to envelope, core, and non-structural proteins. Hepatitis A Virus Antibodies,Anti-HAV,Anti HAV,Antibodies, Hepatitis A

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