Tags

Type your tag names separated by a space and hit enter

Evaluation of inactivated hepatitis A vaccine in Canadians 40 years of age or more.
CMAJ. 1993 Feb 15; 148(4):551-5.CMAJ

Abstract

OBJECTIVE

To assess the side effects and immune responses after three serial doses of a new inactivated hepatitis A vaccine in people 40 years of age or more.

DESIGN

Open, noncomparative trial.

SETTING

A hospital, a regional laboratory and public health units in British Columbia.

PARTICIPANTS

A volunteer sample of 64 healthy adults aged 40 to 61 years who were seronegative for hepatitis A virus (HAV). All were staff or associates of the health facilities. Exclusion criteria included elevated serum alanine and aspartate aminotransferase levels, a history of liver disease and recent travel to areas of high risk for HAV infection.

INTERVENTION

A formalin-inactivated, alum-adsorbed vaccine containing 720 ELISA (enzyme-linked immunosorbent assay) units of antigen from HAV strain HM175 per 1.0-mL dose was injected intramuscularly into the delgoid area. The second and third doses were given 1 and 6 months later respectively.

MAIN OUTCOME MEASURES

A detailed diary of any adverse effects for 3 days after each dose. HAV antibody levels in blood samples taken before and 30 days after each dose.

RESULTS

All subjects completed the planned series of vaccinations and blood tests; symptom diaries were returned after 190 (99%) of 192 vaccinations. Local symptoms, most often soreness, were reported after 46% of the vaccinations but were mild and usually resolved within 24 hours. A temperature of more than 38.0 degrees C was never reported. Seroconversion occurred in all cases after the two primary doses, and the subjects were still seropositive at 6 months. After the booster dose the geometric mean titre was 2380 mIU/mL, all values being 200 mIU/mL or greater.

CONCLUSION

In healthy adults 40 years of age or more the HAV vaccine was well tolerated and highly immunogenic. Final antibody levels were much higher than reported in people passively immunized against HAV with immune serum globulin.

Authors+Show Affiliations

Department of Pediatrics, British Columbia's Children's Hospital, Vancouver.No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8431816

Citation

Scheifele, D W., and G J. Bjornson. "Evaluation of Inactivated Hepatitis a Vaccine in Canadians 40 Years of Age or More." CMAJ : Canadian Medical Association Journal = Journal De l'Association Medicale Canadienne, vol. 148, no. 4, 1993, pp. 551-5.
Scheifele DW, Bjornson GJ. Evaluation of inactivated hepatitis A vaccine in Canadians 40 years of age or more. CMAJ. 1993;148(4):551-5.
Scheifele, D. W., & Bjornson, G. J. (1993). Evaluation of inactivated hepatitis A vaccine in Canadians 40 years of age or more. CMAJ : Canadian Medical Association Journal = Journal De l'Association Medicale Canadienne, 148(4), 551-5.
Scheifele DW, Bjornson GJ. Evaluation of Inactivated Hepatitis a Vaccine in Canadians 40 Years of Age or More. CMAJ. 1993 Feb 15;148(4):551-5. PubMed PMID: 8431816.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of inactivated hepatitis A vaccine in Canadians 40 years of age or more. AU - Scheifele,D W, AU - Bjornson,G J, PY - 1993/2/15/pubmed PY - 1993/2/15/medline PY - 1993/2/15/entrez SP - 551 EP - 5 JF - CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne JO - CMAJ VL - 148 IS - 4 N2 - OBJECTIVE: To assess the side effects and immune responses after three serial doses of a new inactivated hepatitis A vaccine in people 40 years of age or more. DESIGN: Open, noncomparative trial. SETTING: A hospital, a regional laboratory and public health units in British Columbia. PARTICIPANTS: A volunteer sample of 64 healthy adults aged 40 to 61 years who were seronegative for hepatitis A virus (HAV). All were staff or associates of the health facilities. Exclusion criteria included elevated serum alanine and aspartate aminotransferase levels, a history of liver disease and recent travel to areas of high risk for HAV infection. INTERVENTION: A formalin-inactivated, alum-adsorbed vaccine containing 720 ELISA (enzyme-linked immunosorbent assay) units of antigen from HAV strain HM175 per 1.0-mL dose was injected intramuscularly into the delgoid area. The second and third doses were given 1 and 6 months later respectively. MAIN OUTCOME MEASURES: A detailed diary of any adverse effects for 3 days after each dose. HAV antibody levels in blood samples taken before and 30 days after each dose. RESULTS: All subjects completed the planned series of vaccinations and blood tests; symptom diaries were returned after 190 (99%) of 192 vaccinations. Local symptoms, most often soreness, were reported after 46% of the vaccinations but were mild and usually resolved within 24 hours. A temperature of more than 38.0 degrees C was never reported. Seroconversion occurred in all cases after the two primary doses, and the subjects were still seropositive at 6 months. After the booster dose the geometric mean titre was 2380 mIU/mL, all values being 200 mIU/mL or greater. CONCLUSION: In healthy adults 40 years of age or more the HAV vaccine was well tolerated and highly immunogenic. Final antibody levels were much higher than reported in people passively immunized against HAV with immune serum globulin. SN - 0820-3946 UR - https://www.unboundmedicine.com/medline/citation/8431816/Evaluation_of_inactivated_hepatitis_A_vaccine_in_Canadians_40_years_of_age_or_more_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=8431816.ui DB - PRIME DP - Unbound Medicine ER -