Hepatitis B Vaccine in Healthy Hospital Employees

Abstract

A low rate of seroconversion to hepatitis B vaccine is reported. This occurred in healthy hospital employees from two separate institutions. A total of 236 individuals were evaluated in this study and only 53% or 124 persons developed protective levels of antibody to hepatitis B surface antigen following a complete vaccine series. In one hospital, 30% of the vaccine recipients developed antibody but not to a protective level. Employees who received the entire series in the arm or in the arm and buttock (mixed) had a significantly greater number of responders than employees who received the entire series in the buttock (P<.05). Recipients aged 50 to 59 years had a significantly lower response rate to the vaccine (P<.05). There was no correlation with the vaccinee's sex or the timing of the second injection. Vaccine was noted to have frozen in one hospital and accounted for some loss of antigenicity. This failure to respond to the vaccine has necessitated the use of booster injections of vaccine and continued antibody monitoring.

Freezing temperatures in the vaccine cold chain: A systematic literature review

“…Many epidemiological studies have also pointed to vaccine freezing as a possible contributor to low immune response in vaccinated individuals and the existing literature relating freeze exposure to potency loss is compelling enough to suggest some degree of impact on immune response [2][3][4][5][6][17][18][19]. More lab-based studies are needed to augment the literature base in order to gain a more precise understanding of the degree of potency loss associated with common field conditions.…”

Validation of the shake test for detecting freeze damage to adsorbed vaccines

“…[13][14][15][16] Freezedamaged vaccines have lower immunogenicity and are more likely to cause local reactions, such as sterile abscesses. 1,17 The shake test is designed to determine whether adsorbed vaccines have been affected by freezing.…”

Effect of Freezing on Oxytocin Ampules

“…When a vaccine containing an antigen adsorbed to an aluminium adjuvant (e.g. hepatitis B, tetanus toxoid, ..) is damaged by freezing, the loss of potency can never be restored; the damage is permanent (34,35,40,75).…”

“…Other studies have suggested a correlation between freezing of HepB vaccines and lower than expected seroconversion. (37,75,89).…”

“…However, despite this, more deaths could be prevented and illnesses avoided, if vaccines which are sensitive both to excessive heat and excessive cold, were transported and stored correctly (34,75).…”