Hepatitis B vaccine in infants: a randomized controlled trial comparing gluteal versus anterolateral thigh muscle administration

Abstract

A significantly diminished antibody response to hepatitis B vaccine has been demonstrated in adults when the buttock is used as the injection site. However, in Brazil, the buttock continues to be recommended as site of injection for intramuscular administration of vaccines in infants. In this age group, there are no controlled studies evaluating the immunogenicity of the hepatitis B vaccine when administered at this site. In the present study, 258 infants were randomized to receive the hepatitis B vaccine either in the buttock (n = 123) or in the anterolateral thigh muscle (n = 135). The immunization schedule consisted of three doses of hepatitis B vaccine (Engerix Bregister mark or target, 10 microg) at 2, 4 and 9 months of age. There were no significant differences in the proportion of seroconversion (99.3% x 99.2%), or in the geometric mean titer of ELISA anti-HBs (1,862.1 x 1,229.0 mIU/mL) between the two groups. This study demonstrates that a satisfactory serological response can be obtained when the hepatitis B vaccine is administered intramuscularly into the buttock.

Eight years of hepatitis B vaccination in Colombia with a recombinant vaccine: factors influencing hepatitis B virus infection and effectiveness

“…Most health workers said that the vaccine should be applied in the buttock, which is known to lead to a lower serological response. 31,32 Our study has several limitations. This is a cross-sectional study where exposure and infection is measured at the same time.…”

Factors That Influence the Immune Response to Vaccination

“…In adults, HepB vaccination given in the buttock area leads to lower responses than those obtained when it is given in the upper arm (521)(522)(523)(524). However, this is not the case for infants (525). In children receiving Hib vaccination, there is also no difference in GMTs between children who receive the vaccination in the vastus lateralis and those who receive it in the deltoid muscle (526).…”