TY - JOUR
T1 - A two-dose combined vaccine against hepatitis A and hepatitis B in healthy children and adolescents compared to the corresponding monovalent vaccines
AU - Ramonet, Margarita
AU - Da Silveira, Themis Reverbel
AU - Lisker-Melman, Mauricio
AU - Rüttimann, Ricardo
AU - Pernambuco, Eduardo
AU - Cervantes, Yolanda
AU - Cañero-Velascoe, Maria Cristina
AU - Falleiros-Carvalho, Luiza Elena
AU - Azevedo, Tania
AU - Targa-Ferreira, Cristina
AU - Clemens, Sue Ann Costa
N1 - Funding Information:
This study was funded by GlaxoSmithKline Biologicals, Rixensart, Belgium.
PY - 2002
Y1 - 2002
N2 - Background. Immunization against hepatitis A and B has been available for some time, protecting against both infections. With a view to achieving further reduction in the number of interventions and increasing convenience of the vaccinee, we investigated the reactogenicity and immunogenicity of a combined hepatitis A and B vaccine in healthy 4- to 20-year-old subjects at a 0, 6-month schedule. Methods. Two hundred forty-eight study subjects were allocated to two study groups and received either two doses of the combined hepatitis A and B vaccine (68% of subjects) or the corresponding monovalent hepatitis A and hepatitis B vaccines (32% of subjects) concomitantly in opposite arms. Reactogenicity was assessed via diary cards after each vaccination. Serum samples were analyzed at months 1, 2, 6, and 7. Results. All vaccines were well tolerated and very few symptoms were scored as severe. All but one subject seroconverted for anti-hepatitis A virus (anti-HAV) antibodies (98.6%) and 100% of subjects seroconverted for anti-hepatitis B (HBs) antibodies, with respective seroprotection rates of 98.7% for the combined vaccine group and 95.9% for the concomitant vaccine group (p >0.05), respectively. Geometric mean titers were higher in the group receiving the combined vaccine: 6,635 mIU/mL vs. 2,728 mIU/mL (p = 0.0001) for anti-HAV and 3,362 mIU/mL vs. 1,724 mIU/mL (p = 0.0205) for anti-HBs, respectively. Younger subjects had a stronger immune response compared to older subjects. Conclusions. The combined hepatitis A and B vaccine was well tolerated at this two-dose schedule. The combined vaccine had higher immunogenicity, probably explained by a adjuvant effect of the antigens. Vaccination programs requiring fewer injections will most likely have a positive impact on compliance rate and comfort of the vaccinee.
AB - Background. Immunization against hepatitis A and B has been available for some time, protecting against both infections. With a view to achieving further reduction in the number of interventions and increasing convenience of the vaccinee, we investigated the reactogenicity and immunogenicity of a combined hepatitis A and B vaccine in healthy 4- to 20-year-old subjects at a 0, 6-month schedule. Methods. Two hundred forty-eight study subjects were allocated to two study groups and received either two doses of the combined hepatitis A and B vaccine (68% of subjects) or the corresponding monovalent hepatitis A and hepatitis B vaccines (32% of subjects) concomitantly in opposite arms. Reactogenicity was assessed via diary cards after each vaccination. Serum samples were analyzed at months 1, 2, 6, and 7. Results. All vaccines were well tolerated and very few symptoms were scored as severe. All but one subject seroconverted for anti-hepatitis A virus (anti-HAV) antibodies (98.6%) and 100% of subjects seroconverted for anti-hepatitis B (HBs) antibodies, with respective seroprotection rates of 98.7% for the combined vaccine group and 95.9% for the concomitant vaccine group (p >0.05), respectively. Geometric mean titers were higher in the group receiving the combined vaccine: 6,635 mIU/mL vs. 2,728 mIU/mL (p = 0.0001) for anti-HAV and 3,362 mIU/mL vs. 1,724 mIU/mL (p = 0.0205) for anti-HBs, respectively. Younger subjects had a stronger immune response compared to older subjects. Conclusions. The combined hepatitis A and B vaccine was well tolerated at this two-dose schedule. The combined vaccine had higher immunogenicity, probably explained by a adjuvant effect of the antigens. Vaccination programs requiring fewer injections will most likely have a positive impact on compliance rate and comfort of the vaccinee.
KW - Combined vaccines
KW - Hepatitis
KW - Vaccination schedule
UR - http://www.scopus.com/inward/record.url?scp=0036150128&partnerID=8YFLogxK
U2 - 10.1016/S0188-4409(01)00351-4
DO - 10.1016/S0188-4409(01)00351-4
M3 - Article
C2 - 11825634
AN - SCOPUS:0036150128
SN - 0188-4409
VL - 33
SP - 67
EP - 73
JO - Archives of Medical Research
JF - Archives of Medical Research
IS - 1
ER -