TY - JOUR
T1 - Randomized, cross-over, controlled comparison of two inactivated hepatitis A vaccines
AU - Bryan, Joe P.
AU - Henry, Charles H.
AU - Hoffman, Ann G.
AU - South-Paul, Jeannette E.
AU - Smith, Jeffrey A.
AU - Cruess, David
AU - Spieker, J. Michael R.
AU - De Medina, Maria
N1 - Funding Information:
The views and assertions expressed in this article are those of the authors and do not necessarily represent those of the Uniformed Services University of the Health Sciences or the Department of the Navy. The use of trade names in this article is for identification purposes only and does not constitute an endorsement or recommendation. Financial support for the study was provided by Uniformed Services University of the Health Sciences, Bethesda, MD through grant # G187-HS.
PY - 2000/11/22
Y1 - 2000/11/22
N2 - The immunogenicity, tolerability and interchangeability of two hepatitis A vaccines, Vaqta (Merck and Co.) and Havrix (SmithKline) were studied in a randomized, crossover, controlled clinical trial. Vaccine was administered to 201 volunteers at 0 and 26 weeks in one of four vaccine regimens: Havrix-Havrix; Havrix-Vaqta; Vaqta-Havrix or Vaqta-Vaqta. Seroconversion rates (≥10 mIU/ml) for those whose first dose was Vaqta or Havrix, respectively, were: 41/96 (43%) versus 30/95 (32%) (P=0.15) at 2 weeks and 91/98 (93%) versus 84/97 (87%) (P=0.43) at 4 weeks, and 100% at 26 weeks. Geometric mean concentrations (GMC) of total antibody to hepatitis A virus (anti-HAV) for Vaqta and Havrix were 189 and 114 mIU/ml (P=0.011) at 4 weeks and 234 and 136 mIU/ml (P<0.001) at 26 weeks. At 30 weeks, the GMC after two doses of Havrix was 2612 mIU/ml compared with 5497 after two doses of Vaqta (P<0.001). The GMC in the Havrix-Vaqta group was 5672 mIU/ml compared with 3077 mIU/ml in the Vaqta-Havrix group (P<0.001). Less than half of vaccine recipients reported tenderness or pain. In this study, seroconversion rates of the two vaccines were similar. Vaqta produces significantly higher anti-HAV antibody than Havrix. Crossover immunization is well tolerated and results in high antibody concentrations, especially when Vaqta is the booster dose. The significance of higher anti-HAV antibody concentrations in terms of long-term protection is unknown. Copyright (C) 2000 Elsevier Science Ltd.
AB - The immunogenicity, tolerability and interchangeability of two hepatitis A vaccines, Vaqta (Merck and Co.) and Havrix (SmithKline) were studied in a randomized, crossover, controlled clinical trial. Vaccine was administered to 201 volunteers at 0 and 26 weeks in one of four vaccine regimens: Havrix-Havrix; Havrix-Vaqta; Vaqta-Havrix or Vaqta-Vaqta. Seroconversion rates (≥10 mIU/ml) for those whose first dose was Vaqta or Havrix, respectively, were: 41/96 (43%) versus 30/95 (32%) (P=0.15) at 2 weeks and 91/98 (93%) versus 84/97 (87%) (P=0.43) at 4 weeks, and 100% at 26 weeks. Geometric mean concentrations (GMC) of total antibody to hepatitis A virus (anti-HAV) for Vaqta and Havrix were 189 and 114 mIU/ml (P=0.011) at 4 weeks and 234 and 136 mIU/ml (P<0.001) at 26 weeks. At 30 weeks, the GMC after two doses of Havrix was 2612 mIU/ml compared with 5497 after two doses of Vaqta (P<0.001). The GMC in the Havrix-Vaqta group was 5672 mIU/ml compared with 3077 mIU/ml in the Vaqta-Havrix group (P<0.001). Less than half of vaccine recipients reported tenderness or pain. In this study, seroconversion rates of the two vaccines were similar. Vaqta produces significantly higher anti-HAV antibody than Havrix. Crossover immunization is well tolerated and results in high antibody concentrations, especially when Vaqta is the booster dose. The significance of higher anti-HAV antibody concentrations in terms of long-term protection is unknown. Copyright (C) 2000 Elsevier Science Ltd.
KW - Hepatitis A
KW - Hepatitis A vaccine
KW - Prevention
KW - Randomized trial
UR - http://www.scopus.com/inward/record.url?scp=0034703805&partnerID=8YFLogxK
U2 - 10.1016/S0264-410X(00)00301-7
DO - 10.1016/S0264-410X(00)00301-7
M3 - Article
C2 - 11115695
AN - SCOPUS:0034703805
SN - 0264-410X
VL - 19
SP - 743
EP - 750
JO - Vaccine
JF - Vaccine
IS - 7-8
ER -