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Randomized, double-blind study in healthy adults to assess the boosting effect of Vaqta or Havrix after a single dose of Havrix.

Author(s): Connor BA, Phair J, Sack D, McEniry D, Hornick R, Banerjee D, Jensen E, Kuter B

Affiliation(s): Weill Medical College of Cornell University, New York, NY, USA. bconnor@pol.net

Publication date & source: 2001-02-01, Clin Infect Dis., 32(3):396-401. Epub 2001 Jan 19.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

A randomized, double-blind, multicenter study was conducted to investigate the boosting effect of Vaqta or Havrix in 537 healthy adults 18-53 years of age who had received a single dose of Havrix either 24 or 52 weeks earlier. Subjects were randomized in a 2 : 1 ratio to receive either Vaqta or Havrix for their second dose of vaccine and followed for clinical reactions for 14 days after dose 2 was administered. Serum samples were collected immediately before dose 2 was administered and again 4 weeks later and evaluated for hepatitis A antibody (modified hepatitis A virus antibody assay). The booster response rate after administration of the second dose of either vaccine was similar (86.1% for Vaqta vs. 80.1% for Havrix). The geometric mean titers were also similar: 3274 mIU/mL (95% confidence interval [CI], 2776-3858) for Vaqta versus 2423 mIU/mL (95% CI, 1911-3074) for Havrix. The proportion of subjects who reported > or =1 injection-site adverse experiences was lower in the patients receiving Vaqta than in those receiving Havrix (36.6% vs. 59.7%; P<.001). The results of this study indicate that a regimen of Havrix followed by Vaqta is generally well tolerated and highly immunogenic.

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