Journal Article

Randomized, Double-Blind Study in Healthy Adults to Assess the Boosting Effect of Vaqta or Havrix after a Single Dose of Havrix

Bradley A. Connor, John Phair, David Sack, David McEniry, Richard Hornick, Dalfoni Banerjee, Erin Jensen and Barbara Kuter

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 32, issue 3, pages 396-401
Published in print February 2001 | ISSN: 1058-4838
Published online February 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/318522
Randomized, Double-Blind Study in Healthy Adults to Assess the Boosting Effect of Vaqta or Havrix after a Single Dose of Havrix

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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 ⩾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.

Journal Article.  2507 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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