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

B. A. Connor, J. Phair, David Allen Sack, D. McEniry, R. Hornick, D. Banerjee, E. Jensen, B. Kuter

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)396-401
Number of pages6
JournalClinical Infectious Diseases
Volume32
Issue number3
DOIs
StatePublished - 2001

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Hepatitis A Vaccines
Double-Blind Method
Hepatitis A Antibodies
Vaccines
Confidence Intervals

ASJC Scopus subject areas

  • Immunology

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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. / Connor, B. A.; Phair, J.; Sack, David Allen; McEniry, D.; Hornick, R.; Banerjee, D.; Jensen, E.; Kuter, B.

In: Clinical Infectious Diseases, Vol. 32, No. 3, 2001, p. 396-401.

Research output: Contribution to journalArticle

Connor, B. A. ; Phair, J. ; Sack, David Allen ; McEniry, D. ; Hornick, R. ; Banerjee, D. ; Jensen, E. ; Kuter, B. / Randomized, double-blind study in healthy adults to assess the boosting effect of Vaqta or Havrix after a single dose of Havrix. In: Clinical Infectious Diseases. 2001 ; Vol. 32, No. 3. pp. 396-401.
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