Randomized, double-blind study in healthy adults to assess the boosting effect of Vaqta or Havrix after a single dose of Havrix.
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.
Connor
B A
BA
Weill Medical College of Cornell University, New York, NY, USA. bconnor@pol.net
Phair
J
J
Sack
D
D
McEniry
D
D
Hornick
R
R
Banerjee
D
D
Jensen
E
E
Kuter
B
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006506:Hepatitis A / Q000517:prevention & control; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000097:blood*; D006507:Hepatovirus / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D015164:Vaccines, Inactivated