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Efficacy of RIX4414 Live Attenuated Human Rotavirus Vaccine in Finnish Infants

Vesikari, Timo MD*; Karvonen, Aino MD*; Puustinen, Leena MS*; Zeng, Shang-Qin MD*; Szakal, Evelyn Dora MS*; Delem, Andrée MS; De Vos, Beatrice MD

The Pediatric Infectious Disease Journal: October 2004 - Volume 23 - Issue 10 - p 937-943
doi: 10.1097/01.inf.0000141722.10130.50
Original Studies

Background: Rotavirus gastroenteritis, a major cause of mortality and morbidity worldwide, is a vaccine-preventable disease. New safe and effective candidate rotavirus vaccines are needed to replace the withdrawn rhesus rotavirus-based oral vaccine.

Methods: We evaluated a monovalent human rotavirus vaccine, serotype G1, strain RIX4414, for efficacy, immunogenicity and safety in a randomized, double blind, placebo-controlled trial in Finland. We randomly allocated 405 healthy infants to receive 2 doses of vaccine or placebo (ratio 2:1) at ∼2 and 4 months of age. The infants were followed during 2 rotavirus epidemic seasons (2000-2002) for acute gastroenteritis. Rotaviruses in diarrheal stool samples were primarily detected by enzyme-linked immunosorbent assay and confirmed and G-typed by reverse transciption-polymerase chain reaction.

Results: The vaccine was well-tolerated. No vaccine-related serious adverse events were observed during the study period. Rotavirus IgA (enzyme-linked immunosorbent assay) seroconversion rate was 80% after 2 doses. Thirty-eight cases of rotavirus gastroenteritis were detected during the entire follow-up period; 35 of these were of the G1 type. RIX4414 vaccine significantly decreased the occurrence of any rotavirus compared with placebo. Efficacy during the first rotavirus epidemic season was 73% [95% confidence interval (95% CI), 27-91%] and 90% (95% CI 10-100%) against any and severe rotavirus gastroenteritis, respectively, and during the entire follow-up period 72% (95% CI 42-87%) against any and 85% (95% CI 42-97%) against severe rotavirus gastroenteritis (P < 0.05 for all comparisons).

Conclusions: RIX4414 strain of G1 human rotavirus vaccine was well-tolerated, immunogenic and efficacious in infants against rotavirus gastroenteritis during a 2-year period. To further increase vaccine “take” and efficacy, a higher dose of this vaccine may be considered for future efficacy trials.

From the *Vaccine Research Center, University of Tampere Medical School, Tampere, Finland; and †GlaxoSmithKline Biologicals, Rixensart, Belgium (AD, BDV)

Accepted for publication May 28, 2004.

Supported by GlaxoSmithKline Biologicals, Rixensart, Belgium.

Presented as abstracts.24–26

Address for reprints: Professor T.Vesikari, University of Tampere Medical School, University of Tampere, FIN-33014 Tampere, Finland. Fax 358 3 215 8450; E-mail timo.vesikari@uta.fi.

© 2004 Lippincott Williams & Wilkins, Inc.