Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life

被引:101
作者
Block, Stan L.
Vesikari, Timo
Goveia, Michelle G.
Rivers, Stephen B.
Adeyi, Ben A.
Dallas, Michael J.
Bauder, Jeffrey
Boslego, John W.
Heaton, Penny M.
机构
[1] Merck Res Labs, N Wales, PA 19454 USA
[2] Tampere Univ, Sch Med, Tampere, Finland
[3] Kentucky Pediat Adult Res, Bardstown, KY USA
关键词
gastroenteritis; rotavirus vaccine; rotavirus; safety; efficacy;
D O I
10.1542/peds.2006-2058
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
BACKGROUND. Rotavirus is the leading cause of dehydrating acute gastroenteritis in infants worldwide. Previous studies of a live pentavalent human-bovine reassortant rotavirus vaccine have shown it to be efficacious across a range of potencies. OBJECTIVE. Our goal was to evaluate the efficacy, immunogenicity, and safety of pentavalent rotavirus vaccine at the end of shelf life in healthy infants. PATIENTS AND METHODS. During 2002-2004, 1312 healthy infants similar to 6 to 12 weeks old from the United States (47%) and Finland (53%) were randomly assigned to receive 3 oral doses of vaccine (vaccine at similar to 1.1 x 107 infectious U per dose) or placebo similar to 4 to 10 weeks apart. Infants were to be followed for acute gastroenteritis through 1 rotavirus season after vaccination and for adverse events postvaccination. RESULTS. Three doses of pentavalent rotavirus vaccine at the end of shelf life demonstrated efficacy against rotavirus gastroenteritis caused by human G-serotypes included in the vaccine (G1-G4). Efficacy against severe rotavirus gastroenteritis was 100%, and efficacy against any rotavirus gastroenteritis regardless of severity was 72.5%. A threefold rise in G1 serum neutralizing was observed in 57% and in anti-rotavirus immunoglobulin A in 96% of pentavalent rotavirus vaccine recipients. No statistically significant increase in vomiting, diarrhea, or irritability was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients within the 7-day period from each dose. A statistically significant increase in fevers (>= 100.5 degrees F, rectal equivalent) was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients after dose 1. CONCLUSIONS. This pentavalent human-bovine rotavirus vaccine was generally well tolerated, efficacious, and immunogenic at the end of shelf life.
引用
收藏
页码:11 / 18
页数:8
相关论文
共 24 条
  • [1] [Anonymous], MORB MORTAL WKLY REP
  • [2] EVALUATION OF RHESUS ROTAVIRUS MONOVALENT AND TETRAVALENT REASSORTANT VACCINES IN US CHILDREN
    BERNSTEIN, DI
    GLASS, RI
    RODGERS, G
    DAVIDSON, BL
    SACK, DA
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1995, 273 (15): : 1191 - 1196
  • [3] Disease burden and risk factors for hospitalizations associated with rotavirus infection among children in New York State 1989 through 2000
    Chang, HGH
    Glass, RI
    Smith, PF
    Cicirello, HG
    Holman, RC
    Morse, DL
    [J]. PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2003, 22 (09) : 808 - 814
  • [4] Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants
    Clark, HF
    Bernstein, DI
    Dennehy, PH
    Offit, P
    Pichichero, M
    Treanor, J
    Ward, RL
    Krah, DL
    Shaw, A
    Dallas, MJ
    Digilio, L
    Eiden, JJ
    Ivanoff, N
    Kaplan, KM
    Heaton, P
    [J]. JOURNAL OF PEDIATRICS, 2004, 144 (02) : 184 - 190
  • [5] The development of multivalent bovine rotavirus (strain WC3) reassortant vaccine for infants
    Clark, HF
    Offit, PA
    Ellis, RW
    Eiden, JJ
    Krah, D
    Shaw, AR
    Pichichero, M
    Treanor, JJ
    Borian, FE
    Bell, LM
    Plotkin, SA
    [J]. JOURNAL OF INFECTIOUS DISEASES, 1996, 174 : S73 - S80
  • [6] PROTECTIVE EFFECT OF WC3 VACCINE AGAINST ROTAVIRUS DIARRHEA IN INFANTS DURING A PREDOMINANTLY SEROTYPE-1 ROTAVIRUS SEASON
    CLARK, HF
    BORIA, FE
    BELL, LM
    MODESTO, K
    GOUVEA, V
    PLOTKIN, SA
    [J]. JOURNAL OF INFECTIOUS DISEASES, 1988, 158 (03) : 570 - 587
  • [7] Novel rotavirus VP7 typing assay using a one-step reverse transcriptase PCR protocol and product sequencing and utility of the assay for epidemiological studies and strain characterization, including serotype subgroup analysis
    DiStefano, DJ
    Kraiouchkine, N
    Mallette, L
    Maliga, M
    Kulnis, G
    Keller, PM
    Clark, HF
    Shaw, MR
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2005, 43 (12) : 5876 - 5880
  • [8] EPIDEMIOLOGY OF ROTAVIRUS ELECTROPHEROTYPES DETERMINED BY A SIMPLIFIED DIAGNOSTIC-TECHNIQUE WITH RNA ANALYSIS
    DOLAN, KT
    TWIST, EM
    HORTONSLIGHT, P
    FORRER, C
    BELL, LM
    PLOTKIN, SA
    CLARK, HF
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 1985, 21 (05) : 753 - 758
  • [9] Serum IgA levels induced by rotavirus natural infection, but not following immunization with the RRV-TV vaccine (Rotashield™), correlate with protection
    González, R
    Franco, M
    Sarmiento, L
    Romero, M
    Schael, IP
    [J]. JOURNAL OF MEDICAL VIROLOGY, 2005, 76 (04) : 608 - 612
  • [10] ROTAVIRUS AS A CAUSE OF DIARRHEAL MORBIDITY AND MORTALITY IN THE UNITED-STATES
    HO, MS
    GLASS, RI
    PINSKY, PF
    ANDERSON, LJ
    [J]. JOURNAL OF INFECTIOUS DISEASES, 1988, 158 (05) : 1112 - 1116