Evaluation of the safety, reactogenicity and immunogenicity of FluBlok® trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6-59 months

被引:57
作者
King, James C., Jr. [1 ]
Cox, Manon M. [2 ]
Reisinger, Keith [3 ]
Hedrick, James [4 ]
Graham, Irene [5 ]
Patriarca, Peter [6 ]
机构
[1] Univ Maryland, Sch Med, Dept Pediat, Baltimore, MD 21201 USA
[2] Prot Sci Corp, Meriden, CT USA
[3] Primary Phys Res Inc, Pittsburgh, PA USA
[4] Kentucky Pediat Res Ctr, Bardstown, KY USA
[5] St Louis Univ, Ctr Vaccine Dev, St Louis, MO 63103 USA
[6] Biol Consulting Grp Inc, Bethesda, MD USA
关键词
Baculovirus vaccine; Influenza; Children; Immunogenicity; Safety; VIRUS HEMAGGLUTININ; ANTIBODY-RESPONSES; INSECT;
D O I
10.1016/j.vaccine.2009.08.032
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background: Recombinant baculovirus-expressed hemagglutinin (rHA [FluBlok (R)]) influenza vaccine is unique in avoiding production in eggs and its rapid production capability. Objective: Compare the safety and immunogenicity of trivalent FluBlok to egg-grown trivalent influenza vaccine (TIV)in children. Methods: Healthy children were randomized to receive two doses of study vaccines. TIV (7.5 mu g HA/antigen), FluBlok-22.5 (22.5 mu g rHA/antigen), or FluBlok-45 (45 mu g rHA/antigen) were given to 115 children ages 6-35 months. TIV (151 mu g HA/antigen) or HuBlok-45 was given to 41 children ages 36-59 months. Safety and reactogenicity data were collected post-vaccination. Serum hemagglutination-inhibition antibody (HI) titers were measured before and 28 days after vaccination. Results: No serious vaccine-related adverse events occurred and reactogenicity events to equal volumes of TIV or FluBlok were generally similar. However, in the younger children, selected local and systemic symptoms were recorded significantly more frequently to 0.5 mL FluBlok-45 than to 0.25 mL doses of either the FluBlok-22.5 or 7.5 mu g TIV vaccines. In the younger children, the immunogenicity to TIV was generally significantly superior to FluBlok. Serologic responses to FluBlok were higher in the older children than the younger group, but were still somewhat lower compared to TIV. Conclusion: These data suggests that FluBlok is as safe but less immunogenic than similar volumes of TIV, particularly in the youngest children. The immunogenicity data is the converse of what has been observed in adults. Further studies examining the immunogenicity of FluBlok in older children are warranted. (C) 2009 Elsevier Ltd. All rights reserved.
引用
收藏
页码:6589 / 6594
页数:6
相关论文
共 18 条
[1]  
[Anonymous], 2008, MMWR-MORBID MORTAL W, V57, P1
[2]   Influenza-associated deaths among children in the United States, 2003-2004 [J].
Bhat, N ;
Wright, JG ;
Broder, KR ;
Murray, EL ;
Greenberg, ME ;
Glover, MJ ;
Likos, AM ;
Posey, DL ;
Klimov, A ;
Lindstrom, SE ;
Balish, A ;
Medina, MJ ;
Wallis, TR ;
Guarner, J ;
Paddock, CD ;
Shieh, WJ ;
Zaki, SR ;
Sejvar, JJ ;
Shay, DK ;
Harper, SA ;
Cox, NJ ;
Fukuda, K ;
Uyeki, TM .
NEW ENGLAND JOURNAL OF MEDICINE, 2005, 353 (24) :2559-2567
[3]  
*CDC, 2006 US INFL SEAS SU
[4]  
Cox MMJ, 2008, CURR OPIN MOL THER, V10, P56
[5]  
Cox MMJ, 2008, INFLUENZA OTHER RESP, V2, P211, DOI 10.1111/j.1750-2659.2008.00053.x
[6]  
Anonymous, 2006, Morbidity and Mortality Weekly Report, V55, P1
[7]   A comparison of 2 influenza vaccine schedules in 6-to 23-month-old children [J].
Englund, JA ;
Walter, EB ;
Fairchok, MP ;
Monto, AS ;
Neuzil, KM .
PEDIATRICS, 2005, 115 (04) :1039-1047
[8]  
HOLTZ KM, 2003, BIOPROCESS J SEP, P65
[9]   Influenza and the rates of hospitalization for respiratory disease among infants and young children. [J].
Izurieta, HS ;
Thompson, WW ;
Kramarz, P ;
Shay, DK ;
Davis, RL ;
DeStefano, F ;
Black, S ;
Shinefield, H ;
Fukuda, K .
NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (04) :232-239
[10]   HIGH-DOSES OF PURIFIED INFLUENZA-A VIRUS HEMAGGLUTININ SIGNIFICANTLY AUGMENT SERUM AND NASAL SECRETION ANTIBODY-RESPONSES IN HEALTHY-YOUNG ADULTS [J].
KEITEL, WA ;
COUCH, RB ;
CATE, TR ;
HESS, KR ;
BAXTER, B ;
QUARLES, JM ;
ATMAR, RL ;
SIX, HR .
JOURNAL OF CLINICAL MICROBIOLOGY, 1994, 32 (10) :2468-2473