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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.
Vaccine. 2009 Nov 05; 27(47):6589-94.V

Abstract

BACKGROUND

Recombinant baculovirus-expressed hemagglutinin (rHA [FluBlok]) 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 microg HA/antigen), FluBlok-22.5 (22.5 microg rHA/antigen), or FluBlok-45 (45 microg rHA/antigen) were given to 115 children ages 6-35 months. TIV (15 microg HA/antigen) or FluBlok-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 microg 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.

Authors+Show Affiliations

Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD 21201, USA. jking@peds.umaryland.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19716456

Citation

King, James C., et al. "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." Vaccine, vol. 27, no. 47, 2009, pp. 6589-94.
King JC, Cox MM, Reisinger K, et al. 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. Vaccine. 2009;27(47):6589-94.
King, J. C., Cox, M. M., Reisinger, K., Hedrick, J., Graham, I., & Patriarca, P. (2009). 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. Vaccine, 27(47), 6589-94. https://doi.org/10.1016/j.vaccine.2009.08.032
King JC, et al. 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. Vaccine. 2009 Nov 5;27(47):6589-94. PubMed PMID: 19716456.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - King,James C,Jr AU - Cox,Manon M, AU - Reisinger,Keith, AU - Hedrick,James, AU - Graham,Irene, AU - Patriarca,Peter, Y1 - 2009/08/27/ PY - 2009/06/28/received PY - 2009/07/31/revised PY - 2009/08/06/accepted PY - 2009/9/1/entrez PY - 2009/9/1/pubmed PY - 2009/12/17/medline SP - 6589 EP - 94 JF - Vaccine JO - Vaccine VL - 27 IS - 47 N2 - BACKGROUND: Recombinant baculovirus-expressed hemagglutinin (rHA [FluBlok]) 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 microg HA/antigen), FluBlok-22.5 (22.5 microg rHA/antigen), or FluBlok-45 (45 microg rHA/antigen) were given to 115 children ages 6-35 months. TIV (15 microg HA/antigen) or FluBlok-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 microg 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/19716456/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(09)01201-8 DB - PRIME DP - Unbound Medicine ER -