tetano
Editor, Senior Moderator
J Infect Dis. 2014 Dec 23. pii: jiu826. [Epub ahead of print]
[h=1]Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer Blind, Dose-Ranging Study.[/h] Johnson C[SUP]1[/SUP], Hohenboken M[SUP]2[/SUP], Poling T[SUP]3[/SUP], Jaehnig P[SUP]4[/SUP], Kanesa-Thasan N[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A/H3N2 variant (H3N2v) influenza may sustain human-to-human transmission, and an available candidate vaccine would be important.
[h=4]METHODS:[/h] In this phase I, randomized, observer blind, dose-ranging study, 627 healthy subjects≥3 years of age were randomized to receive two vaccinations with H3N2c cell culture derived vaccine doses containing 3.75 ?g, 7.5 ?g or 15 ?g hemagglutinin antigen (HA) of H3N2v with or without MF59[SUP]?[/SUP] adjuvant (an oil-in-water emulsion). This paper reports Day 43 planned interim data.
[h=4]RESULTS:[/h] Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose; the Center for Biologics Evaluation Research and Review (CBER) licensure criteria were met for all groups. Subjects with pre-vaccination HI titers <10 and children 3-<9 years achieve CBER criteria only after receiving two doses of non-adjuvanted H3N2c vaccine. Highest antibody titers were observed in the 7.5 ?g+0.25 mL MF59 groups in all age cohorts. MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events, predominately mild or moderate.
[h=4]CONCLUSIONS:[/h] A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines, especially for pediatric populations. Trial Registration. ClinicalTrials.gov Identifier NCT01855945 (http://clinicaltrials.gov/ct2/show/NCT01855945).
? The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
PMID: 25538277 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25538277
[h=1]Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer Blind, Dose-Ranging Study.[/h] Johnson C[SUP]1[/SUP], Hohenboken M[SUP]2[/SUP], Poling T[SUP]3[/SUP], Jaehnig P[SUP]4[/SUP], Kanesa-Thasan N[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] A/H3N2 variant (H3N2v) influenza may sustain human-to-human transmission, and an available candidate vaccine would be important.
[h=4]METHODS:[/h] In this phase I, randomized, observer blind, dose-ranging study, 627 healthy subjects≥3 years of age were randomized to receive two vaccinations with H3N2c cell culture derived vaccine doses containing 3.75 ?g, 7.5 ?g or 15 ?g hemagglutinin antigen (HA) of H3N2v with or without MF59[SUP]?[/SUP] adjuvant (an oil-in-water emulsion). This paper reports Day 43 planned interim data.
[h=4]RESULTS:[/h] Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose; the Center for Biologics Evaluation Research and Review (CBER) licensure criteria were met for all groups. Subjects with pre-vaccination HI titers <10 and children 3-<9 years achieve CBER criteria only after receiving two doses of non-adjuvanted H3N2c vaccine. Highest antibody titers were observed in the 7.5 ?g+0.25 mL MF59 groups in all age cohorts. MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events, predominately mild or moderate.
[h=4]CONCLUSIONS:[/h] A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines, especially for pediatric populations. Trial Registration. ClinicalTrials.gov Identifier NCT01855945 (http://clinicaltrials.gov/ct2/show/NCT01855945).
? The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
PMID: 25538277 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25538277