tetano
Editor, Senior Moderator
Oxford Journals
Medicine
Journal of Infectious Diseases
Volume203, Issue12
Pp. 1729-1738
Dose-Sparing H5N1 A/Indonesia/05/2005 Pre-pandemic Influenza Vaccine in Adults and Elderly Adults: A Phase III, Placebo-Controlled, Randomized Study
Joanne M. Langley1,
George Risi5,
Michael Caldwell6,
Larry Gilderman7,
Bruce Berwald9,
Charles Fogarty10,
Terry Poling11,
Dennis Riff12,
Mira Baron13,
Louise Frenette3,
Eric Sheldon8,
Harry Collins14,
Marc Shepard15,
Marc Dionne4,
Daniel Brune17,
Linda Ferguson2,
David Vaughn18,
Ping Li16 and
Louis Fries16
+ Author Affiliations
1Canadian Center for Vaccinology, Departments of Pediatrics and Community Health and Epidemiology, IWK Health Centre and Dalhousie University, Halifax
2Colchester Research Group, Truro, Nova Scotia
3Q&T Research, Inc, Sherbrooke
4Unit? de Recherche en Sant? Publique, Quebec City, Quebec, Canada
5Infectious Disease Specialists, PC, Missoula, Montana
6Duchess County Department of Health, Poughkeepsie, New York
7University Clinical Research, Pembroke Pines
8Miami Research Associates, Miami, Florida
9Radiant Research, Inc, St Louis, Missouri
10Spartanburg Medical Research, South Carolina
11Heartland Research Associates, Wichita, Kansas
12Advanced Clinical Research Institute, Anaheim, California
13Rapid Medical Research, Cleveland, Ohio
14Anderson & Collins Clinical, Edison, New Jersey
15Accelovance, Inc, Rockville
16GlaxoSmithKline Biologicals, Columbia, Maryland
17Accelovance, Inc, Peoria, Illinois
18GlaxoSmithKline Biologicals, King of Prussia, Philadelphia, Pennsylvania
Correspondence: Joanne M. Langley, MD, MSc, FRCPC, Canadian Center for Vaccinology, 5850 University Ave, IWK Health Centre, Halifax, NS B3K 6R8, Canada (joanne.langley@dal.ca).
Next Section
Abstract
Background. Highly pathogenic avian influenza H5N1 viruses remain a threat to human health, with potential to become pandemic agents.
Methods. This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03A) adjuvanted H5N1 A/Indonesia/05/2005 (3.75 μg hemagglutinin antigen) prepandemic candidate vaccine in 4561 adults aged 18?91 years.
Results. Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days after the second dose. At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. Neutralizing cross-clade immune responses were demonstrated against clade 1 A/Vietnam/1194/2004. Consistency was demonstrated for 3 consecutive H5N1 vaccine lots. Temporary injection-site pain was more frequent with H5N1 vaccine than placebo (89.3% and 70.7% in the 18?64 and ≥65 years strata vs 22.2% and 14.4% in the placebo groups). Unsolicited adverse event frequency, including medically attended and serious events, was similar between groups through day 364.
Conclusions. In adults and elderly adults, AS03A-adjuvanted H5N1 candidate vaccine was highly immunogenic for A/Indonesia/05/2005, with cross-reactivity against A/Vietnam/1194/2004. Temporary injection site reactions were more frequent with H5N1 vaccine than placebo, although the H5N1 vaccine was well tolerated overall.
http://jid.oxfordjournals.org/content/203/12/1729.full
Medicine
Journal of Infectious Diseases
Volume203, Issue12
Pp. 1729-1738
Dose-Sparing H5N1 A/Indonesia/05/2005 Pre-pandemic Influenza Vaccine in Adults and Elderly Adults: A Phase III, Placebo-Controlled, Randomized Study
Joanne M. Langley1,
George Risi5,
Michael Caldwell6,
Larry Gilderman7,
Bruce Berwald9,
Charles Fogarty10,
Terry Poling11,
Dennis Riff12,
Mira Baron13,
Louise Frenette3,
Eric Sheldon8,
Harry Collins14,
Marc Shepard15,
Marc Dionne4,
Daniel Brune17,
Linda Ferguson2,
David Vaughn18,
Ping Li16 and
Louis Fries16
+ Author Affiliations
1Canadian Center for Vaccinology, Departments of Pediatrics and Community Health and Epidemiology, IWK Health Centre and Dalhousie University, Halifax
2Colchester Research Group, Truro, Nova Scotia
3Q&T Research, Inc, Sherbrooke
4Unit? de Recherche en Sant? Publique, Quebec City, Quebec, Canada
5Infectious Disease Specialists, PC, Missoula, Montana
6Duchess County Department of Health, Poughkeepsie, New York
7University Clinical Research, Pembroke Pines
8Miami Research Associates, Miami, Florida
9Radiant Research, Inc, St Louis, Missouri
10Spartanburg Medical Research, South Carolina
11Heartland Research Associates, Wichita, Kansas
12Advanced Clinical Research Institute, Anaheim, California
13Rapid Medical Research, Cleveland, Ohio
14Anderson & Collins Clinical, Edison, New Jersey
15Accelovance, Inc, Rockville
16GlaxoSmithKline Biologicals, Columbia, Maryland
17Accelovance, Inc, Peoria, Illinois
18GlaxoSmithKline Biologicals, King of Prussia, Philadelphia, Pennsylvania
Correspondence: Joanne M. Langley, MD, MSc, FRCPC, Canadian Center for Vaccinology, 5850 University Ave, IWK Health Centre, Halifax, NS B3K 6R8, Canada (joanne.langley@dal.ca).
Next Section
Abstract
Background. Highly pathogenic avian influenza H5N1 viruses remain a threat to human health, with potential to become pandemic agents.
Methods. This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03A) adjuvanted H5N1 A/Indonesia/05/2005 (3.75 μg hemagglutinin antigen) prepandemic candidate vaccine in 4561 adults aged 18?91 years.
Results. Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days after the second dose. At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. Neutralizing cross-clade immune responses were demonstrated against clade 1 A/Vietnam/1194/2004. Consistency was demonstrated for 3 consecutive H5N1 vaccine lots. Temporary injection-site pain was more frequent with H5N1 vaccine than placebo (89.3% and 70.7% in the 18?64 and ≥65 years strata vs 22.2% and 14.4% in the placebo groups). Unsolicited adverse event frequency, including medically attended and serious events, was similar between groups through day 364.
Conclusions. In adults and elderly adults, AS03A-adjuvanted H5N1 candidate vaccine was highly immunogenic for A/Indonesia/05/2005, with cross-reactivity against A/Vietnam/1194/2004. Temporary injection site reactions were more frequent with H5N1 vaccine than placebo, although the H5N1 vaccine was well tolerated overall.
http://jid.oxfordjournals.org/content/203/12/1729.full