A Two-Part Placebo-Controlled Evaluation of the Safety and Immunogenicity of an A/Indonesia/5/05 Recombinant Hemagglutinin Influenza H5N1 Vaccine With and Without Glucopyranosyl Lipid A (GLA-SE) in Healthy Adults 18-49
Sponsor study identifier
interventional
392
1 country
4
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
October 2011
Actual (reported)The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 16, 2010
Actual (reported)June 22, 2010
Actual (reported)October 2011
Actual (reported)October 2011
Actual (reported)November 26, 2012
Actual (reported)Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.
42 Days
Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.
Day 0, and Day 42
Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age
21 Days
135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vince and Associates Clinical Research
Overland Park, Kansas, 66210, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
University of Rochester
Rochester, New York, 14642, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Treanor JJ, Essink B, Hull S, Reed S, Izikson R, Patriarca P, Goldenthal KL, Kohberger R, Dunkle LM. Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE+GLA) adjuvant. Vaccine. 2013 Nov 19;31(48):5760-5. doi: 10.1016/j.vaccine.2013.08.064. Epub 2013 Sep 27.
The absence of a treatment group receiving a SE- or GLA-alone adjuvanted vaccine formulation is a limitation to the study conclusion.
John Treanor, MD
University of Rochester
392 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2010
First Posted
June 22, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
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Primary Completion
October 2011
Actual (reported)Study Completion
October 2011
Actual (reported)Last Updated
November 26, 2012
Results First Posted
November 26, 2012
Record last verified: 2012-10
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Source: ClinicalTrials.gov.
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