Giuseppe
Emeritus
[fluWho - Sunshine Project]
A Quick Look at Current US-Registered H5N1 Vaccine Trials
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More than 5 dozen clinical trials for H5N1 vaccines have been registered in the US in recent years.
A listing of trials (which includes many taking place outside the US) is available at http://clinicaltrials.gov/ct2/results?term=H5N1
Here is a quick review of many of those that are either ongoing or preparing to recruit human subjects, emphasizing those that relate to new biologicals (and less on studies primarily concerned with adjuvants):
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GLAXOSMITHKLINE
Efficacy studies in the US and Canada, involving more than 5000 adults, of an experimental split virion H5N1 vaccine denominated 1557484A. This is a monovalent A/Indonesia/5/05 based vaccine.
Efficacy studies in Spain, Taiwan, Italy, Belgium, Hong Kong, Singapore, and Thailand of another experimental split virion H5N1 vaccine denominated 1562902A. The composition of this H5N1 vaccine is not stated.
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SANOFI
A US safety and efficacy study of experimental monovalent formulations of its H5N1 vaccine, with the goal of reducing the required dosage. The exact composition of the H5N1 vaccine is not stated, although Sanofi's licensed H5N1 vaccine uses A/Vietnam/1203/2004.
A safety and efficacy study in Belgium and Australia of an experimental split virion H5N1 vaccine. (Related studies in Belgium and the UK assess the efficacy of adjuvants used in the vaccine.)
Further testing an H5N1 vaccine in infants and children in Thailand.
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SOLVAY
Trial involving 400 adults in Finland and Germany of various formulations of an egg-based H5N1 vaccine. The exact composition of the H5N1 vaccine is not stated.
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BAXTER
Safety and efficacy trials underway of a cell culture-produced killed whole virion vaccine, using A/Vietnam/1203/2004. Some study participants receive a booster shot containing A/Indonesia/05/2005. The studies are taking place in Austria and Germany.
Safety and dosing trials underway in Hong Kong and Singapore of a double-dose cell culture-produced killed whole virion vaccine. The exact composition of the H5N1 vaccine is not stated.
Large study, in 9 European countries, of a cell culture-produced killed whole virion vaccine, using A/Vietnam/1203/2004.
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NOVARTIS
Multiple safety and efficacy and dosing trials of H5N1 vaccines that use (or not use) its MF59 adjuvant. This set of trials are in Italy. Exact composition of the vaccine not stated.
Safety trial in Colombia of an H5N1 vaccine in combination with a Southern Hemisphere trivalent seasonal flu vaccine. The exact composition of the H5N1 vaccine is not stated.
Safety trial in Germany of a combination seasonal (presumably North) and H5N1 tetravalent vaccine (i.e. with a total of 4 antigens). The exact composition of the H5N1 component of the vaccine is not stated.
A safety and efficacy trial in the UK of multiple doses of an H5N1 vaccine in combination with/without various combinations of a seasonal (presumably Northern Hemisphere) vaccine and a proprietary adjuvant. The exact composition of the H5N1 vaccine is not stated.
Further testing an H5N1 vaccine in infants and children in Finland.
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NOVAVAX
A US safety and efficacy trial underway of its virus-like particle vaccine. The viral source of the VLPs is not specified.
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US CENTERS FOR DISEASE CONTROL
A safety and efficacy trial of H5N1 vaccine (exact composition undisclosed), in 100 adults at occupational risk of exposure to live H5N1 viruses. Location unstated.
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US NATIONAL INSTITUTES OF HEALTH (HAS COLLABORATION WITH MEDIMMUNE / ASTRAZENECA)
A dose comparison trial of an A/H5N1/Indonesia/05/05-based vaccine in adults who were previously vaccinated with an A/H5N1/Vietnam/1203/2004-based vaccine.
A US dosing trial administering 9 different vaccine formulations using A/H5N1/Vietnam/1203/2004 and/or A/H5N1/Indonesia/05/05.
Plans to enroll 155 US adults in a study that will inject them with a high dosage of an (undescribed) H5N1 vaccine in order to stimulate the subjects to produce high levels of antibodies to the vaccine strain. These antibodies are then collected and used in efforts to produce an immune globulin flu treatment.
Plans to enroll 44 US adults in a safety and efficacy study of a DNA plasmid vaccine delivered in a needle-free transdermal system. The exact composition of the H5N1 vaccine is not stated, although other sources indicate this lab has prepared DNA vaccine plasmids bearing the HA gene of A/Indonesia/5/05. A related study is injecting a DNA vaccine into 45 US adults.
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http://lists.sunshine-project.org/lists/info/flu
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A Quick Look at Current US-Registered H5N1 Vaccine Trials
--------------------------------------------------------
More than 5 dozen clinical trials for H5N1 vaccines have been registered in the US in recent years.
A listing of trials (which includes many taking place outside the US) is available at http://clinicaltrials.gov/ct2/results?term=H5N1
Here is a quick review of many of those that are either ongoing or preparing to recruit human subjects, emphasizing those that relate to new biologicals (and less on studies primarily concerned with adjuvants):
-----
GLAXOSMITHKLINE
Efficacy studies in the US and Canada, involving more than 5000 adults, of an experimental split virion H5N1 vaccine denominated 1557484A. This is a monovalent A/Indonesia/5/05 based vaccine.
Efficacy studies in Spain, Taiwan, Italy, Belgium, Hong Kong, Singapore, and Thailand of another experimental split virion H5N1 vaccine denominated 1562902A. The composition of this H5N1 vaccine is not stated.
------
SANOFI
A US safety and efficacy study of experimental monovalent formulations of its H5N1 vaccine, with the goal of reducing the required dosage. The exact composition of the H5N1 vaccine is not stated, although Sanofi's licensed H5N1 vaccine uses A/Vietnam/1203/2004.
A safety and efficacy study in Belgium and Australia of an experimental split virion H5N1 vaccine. (Related studies in Belgium and the UK assess the efficacy of adjuvants used in the vaccine.)
Further testing an H5N1 vaccine in infants and children in Thailand.
-----
SOLVAY
Trial involving 400 adults in Finland and Germany of various formulations of an egg-based H5N1 vaccine. The exact composition of the H5N1 vaccine is not stated.
-----
BAXTER
Safety and efficacy trials underway of a cell culture-produced killed whole virion vaccine, using A/Vietnam/1203/2004. Some study participants receive a booster shot containing A/Indonesia/05/2005. The studies are taking place in Austria and Germany.
Safety and dosing trials underway in Hong Kong and Singapore of a double-dose cell culture-produced killed whole virion vaccine. The exact composition of the H5N1 vaccine is not stated.
Large study, in 9 European countries, of a cell culture-produced killed whole virion vaccine, using A/Vietnam/1203/2004.
-----
NOVARTIS
Multiple safety and efficacy and dosing trials of H5N1 vaccines that use (or not use) its MF59 adjuvant. This set of trials are in Italy. Exact composition of the vaccine not stated.
Safety trial in Colombia of an H5N1 vaccine in combination with a Southern Hemisphere trivalent seasonal flu vaccine. The exact composition of the H5N1 vaccine is not stated.
Safety trial in Germany of a combination seasonal (presumably North) and H5N1 tetravalent vaccine (i.e. with a total of 4 antigens). The exact composition of the H5N1 component of the vaccine is not stated.
A safety and efficacy trial in the UK of multiple doses of an H5N1 vaccine in combination with/without various combinations of a seasonal (presumably Northern Hemisphere) vaccine and a proprietary adjuvant. The exact composition of the H5N1 vaccine is not stated.
Further testing an H5N1 vaccine in infants and children in Finland.
-----
NOVAVAX
A US safety and efficacy trial underway of its virus-like particle vaccine. The viral source of the VLPs is not specified.
-----
US CENTERS FOR DISEASE CONTROL
A safety and efficacy trial of H5N1 vaccine (exact composition undisclosed), in 100 adults at occupational risk of exposure to live H5N1 viruses. Location unstated.
-----
US NATIONAL INSTITUTES OF HEALTH (HAS COLLABORATION WITH MEDIMMUNE / ASTRAZENECA)
A dose comparison trial of an A/H5N1/Indonesia/05/05-based vaccine in adults who were previously vaccinated with an A/H5N1/Vietnam/1203/2004-based vaccine.
A US dosing trial administering 9 different vaccine formulations using A/H5N1/Vietnam/1203/2004 and/or A/H5N1/Indonesia/05/05.
Plans to enroll 155 US adults in a study that will inject them with a high dosage of an (undescribed) H5N1 vaccine in order to stimulate the subjects to produce high levels of antibodies to the vaccine strain. These antibodies are then collected and used in efforts to produce an immune globulin flu treatment.
Plans to enroll 44 US adults in a safety and efficacy study of a DNA plasmid vaccine delivered in a needle-free transdermal system. The exact composition of the H5N1 vaccine is not stated, although other sources indicate this lab has prepared DNA vaccine plasmids bearing the HA gene of A/Indonesia/5/05. A related study is injecting a DNA vaccine into 45 US adults.
-
http://lists.sunshine-project.org/lists/info/flu
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