Social Affairs
Clinical trial says new vaccine ‘safe'
Apr 26, 2015 / 10:02 AM
A phase 1 clinical trial of an inactivated influenza A/H5N1 pandemic vaccine candidate (IVACFLU-H5N1), involving 75 participants in southern Long An province`s Ben Luc district, has so far proven to safely induce immune responses at various dosage levels in healthy adults.
The vaccine was produced by the Nha Trang-based Institute of Vaccines and Medical Biologicals of Vietnam (IVAC).
Overall results showed that the vaccine candidate can be well tolerated and is immunogenic, Dr. Le Van Be, the institute's head, said.
The study was sponsored by the IVAC and conducted by Ho Chi Minh City Pasteur Institute. It was funded by the World Health Organisation with a grant through the Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services.
Of the 75 people participating in the trial, 32 received a high dose of IVACFLU-H5N1 at 15 mcg/0.5 ml, and 31 with a low dose of 7.5 mcg/0.5ml. The remaining 12 received placebos.
No serious local or systemic adverse events were reported and the high-dose of IVACFLU-H5N1 was shown to be immunogenic according to standard testing methods.
"We confirm the readiness of IVACFLU-H5N1 to progress into phase 2 and 3 clinical trials," Be added.
Influenza is an leading cause of morbidity and mortality worldwide. Seasonal influenza causes 250,000 to 500,000 fatalities and up to five million cases of severe illness each year.
If a highly virulent pandemic strain were to emerge, influenza could cause millions of fatalities around the world.
Vietnam reports more than a million of cases of influenza-like-illnesses every year and has reported isolated cases of avian influenza A/H5N1 in humans, a strain with a particularly high fatality rate.
The strain is being monitored for any evolution or adaptations that could turn it into a form that can spread efficiently among people, which would increase the likelihood of a pandemic.
The IVAC's efforts to develop a locally produced A/H5N1 vaccine will not only benefit Vietnamese people, it would also progress towards producing sufficient regional and global influenza vaccine supplies in case of a pandemic, he said.
To date, Vietnam has not yet had a steady and domestically manufactured supply of influenza vaccine, he said.
With global influenza vaccine development and production resources concentrated amongst just a few manufacturers, current global vaccine production falls significantly short of projected need. It also leaves many middle- and low-income countries without access to these lifesaving preventative measures.
Participation of more influenza vaccine suppliers, like the IVAC, is vital to addressing this disparity, particularly in the event of a pandemic, Be added.
Overall results showed that the vaccine candidate can be well tolerated and is immunogenic, Dr. Le Van Be, the institute's head, said.
The study was sponsored by the IVAC and conducted by Ho Chi Minh City Pasteur Institute. It was funded by the World Health Organisation with a grant through the Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services.
Of the 75 people participating in the trial, 32 received a high dose of IVACFLU-H5N1 at 15 mcg/0.5 ml, and 31 with a low dose of 7.5 mcg/0.5ml. The remaining 12 received placebos.
No serious local or systemic adverse events were reported and the high-dose of IVACFLU-H5N1 was shown to be immunogenic according to standard testing methods.
"We confirm the readiness of IVACFLU-H5N1 to progress into phase 2 and 3 clinical trials," Be added.
Influenza is an leading cause of morbidity and mortality worldwide. Seasonal influenza causes 250,000 to 500,000 fatalities and up to five million cases of severe illness each year.
If a highly virulent pandemic strain were to emerge, influenza could cause millions of fatalities around the world.
Vietnam reports more than a million of cases of influenza-like-illnesses every year and has reported isolated cases of avian influenza A/H5N1 in humans, a strain with a particularly high fatality rate.
The strain is being monitored for any evolution or adaptations that could turn it into a form that can spread efficiently among people, which would increase the likelihood of a pandemic.
The IVAC's efforts to develop a locally produced A/H5N1 vaccine will not only benefit Vietnamese people, it would also progress towards producing sufficient regional and global influenza vaccine supplies in case of a pandemic, he said.
To date, Vietnam has not yet had a steady and domestically manufactured supply of influenza vaccine, he said.
With global influenza vaccine development and production resources concentrated amongst just a few manufacturers, current global vaccine production falls significantly short of projected need. It also leaves many middle- and low-income countries without access to these lifesaving preventative measures.
Participation of more influenza vaccine suppliers, like the IVAC, is vital to addressing this disparity, particularly in the event of a pandemic, Be added.
