A phase 1 clinical trial of an inactivated influenza A/H5N1 pandemicvaccine candidate (IVACFLU-H5N1), involving 75 participants in southernLong An province's Ben Luc district, has so far proven to safely induceimmune 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).
Overallresults showed that the vaccine candidate can be well tolerated and isimmunogenic, Dr. Le Van Be, the institute's head, said.
The studywas sponsored by the IVAC and conducted by Ho Chi Minh City PasteurInstitute. It was funded by the World Health Organisation with a grantthrough the Biomedical Advanced Research and Development Authority ofthe US Department of Health and Human Services.
Of the 75 peopleparticipating in the trial, 32 received a high dose of IVACFLU-H5N1 at15 mcg/0.5 ml, and 31 with a low dose of 7.5 mcg/0.5ml. The remaining 12received placebos.
No serious local or systemic adverse eventswere reported and the high-dose of IVACFLU-H5N1 was shown to beimmunogenic according to standard testing methods.
"We confirm the readiness of IVACFLU-H5N1 to progress into phase 2 and 3 clinical trials," Be added.
Influenzais an leading cause of morbidity and mortality worldwide. Seasonalinfluenza causes 250,000 to 500,000 fatalities and up to five millioncases of severe illness each year.
If a highly virulent pandemic strain were to emerge, influenza could cause millions of fatalities around the world.
Vietnamreports more than a million of cases of influenza-like-illnesses everyyear and has reported isolated cases of avian influenza A/H5N1 inhumans, a strain with a particularly high fatality rate.
Thestrain is being monitored for any evolution or adaptations that couldturn it into a form that can spread efficiently among people, whichwould increase the likelihood of a pandemic.
The IVAC's effortsto develop a locally produced A/H5N1 vaccine will not only benefitVietnamese people, it would also progress towards producing sufficientregional and global influenza vaccine supplies in case of a pandemic, hesaid.
To date, Vietnam has not yet had a steady and domestically manufactured supply of influenza vaccine, he said.
Withglobal influenza vaccine development and production resourcesconcentrated amongst just a few manufacturers, current global vaccineproduction falls significantly short of projected need. It also leavesmany middle- and low-income countries without access to these lifesavingpreventative measures.
Participation of more influenza vaccinesuppliers, like the IVAC, is vital to addressing this disparity,particularly in the event of a pandemic, Be added.-VNA
The vaccine was produced by the Nha Trang-based Institute of Vaccines and Medical Biologicals of Vietnam (IVAC).
Overallresults showed that the vaccine candidate can be well tolerated and isimmunogenic, Dr. Le Van Be, the institute's head, said.
The studywas sponsored by the IVAC and conducted by Ho Chi Minh City PasteurInstitute. It was funded by the World Health Organisation with a grantthrough the Biomedical Advanced Research and Development Authority ofthe US Department of Health and Human Services.
Of the 75 peopleparticipating in the trial, 32 received a high dose of IVACFLU-H5N1 at15 mcg/0.5 ml, and 31 with a low dose of 7.5 mcg/0.5ml. The remaining 12received placebos.
No serious local or systemic adverse eventswere reported and the high-dose of IVACFLU-H5N1 was shown to beimmunogenic according to standard testing methods.
"We confirm the readiness of IVACFLU-H5N1 to progress into phase 2 and 3 clinical trials," Be added.
Influenzais an leading cause of morbidity and mortality worldwide. Seasonalinfluenza causes 250,000 to 500,000 fatalities and up to five millioncases of severe illness each year.
If a highly virulent pandemic strain were to emerge, influenza could cause millions of fatalities around the world.
Vietnamreports more than a million of cases of influenza-like-illnesses everyyear and has reported isolated cases of avian influenza A/H5N1 inhumans, a strain with a particularly high fatality rate.
Thestrain is being monitored for any evolution or adaptations that couldturn it into a form that can spread efficiently among people, whichwould increase the likelihood of a pandemic.
The IVAC's effortsto develop a locally produced A/H5N1 vaccine will not only benefitVietnamese people, it would also progress towards producing sufficientregional and global influenza vaccine supplies in case of a pandemic, hesaid.
To date, Vietnam has not yet had a steady and domestically manufactured supply of influenza vaccine, he said.
Withglobal influenza vaccine development and production resourcesconcentrated amongst just a few manufacturers, current global vaccineproduction falls significantly short of projected need. It also leavesmany middle- and low-income countries without access to these lifesavingpreventative measures.
Participation of more influenza vaccinesuppliers, like the IVAC, is vital to addressing this disparity,particularly in the event of a pandemic, Be added.-VNA
