VietNamNet Bridge – A phase 1 clinical trial of an inactivated influenza A/H5N1 pandemic vaccine candidate (IVACFLU-H5N1), involving 75 participants in 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 Viet Nam (IVAC). Overall results showed that the vaccine candidate can be well tolerated and is immunogenic, Dr. Le Van Be, the institute’s head, said. High doses The study was sponsored by IVAC and conducted by HCM 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….
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