Sweden-based drug development company ISR's application to conduct a phase I/II clinical trial of the dry powder nasal vaccine for SARS-CoV-2 in Bangladesh has been approved.
"We are very happy to have received approval from Bangladesh Medical Research Council (BMRC) National Research Ethics Committee (NREC) for our nasal vaccine trial in Bangladesh," said Ola Winqvist.
"It has been a great team effort with the NRB doctors including Professor Masudul Hassan, Dr Arifur Rahman, Professor Ziauddin Ahmed and Professor Chowdhury Hafiz Ahsan. Bangladesh counter part include Coordinating Investigators, Professor ABM Abdullah, Professor Ahmedul Kabir giving great support to the work of the local CRO, BCTL and laboratory icddrb," he added.
"Our next step is to complete the final steps of drug production as part of final approval. With the support from Dr Shahjahan Sayad from Singapore Resources Development PTE we are ready to start our clinical vaccine trial program for upper respiratory tract infections, where SARS-CoV-2 is the first in a line of vaccines that will be developed.", the ISR CEO said,
The first in human study will be conducted with 150 volunteers at two qualified study sites in Dhaka, Bangladesh. Vaccine and infection naïve volunteers will be randomised to receive 2 vaccine doses or placebo 4 weeks apart.
The study subjects will be monitored for safety and specific T cell and immunoglobulin immune responses.