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 BMRC NREC for our nasal vaccine trial in Bangladesh. It has been a great team effort with the National Coordinating Investigators, professor ABM Abdullah, professor Ahmedul Kabir and professor Shafiqul Islam giving great support to the work of the local CRO, BCTL and laboratory icddr,b. 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.", says CEO Ola Winqvist.
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 randomized 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
This disclosure contains information that ISR is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 01-07-2022 10:21 CET.