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Regulatory press release

Delegation from Bangladesh visits ISR for study preparation

ISR Immune System Regulation
Read the release

ISR is hosting a workshop with a delegation from Bangladesh to prepare for the company's phase I/II clinical trial of the dry powder nasal vaccine for SARS-CoV-2

"We are very happy to have two national coordinating investigators here:  Professor ABM Abdullah, the prime minister's personal physician, and Professor Shafiqul Islam, experienced vaccine coordinator from Dhaka,  Bangladesh, to coordinate our joint efforts to initiate the clinical trial. Their experience and expertise are highly appreciated ", says CEO Ola Winqvist.

The study is now in its final preparation phase where study sites staff, CRO and clinical laboratory all are lined up and getting ready for conducting the trial. ISR is awaiting the regulatory approval whereafter our nasal vaccine candidate will be tested on 150 vaccine and SARS-CoV-2 naïve volunteers  in five dose groups  with two vaccine doses,  28- days  apart. The study subjects will be randomized to vaccine doses or placebo and monitored for safety and specific T cell and immunoglobulin immune responses.

"We are eagerly awaiting the start of the clinical trial. The dry powder  nasal vaccine that is independent of cold chains and self- administered will make a large difference in the ability to reach out and secure vaccination, even in remote areas. Without a global mindset for the vaccination coverage SARS-CoV-2 may be a recurrent endemic for many years to come", says Professor ABM Abdullah

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