eClinical Technology and Industy News

Blue Lake Biotechnology Doses First Child in Clinical Trial of Novel Intranasal Vaccine Against Respiratory Syncytial Virus

Excerpt from the Press Release:

ATHENS, Ga. and LOS GATOS, Calif., June 29, 2023 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious disease, announced that the first child has been dosed in its Phase 1/2a trial (NCT05655182) of BLB201, the company’s intranasal vaccine against respiratory syncytial virus (RSV). The study is assessing the safety, tolerability and immunogenicity of the vaccine in children aged six to 59 months old.

“The past year has demonstrated a need for a vaccine against RSV to protect children and particularly infants, as we’ve seen a dramatic increase in the number of infections and hospitalizations in this highly vulnerable population,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology. “The pharmaceutical industry has struggled to develop a safe and effective RSV vaccine for the youngest people. Our earlier Phase 1 study in adults showed that BLB201 generates significant cellular, mucosal, and humoral immune responses and was well-tolerated without safety signals. We expect the same will hold true in children and are looking forward to future data readouts.”

The BLB201 vaccine will be administered by nasal spray to children 6-59 months of age who may or may not have had prior RSV infection. It will enroll up to 152 participants and evaluate safety and immunogenicity of one or two administrations of BLB201 at two dose levels, compared against placebo.

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