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Trial Set for Respiratory Disease Nasal Spray Vaccine

lung illustration

(Kai Stachowiak, Pixabay)

28 Mar. 2021. A clinical trial is about to begin enrolling participants to test a vaccine given as a nasal spray protecting against respiratory syncytial virus, or RSV. The study will test the safety of a vaccine code-named BLB-201 made by Blue Lake Biotechnology Inc. in Athens, Georgia and Los Gatos, California.

Blue Lake Bio is a subsidiary of CyanVac LLC, with both companies developing vaccines for infectious diseases based on research by their founder Biao He, professor of veterinary medicine at University of Georgia, and the companies’ CEO. Dr. He and colleagues study the canine parainfluenza virus 5, or PIV5, which as the name implies, occurs in dogs. Research by Dr. He shows engineered forms of PIV5 are safe for humans and animals, and can be genetically altered to carry weakened forms of infectious viruses to generate immune responses by recipients. Blue Lake Bio’s lead product is a nasal spray vaccine for Covid-19, as described in a Science & Enterprise story on 27 Sept. 2021.

The company designed BLB-201 to protect against RSV infections. RSV infections affect the airways and cause mild disease in most cases similar to the common cold. In young children or older adults, however, RSV can cause serious lung inflammation or pneumonia. Blue Lake Bio says BLB-201 is designed with a weakened strain of PIV5, engineered to express the protein RSV-F that controls initial stages of infection.

Looking mainly for adverse effects

According to Blue Lake Bio, preclinical findings with multiple animal species show BLB-201 produces immune responses with antibodies and T-cells in the nasal mucous membranes, as well as antibodies in blood serum. The vaccine is given as a single spray in each nostril. The company says nasal spray delivery can make it easier to deliver this and other vaccines to larger populations, particularly for children and others hesitant about syringes.

Blue Lake Bio says the Food and Drug Administration approved the company’s investigational new drug or IND application, officially a request to transport an experimental drug across state lines. An approved IND request is, in effect, clearance to begin a clinical trial. In a CyanVac statement released through Cision, Dr. He calls FDA’s action, “an important milestone toward developing RSV vaccines for young children and older adults, both of which face significant morbidity and mortality risk from RSV infection.”

The early-stage clinical trial plans to enroll 30 healthy individuals, divided between younger adult participants age 18 to 59, and older adults age 60 to 75. All participants will receive a single nasal spray dose of BLB-201 — there’s no control or comparison group — and are then tracked for 28 days looking primarily for adverse effects from the vaccine. During that time, participants will also give blood samples, where their serum will be tested for concentrations of immunoglobulin G antibodies for the RSV-F protein. In addition, participants will be tracked for six months after receiving the vaccine, looking for any serious adverse effects related to the vaccine or other notable health changes.

The study team is led by Paul Spearman, director of infectious diseases at Cincinnati Children’s medical center. “RSV is a common respiratory virus,” notes Spearman, “responsible for the hospitalization of more than three million children every year, and also affects older adults worldwide. A vaccine that can be delivered by nasal spray would be a valuable tool for reducing this burden.”

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