Blue Lake Biotechnology Secures $5 Million Grant to Support Ongoing Pediatric Phase 1/2a Clinical Trial of Intranasal RSV Vaccine Candidate

Funding will increase enrollment of children as young as 12 months old and explore the potential for BLB201 to reduce RSV transmission

ATHENS, Ga. and SAN JOSE, Calif., Oct. 28, 2026 (GLOBE NEWSWIRE) -- Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, today announced that the Gates Foundation has awarded the company $5 million to expand its ongoing Phase 1/2a pediatric clinical trial of BLB201, an intranasal vaccine candidate against respiratory syncytial virus (RSV). The clinical study is currently enrolling both seropositive and seronegative children as young as 12 months of age.

Previously, children between the ages of 18 and 59 months who were seronegative or seropositive for RSV were eligible to enroll in the Phase 1/2a clinical study of BLB201. While the clinical study remains blinded, a separate committee analyzed unblinded interim data through April 2026; after review of these data, the U.S. Food and Drug Administration (FDA) cleared Blue Lake to enroll children as young as 12 months in the study. The data showed that BLB201 had preliminary vaccine efficacy of greater than 70% in preventing RSV symptomatic infection in the study population of 111 enrolled at the time.

“This timely grant gives Blue Lake the ability to expand our ongoing clinical study of our RSV vaccine candidate with a focus on toddlers as young as 12 months old in the 2026-2027 RSV season,” said Biao He, Ph.D., CEO of Blue Lake Biotechnology. “Besides building a larger dataset for safety and efficacy of BLB201 in preventing symptomatic RSV infection, the study will also explore the potential for BLB201 to reduce transmission of RSV between family members.”

About RSV 

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus and one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people, it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under five years old and up to 180,000 older adults are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year. 

While maternal vaccines or monoclonal antibodies are recommended for protecting infants and certain other at-risk children from RSV, there is no RSV vaccine licensed for universal use in infants and young children. Such a vaccine is needed to fully protect young populations from the significant risks of severe RSV disease.  

About BLB201 

BLB201 is an RSV vaccine candidate that is being evaluated in Phase 1/2a clinical testing in children ages eight to 59 months of age. It has received Fast Track designation from the US Food and Drug Administration for the prevention of RSV-associated acute respiratory disease in adults (>60 years) and pediatric populations. BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector, which is not known to cause human disease. PIV5 has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. Blue Lake Biotechnology is developing BLB201 as an intranasal vaccine to prevent acute and severe disease associated with RSV infection. Phase 1 clinical trial results demonstrate BLB201's safety and ability to induce antibody and cell-mediated immune responses, positioning it as a promising candidate in the fight against RSV. 

About Blue Lake Biotechnology 

Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform mimics natural infections by expressing a protein from a targeted pathogen in a proprietary parainfluenza virus 5 vector. Clinical data have shown that administration of our intranasal vaccine candidates stimulates all three pillars of the immune system, including mucosal immunity, which may be beneficial in preventing transmission of pathogens and spread of disease. We have a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for efficacy against symptomatic infection following a single intranasal dose, with few vaccine-related side effects. 

Learn more at Blue Lake Biotechnology

Contact:
Samuel Wu, Chief Business Officer  
Blue Lake Biotechnology, Inc.   
swu@bluelakebiotechnology.com