Redeeflu™ nasal vaccine candidate utilizes a proprietary M2 deleted, single replication (M2SR) influenza virus.
The M2 gene is essential for the influenza virus to spread in the patient and the deletion of the M2 gene restricts the virus to a single replication cycle in the host.
The body recognizes M2SR as an influenza infection and activates its robust immune response, but because the virus can only replicate once, it cannot spread to other cells and cause symptoms of real influenza infection.
Redeeflu is administered intranasally.
The RedeeFlu viruses can be engineered to express the HA and neuraminidase antigens (NA) of any influenza virus and can be manufactured in cell lines that stably express the M2 protein.
This vaccine technology is currently enrolled in 3 phase 1 trials:
Clinical Trial NCT03999554: Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria.
The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza when delivered at higher dosages or in two doses.
Clinical Trial NCT02822105: Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers
The purpose is of this study is to assess the safety and tolerability of three dose levels of H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult subjects.
Clinical Trial NCT03553940: Safety and Immunogenicity Study of an Influenza Vaccination Strategy Including an H3N2 M2SR Prime Followed by a Seasonal Quadrivalent Inactivated Vaccine Boost in a Pediatric Population 9-17 Years Old
This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy adolescents and children, 9-17 years of age.
This clinical trial is designed to assess the safety and immunogenicity of a prime-boost regimen of H3N2 M2SR intranasal influenza vaccine (manufactured by FluGen) followed by licensed inactivated Quadrivalent Influenza Vaccine (QIV) boost administered intramuscularly.
The primary study objective is to assess the safety and reactogenicity of a monovalent live attenuated influenza H3N2 M2SR vaccine.