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Safety and Immunogenicity of a Novel Intranasal Influenza Vaccine (NasoVAX): A Phase 2 Randomized, Controlled Trial
| Content Provider | MDPI |
|---|---|
| Author | O’Rourke, Anna Wight Tasker, Sybil Suyundikov, Anvar Booth, Peta-Gay Jackson Bart, Stephan Krishnan, Vyjayanthi Zhang, Jianfeng Anderson, Katie J. Georges, Bertrand Roberts, M. Scot |
| Copyright Year | 2021 |
| Description | Annual influenza vaccination greatly reduces morbidity and mortality, but effectiveness remains sub-optimal. Weaknesses of current vaccines include low effectiveness against mismatched strains, lack of mucosal and other effective tissue-resident immune responses, weak cellular immune responses, and insufficiently durable immune responses. The safety and immunogenicity of NasoVAX, a monovalent intranasal influenza vaccine based on a replication-deficient adenovirus type 5 platform, were evaluated in a placebo-controlled single ascending-dose study. Sixty healthy adults (18–49 years) received a single intranasal dose of $1×10^{9}$ viral particles (vp), 1 × $10^{10}$ vp, or 1 × $10^{11}$ vp of NasoVAX or placebo. NasoVAX was well-tolerated and elicited robust influenza-specific systemic and mucosal immune responses. The highest NasoVAX dose and the approved $Fluzone^{®}$ influenza vaccine elicited comparable hemagglutination inhibition (HAI) geometric mean titers (152.8 vs. 293.4) and microneutralization (MN) geometric mean titers (142.5 vs. 162.8), with NasoVAX HAI titers maintained more than 1-year on average following a single dose. Hemagglutinin-specific T cells responses were also documented in peripheral mononuclear cell (PBMC) preparations. Consistent with the intranasal route of administration, NasoVAX elicited antigen-specific mucosal IgA responses in the nasopharyngeal cavity with an increase of approximately 2-fold over baseline GMT at the mid- and high-doses. In summary, NasoVAX appeared safe and elicited a broad immune response, including humoral, cellular, and mucosal immunity, with no impact of baseline anti-adenovirus antibody at the most immunogenic dose. |
| Starting Page | 224 |
| e-ISSN | 2076393X |
| DOI | 10.3390/vaccines9030224 |
| Journal | Vaccines |
| Issue Number | 3 |
| Volume Number | 9 |
| Language | English |
| Publisher | MDPI |
| Publisher Date | 2021-03-05 |
| Access Restriction | Open |
| Subject Keyword | Vaccines Infectious Diseases Influenza Vaccine Intranasal Vaccine Adenovirus Vector Nasovax Mucosal Immunity Pre-existing Immunity |
| Content Type | Text |
| Resource Type | Article |
