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- Title
Safety and Immunogenicity of a Novel Intranasal Influenza Vaccine (NasoVAX): A Phase 2 Randomized, Controlled Trial.
- Authors
Tasker, Sybil; Wight O'Rourke, Anna; Suyundikov, Anvar; Jackson Booth, Peta-Gay; Bart, Stephan; Krishnan, Vyjayanthi; Zhang, Jianfeng; Anderson, Katie J.; Georges, Bertrand; Roberts, M. Scot; Montomoli, Emanuele; Trombetta, Claudia Maria
- Abstract
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 1×109 viral particles (vp), 1 × 1010 vp, or 1 × 1011 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.
- Subjects
INFLUENZA vaccines; INTRANASAL administration; IMMUNE response; T cells; BLOOD agglutination; IMMUNIZATION of children
- Publication
Vaccines, 2021, Vol 9, Issue 3, p224
- ISSN
2076-393X
- Publication type
Article
- DOI
10.3390/vaccines9030224