NasoVAX is a recombinant intranasal vaccine that is being developed for both seasonal and pandemic use. NasoVAX can activate the humoral, mucosal and cellular immune arms in unison for a more comprehensive immune response.
NasoVAX is indicated to prevent influenza, seasonal as well as pandemic
NasoVAX is administered by intranasal spray, the dosage is being evaluated in clinical trials
NasoVAX Clinical Trials
Clinical Trial NCT03232567: Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
- This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age.
- Subjects will be screened within 28 days of randomization (Day 1).
- Approximately 60 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be enrolled into 3 sequential cohorts of 20 subjects each defined by the viral particle dose (1×10(9th), 1×10(10th), and 1×10(11th) vp).
- Within each cohort and its sentinel group, subjects will be randomized in a 3:1 ratio to receive 1 intranasal dose of NasoVAX or placebo (Day 1).
- A sentinel group of 5 subjects from each cohort will be dosed and followed through Day 8.
- Dosing of the remainder of each cohort may proceed if no events meeting stopping criteria have occurred.
- The SRC, consisting of the Investigator, the Medical Monitor, and a Sponsor Representative, will review AE, reactogenicity, and laboratory data through Day 8 for all subjects in each cohort before subjects are randomized to the next higher dose.
- If any event meeting stopping criteria occur, the SRC will review all available safety information before additional patients are dosed.
Clinical Trial NCT03760549: Study of the Safety and Immunogenicity of NasoVAX Extension
- This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days).
- Up to 15 subjects who received NasoVAX at the 1×10(11th) vp dose in Study ALT-103-201 will be screened, and a serum sample will be collected from each eligible subject for evaluation of influenza HAI assay against influenza A/California/07/2009(H1N1), a strain homologous to the one used for NasoVAX (monovalent AdcoCA09.HA).
- Ad5 antibody neutralization assay may also be performed