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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
Single ascending dose study
Optimal Health Research
Rockville, Maryland, United States
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Time frame: Day 1 to Day 181
Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability]
Reactogenicity: counts and percentages of subjects with 'yes' to any reactogenicity event (nasal irritation, sneezing, nasal congestion, sore throat, change in smell, change in taste, change in vision, eye pain, headache, fatigue, muscle ache, nausea, vomiting, diarrhea, chills, fever)
Time frame: 14-days after vaccination
Geometric Mean Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum
The antilog of the mean of the log-transformed antibody titers for humoral immune response to NasoVAX at Day 29 by HAI
Time frame: Day 1 to Day 29
Geometric Mean Ratio of Postvaccination and Prevaccination Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum
The ratio of postvaccination and prevaccination geometric mean titers within the same dose group for humoral immune response to NasoVAX at Day 29 by HAI
Time frame: Day 1 to Day 29
Seroprotection Rate
The percentage of subjects with an HAI titer greater than or equal to 1:40
Time frame: Day 1 to Day 29
Seroconversion Rate
The percentage of subjects with either a baseline HAI titer less than 1:10 and a postvaccination titer greater than or equal to 1:40 or a baseline HAI titer greater than or equal to 1:10 and a 4-fold increase in postvaccination HAI titer relative to baseline
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Time frame: Day 1 to Day 29
Antibody Level Measured by Microneutralization in Serum
Geometric mean titer (GMT) for humoral immune response to NasoVAX at Day 29 by microneutralization
Time frame: Day 1 to Day 29
Antibody Responder Rate by Microneutralization
The percentages of subjects with 2-fold and 4-fold rises from baseline in antibody level measured by microneutralization
Time frame: Day 1 to Day 29