Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
- Conditions
- Influenza
- Interventions
- Biological: NasoVAX
- Registration Number
- NCT03232567
- Lead Sponsor
- Altimmune, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo NasoVAX Normal saline administered by intranasal spray at a single dose NasoVAX medium dose NasoVAX NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo NasoVAX low dose NasoVAX NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo NasoVAX high dose NasoVAX NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo
- Primary Outcome Measures
Name Time Method Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability] Day 1 to Day 181 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
Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability] 14-days after vaccination 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)
- Secondary Outcome Measures
Name Time Method Geometric Mean Ratio of Postvaccination and Prevaccination Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum Day 1 to Day 29 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
Antibody Responder Rate by Microneutralization Day 1 to Day 29 The percentages of subjects with 2-fold and 4-fold rises from baseline in antibody level measured by microneutralization
Geometric Mean Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum Day 1 to Day 29 The antilog of the mean of the log-transformed antibody titers for humoral immune response to NasoVAX at Day 29 by HAI
Seroprotection Rate Day 1 to Day 29 The percentage of subjects with an HAI titer greater than or equal to 1:40
Antibody Level Measured by Microneutralization in Serum Day 1 to Day 29 Geometric mean titer (GMT) for humoral immune response to NasoVAX at Day 29 by microneutralization
Seroconversion Rate Day 1 to Day 29 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
Trial Locations
- Locations (1)
Optimal Health Research
🇺🇸Rockville, Maryland, United States