Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT02822105|
Recruitment Status : Active, not recruiting
First Posted : July 4, 2016
Last Update Posted : August 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Flu||Biological: the H3N2 M2SR monovalent influenza vaccine Other: Placebo||Phase 1|
Healthy adult subjects will be screened with the objective to randomize 96 subjects with the lowest levels of H3 hemagglutination inhibition (HAI) titers that meet all inclusion/exclusion criteria and have signed an informed consent. Subjects will be rank ordered from low to high based on their HAI titer. Subjects will then be assigned treatment based on a randomization to either active vaccine or placebo. The first two subjects dosed in each dose cohort will serve as sentinels and will receive active IP (not randomized).
Subjects will receive a single dose inoculation of the H3N2 M2SR seasonal monovalent influenza vaccine administered intranasally as a liquid formulation, or placebo (saline). The sentinel subjects will be vaccinated in dose cohort 1 and a safety monitoring committee (SMC) will conduct a review of safety data, tolerability, reactogenicity, and clearance of infectious virus prior to dosing the remaining subjects of the cohort with active or placebo.
After the last subject in the cohort has been followed for at least 7 days the SMC will conduct another review of safety data prior to proceeding to the next higher dose level: Cohort 2. The same processes of sentinel subject dosing and SMC review will be conducted for Cohorts 2 and 3.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 1 Clinical Study To Investigate The Safety And Immunogenicity Of The H3N2 (A/Brisbane/10/2007) M2SR Monovalent Influenza Vaccine|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Experimental: H3N2 M2SR monovalent influenza vaccine
This group will receive a low, medium or high dose of the H3N2 M2SR monovalent influenza vaccine administered intranasally. It will be compared with placebo in a 3:1 ratio.
Biological: the H3N2 M2SR monovalent influenza vaccine
The H3N2 Bris10 M2SR influenza vaccine candidate (Bris10 M2SR) is formulated to contain different levels of an M2-deleted non-replicating influenza virus expressing the HA and NA genes of influenza strain A/Brisbane/10/2007.
This group will receive saline administered intranasally.
- Frequency and severity of local and systemic adverse events (AEs) through 28 days vaccination and cumulatively through Day 180 [ Time Frame: from baseline through study completion (Day 180) ]Record adverse events
- Percentage of subjects demonstrating seroconversion to vaccine hemagglutinin antigen and the magnitude of the immune response [ Time Frame: from baseline through study completion (Day 180) ]Test antibodies pre and post vaccination
- Length of time that vaccine virus shedding is detected [ Time Frame: at 24, 48 and 72 hours post-vaccination and on day 7 post vaccination ]Test nasal swabs for virus
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822105
|United States, Kansas|
|Lenexa, Kansas, United States, 66219|
|Study Director:||Renee Herber||FluGen Inc|
|Principal Investigator:||Carlos Fierro, MD||Johnson County Clin Trials|