This study evaluates an investigational vaccine that is designed to protect humans against infection with SARS-CoV-2, the novel coronavirus causing COVID-19 disease. The investigational vaccine, MV-014-212, is a live attenuated vaccine against respiratory syncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212 is administered as drops or a spray in the nose. Specifically, this study analyzes the safety of, and the immune response to, the vaccine when administered to healthy adults between the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have not received a prior vaccine against COVID-19.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
Single intranasal dose on Day 1, by intranasal drops
Single intranasal dose on Day 1, by intranasal drops
Single intranasal dose on Day 1, by intranasal drops
Intranasal dose on Day 1 by intranasal drops. Followed by a second, identical dose on Day 36 by intranasal drops
Single intranasal dose on Day 1, by intranasal spray
Johnson County Clin-Trials
Lenexa, Kansas, United States
RECRUITINGWake Research
Raleigh, North Carolina, United States
RECRUITINGSolicited adverse events (AEs)
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration.
Time frame: Immediate post-vaccination period
Unsolicited AEs
Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine.
Time frame: Immediate post-vaccination period
Serious adverse events (SAEs)
Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Time frame: Full study duration, an average of 1 year
Medically attended adverse events (MAEs)
Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs.
Time frame: Full study duration, an average of 1 year
Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein
Change in serum neutralizing antibody (nAb) titers against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Time frame: Baseline through Day 29, an average of five (5) weeks
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Time frame: Baseline through Day 29, an average of five (5) weeks
Potential vaccine virus shedding: frequency
Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall
Time frame: Baseline through Day 29, an average of four (4) weeks
Potential vaccine virus shedding: magnitude
If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall
Time frame: Baseline through Day 29, an average of four (4) weeks
Potential vaccine virus shedding: duration
If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall
Time frame: Baseline through Day 29, an average of four (4) weeks
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