The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in the Human Viral Challenge model.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
MV-012-968 is a recombinant, live attenuated RSV vaccine.
Saline solution
hVIVO Services Ltd
London, United Kingdom
Frequency of symptomatic RSV infection, as defined as the occurrence of both:
* At least 1 quantifiable plaque assay sample in nasal wash specimens and * Symptoms meeting either: (i) a symptom of any grade from 2 different symptom categories from the participant Symptom Diary Card \[SDC\] (Upper Respiratory, Lower Respiratory, Systemic) or (ii) at least 1 Grade 2 upper or lower respiratory symptom from the participant SDC
Time frame: 10 days (days 2 to 12)
Frequency of symptomatic RSV infection, as defined as occurrence of both:
* Two Quantifiable RT-qPCR samples on 2 consecutive days (i.e. at least 1 on each of 2 consecutive days) in nasal wash specimens and * Symptoms meeting either: (i) a symptom of any grade from 2 different symptom categories from the SDC (Upper Respiratory, Lower Respiratory, Systemic) or (ii) at least 1 Grade 2 upper or lower respiratory symptom from the participant SDC
Time frame: 10 days (days 2 to 12)
Frequency of RSV infection, as defined as the occurrence of 2 quantifiable RT-qPCR samples on 2 consecutive days (i.e. at least 1 on each of 2 consecutive days) in nasal wash specimens
Time frame: 10 days (Day 2 to 12)
Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens
Time frame: 10 days (Day 2 to 12)
Mean daily total symptom score using the SDC
Time frame: 10 days (Day 2 to 12)
Mean daily weight of nasal (mucus) discharge
Time frame: 10 days (Day 2 to 12)
RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens
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Time frame: 10 days (Day 2 to 12)
Peak RSV load, as measured by RT-qPCR of nasal wash specimens
Time frame: 10 days (Day 2 to 12)
Frequency of solicited adverse events (AEs) as reported in the Subject Vaccination Diary Card, categorized by severity. Solicited AEs are predefined AEs that may occur after study vaccine administration.
Time frame: Time Frame: 7 days (Day -28 to -21)
Frequency of unsolicited AEs after study vaccination, categorized by severity and by study vaccine relatedness.
Unsolicited AEs are any untoward medical occurrences in a participant administered the study vaccine, regardless of causal relationship to the study vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the study vaccine.
Time frame: 28 days (Day -28 to 0)
Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.
Time frame: 29 days (Day 0 to 28)
Frequency of serious AEs (SAEs) after study vaccination, categorized by study vaccine relatedness.
SAEs are AEs, whether considered causally related to the study 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: 180 days (Day -28 to 152)
Frequency of medically attended AEs (MAEs) after study vaccination, categorized by study vaccine relatedness.
MAEs are AEs, whether considered causally related to the study 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, 'checkups', and vaccinations, are not considered MAEs
Time frame: 180 days (Day -28 to 152)