Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants
This is a single-centre, randomized, double-blind, placebo-controlled study in healthy adult participants to assess the pre-exposure prophylactic antiviral activity of Neumifil via a human viral challenge model. Participants will enter the quarantine unit on Day -4. Participants will be randomized to receive either active (single dose), active (multiple dose) or placebo in a 3:3:4 ratio followed by influenza viral challenge on Day 0. Participants will leave the unit on Day 8, provided that no virus is detected by a qualitative virus antigen test and the participant has no clinically significant symptoms. A final follow-up will be performed on Day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
104
hVIVO Services Limited
London, United Kingdom
Incidence of Symptomatic Influenza Infection
Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point. Viral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).
Time frame: Day 1 to Day 8
Severity of Symptoms
Change in Peak Total Symptom Score (TSS) as measured by graded symptom scoring system collected 3 times daily; symptom questionnaire was graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. The range was 0 to 33.
Time frame: Day 1 to Day 8
Area Under the Curve (AUC) Over Time of Total Symptom Score (TSS)
Participants completed a self-assessment symptom score 3 times daily, graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. Range 0 to 33
Time frame: Day 1 to Day 8
Viral Shedding Over Time
Measurement of influenza viral load (VL) area under the curve (VL-AUC) of quantifiable measurements by RT-qPCR in nasal samples. The AUC is expressed as the log to the base 10 copies in a mL of nasal fluid multiplied by the time in days \[(log10 copies/mL)\*day\]. The higher the viral load AUC, by PCR, the worse the outcome.
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Time frame: Day 1 (pm) to Day 8 (am)
Viral Shedding Over Time
Measurement of influenza viral load (VL) in nasal samples over time (VL-AUC) measured by viral culture. Nasal secretions were cultured and the Tissue Culture Infectious Dose (TCID50) calculated. The AUC of log to the base 10 of the TCID50 in each mL of nasal secretions, multiplied by the time in days \[(log10 TCID50/mL)\*day\] was calculated. The higher the viral load AUC by culture, the worse the outcome.
Time frame: Day 1 (pm) to Day 8 (am)
Weight of Nasal Discharge
Measurement of total weight of mucus produced by participants. The total weight of used tissues was measured to assess the weight of mucus produced. The greater the weight of the tissues the more mucus produced and the worse the outcome.
Time frame: Day 1 (am) to Day 8 (am)
Nasal Discharge
The number of tissues used by participants were counted. The greater the number of tissues used the worse the outcome.
Time frame: Day 1 (am) to Day 8 (am)
Adverse Events, Solicited
Number of participants reporting a solicited adverse event during the treatment period of IMP
Time frame: From intake of first dose of IMP (Day -3) up to 12 hours post the last IMP dose (Day -1)
Adverse Events, Unsolicited
Number of participants reporting treatment emergent adverse events, unsolicited
Time frame: From intake of first dose of IMP on Day -3 to Day 28