Adults 18 to 55, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Degree of Nasopharyngeal Viral Shedding as Determined by Quantitative Polymerase Chain Reaction qPCRPrimary· Throughout 9 days (Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10) after viral Inoculation (Day1) of the challenge phase. Nasal swabs taken twice a day (b.i.d) at least 8 hours apart.
Measure of nasopharyngeal viral shedding during challenge; recorded as viral area under curve (vAUC) as determined by quantitative real time polymerase chain reaction (qRT-PCR). vAUC is calculated by plotting the log viral particles number/ml for each time point against time and is using the trapezoidal rule.
Group
Value
95% CI
MVA-NP+M1 (ITT)
649.7
552.7 – 746.7
Placebo (ITT)
726.1
604.0 – 848.2
MVA-NP+M1 (PP)
646.5
548.3 – 744.7
Placebo (PP)
726.1
604.0 – 848.2
MVA-NP+M1 (Challenge)
649.7
552.7 – 746.7
Placebo (Challenge)
726.1
604.0 – 848.2
Number and Percentage of Virologically Confirmed Influenza-Like IllnessSecondary· 9 days from day 2 to day 10
Incidence (frequency tabulation) of laboratory-confirmed influenza-like illness compared between vaccine and placebo arms Virologically confirmed influenza-like illness (ILI) is defined as having respiratory or flu-like symptom occurring on two consecutive days, along with a positive qPCR or qCulture result.
Virologically confirmed Influenza-like Illness
Group
Value
95% CI
MVA-NP+M1 (ITT)
43
Placebo (ITT)
29
No Virologically Confirmed Influenza-like Illness
Group
Value
95% CI
MVA-NP+M1 (ITT)
28
Placebo (ITT)
18
Percentage of Participants With Attack Rate of Challenge Agent (qRT-PCR)Secondary· 9 days from day 2 to day 10
The attack rate is defined as the percentage of inoculated participants with at least two consecutive positive swabs as determined by qRT-PCR within the timespan of two consecutive days
qPCR-confirmed influenza
Group
Value
95% CI
MVA-NP+M1 (ITT)
90.1
80.7 – 95.9
Placebo (ITT)
97.9
88.7 – 99.9
No qPCR influenza
Group
Value
95% CI
MVA-NP+M1 (ITT)
9.9
4.1 – 19.3
Placebo (ITT)
2.1
0.1 – 11.3
Percentage of Participants With Quantitative Culture Attack Rate of Challenge Agent (qCulture)Secondary· 9 days from day 2 to day 10
The attack rate is defined as the percentage of inoculated participants with at least two consecutive positive swabs as determined by qCulture within the timespan of two consecutive days
qCulture confirmed influenza
Group
Value
95% CI
MVA-NP+M1 (ITT)
77.5
66.0 – 86.5
Placebo (ITT)
85.1
71.7 – 93.8
No qCulture-confirmed influenza
Group
Value
95% CI
MVA-NP+M1 (ITT)
22.5
13.5 – 34.0
Placebo (ITT)
14.9
6.2 – 28.3
Time to Start of Viral Shedding (qPCR) From Virus InoculationSecondary· 9 days from day 2 to day 10
The Time to Start of Viral Shedding (qPCR) is calculated as (datetime of first of two positive swabs (qPCR) within 2 consecutive days - challenge datetime)/(60\*60)
Group
Value
95% CI
MVA-NP+M1 (ITT)
24.40
24.30 – 24.50
Placebo (ITT)
24.30
24.20 – 24.50
Time to Start of Viral Shedding (qCulture) From Virus InoculationSecondary· 9 days from day 2 to day 10
Time to Start of Viral Shedding (qCulture) is calculated as (datetime of first of two positive swabs (qCulture) within 2 consecutive days - challenge datetime)/(60\*60)
Group
Value
95% CI
MVA-NP+M1 (ITT)
35.9
35.60 – 48.00
Placebo (ITT)
47.6
24.70 – 48.50
Peak Viral Shedding (qPCR) After the Virus InoculationSecondary· 9 days from Day 2 to Day 10
This is measured by the highest viral load concentration by qPCR
Group
Value
95% CI
MVA-NP+M1 (ITT) Successful Attack
5.876
5.430 – 6.322
Placebo (ITT) Successful Attack
6.054
5.521 – 6.587
Peak Viral Shedding (qCulture) After Virus InoculationSecondary· 9 days from day 2 to day 10
This is measured by the highest viral load concentration by qCulture.
Group
Value
95% CI
MVA-NP+M1 (ITT) Successful Attack
4.073
3.683 – 4.463
Placebo (ITT) Successful Attack
4.069
3.442 – 4.695
Time to Peak of Viral Shedding (qPCR) From the Viral InoculationSecondary· 9 days from day 2 to day 10
This is calculated as (datetime of highest viral load concentration (qPCR) - challenge datetime)/(60\*60)
Group
Value
95% CI
MVA-NP+M1 (ITT)
72.20
60.00 – 96.00
Placebo (ITT)
107.90
72.20 – 119.80
Time to Peak of Viral Shedding (qCulture) From the Viral InoculationSecondary· 9 days from day 2 to day 10
This is calculated as (datetime of highest viral load concentration (qCulture) - challenge datetime)/(60\*60)
Group
Value
95% CI
MVA-NP+M1 (ITT)
83.40
60.10 – 96.30
Placebo (ITT)
83.80
60.10 – 96.40
Duration of Viral Shedding (qPCR) After the Virus InoculationSecondary· 9 days from day2 to day10
It is calculated as (datetime of first negative swab (qPCR) following the last positive swab (qPCR) - datetime of first positive of two positive swabs (qPCR) within 2 consecutive days)/(60\*60)
Group
Value
95% CI
MVA-NP+M1 (ITT) Successful Attack
170.80
157.08 – 184.52
Placebo (ITT) Successful Attack
172.47
156.99 – 187.94
Duration of Viral Shedding (qCulture) After the Virus InoculationSecondary· 9 days from day 2 to day 10
It is calculated as (datetime of first negative swab (qCulture) following the last positive swab (qCulture) - datetime of first positive of two positive swabs (qCulture) within 2 consecutive days)/(60\*60)
Group
Value
95% CI
MVA-NP+M1 (ITT) Successful Attack
118.19
105.07 – 131.31
Placebo (ITT) Successful Attack
121.78
106.33 – 137.23
Adverse events — posted to ClinicalTrials.gov
Time frame: Any time during the study from the first administration of any study drug until the last study-related activity (the outpatient visit at 27 days ±3 days following the challenge or 6 months following vaccination ±14 days, whichever is longer).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A Phase 2, single center, randomized, double blind study evaluating the safety, efficacy, and immunogenicity of MVA NP+M1 in the H3N2 human influenza challenge model; on healthy adult volunteers.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
· Phase 3
· recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
· Phase 1
· recruiting
NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes
· NA
· recruiting
NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy
· Phase 3
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Barinthus Biotherapeutics
Last refreshed: 18 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03883113.