Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MVA-NP+M1 · 2 trials · 2 indications
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.
Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.
Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.
Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.
Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits
Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration
| Arm | Type | Description |
|---|---|---|
| MVA-NP+M1 & H3N2 Challenge Virus | EXPERIMENTAL | Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml) |
| Saline Placebo & H3N2 Challenge Virus | PLACEBO_COMPARATOR | Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml) |
| Single intramuscular injection of MVA-NP+M1 vaccine | EXPERIMENTAL | MVA-NP+M1, a novel vaccine will be administered intramuscular. The total volume given is 0.5ml and the dose given is 1.5E8 pfu. Each volunteer will receive one single injection only over a few seconds. |
| Name | Type | Description |
|---|---|---|
| MVA-NP+M1 | BIOLOGICAL | Trial Vaccine |
| Saline | BIOLOGICAL | Sodium Chloride Placebo |
| H3N2 (A/Belgium/2417/2015) | BIOLOGICAL | Challenge Agent |
Inclusion Criteria: * Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment. * Non-smokers or those who stopped smoking ≥ 3 months prior to screening 1 visit. * Willingness to remain in isolation for the duration of the study. * A female participant is eligible for this ...
MVA-NP+M1 is an investigational vaccine being studied for use against influenza, including in a human challenge model for the H3N2 strain. It has also been tested in healthy human volunteers to evaluate its safety and immunogenicity. The vaccine is still in clinical development and is not approved for commercial use.
MVA-NP+M1 is being developed by Barinthus Biotherapeutics plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol BRNS. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in human volunteers and in an influenza challenge model.
MVA-NP+M1 has completed a Phase 1 trial and a Phase 2 trial. The Phase 1 study assessed safety and immunogenicity in healthy volunteers, while the Phase 2 study evaluated efficacy in an influenza H3N2 human challenge model. Both trials are completed, and the vaccine remains investigational.
MVA-NP+M1 has been studied in two completed clinical trials. NCT03277456 was an early Phase 1 study in the United Kingdom with 6 healthy volunteers to assess safety and immunogenicity. NCT03883113 was a Phase 2 efficacy trial in Belgium with 145 participants using an influenza H3N2 human challenge model.
MVA-NP+M1 is an investigational vaccine candidate designed to target influenza, but it is not the same as licensed seasonal flu vaccines. It is being studied for its ability to provide protection against influenza, including the H3N2 strain, but it has not been approved for use in the general population.