CompletedPhase 2

Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model

Belgium145 participantsStarted 2019-06-03

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
✓. Of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 6 months prior to vaccination to 6 months after administration of the influenza challenge virus. Highly effective methods of contraception include 1 or more of the following:

What they're measuring

Degree of Nasopharyngeal Viral Shedding as Determined by Quantitative Polymerase Chain Reaction qPCR

Timeframe: 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.

Trial details

NCT IDNCT03883113

SponsorBarinthus Biotherapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-16

Results submitted2020-12-04

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