CompletedPhase 1

Cholera Toxin B Subunit (CTB) Administered by Mucosal Way in Healthy Adult Volunteer

France40 participantsStarted 2006-04

Plain-language summary

It is a biomedical research without direct individual benefit, exploring and comparing the mucosal immune response after oral, nasal and sublingual administration of B-subunit of non-toxic cholera toxin (CTB) in healthy adult volunteers.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult male between 18 and 50 years, * Adult female aged 18 to 50 years under oral contraception (pill) for at least 6 months, or IUD for at least 6 under, and agreeing to carry out a pregnancy test during the initial clinical visit * Affiliate or entitled to Social Security * Signing the informed consent of the volunteer Exclusion Criteria: * Seropositive patient for HIV, Hepatitis B, Hepatitis C (oral questioning) * Pregnant Woman, parturient or breast-feeding * News hospitalized for other reasons that the research * Minor, Major under supervision * Participation in a current or recent study or at present in period of exclusion

What they're measuring

The primary criteria which will estimate this immune response is the production of immunoglobulin A1, A2 and G totals specific to the CTB contained at the level of salivary secretions or produced by mononuclear cells of peripheral blood.

Timeframe: every week during 5 weeks

Trial details

NCT IDNCT00820144

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-04

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