NCT00820144

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

January 2, 2009

Last Update Submit

March 26, 2026

Conditions

Infection

Keywords

immune responseb-subunit of cholera toxinmucosal wayhealthy volonteersvaccine

Outcome Measures

Primary Outcomes (1)

  • 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.

    every week during 5 weeks

Secondary Outcomes (1)

  • The secondary criteria of judgment are other phenotypic and functional changes induced on the immune cells present in saliva or in the blood after administration of CTB.

    every week during 5 weeks

Study Arms (5)

1

EXPERIMENTAL

voie nasale 0.25 mg

Biological: CTB by nasal way

2

EXPERIMENTAL

0.5mg of CTB by oral way

Biological: absorption of CTB by oral way

3

EXPERIMENTAL

1mg of dukoral by oral way

Biological: absorption of dukoral by oral way

4

EXPERIMENTAL

0.25mg of CTB by sublingual way

Biological: absorption of CTB by sublingual way

5

EXPERIMENTAL

1mg of CTB by sublingual way

Biological: absorption of CTB by sublingual way

Interventions

CTB by nasal wayBIOLOGICAL
1
absorption of CTB by oral wayBIOLOGICAL

absorption of CTB by oral way

2
absorption of dukoral by oral wayBIOLOGICAL

absorption of dukoral by oral way

3
absorption of CTB by sublingual wayBIOLOGICAL

absorption of CTB by sublingual way

4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire d'anatomo-pathologie, hôpital Pasteur

Nice, 06000, France

Location

Related Publications (1)

  • Cuburu N, Kweon MN, Song JH, Hervouet C, Luci C, Sun JB, Hofman P, Holmgren J, Anjuere F, Czerkinsky C. Sublingual immunization induces broad-based systemic and mucosal immune responses in mice. Vaccine. 2007 Dec 12;25(51):8598-610. doi: 10.1016/j.vaccine.2007.09.073. Epub 2007 Oct 25.

    PMID: 17996991RESULT

MeSH Terms

Conditions

Infections

Study Officials

  • Paul HOFMAN, Professor

    Departement d'anatomo-pathologie, CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2009

First Posted

January 12, 2009

Study Start

April 1, 2006

Primary Completion

April 1, 2006

Study Completion

February 1, 2007

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)