InfectionPhase 1NCT00820144
Cholera Toxin B Subunit (CTB) Administered by Mucosal Way in Healthy Adult Volunteer
A Phase 1 study testing CTB by nasal way, absorption of CTB by oral way and absorption of dukoral by oral way in people with Infection, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- CTB by nasal way, absorption of CTB by oral way and absorption of dukoral by oral way
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Feb 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Exploration of the Immune Response Using the B-subunit of Cholera Toxin Administered by Mucosal Way in Healthy Adult Volunteer: Potential Role in Development of Vaccine Processes
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.
Read the detailed description
The immense majority of the infections involve the mucosal surfaces as a gateway of the pathogenic agent. These mucosal surfaces are mainly represented by the gastrointestinal, respiratory and urogenital tract. These mucosal surfaces contain a highly developed immune system, which can exploit in a mucus vaccine approach to fight against infectious agents upon their penetration in the body. It has been established that to be effective against infection mucosa, a vaccine must stimulate the local immune system. This objective is reached much more efficiently when the vaccine is administered by mucosal way (oral, nasal) than by the parenteral classical way. Recent works allowed developing a new non invasive system of administration of vaccines. It is based on the mucosal administration (oral, nasal, rectal, vaginal) comprising a combination of antigen bound (either chemically or by genetic fusion) to the non-toxic subunit of cholera toxin or CTB (Cholera Toxin B subunit). This subunit has an exceptional affinity for GM1 ganglioside expressed on the surface of all nucleated cells. So, the mucosal administration (by oral or nasal route) of a low dose of an antigen linked to the CTB - Mucosal vector with immunomodulatory properties - Leads powerful secretor immune responses in the exposed mucous As well as in distant mucous, with a strong production of secretories IgA.
The developed methods of exploration have to allow to characterize the cells which live (or which migrate) in the mucous membrane investigated on the functional and phenotypic plan.
This research should lead to a range of standardized operating procedures, allowing to evaluate the immunogenicity of vaccines candidates to the mucous administration and of predictive markers of the type of immune response generated.
The main objective of the study is to analyse at the healthy voluntary subjects the systematic immunizing answer induced after nasal, oral or sublingual administration of the CTB from blood samples - the lymphoid "compartment" the most accessible at the man- from saliva and from nasal wash. The immune response after administration of the CTB By sublingual way should be comparable in that of two other ways in term of intensity of the response, however, with a different IgA / IgG report.
The secondary objective of the study is to establish a range of tests to predict the character and the intensity of this response by analyzing the expression of B cells certain surface molecules marking their future for the production of Antibodies.
It is a regional prospective monocentric study conducted in opened without direct individual profit. The study will be conducted over 3 years including 24 months of recruitment for each patient with a follow-up of 35 days and 6 months of operation data.
- Conditions
- Infection
- Being tested
- CTB by nasal way, absorption of CTB by oral way, absorption of dukoral by oral way, absorption of CTB by sublingual way
- Keywords
- immune response, b-subunit of cholera toxin, mucosal way, healthy volonteers, vaccine
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTB by nasal wayBiological
absorption of CTB by oral wayBiological
absorption of CTB by oral way
absorption of dukoral by oral wayBiological
absorption of dukoral by oral way
absorption of CTB by sublingual wayBiological
absorption of CTB by sublingual way
absorption of CTB by sublingual wayBiological
absorption of CTB by sublingual way
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | voie nasale 0.25 mg Receives: Biological: CTB by nasal way |
| 2 | Experimental | 0.5mg of CTB by oral way Receives: Biological: absorption of CTB by oral way |
| 3 | Experimental | 1mg of dukoral by oral way Receives: Biological: absorption of dukoral by oral way |
| 4 | Experimental | 0.25mg of CTB by sublingual way Receives: Biological: absorption of CTB by sublingual way |
| 5 | Experimental | 1mg of CTB by sublingual way Receives: Biological: absorption of CTB by sublingual way |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: every week during 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startApr 2006
- Primary completionApr 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul HOFMAN, Professor, Principal investigator, Departement d'anatomo-pathologie, CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820144
- Sponsor's protocol ID
- PHRC 2003 CTB
- Status last verified
- Mar 2026
- First submitted
- 2 Jan 2009
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17996991
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Exploration of the Immune Response Using the B-subunit of Cholera Toxin Administered by Mucosal Way in Healthy Adult Volunteer: Potential Role in Development of Vaccine Processes
- ClinicalTrials.gov ID
- NCT00820144
- Acronym / sponsor ID
- PHRC 2003 CTB
- Conditions
- Infection
- Keywords
- immune response, b-subunit of cholera toxin, mucosal way, healthy volonteers, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The immense majority of the infections involve the mucosal surfaces as a gateway of the pathogenic agent. These mucosal surfaces are mainly represented by the gastrointestinal, respiratory and urogenital tract. These mucosal surfaces contain a highly developed immune system, which can exploit in a mucus vaccine approach to fight against infectious agents upon their penetration in the body. It has been established that to be effective against infection mucosa, a vaccine must stimulate the local immune system. This objective is reached much more efficiently when the vaccine is administered by mucosal way (oral, nasal) than by the parenteral classical way. Recent works allowed developing a new non invasive system of administration of vaccines. It is based on the mucosal administration (oral, nasal, rectal, vaginal) comprising a combination of antigen bound (either chemically or by genetic fusion) to the non-toxic subunit of cholera toxin or CTB (Cholera Toxin B subunit). This subunit has an exceptional affinity for GM1 ganglioside expressed on the surface of all nucleated cells. So, the mucosal administration (by oral or nasal route) of a low dose of an antigen linked to the CTB - Mucosal vector with immunomodulatory properties - Leads powerful secretor immune responses in the exposed mucous As well as in distant mucous, with a strong production of secretories IgA.
The developed methods of exploration have to allow to characterize the cells which live (or which migrate) in the mucous membrane investigated on the functional and phenotypic plan.
This research should lead to a range of standardized operating procedures, allowing to evaluate the immunogenicity of vaccines candidates to the mucous administration and of predictive markers of the type of immune response generated.
The main objective of the study is to analyse at the healthy voluntary subjects the systematic immunizing answer induced after nasal, oral or sublingual administration of the CTB from blood samples - the lymphoid "compartment" the most accessible at the man- from saliva and from nasal wash. The immune response after administration of the CTB By sublingual way should be comparable in that of two other ways in term of intensity of the response, however, with a different IgA / IgG report.
The secondary objective of the study is to establish a range of tests to predict the character and the intensity of this response by analyzing the expression of B cells certain surface molecules marking their future for the production of Antibodies.
It is a regional prospective monocentric study conducted in opened without direct individual profit. The study will be conducted over 3 years including 24 months of recruitment for each patient with a follow-up of 35 days and 6 months of operation data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CTB by nasal wayvoie nasale 0.25 mg |
| 2 | Experimental | Biological: absorption of CTB by oral way0.5mg of CTB by oral way |
| 3 | Experimental | Biological: absorption of dukoral by oral way1mg of dukoral by oral way |
| 4 | Experimental | Biological: absorption of CTB by sublingual way0.25mg of CTB by sublingual way |
| 5 | Experimental | Biological: absorption of CTB by sublingual way1mg of CTB by sublingual way |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTB by nasal way | Biological | 1 |
| absorption of CTB by oral wayabsorption of CTB by oral way | Biological | 2 |
| absorption of dukoral by oral wayabsorption of dukoral by oral way | Biological | 3 |
| absorption of CTB by sublingual wayabsorption of CTB by sublingual way | Biological | 4 |
| absorption of CTB by sublingual wayabsorption of CTB by sublingual way | Biological | 5 |
Primary outcome
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.
Time frame: every week during 5 weeks
1 secondary outcome
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.
Time frame: every week during 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 17996991Cuburu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul HOFMAN, Professor principal investigator
Departement d'anatomo-pathologie, CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTB by nasal way, absorption of CTB by oral way and absorption of dukoral by oral way in people with Infection, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: every week during 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.