Hookworm InfectionHIRP-01NCT02262403
Hookworm Immune Regulation Project
A study testing Blood and feces sampling in people with Hookworm Infection, run by Brugmann University Hospital at 1 site in Vietnam.
Trial summary
The main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution after infection treatment and during potential naturally reinfection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hookworm Infection
- What is being tested?
- Blood and feces sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2014to Dec 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old adults in good health status
- To live in rural regions at risk of soil transmitted helminthes
- Hookworm infection (infected group)
- Uninfected by Hookworms (control group)
Who cannot join
- Pregnant woman
- Positive allergic history
- Auto-immune and/or HIV disease
- Antihelminthics drug in the last 6 months and other current parasitic infection
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Pham Ngoc Thach University of Medecine
Ho Chi Minh City, Distict 10
About this study
Official title: Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection
The main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution after infection treatment and during potential naturally reinfection.
Read the detailed description
Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be recruited and treated according to Good Clinical Practice recommendations.
Allergy will be excluded by skin prick tests. Amount and phenotype of Treg will be explored at several time points. Subsequent culture with environmental antigen will be performed on cryopreserved cells.
- Conditions
- Hookworm Infection
- Being tested
- Blood and feces sampling
- Keywords
- Hookworm, Helminths, Treg, Immune regulation, Vietnam, Allergic diseases
- Medical subject headings
- Hookworm Infections, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and feces samplingOther
Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Hookworm infected | Experimental | The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed. Receives: Other: Blood and feces sampling |
| Non infected (hookworms) healthy subjects | Active comparator | All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group. Receives: Other: Blood and feces sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount and phenotype of Treg
Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study start1 Aug 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hookworm 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Principal investigator, Olivier Michel, Brugmann University Hospital
- Investigators
- Virginie Doyen, MD, Principal investigator, CHU Brugmann - ULB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262403
- Sponsor's protocol ID
- CHUB-HIRP-01
- Acronym
- HIRP-01
- Status last verified
- Feb 2021
- First submitted
- 16 Sep 2014
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Flohr C, Tuyen LN, Quinnell RJ, Lewis S, Minh TT, Campbell J, Simmons C, Telford G, Brown A, Hien TT, Farrar J, Williams H, Pritchard DI, Britton J. Reduced helminth burden increases allergen skin sensitization but not clinical allergy: a randomized, double-blind, placebo-controlled trial in Vietnam. Clin Exp Allergy. 2010 Jan;40(1):131-42. doi: 10.1111/j.1365-2222.2009.03346.x. Epub 2009 Sep 15.
PubMed 19758373Flohr C, Tuyen LN, Lewis S, Quinnell R, Minh TT, Liem HT, Campbell J, Pritchard D, Hien TT, Farrar J, Williams H, Britton J. Poor sanitation and helminth infection protect against skin sensitization in Vietnamese children: A cross-sectional study. J Allergy Clin Immunol. 2006 Dec;118(6):1305-11. doi: 10.1016/j.jaci.2006.08.035. Epub 2006 Oct 13.
PubMed 17157661Finlay CM, Walsh KP, Mills KH. Induction of regulatory cells by helminth parasites: exploitation for the treatment of inflammatory diseases. Immunol Rev. 2014 May;259(1):206-30. doi: 10.1111/imr.12164.
PubMed 24712468Sakaguchi S, Vignali DA, Rudensky AY, Niec RE, Waldmann H. The plasticity and stability of regulatory T cells. Nat Rev Immunol. 2013 Jun;13(6):461-7. doi: 10.1038/nri3464. Epub 2013 May 17.
PubMed 23681097
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection
- ClinicalTrials.gov ID
- NCT02262403
- Acronym / sponsor ID
- HIRP-01 / CHUB-HIRP-01
- Conditions
- Hookworm Infection
- Keywords
- Hookworm, Helminths, Treg, Immune regulation, Vietnam, Allergic diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Oct 2014 (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.
The main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution after infection treatment and during potential naturally reinfection.
Detailed description
Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be recruited and treated according to Good Clinical Practice recommendations.
Allergy will be excluded by skin prick tests. Amount and phenotype of Treg will be explored at several time points. Subsequent culture with environmental antigen will be performed on cryopreserved cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hookworm infected | Experimental | Other: Blood and feces samplingThe amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed. |
| Non infected (hookworms) healthy subjects | Active comparator | Other: Blood and feces samplingAll the tests done in the experimental hookworm infected group will be also done in the comparator non infected group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old adults in good health status
- To live in rural regions at risk of soil transmitted helminthes
- Hookworm infection (infected group)
- Uninfected by Hookworms (control group)
Key exclusion criteria (4 listed)
- Pregnant woman
- Positive allergic history
- Auto-immune and/or HIV disease
- Antihelminthics drug in the last 6 months and other current parasitic infection
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 |
|---|---|---|
| Blood and feces samplingBlood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care. | Other | Hookworm infected, Non infected (hookworms) healthy subjects |
Primary outcome
Amount and phenotype of Treg
Time frame: 0-12 weeks
Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 19758373Flohr C, Tuyen LN, Quinnell RJ, Lewis S, Minh TT, Campbell J, Simmons C, Telford G, Brown A, Hien TT, Farrar J, Williams H, Pritchard DI, Britton J. Reduced helminth burden increases allergen skin sensitization but not clinical allergy: a randomized, double-blind, placebo-controlled trial in Vietnam. Clin Exp Allergy. 2010 Jan;40(1):131-42. doi: 10.1111/j.1365-2222.2009.03346.x. Epub 2009 Sep 15.
- Background: PubMed 17157661Flohr C, Tuyen LN, Lewis S, Quinnell R, Minh TT, Liem HT, Campbell J, Pritchard D, Hien TT, Farrar J, Williams H, Britton J. Poor sanitation and helminth infection protect against skin sensitization in Vietnamese children: A cross-sectional study. J Allergy Clin Immunol. 2006 Dec;118(6):1305-11. doi: 10.1016/j.jaci.2006.08.035. Epub 2006 Oct 13.
- Background: PubMed 24712468Finlay CM, Walsh KP, Mills KH. Induction of regulatory cells by helminth parasites: exploitation for the treatment of inflammatory diseases. Immunol Rev. 2014 May;259(1):206-30. doi: 10.1111/imr.12164.
- Background: PubMed 23681097Sakaguchi S, Vignali DA, Rudensky AY, Niec RE, Waldmann H. The plasticity and stability of regulatory T cells. Nat Rev Immunol. 2013 Jun;13(6):461-7. doi: 10.1038/nri3464. Epub 2013 May 17.
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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.
Virginie Doyen, MD principal investigator
CHU Brugmann - ULB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and feces sampling in people with Hookworm Infection, run by Brugmann University Hospital at 1 site in Vietnam.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. 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 Vietnam. 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.
Are results available for this study?
Results are not available in the source record.
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?
Amount and phenotype of Treg (time frame: 0-12 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 NCT02262403, which also lists 4 linked publications.
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 21 Feb 2021.