Necator Americanus InfectionCHHILNCT03126552
Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical Center
A study testing Necator americanus L3 larvae in people with Necator Americanus Infection, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae once and will retain infection for up to 2 years. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Necator Americanus Infection
- What is being tested?
- Necator americanus L3 larvae
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2017to 22 Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject is aged ≥ 18 and ≤ 45 years.
- Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits.
- Subjects are able to respond to phone or email within 24 hours during the first 12 weeks of the study.
- Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
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- For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
- Subject has signed informed consent
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immune-deficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:
- history of severe asthma or other health conditions that may require future steroid use;
- body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening;
- positive HIV, HBV or HCV screening tests;
- the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period;
- having one of the following laboratory abnormalities: ferritine <10 ug/L, transferrine <2.04 g/L or Hb <7.5 mmol/L for females or <8.5 mmol/L for males.
- history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years;
- any history of treatment for severe psychiatric disease by a psychiatrist in the past year;
- history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- Known hypersensitivity to or contra-indications for use of albendazole. Including co-medication known to interact with albendazole metabolism (e.g. carbamazepine, phenobarbital, phenytoin, cimetidine, theophylline, dexamethasone).
- Known type 1 hypersensitivity to amphotericin B or gentamicin.
- For female subjects: positive urine pregnancy test at screening.
- Positive faecal PCR or Kato-Katz for hookworm at screening, any known history of hookworm infection or treatment for hookworm infection or possible exposure to hookworm in the past.
- Being an employee or student of the department of Parasitology of the LUMC.
- Current or past scars, tattoos, or other disruptions of skin integrity at the intended site of larval application.
- Subjects with planned travel to hookworm-endemic areas with a stay in non-hygienic environment during this trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae once and will retain infection for up to 2 years.
Read the detailed description
Four volunteers will be exposed to 50 Necator americanus L3 larvae. Volunteers will be followed on a weekly basis until week 12 after infection. If volunteers develop a patent infection, defined by detectable egg production in stool by microscopy at any timepoint within week 9 to 12, they will be scheduled to donate faeces on request.
Two years after infection or if volunteers do not excrete eggs detectable by microscopy on week 9 to 12, volunteers will be treated with a 3-day regimen of albendazole to abrogate the infection. Retreatment with albendazole will be given to volunteers who remain positive for hookworm after treatment.
Six months after the treatment, volunteers will undergo their last visit.
- Conditions
- Necator Americanus Infection
- Being tested
- Necator americanus L3 larvae
- Keywords
- hookworm, controlled human infection model
- Medical subject headings
- Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Necator americanus L3 larvaeBiological
50 Necator americanus L3 larvae
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Four healthy hookworm-naive volunteers will be infected with 50 Necator americanus L3 larvae. Receives: Biological: Necator americanus L3 larvae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection.
Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection.
Measured: 12 weeks
Secondary outcomes (3)
Number of adverse events following single exposure to hookworm larvae
Number of adverse events following single exposure to hookworm larvae
Measured: 2 years
Humoral (antibody) and cellular immunological changes after controlled human hookworm infection
Humoral (antibody) and cellular immunological changes after controlled human hookworm infection
Measured: 2 years
Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR
Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Apr 2017
- Primary completion15 Aug 2017
- Study completion22 Nov 2021
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 Necator Americanus InfectionStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meta Roestenberg, Leiden University Medical Center
- Investigators
- Meta Roestenberg, MD, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126552
- Sponsor's protocol ID
- CHHIL
- Acronym
- CHHIL
- Status last verified
- Dec 2021
- First submitted
- 29 Mar 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoogerwerf MA, Coffeng LE, Brienen EAT, Janse JJ, Langenberg MCC, Kruize YCM, Gootjes C, Manurung MD, Dekker M, Becker L, Erkens MAA, van der Beek MT, Ganesh MS, Feijt C, Winkel BMF, Westra IM, Meij P, Loukas A, Visser LG, de Vlas SJ, Yazdanbakhsh M, van Lieshout L, Roestenberg M. New Insights Into the Kinetics and Variability of Egg Excretion in Controlled Human Hookworm Infections. J Infect Dis. 2019 Aug 9;220(6):1044-1048. doi: 10.1093/infdis/jiz218.
PubMed 31077279
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical Center
- ClinicalTrials.gov ID
- NCT03126552
- Acronym / sponsor ID
- CHHIL / CHHIL
- Conditions
- Necator Americanus Infection
- Keywords
- hookworm, controlled human infection model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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.
Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae once and will retain infection for up to 2 years.
Detailed description
Four volunteers will be exposed to 50 Necator americanus L3 larvae. Volunteers will be followed on a weekly basis until week 12 after infection. If volunteers develop a patent infection, defined by detectable egg production in stool by microscopy at any timepoint within week 9 to 12, they will be scheduled to donate faeces on request.
Two years after infection or if volunteers do not excrete eggs detectable by microscopy on week 9 to 12, volunteers will be treated with a 3-day regimen of albendazole to abrogate the infection. Retreatment with albendazole will be given to volunteers who remain positive for hookworm after treatment.
Six months after the treatment, volunteers will undergo their last visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: Necator americanus L3 larvaeFour healthy hookworm-naive volunteers will be infected with 50 Necator americanus L3 larvae. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject is aged ≥ 18 and ≤ 45 years.
- Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits.
- Subjects are able to respond to phone or email within 24 hours during the first 12 weeks of the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Necator americanus L3 larvae50 Necator americanus L3 larvae | Biological | Intervention |
Primary outcome
Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection.
Time frame: 12 weeks
Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection.
3 secondary outcomes
Number of adverse events following single exposure to hookworm larvae
Time frame: 2 years
Humoral (antibody) and cellular immunological changes after controlled human hookworm infection
Time frame: 2 years
Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR
Time frame: 12 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 21 Dec 2021.
- Results publication: PubMed 31077279Hoogerwerf MA, Coffeng LE, Brienen EAT, Janse JJ, Langenberg MCC, Kruize YCM, Gootjes C, Manurung MD, Dekker M, Becker L, Erkens MAA, van der Beek MT, Ganesh MS, Feijt C, Winkel BMF, Westra IM, Meij P, Loukas A, Visser LG, de Vlas SJ, Yazdanbakhsh M, van Lieshout L, Roestenberg M. New Insights Into the Kinetics and Variability of Egg Excretion in Controlled Human Hookworm Infections. J Infect Dis. 2019 Aug 9;220(6):1044-1048. doi: 10.1093/infdis/jiz218.
- Individual participant dataSharing planned: No
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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.
Meta Roestenberg, MD, PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Necator americanus L3 larvae in people with Necator Americanus Infection, run by Leiden University Medical Center at 1 site in Netherlands.
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 25 inclusion and 0 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 21 Dec 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 Netherlands. 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?
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?
Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection. (time frame: 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 NCT03126552, 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 21 Dec 2021.