Necator Americanus InfectionReCHHI1NCT03257072
Repeated Controlled Human Hookworm Infection
A study testing 50 Necator americanus L3 larvae, 100 Necator americanus L3 larvae and 150 Necator americanus L3 larvae in people with Necator Americanus Infection, run by Meta Roestenberg at 1 site in Netherlands.
Trial summary
Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae for a maximum of three times. 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?
- 50 Necator americanus L3 larvae, 100 Necator americanus L3 larvae and 150 Necator americanus L3 larvae
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2018to 30 Aug 2018
- 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
- Subject is aged ≥ 18 and ≤ 45 years and in good health.
- 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.
- Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
- For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
- Subject has signed informed consent.
Who cannot join
- 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:
- 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 <7.0 mmol/L for females or <8.0 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;
Show all 17Show fewer
- 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 allergy to amphotericin B or gentamicin
- For female subjects: positive urine pregnancy test at screening
- Positive faecal qPCR 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 during this trial
- Receipt of a vaccine within 4 weeks prior to the study initiation
- Known food allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeated Controlled Human Hookworm Infection in Healthy Dutch Volunteers
Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae for a maximum of three times.
Read the detailed description
Twenty-four volunteers will be allocated equally into three groups (i.e. group A, B, C). Group A, B, and C will have one, two, and three infections respectively. Every infection will be performed with 50 L3 Necator americanus larvae. Group A will receive infection at week 4 only. Group B will be infected at week 2 and week 4. Group C will be infected at week 0, 2 and 4. To maintain blinding, group A and B will receive mock infections with water at week 0 and week 0 and 2 respectively. The interval between each CHHI is 2 weeks. Before every infection, the safety will be assessed by a review of adverse events data with a local safety monitor.
Sixteen weeks after the last infection (week 20), all volunteers will be offered treatment with a 3-day regimen of albendazole to abrogate infection. Volunteers with average egg counts >250 eggs per gram will be asked if they would be willing to keep their infection for a maximum of two years (chronic donors). No more than four volunteers will be selected to be chronic donors. Six months after the last infection (or after the last donation for the chronic donors) volunteers will undergo their last visit.
- Conditions
- Necator Americanus Infection
- Being tested
- 50 Necator americanus L3 larvae, 100 Necator americanus L3 larvae, 150 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.
50 Necator americanus L3 larvaeBiological
1x50 Necator americanus L3 larvae
100 Necator americanus L3 larvaeBiological
2x50 Necator americanus L3 larvae
150 Necator americanus L3 larvaeBiological
3x50 Necator americanus L3 larvae
| Study group | Role | What they receive |
|---|---|---|
| A: 50 Necator americanus L3 larvae | Experimental | Mock infections with water at week 0 and 2, infection with 50 Necator americanus L3 larvae at week 4 Receives: Biological: 50 Necator americanus L3 larvae |
| B: 100 Necator americanus L3 larvae | Experimental | Mock infections with water at week 0, infection with 50 Necator americanus L3 larvae at week 2 and 4 Receives: Biological: 100 Necator americanus L3 larvae |
| C: 150 Necator americanus L3 larvae | Experimental | Infection with 50 Necator americanus L3 larvae at week 0, 2 and 4 Receives: Biological: 150 Necator americanus L3 larvae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Frequency of adverse events as compared between study groups A, B and C.
Measured: 28 weeks
Magnitude of adverse events
Magnitude of adverse events as compared between study groups A, B and C.
Measured: 28 weeks
Secondary outcomes (3)
Variability in egg secretion
Variability in egg secretion by Kato-Katz from week 16 to 20
Measured: 20 weeks
Lowest dose at which there is 100% patent hookworm infection
The lowest dose at which there is 100% patent hookworm infection, as defined by a positive Kato-Katz at any time between week 16 to 20
Measured: 20 weeks
Comparison of the average number of eggs secreted
Comparison of the average number of eggs secreted by Kato-Katz and qPCR between different groups in weeks 16-20 after the infection
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start10 Jan 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, placebo-controlled, dose-escalation trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meta Roestenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meta Roestenberg, Leiden University Medical Center
- Investigators
- Meta Roestenberg, MD. PhD., Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257072
- Sponsor's protocol ID
- ReCHHI1
- Acronym
- ReCHHI1
- Status last verified
- Nov 2020
- First submitted
- 10 Aug 2017
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoogerwerf MA, Koopman JPR, Janse JJ, Langenberg MCC, van Schuijlenburg R, Kruize YCM, Brienen EAT, Manurung MD, Verbeek-Menken P, van der Beek MT, Westra IM, Meij P, Visser LG, van Lieshout L, de Vlas SJ, Yazdanbakhsh M, Coffeng LE, Roestenberg M. A Randomized Controlled Trial to Investigate Safety and Variability of Egg Excretion After Repeated Controlled Human Hookworm Infection. J Infect Dis. 2021 Mar 3;223(5):905-913. doi: 10.1093/infdis/jiaa414.
PubMed 32645714
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Controlled Human Hookworm Infection in Healthy Dutch Volunteers
- ClinicalTrials.gov ID
- NCT03257072
- Acronym / sponsor ID
- ReCHHI1 / ReCHHI1
- Conditions
- Necator Americanus Infection
- Keywords
- hookworm, controlled human infection model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Meta RoestenbergUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 22 Aug 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.
Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae for a maximum of three times.
Detailed description
Twenty-four volunteers will be allocated equally into three groups (i.e. group A, B, C). Group A, B, and C will have one, two, and three infections respectively. Every infection will be performed with 50 L3 Necator americanus larvae. Group A will receive infection at week 4 only. Group B will be infected at week 2 and week 4. Group C will be infected at week 0, 2 and 4. To maintain blinding, group A and B will receive mock infections with water at week 0 and week 0 and 2 respectively. The interval between each CHHI is 2 weeks. Before every infection, the safety will be assessed by a review of adverse events data with a local safety monitor.
Sixteen weeks after the last infection (week 20), all volunteers will be offered treatment with a 3-day regimen of albendazole to abrogate infection. Volunteers with average egg counts >250 eggs per gram will be asked if they would be willing to keep their infection for a maximum of two years (chronic donors). No more than four volunteers will be selected to be chronic donors. Six months after the last infection (or after the last donation for the chronic donors) volunteers will undergo their last visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- double-blind, placebo-controlled, dose-escalation trial
| Arm | Type | Receives |
|---|---|---|
| A: 50 Necator americanus L3 larvae | Experimental | Biological: 50 Necator americanus L3 larvaeMock infections with water at week 0 and 2, infection with 50 Necator americanus L3 larvae at week 4 |
| B: 100 Necator americanus L3 larvae | Experimental | Biological: 100 Necator americanus L3 larvaeMock infections with water at week 0, infection with 50 Necator americanus L3 larvae at week 2 and 4 |
| C: 150 Necator americanus L3 larvae | Experimental | Biological: 150 Necator americanus L3 larvaeInfection with 50 Necator americanus L3 larvae at week 0, 2 and 4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is aged ≥ 18 and ≤ 45 years and in good health.
- 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.
- Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
- For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
Key exclusion criteria (17 listed)
- 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:
- 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 allergy to amphotericin B or gentamicin
- For female subjects: positive urine pregnancy test at screening
- Positive faecal qPCR 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
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 |
|---|---|---|
| 50 Necator americanus L3 larvae1x50 Necator americanus L3 larvae | Biological | A: 50 Necator americanus L3 larvae |
| 100 Necator americanus L3 larvae2x50 Necator americanus L3 larvae | Biological | B: 100 Necator americanus L3 larvae |
| 150 Necator americanus L3 larvae3x50 Necator americanus L3 larvae | Biological | C: 150 Necator americanus L3 larvae |
Primary outcome
Frequency of adverse events
Time frame: 28 weeks
Frequency of adverse events as compared between study groups A, B and C.
Magnitude of adverse events
Time frame: 28 weeks
Magnitude of adverse events as compared between study groups A, B and C.
3 secondary outcomes
Variability in egg secretion
Time frame: 20 weeks
Lowest dose at which there is 100% patent hookworm infection
Time frame: 20 weeks
Comparison of the average number of eggs secreted
Time frame: 20 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 18 Nov 2020.
- Results publication: PubMed 32645714Hoogerwerf MA, Koopman JPR, Janse JJ, Langenberg MCC, van Schuijlenburg R, Kruize YCM, Brienen EAT, Manurung MD, Verbeek-Menken P, van der Beek MT, Westra IM, Meij P, Visser LG, van Lieshout L, de Vlas SJ, Yazdanbakhsh M, Coffeng LE, Roestenberg M. A Randomized Controlled Trial to Investigate Safety and Variability of Egg Excretion After Repeated Controlled Human Hookworm Infection. J Infect Dis. 2021 Mar 3;223(5):905-913. doi: 10.1093/infdis/jiaa414.
- 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 50 Necator americanus L3 larvae, 100 Necator americanus L3 larvae and 150 Necator americanus L3 larvae in people with Necator Americanus Infection, run by Meta Roestenberg 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 6 inclusion and 17 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 18 Nov 2020. 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?
Frequency of adverse events (time frame: 28 weeks). The study lists 2 primary outcomes in all. 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 NCT03257072, 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 18 Nov 2020; AzTrials last refreshed its copy on 27 Oct 2026.