Necator Americanus InfectionITCHHINCT03702530
Immunisation, Treatment and Controlled Human Hookworm Infection
A study testing 3x 50 L3 larvae immunisation with albendazole treatment and 2x 50 L3 larvae infection in people with Necator Americanus Infection, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
24 healthy volunteers will be immunized with three times 50 L3 larvae or placebo followed by treatment with albendazol and subsequently challenged with twice 50 L3 larvae. 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?
- 3x 50 L3 larvae immunisation with albendazole treatment and 2x 50 L3 larvae infection
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Dec 2018to 2 Sep 2019
- 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 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 and 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 agrees to refrain from travel to a hookworm endemic area during the course of the trial.
- 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:
- 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 <6.5 mmol/L for females or <7.5 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;
Show all 15Show fewer
- history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset;
- inflammmatory bowel syndrome;
- regular constipation, resulting in bowel movements less than three times per week.
- 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 for hookworm at screening, any known history of hookworm infection or treatment for hookworm infection.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
24 healthy volunteers will be immunized with three times 50 L3 larvae or placebo followed by treatment with albendazol and subsequently challenged with twice 50 L3 larvae.
Read the detailed description
24 healthy hookworm-naive volunteers will be randomized in a 2:1 allocation to either the intervention group or placebo. Volunteers in the intervention group will be immunized three times with 50 L3 larvae of Necator americanus with three-week intervals. Two weeks after each immunization, volunteers will be treated with albendazole. Four weeks after the last treatment all volunteers are challenged with controlled human hookworm infection consisting of two doses of 50 L3 larvae with a two week interval. 16 weeks after the first challenge all volunteers will be treated with albendazole, except up to four volunteers who will be asked to remain as chronic donors for future hookworm studies.
- Conditions
- Necator Americanus Infection
- Being tested
- 3x 50 L3 larvae immunisation with albendazole treatment, 3x placebo immunisation with albendazole treatment, 2x 50 L3 larvae infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3x 50 L3 larvae immunisation with albendazole treatmentBiological
Immunisation with 50 Necator americanus L3 larvae at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
3x placebo immunisation with albendazole treatmentOther
Mock immunisation with water at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
2x 50 L3 larvae infectionBiological
After (mock) immunisation, infection with 50 Necator americanus larvae at week 13 and 15
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 3x 50 L3 larvae immunisation with albendazole treatment and 2x 50 L3 larvae infection Receives: Biological: 3x 50 L3 larvae immunisation with albendazole treatment; Biological: 2x 50 L3 larvae infection |
| Placebo | Placebo comparator | 3x placebo immunisation with albendazole treatment and 2x 50 L3 larvae infection Receives: Other: 3x placebo immunisation with albendazole treatment; Biological: 2x 50 L3 larvae infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between egg counts between intervention and placebo group
Comparison of average egg counts from week 25-29 of the trial (which is week 12 to 16 after controlled human hookworm infection) by Kato-Katz between intervention group and placebo group
Measured: week 25-29
Secondary outcomes (2)
Frequency of adverse events
Comparison of frequency of adverse events collected during immunisation phase and after controlled human hookworm infection between intervention and placebo group
Measured: week 0-29
Severity of adverse events
Comparison of severity of adverse events collected during immunisation phase and after controlled human hookworm infection between intervention and placebo group
Measured: week 0-29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start17 Dec 2018
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Volunteers are randomized into either the intervention or the placebo group (2:1 allocation). The two groups run parallel in the trial. At the moments of immunization in the intervention group volunteers in the placebo group receive a mock infection with water to maintain blinding.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 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
- M. Roestenberg, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702530
- Sponsor's protocol ID
- ITCHHI
- Acronym
- ITCHHI
- Status last verified
- Sep 2019
- First submitted
- 10 Aug 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoogerwerf MA, Janse JJ, Kuiper VP, van Schuijlenburg R, Kruize YC, Sijtsma JC, Nosoh BA, Koopman JR, Verbeek-Menken PH, Westra IM, Meij P, Brienen EA, Visser LG, van Lieshout L, Jochems SP, Yazdanbakhsh M, Roestenberg M. Protective efficacy of short-term infection with Necator americanus hookworm larvae in healthy volunteers in the Netherlands: a single-centre, placebo-controlled, randomised, controlled, phase 1 trial. Lancet Microbe. 2023 Dec;4(12):e1024-e1034. doi: 10.1016/S2666-5247(23)00218-5.
PubMed 38042152
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunisation, Treatment and Controlled Human Hookworm Infection
- ClinicalTrials.gov ID
- NCT03702530
- Acronym / sponsor ID
- ITCHHI / ITCHHI
- Conditions
- Necator Americanus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 11 Oct 2018 (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.
24 healthy volunteers will be immunized with three times 50 L3 larvae or placebo followed by treatment with albendazol and subsequently challenged with twice 50 L3 larvae.
Detailed description
24 healthy hookworm-naive volunteers will be randomized in a 2:1 allocation to either the intervention group or placebo. Volunteers in the intervention group will be immunized three times with 50 L3 larvae of Necator americanus with three-week intervals. Two weeks after each immunization, volunteers will be treated with albendazole. Four weeks after the last treatment all volunteers are challenged with controlled human hookworm infection consisting of two doses of 50 L3 larvae with a two week interval. 16 weeks after the first challenge all volunteers will be treated with albendazole, except up to four volunteers who will be asked to remain as chronic donors for future hookworm studies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Volunteers are randomized into either the intervention or the placebo group (2:1 allocation). The two groups run parallel in the trial. At the moments of immunization in the intervention group volunteers in the placebo group receive a mock infection with water to maintain blinding.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: 3x 50 L3 larvae immunisation with albendazole treatment, Biological: 2x 50 L3 larvae infection3x 50 L3 larvae immunisation with albendazole treatment and 2x 50 L3 larvae infection |
| Placebo | Placebo comparator | Other: 3x placebo immunisation with albendazole treatment, Biological: 2x 50 L3 larvae infection3x placebo immunisation with albendazole treatment and 2x 50 L3 larvae infection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 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 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 and is available to attend all study visits.
- Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
Key exclusion criteria (15 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 for hookworm at screening, any known history of hookworm infection or treatment for hookworm 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 |
|---|---|---|
| 3x 50 L3 larvae immunisation with albendazole treatmentImmunisation with 50 Necator americanus L3 larvae at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8 | Biological | Intervention |
| 3x placebo immunisation with albendazole treatmentMock immunisation with water at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8 | Other | Placebo |
| 2x 50 L3 larvae infectionAfter (mock) immunisation, infection with 50 Necator americanus larvae at week 13 and 15 | Biological | Intervention, Placebo |
Primary outcome
Difference between egg counts between intervention and placebo group
Time frame: week 25-29
Comparison of average egg counts from week 25-29 of the trial (which is week 12 to 16 after controlled human hookworm infection) by Kato-Katz between intervention group and placebo group
2 secondary outcomes
Frequency of adverse events
Time frame: week 0-29
Severity of adverse events
Time frame: week 0-29
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 4 Sep 2019.
- Derived from this study: PubMed 38042152Hoogerwerf MA, Janse JJ, Kuiper VP, van Schuijlenburg R, Kruize YC, Sijtsma JC, Nosoh BA, Koopman JR, Verbeek-Menken PH, Westra IM, Meij P, Brienen EA, Visser LG, van Lieshout L, Jochems SP, Yazdanbakhsh M, Roestenberg M. Protective efficacy of short-term infection with Necator americanus hookworm larvae in healthy volunteers in the Netherlands: a single-centre, placebo-controlled, randomised, controlled, phase 1 trial. Lancet Microbe. 2023 Dec;4(12):e1024-e1034. doi: 10.1016/S2666-5247(23)00218-5.
- 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.
M. Roestenberg, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3x 50 L3 larvae immunisation with albendazole treatment and 2x 50 L3 larvae infection 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 8 inclusion and 15 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 4 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Difference between egg counts between intervention and placebo group (time frame: week 25-29). 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 NCT03702530, 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 4 Sep 2019.