Repeated Controlled Human Hookworm Infection

NCT03257072 | Completed

• 1 other identifier: ReCHHI1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae for a maximum of three times.

Conditions

Necator Americanus Infection

Keywords

hookworm; controlled human infection model

Outcome Measures

Primary Outcomes (2)

• Frequency of adverse events

  Frequency of adverse events as compared between study groups A, B and C.

  28 weeks

• Magnitude of adverse events

  Magnitude of adverse events as compared between study groups A, B and C.

  28 weeks

Secondary Outcomes (3)

• Variability in egg secretion

  20 weeks

• Lowest dose at which there is 100% patent hookworm infection

  20 weeks

• Comparison of the average number of eggs secreted

  20 weeks

Study Arms (3)

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

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

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

Biological: 150 Necator americanus L3 larvae

Interventions

50 Necator americanus L3 larvae BIOLOGICAL

1x50 Necator americanus L3 larvae

A: 50 Necator americanus L3 larvae

100 Necator americanus L3 larvae BIOLOGICAL

2x50 Necator americanus L3 larvae

B: 100 Necator americanus L3 larvae

150 Necator americanus L3 larvae BIOLOGICAL

3x50 Necator americanus L3 larvae

C: 150 Necator americanus L3 larvae

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Meta Roestenberg: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 32645714 RESULT

MeSH Terms

Conditions

Ancylostomiasis

Condition Hierarchy (Ancestors)

Hookworm Infections; Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Study Officials

• Meta Roestenberg, MD. PhD.

  LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double-blind, placebo-controlled, dose-escalation trial

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 22, 2017
• Study Start: January 10, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)