Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical Center

NCT03126552 | Completed

• 1 other identifier: CHHIL
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Necator Americanus Infection

Keywords

hookworm; controlled human infection model

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (3)

• Number of adverse events following single exposure to hookworm larvae

  2 years

• Humoral (antibody) and cellular immunological changes after controlled human hookworm infection

  2 years

• Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR

  12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Four healthy hookworm-naive volunteers will be infected with 50 Necator americanus L3 larvae.

Biological: Necator americanus L3 larvae

Interventions

Necator americanus L3 larvae BIOLOGICAL

50 Necator americanus L3 larvae

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31077279 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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 24, 2017
• Study Start: April 1, 2017
• Primary Completion: August 15, 2017
• Study Completion: November 22, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)