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Completed

NCT Number: NCT04258670

Spontaneous Antigenemia in Loiasis

This prospective study will enroll and follow 60 loiasis patients with high worm burden to monitor the spontaneous release of filarial antigen in peripheral blood. This study will define the cross-reactive antigen profile of persons with spontaneous loiasis antigenemia, and determine whether it varies with time.

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Key information

Conditions

Loiasis Elephantiasis, Filarial Filariasis Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphatic Filariasis Lymphedema Mosquito-Borne Diseases Nematode Infections Parasitic Diseases Secernentea Infections Spirurida Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Research on Filariasis and other Tropical Diseases (CRFilMT)

Yaoundé, Cameroon

About this study

Global efforts to eradicate lymphatic filariasis (LF) depend on rapid diagnostic tests (RDTs) that detect Wuchereria bancrofti circulating filarial antigen but these tests are unreliable in African nations where Loa loa is co-endemic because they yield false-positive results in some individuals with loiasis. The goals of this project are to define the cross-reactive antigen profile of persons with spontaneous antigenemia, how it varies over time, and to determine which L. loa antigens in cross-reactive sera best distinguish loiasis cross-reactivity from LF.

This prospective study will prospectively enroll 50 adults who presented with cross-reactive antigenemia at screening and 10 negative controls. Participants will followed for one year and tested every three months for persistence of antigenemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to give informed consent
  • Loiasis Mf count > 20,000 Mf/mL
  • Resident of study area
  • No evidence of severe or systemic comorbidities
  • Consent to storage of blood samples for future study

Exclusion criteria

  • Subject plans to move from the study area during subsequent 12 months

Treatment and study plan

No intervention

Other

Patients in these cohorts will not be given anti-filariasis therapies because these drugs are not approved for use in patients with high worm burdens (>20,000 Mf/mL)

Primary outcomes

  1. prevalence of specific cross-reactive L. loa antigens at baseline

    Time frame: 1 day

    Prevalence of filariasis test strip (FTS) positive individuals at screening. Cross-reactive proteins in plasma will be identified by mass-spectrometry to identify a cross-reactive biomarker

Secondary outcomes

  1. Recurrence of cross-reactive antigenemia

    Time frame: quarterly for 1 year

    To determine if the same antigens are present at each follow up

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Center for Research on Filariasis and Other Tropical Diseases, Cameroon
  • Doris Duke Charitable Foundation

Registry information

Official study title

Spontaneous Antigenemia in Loiasis, A Study of the Loiasis Antigens Responsible for Cross-reactivity in the Rapid Diagnostic Test for Lymphatic Filariasis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2020
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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