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Spontaneous Antigenemia in Loiasis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04258670
Enrollment
86
Registered
2020-02-06
Start date
2020-01-23
Completion date
2021-05-31
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loiasis, Lymphatic Filariasis

Keywords

diagnostics, cross-reactivity

Brief summary

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.

Detailed description

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.

Interventions

OTHERNo intervention

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)

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
Doris Duke Charitable Foundation
CollaboratorOTHER
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of specific cross-reactive L. loa antigens at baseline1 dayPrevalence 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

MeasureTime frameDescription
Recurrence of cross-reactive antigenemiaquarterly for 1 yearTo determine if the same antigens are present at each follow up

Countries

Cameroon

Contacts

PRINCIPAL_INVESTIGATORPhilip Budge, MD, PhD

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026