ClinicalTrials.gg
CompletedNCT04258670Updated Aug 21, 2026

Spontaneous Antigenemia in Loiasis

An observational study in Loiasis and Lymphatic Filariasis, sponsored by Washington University School of Medicine. Completed at 1 site in Cameroon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Loiasis
  • Lymphatic Filariasis

Keywords

  • diagnostics
  • cross-reactivity
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In context

Elephantiasis, Filarial

42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.

This study's enrollment of 86 is below the median of 12,930 across 13 observational studies indexed under Elephantiasis, Filarial.

Browse Elephantiasis, Filarial studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.

Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will be conducted in the Okola health district (Lékié Division, Centre Region, Cameroon), situated about 40km northeast of Yaoundé, the political capital city of Cameroon. The Okola health district is highly endemic for loiasis. Participant will be recruited among those excluded from an Onchocerciasis study due to high Mf counts >20,000/mL.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to give
  • 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

Exclusion Criteria:

  • Subject plans to move from the study area during subsequent 12 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cross-reactive loiasis

    This cohort will prospectively enroll 50 adults (age 18+) with cross-reactive antigenemia based on a positive filariasis test strip (FTS) and L. loa Mf counts \>20,000 Mf/mL.

    Other: No intervention

  • non-cross-reactive loiasis

    This cohort will prospectively enroll 10 adults (age 18+) with a negative filariasis test strip (FTS) and L. loa Mf counts \>20,000 Mf/mL.

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)

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What researchers measure

Primary outcomes

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

    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

    Time frame: 1 day

Secondary outcomes

  1. Recurrence of cross-reactive antigenemia

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

    Time frame: quarterly for 1 year

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Study locations

1 site
  • Centre for Research on Filariasis and other Tropical Diseases (CRFilMT)
    Yaoundé, Cameroon
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The deidentified IPD for all primary and secondary outcomes will be made publicly available either as a supplementary file in a research publication and/or made publicly available in a data repository maintained by the Becker Biomedical Library at Washington University.

Time frame: The data will be made available following publication. It will remain available indefinitely.

Access criteria: The data will be made publicly available.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in May 2021, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2020
First posted
Feb 6, 2020
StartActual
Jan 23, 2020
Primary completionActual
May 31, 2021
CompletionActual
May 31, 2021
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04258670
Collaborators
Doris Duke Charitable Foundation, Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Responsible party
Sponsor
First posted
Feb 6, 2020
Start date
Jan 23, 2020
Primary completion
May 31, 2021
Completion
May 31, 2021
Last update
Aug 21, 2026

Study contacts

Philip Budge, MD, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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