ClinicalTrials.gg
CompletedNCT06350851Obi1Updated Sep 30, 2026

Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination

An interventional study of Biological samples collection (blood drawing + feces) in Onchocerciasis, Loiasis and Mansonelliasis, sponsored by Bioaster. Completed at 1 site in Cameroon. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Bioaster · Not applicable, Interventional, and Diagnostic

Updated Sep 30, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,128
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.

To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.

At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.

Read the detailed description

Onchocerciasis, also known as river blindness, stands as the second leading cause of infectious blindness worldwide. According to estimates by the World Health Organization (WHO), approximately 25 million people are infected globally, with another 90 million at risk. Over 99% of these cases occur in Africa, and vision loss affects around 1.15 million individuals. The primary strategy for combating onchocerciasis currently is Community Directed Treatment with Ivermectin (CDTI), requiring a minimum of 80% therapeutic coverage for 10 -15 years.

Areas of West and Central Africa endemic for loiasis and mansonellasis, where ivermectin may trigger severe side effects, pose a significant challenge in the battle against onchocerciasis. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. This situation underscores the importance of improving the specificity of onchocerciasis diagnosis to reduce cross-reactivity and false results due to other parasitic helminths in co-endemic regions. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.

To this end, a series of cross-sectional studies will be carried out to build up a bank of well-characterized biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. These studies will take place in the Centre, Littoral, West and South regions of Cameroon over a one year period. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected. The study will begin with a screening phase during which potential participants will be diagnosed for the different filariasis. Following this screening phase, individuals meeting the inclusion criteria will be selected. Once consent has been obtained, blood samples will be taken for test development and validation of the onchocerciasis RDT. In fact, venous blood sample (in a tube containing EDTA) will be taken for each participant, by venipuncture. After collection, the tube(s) containing the blood will be stored in a cooler containing ice and transported to the laboratory within 6 hours of collection. Once at the laboratory, the plasma will be immediately prepared, then aliquoted and stored at -80ºC until transfer to BIOASTER for development and evaluation of the new diagnostic test for onchocerciasis.

At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.

02

Conditions studied

  • Onchocerciasis
  • Loiasis
  • Mansonelliasis
  • Healthy Volunteers

Keywords

  • Onchocerca volvulus
  • Loa loa
  • Mansonella perstans
  • Biplex Rapid Diagnostic Test
  • Neglected Tropical Diseases
03

In context

Onchocerciasis

35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.

This study's enrollment of 1,128 is above the median of 216 across 26 interventional studies indexed under Onchocerciasis.

Browse Onchocerciasis studies →

Lead sponsor

Bioaster is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Subjects informed of the objectives of the study and who signed a consent form
  • Subjects without filariasis (for control subjects), or
  • Subjects mono-infected with Onchocerca volvulus, or
  • Subjects mono-infected with Loa loa, or
  • Subjects mono-infected with Mansonella perstans or alternatively co-infected with Mansonella perstans and Loa loa

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Subjects having taken antihelminthic treatment less than 6 months before the inclusion date
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,128 participants (actual)

Study arms

  • Other
    Group1: Control subjects (non-infected with filariasis)

    Blood drawing + feces sample collection

    Biological: Biological samples collection (blood drawing + feces)

  • Other
    Group 2: Subjects mono-infected with Onchocerca volvulus

    Blood drawing + feces sample collection

    Biological: Biological samples collection (blood drawing + feces)

  • Other
    Group 3: Subjects mono-infected with Loa loa

    Blood drawing + feces sample collection

    Biological: Biological samples collection (blood drawing + feces)

  • Other
    Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa)

    Blood drawing + feces sample collection

    Biological: Biological samples collection (blood drawing + feces)

Interventions

  • BiologicalBiological samples collection (blood drawing + feces)

    Blood and feces samples will be collected from each volunteer.

06

What researchers measure

Primary outcomes

  1. Evaluation of the performance of the prototype diagnostic test

    The prototype will be evaluated with all plasma samples in order to determine the dynamic range of the test and the associated variability, as well as its performance in terms of sensitivity and specificity in relation to non-infected samples, and the absence of cross-reactivity with samples infected by Loa loa and Mansonella perstans.

    Time frame: Up to 52 weeks

07

Study locations

1 site
  • Higher Institute for Scientific and Medical Research
    Yaoundé, Cameroon 5797, Cameroon
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Apr 2024 to primary completion in Apr 2025, 12 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Dec 2025 → Apr 2025 and completion Dec 2025 → Oct 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Mar 22, 2024
First posted
Apr 5, 2024
StartActual
Apr 15, 2024
Primary completionActual
Apr 19, 2025was Dec 2025
CompletionActual
Oct 15, 2025was Dec 2025
Last update
Sep 30, 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.
Status
Recruiting→Completed
changed Sep 30, 2026
Sites
1 site added, 1 site removed
Show site
  • Higher Institute for Scientific and Medical Research · Yaoundé, Cameroon
Show 1 removed
  • Higher Institute for Scientific and Medical Research · Yaounde, Cameroon
Sep 30, 2026
Primary completion
Dec 2025→Apr 19, 2025 (actual)
Sep 30, 2026
Study completion
Dec 2025→Oct 15, 2025 (actual)
Sep 30, 2026
Enrollment
400 (estimated)→1128 (actual)
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Higher Institute for Scientific and Medical Research · Yaoundé, Cameroon
    Show 1 removed
    • Higher Institute for Scientific and Medical Research · Yaounde, Cameroon
    Primary completion Dec 2025→Apr 19, 2025 (now actual)
    Study completion Dec 2025→Oct 15, 2025 (now actual)
    Enrollment 400 (estimated)→1128 (actual)
    + 3 other changes: index terms, verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06350851
Lead sponsor
Bioaster
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
Apr 15, 2024
Primary completion
Apr 19, 2025
Completion
Oct 15, 2025
Last update
Sep 30, 2026

Study contacts

Philippe LEISSNER
study director · Bioaster
Joseph KAMGNO
principal investigator · ISM (Higher Institute for Scientific and Medical Research)

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 Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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