OnchocerciasisObi1NCT06350851
Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination
A study testing Biological samples collection (blood drawing + feces) in people with Onchocerciasis and Loiasis, run by Bioaster at 1 site in Cameroon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onchocerciasis, Loiasis, Mansonelliasis
- What is being tested?
- Biological samples collection (blood drawing + feces)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,128 participants
- Where
- 1 siteCameroon
- Study dates
- 15 Apr 2024to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breast-feeding women
- Subjects having taken antihelminthic treatment less than 6 months before the inclusion date
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Higher Institute for Scientific and Medical Research
Yaoundé, Cameroon, 5797
About this study
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.
- Conditions
- Onchocerciasis, Loiasis, Mansonelliasis, Healthy Volunteers
- Being tested
- Biological samples collection (blood drawing + feces)
- Keywords
- Onchocerca volvulus, Loa loa, Mansonella perstans, Biplex Rapid Diagnostic Test, Neglected Tropical Diseases
- Medical subject headings
- Onchocerciasis, Loiasis, Mansonelliasis, Dipetalonema Infections, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples collection (blood drawing + feces)Biological
Blood and feces samples will be collected from each volunteer.
| Study group | Role | What they receive |
|---|---|---|
| Group1: Control subjects (non-infected with filariasis) | Other | Blood drawing + feces sample collection Receives: Biological: Biological samples collection (blood drawing + feces) |
| Group 2: Subjects mono-infected with Onchocerca volvulus | Other | Blood drawing + feces sample collection Receives: Biological: Biological samples collection (blood drawing + feces) |
| Group 3: Subjects mono-infected with Loa loa | Other | Blood drawing + feces sample collection Receives: Biological: Biological samples collection (blood drawing + feces) |
| Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa) | Other | Blood drawing + feces sample collection Receives: Biological: Biological samples collection (blood drawing + feces) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start15 Apr 2024
- Primary completion19 Apr 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnchocerciasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe LEISSNER, Study director, BioasterJoseph KAMGNO, Principal investigator, ISM (Higher Institute for Scientific and Medical Research)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350851
- Sponsor's protocol ID
- BA161WP1
- Acronym
- Obi1
- Status last verified
- Oct 2025
- First submitted
- 22 Mar 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination
- ClinicalTrials.gov ID
- NCT06350851
- Acronym / sponsor ID
- Obi1 / BA161WP1
- Conditions
- Onchocerciasis, Loiasis, Mansonelliasis, Healthy Volunteers
- Keywords
- Onchocerca volvulus, Loa loa, Mansonella perstans, Biplex Rapid Diagnostic Test, Neglected Tropical Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- BioasterUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1: Control subjects (non-infected with filariasis) | Other | Biological: Biological samples collection (blood drawing + feces)Blood drawing + feces sample collection |
| Group 2: Subjects mono-infected with Onchocerca volvulus | Other | Biological: Biological samples collection (blood drawing + feces)Blood drawing + feces sample collection |
| Group 3: Subjects mono-infected with Loa loa | Other | Biological: Biological samples collection (blood drawing + feces)Blood drawing + feces sample collection |
| Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa) | Other | Biological: Biological samples collection (blood drawing + feces)Blood drawing + feces sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women
- Subjects having taken antihelminthic treatment less than 6 months before the inclusion date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samples collection (blood drawing + feces)Blood and feces samples will be collected from each volunteer. | Biological | Group 2: Subjects mono-infected with Onchocerca volvulus, Group 3: Subjects mono-infected with Loa loa, Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa), Group1: Control subjects (non-infected with filariasis) |
Primary outcome
Evaluation of the performance of the prototype diagnostic test
Time frame: Up to 52 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Higher Institute for Scientific and Medical research websiteLink provided by the sponsor.
- BIOASTER websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Onchocerciasis
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Active, not recruitingPhase 3
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
Onchocerciasis
Active, not recruitingPhase 2
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
Onchocercal Subcutaneous Nodule, Onchocerciasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe LEISSNER study director
Bioaster
Joseph KAMGNO principal investigator
ISM (Higher Institute for Scientific and Medical Research)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples collection (blood drawing + feces) in people with Onchocerciasis and Loiasis, run by Bioaster at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the performance of the prototype diagnostic test (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.