Understanding immune responses to mosquito bites
Characterizing the Humoral Immune Response Against Salivary Antigens of Southeast Asian Mosquito Vectors of Malaria and Dengue With a Human Challenge Model
This study is testing how people's immune systems react to mosquito bites from different species to see if it can help us better understand and fight diseases like malaria and dengue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Mae Sot, Tak) |
| Trial ID | NCT04478370 on ClinicalTrials.gov |
What this trial studies
This study investigates the humoral immune response to mosquito saliva antigens by exposing participants to controlled bites from various mosquito species. It employs a human challenge model with five arms, where 150 participants will be randomly assigned to different exposure levels and mosquito species. The study aims to identify and validate immunological markers that indicate human exposure to malaria and dengue vectors, which could enhance epidemiological assessments and intervention strategies. Participants will be monitored over a period of 112 days, with specific follow-up visits to assess their immune responses.
Who should consider this trial
Good fit: Ideal candidates are healthy Thai, Burmese, or Karen individuals aged 18 to 60 who have lived in Mae Sot for the past year.
Not a fit: Patients with a history of travel to malaria-endemic areas or those with hypersensitivity to mosquito bites may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immunological markers for monitoring exposure to malaria and dengue, enhancing public health interventions.
How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding immune responses to mosquito bites.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy male or female participant judged by a responsible physician with no abnormality identified on a medical evaluation; * Thai, Burmese or Karen ethnicity; * Aged ≥ 18 to \<60 years old; * Living in Mae Sot city for the last 12 months; * Willing to participate in the activity and able to give informed consent for participating in the study; * Able to tolerate direct mosquito exposure. Exclusion Criteria: * History of travel in a malaria endemic are (rural village) in the last 12 months, or plan to do so during the study; * Medication or condition deemed to interfere with the outcome measure by a responsible physician; * Moderate and severe anemia (haemoglobin concentration less than 110 g/L of blood); * Hypersensitivity or anaphylaxis to mosquito bites; * Pregnant women
Where this trial is running
Mae Sot, Tak
- Shoklo Malaria Research unit (SMRU) — Mae Sot, Tak, Thailand (Recruiting)
Study contacts
- Principal investigator: François Nosten — Shoklo Malaria Research Unit
- Study coordinator: Victor Chaumeau
- Email: victor@shoklo-unit.com
- Phone: +6655532026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.