Malaria,FalciparumPhase 3NCT05150808
Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania
A Phase 3 study testing IRS insecticide: Vectron T500 in people with Malaria,Falciparum, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
Malaria is a major public health problem in Africa. An important way to control the disease is by Indoor Residual Spraying of insecticide in houses. Insecticide resistance has become a major problem. This trial will evaluate a novel insecticide against those insecticide resistant mosquito vectors in Tanzania E Africa. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- IRS insecticide: Vectron T500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Phase 3
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All households who consent to IRS malaria control
Who cannot join
- none
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Tanzania1 site, 1 recruiting
- Recruiting
National Institute of Medical Research
Muheza
Patrick Tungu, Dr, +255715487232, patrickkjiatungu@hotmail.com
United Kingdom1 site, 1 recruiting
- Recruiting
London School of Hygiene & Tropical Medicine
London, WC1E 7HT
Mark W Rowland, PhD, +44 7595090405 ext. 4719, mark.rowland@lshtm.ac.uk
Terri O O'Halloran, BA, +44 7762477027 ext. 4718, Terri.O'Halloran@lshtm.ac.uk
About this study
Official title: WHO Phase III Evaluation of Vectron T500 (Broflanilide 50WP) for IRS in Tanzania
Malaria is a major public health problem in Africa. An important way to control the disease is by Indoor Residual Spraying of insecticide in houses. Insecticide resistance has become a major problem. This trial will evaluate a novel insecticide against those insecticide resistant mosquito vectors in Tanzania E Africa.
Read the detailed description
Background: Indoor residual spraying (IRS) is one of the major methods of malaria vector control across sub-Saharan Africa, responsible for reducing malaria incidence by 10% since 2000. However, effective vector control is increasingly threatened by the rapid spread of insecticide resistance. Consequently, there have been investments in the development of new insecticides for IRS that possess novel modes of action with long residual activity, low mammalian and environmental toxicity and minimal cross-resistance. VECTRONTM T500, a new IRS insecticide containing the active ingredient broflanilide 50% WP, has been shown to be efficacious against both pyrethroid-susceptible and -resistant vector strains on mud and concrete substrates in phase II experimental hut trials in Tanzania.
Method: A two-arm non-inferiority cluster randomized controlled trial will be conducted in Muheza District, Tanga Region, Tanzania. VECTRONTM T500 will be compared to the IRS formulation Fludora® Fusion (active ingredients: clothianidin 50% WP + deltamethrin 6.25% WP). The predominant malaria vectors in the study area are pyrethroid-resistant Anopheles gambiae s.s., An. arabiensis and An. funestus s.s. Sixteen selected clusters of 75-200 households in each cluster will be pair-matched on baseline vector densities and allocated to reference and intervention arms. Consenting households in the intervention arm will be sprayed with VECTRONTM T500 and those in the reference arm will receive Fludora® Fusion. Monthly CDC light traps will collect mosquitoes to determine vector density, indoor biting, sporozoite and entomological inoculation rates (EIR). Phenotypic resistance to IRS active ingredients will be assessed using CDC bottle bioassays. Molecular and metabolic resistance mechanisms will be characterised among Anopheles field populations from both trial arms. Residual efficacy of both brands of insecticide will be monitored for 12 months post-spraying. A semi-structured questionnaire and focus group discussions will explore social and cultural factors that influence acceptability, perceived adverse effects and benefits of IRS.
Discussion: This protocol describes a phase III non-inferiority evaluation of a novel IRS product to reduce the density and EIR of pyrethroid-resistant Anopheles vectors. If VECTRONTM T500 proves non-inferior to Fludora® Fusion, it may be considered as an additional vector control product for malaria prevention and insecticide resistance management schemes.
- Conditions
- Malaria,Falciparum
- Being tested
- IRS insecticide: Vectron T500
- Keywords
- vector control, insecticide, indoor residual spraying of mosquitoes
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRS insecticide: Vectron T500Other
Also called broflanilide
public health insecticide
| Study group | Role | What they receive |
|---|---|---|
| Intervention IRS | Active comparator | Intervention IRS insecticide will be sprayed on the walls and ceilings of 8 clusters Receives: Other: IRS insecticide: Vectron T500 |
| Control IRS | Active comparator | WHO approved IRS insecticide will be sprayed on the walls and ceilings of 8 clusters Receives: Other: IRS insecticide: Vectron T500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vector density
Reduction in vector population density
Measured: 12-15 months
Sporozoite rate
Reduction in sporozoite rate
Measured: 12-15 months
Entomological inoculation rate EIR
Reduction in EIR
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Oct 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malaria,FalciparumStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomised Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150808
- Sponsor's protocol ID
- Ph3 Vectron Tz
- Other IDs
- ITDCZI93
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mbewe NJ, Tungu PK, Messenger LA, Bradley J, Mangesho PE, Shirima B, Moshi O, Shayo MF, Seif M, Portwood NM, Snetselaar J, Azizi S, Magogo F, Mabenga P, Sudi W, Mlay G, Kirby MJ, Mosha FW, Kisinza W, Matowo J, Small G, Rowland MW. A noninferiority cluster randomised evaluation of a broflanilide indoor residual spraying insecticide, VECTRON T500, for malaria vector control in Tanzania. Sci Rep. 2025 Apr 29;15(1):15013. doi: 10.1038/s41598-025-99809-9.
PubMed 40301570Tungu PK, Rowland MW, Messenger LA, Small GJ, Bradley J, Snetselaar J, Kirby MJ, Mbewe NJ. Large-scale (Phase III) evaluation of broflanilide 50WP (VECTRON T500) for indoor residual spraying for malaria vector control in Northeast Tanzania: study protocol for a two-arm, non-inferiority, cluster-randomised community trial. BMC Infect Dis. 2022 Feb 21;22(1):171. doi: 10.1186/s12879-022-07138-3.
PubMed 35189830
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHO Phase III Evaluation of Vectron T500 (Broflanilide 50WP) for IRS in Tanzania
- ClinicalTrials.gov ID
- NCT05150808
- Acronym / sponsor ID
- Ph3 Vectron Tz
- Conditions
- Malaria,Falciparum
- Keywords
- vector control, insecticide, indoor residual spraying of mosquitoes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
Malaria is a major public health problem in Africa. An important way to control the disease is by Indoor Residual Spraying of insecticide in houses. Insecticide resistance has become a major problem. This trial will evaluate a novel insecticide against those insecticide resistant mosquito vectors in Tanzania E Africa.
Detailed description
Background: Indoor residual spraying (IRS) is one of the major methods of malaria vector control across sub-Saharan Africa, responsible for reducing malaria incidence by 10% since 2000. However, effective vector control is increasingly threatened by the rapid spread of insecticide resistance. Consequently, there have been investments in the development of new insecticides for IRS that possess novel modes of action with long residual activity, low mammalian and environmental toxicity and minimal cross-resistance. VECTRONTM T500, a new IRS insecticide containing the active ingredient broflanilide 50% WP, has been shown to be efficacious against both pyrethroid-susceptible and -resistant vector strains on mud and concrete substrates in phase II experimental hut trials in Tanzania.
Method: A two-arm non-inferiority cluster randomized controlled trial will be conducted in Muheza District, Tanga Region, Tanzania. VECTRONTM T500 will be compared to the IRS formulation Fludora® Fusion (active ingredients: clothianidin 50% WP + deltamethrin 6.25% WP). The predominant malaria vectors in the study area are pyrethroid-resistant Anopheles gambiae s.s., An. arabiensis and An. funestus s.s. Sixteen selected clusters of 75-200 households in each cluster will be pair-matched on baseline vector densities and allocated to reference and intervention arms. Consenting households in the intervention arm will be sprayed with VECTRONTM T500 and those in the reference arm will receive Fludora® Fusion. Monthly CDC light traps will collect mosquitoes to determine vector density, indoor biting, sporozoite and entomological inoculation rates (EIR). Phenotypic resistance to IRS active ingredients will be assessed using CDC bottle bioassays. Molecular and metabolic resistance mechanisms will be characterised among Anopheles field populations from both trial arms. Residual efficacy of both brands of insecticide will be monitored for 12 months post-spraying. A semi-structured questionnaire and focus group discussions will explore social and cultural factors that influence acceptability, perceived adverse effects and benefits of IRS.
Discussion: This protocol describes a phase III non-inferiority evaluation of a novel IRS product to reduce the density and EIR of pyrethroid-resistant Anopheles vectors. If VECTRONTM T500 proves non-inferior to Fludora® Fusion, it may be considered as an additional vector control product for malaria prevention and insecticide resistance management schemes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Cluster Randomised Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention IRS | Active comparator | Other: IRS insecticide: Vectron T500Intervention IRS insecticide will be sprayed on the walls and ceilings of 8 clusters |
| Control IRS | Active comparator | Other: IRS insecticide: Vectron T500WHO approved IRS insecticide will be sprayed on the walls and ceilings of 8 clusters |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All households who consent to IRS malaria control
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| IRS insecticide: Vectron T500Also: broflanilidepublic health insecticide | Other | Control IRS, Intervention IRS |
Primary outcome
Vector density
Time frame: 12-15 months
Reduction in vector population density
Sporozoite rate
Time frame: 12-15 months
Reduction in sporozoite rate
Entomological inoculation rate EIR
Time frame: 12-15 months
Reduction in EIR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 40301570Mbewe NJ, Tungu PK, Messenger LA, Bradley J, Mangesho PE, Shirima B, Moshi O, Shayo MF, Seif M, Portwood NM, Snetselaar J, Azizi S, Magogo F, Mabenga P, Sudi W, Mlay G, Kirby MJ, Mosha FW, Kisinza W, Matowo J, Small G, Rowland MW. A noninferiority cluster randomised evaluation of a broflanilide indoor residual spraying insecticide, VECTRON T500, for malaria vector control in Tanzania. Sci Rep. 2025 Apr 29;15(1):15013. doi: 10.1038/s41598-025-99809-9.
- Derived from this study: PubMed 35189830Tungu PK, Rowland MW, Messenger LA, Small GJ, Bradley J, Snetselaar J, Kirby MJ, Mbewe NJ. Large-scale (Phase III) evaluation of broflanilide 50WP (VECTRON T500) for indoor residual spraying for malaria vector control in Northeast Tanzania: study protocol for a two-arm, non-inferiority, cluster-randomised community trial. BMC Infect Dis. 2022 Feb 21;22(1):171. doi: 10.1186/s12879-022-07138-3.
- Individual participant dataSharing planned: No
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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.
London School of Hygiene & Tropical Medicine
London, United Kingdom
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IRS insecticide: Vectron T500 in people with Malaria,Falciparum, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania, United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vector density (time frame: 12-15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150808, which also lists 2 linked publications.
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 9 Dec 2021.