Malaria VivaxPhase 3PvSTATEMNCT06923592
Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar
A Phase 3 study testing PvSeroTAT in people with Malaria Vivax and Malaria Falciparum, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
The resilience of P. vivax to malaria elimination efforts is due to its ability to form dormant liver stages (hypnozoites) that reactivate weeks to months after the initial infection causing recurrent episodes of malaria (relapses) and ongoing parasite transmission. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Malaria Vivax, Malaria Falciparum, Plasmodium Vivax
- What is being tested?
- PvSeroTAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 May 2025to 28 Apr 2027
- Phase
- Phase 3
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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant will remain in the study area for at least the next month.
- Participant is older than 12 months
Who cannot join
- Participant is unwilling to participate.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Ethiopia1 site, 1 recruiting
- Not yet recruiting
Armauer Hansen Research Institute
Addis Ababa
Fitsum T Girma, PhD, +251113483752, fitsum.girma@ahri.gov.et
Madagascar1 site, 1 recruiting
- Recruiting
Institut Pasteur de Madagascar
Antananarivo
Rindra Randremanana, PhD, +261209741272, rrandrem@pasteur.mg
About this study
Official title: Serological Testing and Treatment for Plasmodium Vivax Malaria: a Cluster-Randomised Trial in Ethiopia and Madagascar
The resilience of P. vivax to malaria elimination efforts is due to its ability to form dormant liver stages (hypnozoites) that reactivate weeks to months after the initial infection causing recurrent episodes of malaria (relapses) and ongoing parasite transmission. Relapses account for a majority of recurrent infections and clinical cases of P. vivax malaria, and therefore have a significant effect on morbidity at the individual level.
With current technology, it is not possible to directly measure hypnozoite biomarkers. Rather than directly detecting hypnozoites, our team developed an indirect approach by measuring antibodies induced by the primary blood-stage infection. Antibodies to different blood-stage antigens decay at different rates. Measuring antibodies to a carefully selected panel of P. vivax antigens can aid to identify individuals who have been infected within the previous 9 months (approximately the lifespan of hypnozoites).
Read more
A serological test based on selected P. vivax antigens can detect recent exposure and predict future relapses. Coupling this test with a safe and efficacious primaquine treatment regimen, results in a population-based intervention to target the hypnozoite reservoir. This intervention is referred to as Plasmodium vivax Serological Testing and Treatment (PvSeroTAT).
PvSTATEM is a cluster randomised trial in Madagascar and Ethiopia. This study will provide insights into the feasibility, acceptability, and efficacy of the PvSeroTAT approach. In this study, individuals, randomised by clusters, will be tested for the presence of serological markers of a recent P. vivax infection, followed by a targeted drug treatment intervention aimed at killing P. vivax hypnozoites.
Read the detailed description
In each country, 24 clusters (48 clusters in total) will be randomly allocated using computer generated numbers to one of the two interventions:
Arm 1 (PvSeroTAT intervention) or Arm 2 (Control arm). Within each cluster, approximately 400 participants (range 100-600) will be enrolled, based on the trial's inclusion and exclusion criteria. At baseline (month 0) and month 6 serology for P. vivax infections will be performed in all study participants. In the clusters in the PvSeroTAT arm, participants with a positive P. vivax serology at baseline or month 6 will be approached for treatment. First G6PD enzyme activity will be measured. If the enzyme activity is normal and no other contra-indication for treatment are found, the participants will be treated with 14 days of primaquine 0.25mg/kg/day OR 7 days of primaquine 0.5mg/kg (Ethiopia) or 7 days of primaquine 0.5mg/kg/day (Madagascar), and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar). It is possible that a participant could receive a radical P. vivax treatment at both baseline (month 0) and month 6. Participants will be monitored for side effects and adherence during the first 7 days after the start of antimalarial treatments. In addition, blood samples will be taken to measure hemoglobin levels to monitor for post-treatment hemolysis.
In the clusters in both arms, the incidence of malaria will be monitored through passive case detection in health posts up to 18 months after the first intervention. All cases that are detected during the passive case detection will be treated according to the national guidelines.
At month 12 and month 18 of the study, a cross sectional survey will be conducted in all study clusters. Blood samples will be taken to determine the prevalence of P. vivax and P. falciparum through PCR assays.
- Being tested
- PvSeroTAT, Control
- Keywords
- Plasmodium vivax, Vivax, PvSeroTAT, PvSTATEM, Primaquine, serology, Cluster randomised trial, G6PD
- Medical subject headings
- Malaria, Vivax, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PvSeroTATCombination product
Two rounds (month 0 and month 6) of serological screening for antibodies against P. vivax in the blood of all eligible cluster inhabitants. In the clusters in the PvSeroTAT arm, participants with a positive P. vivax serology at baseline or month 6 will be treated with 14 days of primaquine 0.25mg/kg/day OR 7 days of primaquine 0.5mg/kg (Ethiopia) or 7 days of primaquine 0.5mg/kg/day (Madagascar), and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar)
ControlDiagnostic test
Two rounds (month 0 and month 6) of serological screening for antibodies against P. vivax in the blood of a subset of eligible cluster inhabitants. Serological status will be assessed at a later stage (months later) and will not lead to treatment of sero-positive individuals.
| Study group | Role | What they receive |
|---|---|---|
| PvSeroTAT intervention | Experimental | Not described Receives: Combination Product: PvSeroTAT |
| Control arm | Other | Not described Receives: Diagnostic Test: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals with PCR detectable P. vivax blood-stage infections 6 months after the second round of PvSeroTAT or 6 months after the second round of blood sampling in the control clusters.
6 months after the second round of PvSeroTAT, a blood sample will be collected from participants through fingerprick in the intervention clusters. In the control clusters a blood sample to determine PCR prevalence will be collected 6 months after the second round of blood sampling in that control cluster.
Measured: 6 months after the second round of PvSeroTAT or 6 months after the second round of blood sampling in the control clusters.
Secondary outcomes (21)
Proportion of individuals with PCR detectable P. vivax blood-stage infections 12 months after the second round of PvSeroTAT or 12 months after the second round of blood sampling in the control clusters.
12 months after the second round of PvSeroTAT, a blood sample will be collected from participants through fingerprick in the intervention clusters. In the control clusters a blood sample to determine PCR prevalence will be collected 12 months after the second round of blood sampling in that control cluster.
Measured: 12 months after the second round of PvSeroTAT or 12 months after the second round of blood sampling in the control clusters.
Proportion of individuals with PCR detectable P. vivax blood-stage infections 6 months after the first round of PvSeroTAT (before second round) or 6 months after the first round of blood sampling in the control clusters.
6 months after the first round of PvSeroTAT, a blood sample will be collected from participants through fingerprick in the intervention clusters. In the control clusters a blood sample to determine PCR prevalence will be collected 6 months after the first round of blood sampling in that control cluster.
Measured: 6 months after the first round of PvSeroTAT or 6 months after the first round of blood sampling in the control clusters.
Decrease of mean cluster prevalence of PCR detectable P. vivax blood-stage infections at month 6 after the first round of PvSeroTAT or 6 months after the first round of blood sampling in the control clusters, compared to baseline.
Measured: 6 months after the first round of PvSeroTAT or 6 months after the first round of blood sampling in the control clusters.
Decrease of mean cluster prevalence of PCR detectable P. vivax blood-stage infections at month 12 after the first round of PvSeroTAT or 12 months after the first round of blood sampling in the control clusters, compared to baseline.
Measured: 12 months after the first round of PvSeroTAT or 12 months after the first round of blood sampling in the control clusters.
Decrease of mean cluster prevalence of PCR detectable P. vivax blood-stage infections at month 18 after the first round of PvSeroTAT or 18 months after the first round of blood sampling in the control clusters, compared to baseline.
Measured: 18 months after the first round of PvSeroTAT or 18 months after the first round of blood sampling in the control clusters.
Incidence of clinical cases of P. vivax and P. falciparum malaria during the 6 months after the first round of PvSeroTAT or during the 6 months after the first round of blood sampling in the control clusters.
Measured: 6 months after the first round of PvSeroTAT or 6 months after the first round of blood sampling in the control clusters.
Incidence of clinical cases of P. vivax and P. falciparum malaria during the 12 months after the first round of PvSeroTAT or during the 12 months after the first round of blood sampling in the control clusters.
Measured: 12 months after the first round of PvSeroTAT or 12 months after the first round of blood sampling in the control clusters.
Incidence of clinical cases of P. vivax and P. falciparum malaria during the 18 months after the first round of PvSeroTAT or during the 18 months after the first round of blood sampling in the control clusters.
Measured: 18 months after the first round of PvSeroTAT or 18 months after the first round of blood sampling in the control clusters.
Hemoglobin level at day 3
Measured: Day 3
Hemoglobin level at day 7
Measured: Day 7
Decrease in Hemoglobin between baseline and day 3 (absolute and proportional)
Measured: Day 3
Decrease in Hemoglobin between baseline and day 7 (absolute and proportional)
Measured: Day 7
Incidence of potential signs of clinically relevant Haemolysis
25% drop in hemoglobin or hemoglobin<7gram/dL or macroscopic haemoglobinuria or the need for a blood transfusion
Measured: 7 days
Incidence of Serious Adverse Events
Measured: 18 months after the first round of PvSeroTAT or 18 months after the first round of blood sampling in the control clusters.
Coverage of serological tests for P. vivax antibodies as proportion of number of individuals per cluster
Measured: Day 0 of month 0 or month 6
Proportion of eligible individuals that refuses participation in the study
Measured: Day 0 of month 0 or month 6
Proportion of participants with positive P. vivax serology that refuses P. vivax treatment
Measured: Day 1 of drug administration
Proportion of serological positive individuals that start primaquine treatment
Measured: Day 1 of drug administration
Proportion of study participants that complete the 14-day or 7-day course of primaquine treatment.
Measured: Day of start of treatment until day 7 of treatment
Proportion of individuals that vomits at least once within 1 hour after treatment
Measured: Day of start of treatment until day 7 of treatment
Proportion of individuals that vomits twice within 1 hour after treatment.
Measured: Day of start of treatment until day 7 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start12 May 2025
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria VivaxStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In each country, 24 clusters (48 clusters in total) will be randomly allocated to one of the two interventions: Arm 1 (PvSeroTAT intervention) or Arm 2 (Control arm). Within each cluster, approximately 400 participants (range 100-600) that fulfill the inclusion and exclusion criteria will be enrolled. At baseline (month 0) and month 6 serology for P. vivax infections will be performed in all study participants. In the clusters in the PvSeroTAT arm, participants with a positive P. vivax serology at baseline or month 6 will be treated with 14 days of primaquine 0.25mg/kg/day OR 7 days of primaquine 0.5mg/kg (Ethiopia) or 7 days of primaquine 0.5mg/kg/day (Madagascar), and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar)
- Masking
- None (open label)
- Enrolment
- 19,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, Institut Pasteur de Madagascar, Armauer Hansen Research Institute, Ethiopia
- Responsible party
- Sponsor
- Investigators
- Chris Drakeley, Principal investigator, London School of Hygiene and Tropical MedicineMichael T White, Principal investigator, Institut PasteurRindra Randremanana, Principal investigator, Institut Pasteur de MadagascarFitsum G Tadesse, Principal investigator, Armauer Hansen Research Institute, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923592
- Sponsor's protocol ID
- 29643
- Acronym
- PvSTATEM
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised demographic data (e.g. age and sex). P. vivax serology results. Clinical parameters such as hemoglobin levels and clinical symptoms. Results of PCR assays for Plasmodium vivax and Plasmodium falciparum.