Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorLondon School of Hygiene and Tropical Medicine
About this trial
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).
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant will remain in the study area for at least the next month.
Participant is older than 12 months
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PvSeroTAT
Combination productTwo 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 (Ethiopia) or 7 days of primaquine 0.5mg/kg/day (Madagascar), and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar)
Control
Diagnostic testTwo 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.
Treatment groups
19,200 Participants
are divided into 2 treatment groupsGroup A: PvSeroTAT interventionExperimental treatment 1 intervention
Group B: Control armOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months after the second round of PvSeroTAT or 6 months after the second round of blood sampling in the control clusters.Secondary outcomes
1
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.
Time frame
12 months after the second round of PvSeroTAT or 12 months after the second round of blood sampling in the control clusters.2
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.
Time frame
6 months after the first round of PvSeroTAT or 6 months after the first round of blood sampling in the control clusters.3
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.
Time frame
6 months after the first round of PvSeroTAT or 6 months after the first round of blood sampling in the control clusters.4
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.
Time frame
12 months after the first round of PvSeroTAT or 12 months after the first round of blood sampling in the control clusters.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
London School of Hygiene and Tropical Medicine
Lead sponsor
Institut Pasteur
Collaborator
Institut Pasteur de Madagascar
Collaborator
Armauer Hansen Research Institute, Ethiopia
Collaborator
Source ClinicalTrials.gov