NCT06923592

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,200

participants targeted

Target at P75+ for phase_3

Timeline
12mo left

Started May 2025

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
May 2025Apr 2027

First Submitted

Initial submission to the registry

April 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2027

Last Updated

March 24, 2026

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

April 3, 2025

Last Update Submit

March 19, 2026

Conditions

Malaria VivaxMalaria FalciparumPlasmodium VivaxPlasmodium Falciparum

Keywords

Plasmodium vivaxVivaxPvSeroTATPvSTATEMPrimaquineserologyCluster randomised trialG6PD

Outcome Measures

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.

    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 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 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.

    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.

    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.

    18 months after the first round of PvSeroTAT or 18 months after the first round of blood sampling in the control clusters.

  • +16 more secondary outcomes

Study Arms (2)

PvSeroTAT intervention

EXPERIMENTAL
Combination Product: PvSeroTAT

Control arm

OTHER
Diagnostic Test: Control

Interventions

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 (Ethiopia) or 7 days of primaquine 0.5mg/kg/day (Madagascar), and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar)

PvSeroTAT intervention
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.

Control arm

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant will remain in the study area for at least the next month.
  • Participant is older than 12 months

You may not qualify if:

  • Participant is unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Armauer Hansen Research Institute

Addis Ababa, Ethiopia

NOT YET RECRUITING

Institut Pasteur de Madagascar

Antananarivo, Madagascar

RECRUITING

Related Links

MeSH Terms

Conditions

Malaria, VivaxMalaria, Falciparum

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Chris Drakeley

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Michael T White

    Institut Pasteur

    PRINCIPAL INVESTIGATOR

  • Rindra Randremanana

    Institut Pasteur de Madagascar

    PRINCIPAL INVESTIGATOR

  • Fitsum G Tadesse

    Armauer Hansen Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rob W van der Pluijm

CONTACT

0033145688000rvanderp@pasteur.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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 (Ethiopia) or 7 days of primaquine 0.5mg/kg/day (Madagascar), and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 11, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

April 28, 2027

Last Updated

March 24, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the manuscripts detailing the results of the study.

Locations

ET(1)MA(1)