Infections in Migrants in Sweden - the Importance of Malaria and Other Parasitic Infections (MMS)

October 7, 2021 updated by: Region Stockholm

Malaria is a parasitic disease causing substantial morbidity and mortality globally. Malaria is a potentially severe and fatal disease in non-immune individuals. In areas of intense transmission infections individuals acquired immunity that protect against clinical disease. Nonetheless, immunity is not regarding sterilizing and repeated infections often result in an asymptomatic carriage of malaria parasites. These chronic apparently asymptomatic infections have been associated with anemia, cognitive dysfunction and adverse events during pregnancy.

Global migration has increased over the last decade and has resulted in an increasing number of migrants from malaria endemic regions arriving in non-endemic countries. Migrants from malaria endemic countries may carry asymptomatic infections with malaria parasites, as well as other parasitic infections such as strongyloides and schistosomiasis, with a possible negative impact on health in this group. The prevalence of asymptomatic malaria and other parasites is not fully elucidated in migrants from different regions. Moreover, the longevity of asymptomatic carriage of malaria parasites in absence of re-exposure is not known.

The aim of this study is to assess the prevalence of malaria parasites and other parasitic infections in migrants in Sweden, both newly arrived and migrants with longer residency, and intend to evaluate the need for screening for various parasitic infections in migrants arriving in Sweden. Moreover, this study will also assess antibody responses to malaria and other parasitic diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study participants are recruited in different ways, participation in the study is offered when attending an asylum health clinic at several sites in the Stockholm county. Secondly, patients attending the Infectious Disease outpatient clinic for non-febrile diseases (e.g. follow up of hepatitis, treatment for latent tuberculosis). Thirdly, quota refugees from Democratic Republic of the Congo or Uganda with arrival in Sweden in the years 2015-2019 with postal address in Stockholm, will be invited by letter to participate in the study .

A venous blood sample (EDTA tube) is collected from study participants at one occasion and a questionnaire including questions about patient origin and previous malaria are completed with the aid of a translator.

Blood samples are analysed in the research laboratory, where a malaria rapid diagnostic test (RDT) is performed and haemoglobin concentrations are measured (using Hemocue, point of care test) the same day as sample collection. The samples are then centrifuged, aliquoted, and stored frozen at the research laboratory. Presence of malaria parasites are analysed by realtime-PCR of the species specific 18SRNA gene in a multiplex assay. Serologic markers for other parasitic diseases (eg. schistosomiasis and strongyloides) are analysed in plasma. These analyses are performed at the reference laboratory at the Public Health Agency of Sweden.

Projected sample size is estimated using the formula n=(Z^2xP(1-P))/d^2 where P is the expected prevalence based on previous studies (5%) and d is the precision (1.5%) and Z is the confidence interval (95%). Based on these assumptions, the required sample size is n=715.

All RDT or PCR positive individuals are referred to the Department of Infectious Diseases or the Department of Pediatrics at the regional hospital for further investigations and treatment. Results from complete blood count are assessed and followed up according to clinical routine at each centre where samples were collected. Contact information to the study participant are included as part of the recruitment and consent procedures in order to be able to contact the study participants for referral.

Moreover, antibody responses to crude parasite extracts and specific antigens are assessed by ELISA and Luminex. In a subset of participants peripheral blood mononuclear cells, PBMC, are prepared in follow up samples to assess the cellular immune response. The magnitude and breadth of antibody and cellular responses are assessed in relation to duration of residency in a malaria free country. An estimation of the long- term decay kinetics using a sero-epidemiological mathematical model is performed.

All data will be handled according to the EU GDPR (General Data Protection Regulation) superseded all EU member states' data protection laws based on the 1995 Data Protection Directive (DPD), (GDPR, EU 2016/679 and SFS 2018:218). The patient register, containing all collected data and analysis results, is kept pseudonymizised and stored in a secure server at Karolinska University Hospital. The key to pseudonumization is kept in a secure locker at the institution.

Collected blood specimens are stored in Stockholm Medical Biobank located at Karolinska University Hospital in Solna. Handling of these stored samples is governed by the Act on Biobanks in Health Care (SFS 2002: 297).

Study Type

Observational

Enrollment (Anticipated)

715

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Asylum Health Care Facilities in SLSO and Karolinska University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Migrants born in countries where malaria is endemic are invited to participate in the study at migration health care units and in the antenatal care during pregnancy.
  2. Immigrants from malaria endemic countries living in Sweden are invited to participate with voluntary blood sampling on one occasion. The study is advertised in posters in waiting areas at health clinics.
  3. Family members to individuals that are diagnosed with malaria at Karolinska University Hospital or other hospitals in Stockholm and Västerås are invited to the study at in-patient clinics.
  4. Persons with origin in Democratic Republic of the Congo and Uganda arrived in Sweden between 2015-2019 are invited by an addressed letter

Description

Inclusion Criteria:

  • Born in a malaria endemic country (a country with reported indigenous spread of malaria according to World Malaria Report 2019)

Exclusion Criteria:

  • Inability to understand study information or sign informed consent, except for children where legal guardian is asked for consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Migrants from malaria endemic countries arriving to or living in Sweden
The study population consists of participants born in a malaria endemic country living in Sweden, irrespective of time of residency in Sweden (e.g newly arrived migrants as well as individuals with longer residency in Sweden or another non-endemic country). Participants of all ages can be included in the study.
Diagnostic test: Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases
All individuals are tested. Individuals with demonstrated parasitic disease are referred to the Infectious diseases or Pediatric clinic for evaluation and treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parasite prevalence
Time Frame: Measured at one occasion within 10 years from arrival in Sweden
Number of participants with ongoing malaria infection
Measured at one occasion within 10 years from arrival in Sweden
Prevalence of other parasites focusing on strongyloides and schistosomiasis
Time Frame: Measured at one occasion within 10 years from arrival in Sweden
Number of participants showing serological response to strongyloides and schistosomiasis
Measured at one occasion within 10 years from arrival in Sweden

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune responses to malaria and other parasites
Time Frame: A blood specimen will be collected from participants upon inclusion, and a subset of volunteers will be asked to contribute with a second blood sample after 6-12 months
Levels and breadth of P. falciparum specific antibody and memory B cell responses.
A blood specimen will be collected from participants upon inclusion, and a subset of volunteers will be asked to contribute with a second blood sample after 6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Investigators

  • Principal Investigator: Anna Farnert, MD, Prof, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2019

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (ACTUAL)

October 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMS2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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