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A Longitudinal Systems Biological Analysis of Naturally Acquired Malaria Immunity in Mali

29. März 2022 aktualisiert von: National Institute of Allergy and Infectious Diseases (NIAID)
Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Optimism that an effective malaria vaccine can be developed is derived in part from the observation that repeated Pf infections can induce protective immunity; however, the mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study is to apply systems biological tools to an observational cohort in an area of intense seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired malaria immunity. This year-long observational-cohort study of 700 individuals (3 months and 25 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be detected by passive and active surveillance. Immune parameters of malaria-protected and -susceptible individuals will be assayed from blood samples collected at strategic time points relative to the malaria season. The primary objective is to identify genome-wide expression profiles induced by Pf infection that are associated with protection from malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific antibody profiles that are associated with protection from malaria using a protein microarray representing 2000 Pf proteins (40 percent of the Pf proteome). Exploratory objectives for this study are to compare the magnitude and quality of the Pf-specific CD4 plus T cell response in malaria-protected and -susceptible individuals and determine how this response varies with age and among individuals before, during, and after malaria season, as well as compare various immune parameters in Pf-infected and uninfected individuals at the end of the dry season to investigate host immune factors associated with chronic asymptomatic Pf infection....

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Optimism that an effective malaria vaccine can be developed is derived in part from the observation that repeated Pf infections can induce protective immunity; however, the mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study is to apply systems biological tools to an observational cohort in an area of intense seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired malaria immunity. This observational-cohort study of individuals (3 months and 40 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be detected by passive and active surveillance. Immune parameters of malaria-protected and -susceptible individuals will be assayed from blood samples collected at strategic time points relative to the malaria season. The primary objective is to identify genome-wide expression profiles induced by Pf infection that are associated with protection from malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific antibody profiles that are associated with protection from malaria using a protein microarray representing 2000 Pf proteins (approximately 40% of the Pf proteome). Exploratory objectives for this study are to compare the magnitude and quality of the Pf-specific CD4+ T cell response in malaria-protected and -susceptible individuals and determine how this response varies with age and among individuals before, during, and after malaria season, as well as compare various immune parameters in Pf-infected and uninfected individuals at the end of the dry season to investigate host immune factors associated with chronic asymptomatic Pf infection.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

1188

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Mali
      • Bamako, Mali
        • University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

3 Monate bis 40 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

All study subjects will be selected from the village of Kalifabougou, Mali. Male and female volunteers 3 months to 40 years of age will be included. This age range captures the period over which immunity to malaria is acquired in areas of intense Pf transmission like Mali. There is no exclusion based on race, ethnicity, or gender.@@@

Beschreibung

  • INCLUSION CRITERIA:

Individuals 3 months to 40 years of age are eligible to enter the study if they agree to:

  • Live in Kalifabougou for the duration of the study (12 months).
  • Have blood specimens stored for future studies.

EXCLUSION CRITERIA:

The following eligibility criteria are exclusionary:

  • Anemia (hemoglobin less than 7 g/dL).
  • Current use of antimalarials, corticosteroids, or other immuno-suppressants.
  • Underlying heart disease, bleeding disorder, or other conditions that, in the judgment of the clinical investigators, could increase the risk to the study subjects.
  • Fever greater than or equal to 37.5 degrees Celsius or evidence of an acute infection.
  • Currently pregnant or planning to become pregnant during the study period.

(Asymptomatic Pf infection at enrollment is not exclusionary).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
observational cohort
This observational-cohort study of individuals (3 months and 40 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pf expression profiles
Zeitfenster: Triannual cross-sectional surveys and convalescence visits
Identify genome-wide progression profiles induced by Plasmonium falciparum infection that are assocaited with malaria immunity
Triannual cross-sectional surveys and convalescence visits

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
serum cytokine profiles
Zeitfenster: Triannual cross-sectional surveys and convalescence visits
Examine the relationship between age (surrogate for cumulative Pf exposure) and the gene-expression and serum cytokine profilesinduced by Pf infection.
Triannual cross-sectional surveys and convalescence visits
Pf-specific antibody profiles
Zeitfenster: Triannual cross-sectional surveys and convalescence visits
Identify Pf-specific antibody profiles that are associated with malaria immunity by using a protein microarray representing 2000 Pf proteins (approx. 40% of the Pf proteome), and determine how these profiles change with age. The objective is to validate and extend findings from a preliminary study performed in the nearby village of Kambila, Mali, where a protein microarray containing approx. 23% of the Pf proteome was used to profile Pf-specific antibody responses in children and adults before and after the 6-month malaria season
Triannual cross-sectional surveys and convalescence visits

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Ermittler

  • Hauptermittler: Peter D Crompton, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2011

Primärer Abschluss (Tatsächlich)

28. März 2022

Studienabschluss (Tatsächlich)

29. März 2022

Studienanmeldedaten

Zuerst eingereicht

23. März 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. März 2011

Zuerst gepostet (Schätzen)

24. März 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. März 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. März 2022

Zuletzt verifiziert

1. März 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 999911126
  • 11-I-N126

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