Immunity to liver-stage Plasmodium falciparum in peripheral and tissue-resident immune cells

Immunity to liver-stage Plasmodium falciparum in peripheral and tissue-resident immune cells - Liver-stage T cell and innate cell immunity (LYTIC)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49766

Enrollment

Registered

2020-05-18

Start date

2022-12-13

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malaria Plasmodium falciparum

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients (M/F) over 18 years of age undergoing medically-indicated partial liver resection for underlying disease and who have provided written informed consent.

Exclusion criteria

Exclusion criteria: Patients who have received immunosuppressive and/or cytostatic agents within the past 3 months, with the exception of topical or inhaled steroids. Patients who are known to have infection with humanimmunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), or other known clinically-relevant immunodeficient states.

Design outcomes

Primary

Measure	Time frame
(Refer to Protocol Section 8) Study parameters/endpoints Main study endpoints: • Establishment of an in vitro assay to study recognition and killing of P. falciparum-infected hepatocytes by: o cytolytic CD8+ T cells o hepatic and peripheral innate/innate-like lymphocytes	—

Secondary

Measure	Time frame
(Refer to Protocol Section 8) Secondary study endpoints: • Recognition (IFNγ and CD107a expression) and killing (lysis or apoptosis) of P. falciparum-infected hepatocytes by cytolytic CD8+ T cell line • Differences in recognition and killing of P. falciparum-infected hepatocytes between liver-resident and peripheral blood lymphocytes • Identity of the individual lymphocyte (sub-)populations which contribute to recognition and killing of P. falciparum-infected hepatocytes	—

Measure

Time frame

(Refer to Protocol Section 8) Secondary study endpoints: • Recognition (IFNγ and CD107a expression) and killing (lysis or apoptosis) of P. falciparum-infected hepatocytes by cytolytic CD8+ T cell line • Differences in recognition and killing of P. falciparum-infected hepatocytes between liver-resident and peripheral blood lymphocytes • Identity of the individual lymphocyte (sub-)populations which contribute to recognition and killing of P. falciparum-infected hepatocytes

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Countries

Netherlands

Outcome results