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NCT02153996 · ClinicalTrials.gov registry record
Longitudinal Analysis of Plasmodium Falciparum-Specific Immunity in Travelers and Immigrants From Malaria Endemic Areas to the United States
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- 3
- Enrollment target
NCT02153996: Clinical Trial study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02153996 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02153996 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study Summary
Plasmodium falciparum malaria is a major cause of morbidity and mortality in tropical and sub-tropical areas worldwide. Repeated P. falciparum infections in endemic areas induce protective immunity, thus providing optimism that an effective malaria vaccine can be developed. Key to the development of such a vaccine is an understanding of the immune mechanisms underlying protection and the longevity of these responses in the absence of continuous P. falciparum exposure. Anecdotal evidence suggests clinical immunity to malaria wanes within months to years after an immune individual leaves an endemic area. A detailed, systematic description of the quality and longevity of the P. falciparum-specific humoral and cellular immune responses in such individuals over time in the absence of ongoing exposure is lacking. This protocol will attempt to fill this knowledge gap through comprehensive longitudinal immunological analyses of two populations of healthy adult volunteers: 1) naive travelers returning from malaria endemic areas recently treated (within 2 weeks) for acute P. falciparum malaria and referred from hospitals in the metropolitan Washington DC area; and 2) immigrants from malaria endemic areas living in the metropolitan Washington DC area with serologic evidence of past P. falciparum exposure. In both groups, venipuncture and possibly apheresis will be performed for the isolation of plasma, RNA and peripheral blood mononuclear cells (PBMCs) which will be analysed to understand the components of innate and adaptive immunity to malaria. Na(SqrRoot) ve travelers returning from malaria endemic areas recently treated for acute malaria will undergo venipuncture at enrollment, then once every 2 weeks for 2 months, then every 3 months for 1 year, and then every 6 months for up to 5 years. Immigrants will be seen every three months for one year and then every six months for up to 5 years. All subjects who return to the U.S. from a malaria endemic area will be evaluated wit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-05-15 |
| Est. Completion | 2016-03-15 |
Why NCT02153996 stopped before completion
NCT02153996 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02153996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02153996 about?
NCT02153996 is a clinical study titled "Longitudinal Analysis of Plasmodium Falciparum-Specific Immunity in Travelers and Immigrants From Malaria Endemic Areas to the United States". Plasmodium falciparum malaria is a major cause of morbidity and mortality in tropical and sub-tropical areas worldwide. Repeated P. falciparum infections in endemic areas induce protective immunity, thus providing optimism that an effective malaria vaccine can be developed. Key to the development of...
What is the current status of trial NCT02153996?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2014-05-15. Estimated completion is 2016-03-15.
Who is sponsoring clinical trial NCT02153996?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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