Rethinking detection of pre-existing and intervening Plasmodium infections in malaria clinical trials

Owalla, Tonny J.; Hergott, Dianna E. B.; Seilie, Annette M.; Staubus, Weston; Chavtur, Chris; Chang, Ming; Kublin, James G.; Egwang, Thomas G.; Murphy, Sean C.

doi:10.3389/fimmu.2022.1003452

Cited by 9Malaria Research and ControlBird parasitology and diseasesParasitic Infections and Diagnostics

Rethinking detection of pre-existing and intervening Plasmodium infections in malaria clinical trials

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Owalla, Tonny J., Hergott, Dianna E. B., Seilie, Annette M., Staubus, Weston, Chavtur, Chris, Chang, Ming, Kublin, James G., Egwang, Thomas G. +1 more·2022·Frontiers in Immunology

DOI 10.3389/fimmu.2022.1003452PMC PMC9531235

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Abstract

Pre-existing and intervening low-density Plasmodium infections complicate the conduct of malaria clinical trials. These infections confound infection detection endpoints, and their immunological effects may detract from intended vaccine-induced immune responses. Historically, these infections were often unrecognized since infrequent and often analytically insensitive parasitological testing was performed before and during trials. Molecular diagnostics now permits their detection, but investigators must weigh the cost, complexity, and personnel demands on the study and the laboratory when scheduling such tests. This paper discusses the effect of pre-existing and intervening, low-density Plasmodium infections on malaria vaccine trial endpoints and the current methods employed for their infection detection. We review detection techniques, that until recently, provided a dearth of cost-effective strategies for detecting low density infections. A recently deployed, field-tested, simple, and cost-effective molecular diagnostic strategy for detecting pre-existing and intervening Plasmodium infections from dried blood spots (DBS) in malaria-endemic settings is discussed to inform new clinical trial designs. Strategies that combine sensitive molecular diagnostic techniques with convenient DBS collections and cost-effective pooling strategies may enable more thorough and informative infection monitoring in upcoming malaria clinical trials and epidemiological studies.

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The absence of congenital malaria in India may be due to effective control measures or underreporting associated with diagnostic limitations.
“while the absence of congenital malaria in India may be due to effective control measures or underreporting associated with diagnostic limitations [191–193].”
From Current update on malaria in pregnancy: a systematic review (2025) · cites this paper as [192]
The section on low-density Plasmodium infections (page unavailable) says infections can go undetected when testing is insufficiently sensitive, supporting the general concern about diagnostic limitations. It does not address congenital malaria in India, its reported absence, or effective control measures as an explanation. (LLM, conf=0.84)
Experimental — accuracy not yet measured
High prevalence rates of malaria occur in regions such as Niger and Sudan.
“High prevalence rates in regions such as Niger and Sudan underscore.the need for improved maternal screening and preventive measures”
From Current update on malaria in pregnancy: a systematic review (2025) · cites this paper as [192]
The section “Low density Plasmodium infections – a frequent complicating factor worldwide” reports frequent infections in Uganda and Mozambique, supporting the general point that malaria infections can be common in endemic settings. It does not report prevalence in Niger or Sudan, the regions named in the claim, and its figures concern low-density infections rather than overall malaria prevalence. (LLM, conf=0.82)
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Current update on malaria in pregnancy: a systematic review
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Authors: Owalla, T. J., Hergott, D. E. B., Seilie, A. M., Staubus, W., Chavtur, C., Chang, M., Kublin, J. G., Egwang, T. G., & Murphy, S. C.
Affiliations: University of Washington (US)
Corresponding author: Murphy, Sean C.
ORCID: Owalla, Tonny J.
Hergott, Dianna E. B.
Chang, Ming
Kublin, James G.
Egwang, Thomas G.
Murphy, Sean C.
Venue: Frontiers in Immunology
Publisher: Frontiers Media SA
Published: 2022-09-20
Volume: 13
Pages: 1003452-1003452
ISSN: 1664-3224 (ISSN-L)
DOI: 10.3389/fimmu.2022.1003452
PMC: PMC9531235
OpenAlex: W4296401014
Cited by: 9
References: 50
Citations by year: 2026: 1 · 2025: 2 · 2024: 2 · 2023: 4
FWCI: 0.40
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (vor)
Locations: Frontiers in Immunology (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Greater South Information System
Funders: National Institutes of Health
National Institute of Allergy and Infectious Diseases (R21AI146763)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
Life Sciences › Immunology and Microbiology › Parasitology › Bird parasitology and diseases
Life Sciences › Immunology and Microbiology › Parasitology › Parasitic Infections and Diagnostics
Keywords: infection detection, dried blood spots, molecular diagnosis, malaria-endemic settings, infection monitoring
MeSH terms: Humans, Malaria, Plasmodium falciparum, Malaria Vaccines, Molecular Diagnostic Techniques

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Rethinking detection of pre-existing and intervening Plasmodium infections in malaria clinical trials

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