ArticlePLoS neglected tropical diseases2016
Safety and Reproducibility of a Clinical Trial System Using Induced Blood Stage Plasmodium vivax Infection and Its Potential as a Model to Evaluate Malaria Transmission.
Article in PLoS neglected tropical diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Clinical Study to Assess the Safety and Feasibility of Controlled Blood-stage Plasmodium Vivax Human Malaria Infection Through Experimental Inoculation of Cryopreserved Infected Erythrocytes in Healthy Thai Adults
Induced Blood-Stage Plasmodium Vivax Infection With HMPBS02-Pv Challenge Agent in Healthy Malaria-Naive Adults to Produce a Plasmodium Vivax Parasite Cell Bank for Future Studies
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Evaluation of a multiphasic parasite clearance profile after treatment of experimental human infection with the investigational anti-malarial M5717 using segmented mixed effect models.Malaria journal · 2023Pooled it
- A controlled human malaria infection model enabling evaluation of transmission-blocking interventions.The Journal of clinical investigation · 2018Trial
- Trial
- Controlled human malaria infection: overview and potential application in the evaluation of transmission-blocking interventions in malaria-endemic areas.Malaria journal · 2025Review
- Clinical challenges and technological breakthroughs in helminthic therapy for diabetes.Frontiers in immunology · 2025Review
- Controlled human malaria infection studies: insights into recent advances and key immunological and ethical implementation lessons.Frontiers in immunology · 2025Review
- Controlled Human Malaria Infection Studies in Africa-Past, Present, and Future.Current topics in microbiology and immunology · 2024Review
- Controlled Human Infection Models To Accelerate Vaccine Development.Clinical microbiology reviews · 2022Review
- Systems biology of malaria explored with nonhuman primates.Malaria journal · 2022Review
- Monoclonal antibodies for malaria prevention.Molecular therapy : the journal of the American Society of Gene Therapy · 2022Review
- Antimalarial Activity of Artefenomel Against Asexual Parasites and Transmissible Gametocytes During Experimental Blood-Stage Plasmodium vivax Infection.The Journal of infectious diseases · 2022Article
- Posttreatment Transaminase Elevations in Controlled Human Malaria Infection and Naturally Acquired Malaria.The Journal of infectious diseases · 2022Article
- The challenges ofFrontiers in immunology · 2022Article
- Haematological response in experimental human Plasmodium falciparum and Plasmodium vivax malaria.Malaria journal · 2021Article
- Controlled human malaria infection with a clone of Plasmodium vivax with high-quality genome assembly.JCI insight · 2021Article
- Identification of the asymptomatic Plasmodium falciparum and Plasmodium vivax gametocyte reservoir under different transmission intensities.PLoS neglected tropical diseases · 2021Article
- Article
- Progress towards the development of aExpert review of vaccines · 2021Review
- Safety and feasibility of apheresis to harvest and concentrate parasites from subjects with induced blood stage Plasmodium vivax infection.Malaria journal · 2021Article
- Liver Function Test Abnormalities in Experimental and ClinicalThe American journal of tropical medicine and hygiene · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInterventions to interrupt transmission of malaria from humans to mosquitoes represent an appealing approach to assist malaria elimination. A limitation has been the lack of systems to test the efficacy of such interventions before proceeding to efficacy trials in the field. We have previously demonstrated the feasibility of induced blood stage malaria (IBSM) infection with Plasmodium vivax. In this study, we report further validation of the IBSM model, and its evaluation for assessment of transmission of P. vivax to Anopheles stephensi mosquitoes.
methodsSix healthy subjects (three cohorts, n = 2 per cohort) were infected with P. vivax by inoculation with parasitized erythrocytes. Parasite growth was monitored by quantitative PCR, and gametocytemia by quantitative reverse transcriptase PCR (qRT-PCR) for the mRNA pvs25. Parasite multiplication rate (PMR) and size of inoculum were calculated by linear regression. Mosquito transmission studies were undertaken by direct and membrane feeding assays over 3 days prior to commencement of antimalarial treatment, and midguts of blood fed mosquitoes dissected and checked for presence of oocysts after 7-9 days.
resultsThe clinical course and parasitemia were consistent across cohorts, with all subjects developing mild to moderate symptoms of malaria. No serious adverse events were reported. Asymptomatic elevated liver function tests were detected in four of six subjects; these resolved without treatment. Direct feeding of mosquitoes was well tolerated. The estimated PMR was 9.9 fold per cycle. Low prevalence of mosquito infection was observed (1.8%; n = 32/1801) from both direct (4.5%; n = 20/411) and membrane (0.9%; n = 12/1360) feeds.
conclusionThe P. vivax IBSM model proved safe and reliable. The clinical course and PMR were reproducible when compared with the previous study using this model. The IBSM model presented in this report shows promise as a system to test transmission-blocking interventions. Further work is required to validate transmission and increase its prevalence.
trial registrationAnzctr.org.au ACTRN12613001008718.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.