Trial reportMalaria journal2015
Lessons learnt from the first controlled human malaria infection study conducted in Nairobi, Kenya.
Trial report in Malaria journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.
- Reproducibility of malaria sporozoite challenge model in humans for evaluating efficacy of vaccines and drugs: a systematic review.BMC infectious diseases · 2021Pooled it
- Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.Vaccine · 2021Guideline
- Reduced Ebola vaccine responses in CMV+ young adults is associated with expansion of CD57+KLRG1+ T cells.The Journal of experimental medicine · 2020Trial
- DSM265 for Plasmodium falciparum chemoprophylaxis: a randomised, double blinded, phase 1 trial with controlled human malaria infection.The Lancet. Infectious diseases · 2017Trial
- Is India ready for controlled human infection studies? A narrative review of stakeholders' perceptions & regulatory preparedness.Dialogues in health · 2026Review
- Balancing altruism, risk and ethics: Vietnamese students' views on human challenge studies.PloS one · 2026Article
- Acceptability of advanced Controlled Human Infection Models: The case of a pneumococcal challenge in people living with HIV and mycobacterial challenge with Bacillus Calmette Guerin in Malawi.PLOS global public health · 2026Article
- How community members in Uganda perceive controlled human infection studies.Research ethics · 2025Article
- Experiences, perceptions and ethical considerations of the malaria infection study in Thailand.BMC medical ethics · 2025Article
- Development of an intranasal, universal influenza vaccine in an EU-funded public-private partnership: the FLUniversal consortium.Frontiers in immunology · 2025Article
- Considerations in planning a controlled human infection model in at-risk groups in sub-Saharan Africa: the case for pneumococcal challenge in people living with HIV in Malawi and a report of stakeholder consultation.Wellcome open research · 2024Article
- Biopreserving Pathogens: Promise & Peril.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2024Article
- Challenges in Developing a Controlled Human Tuberculosis Challenge Model.Current topics in microbiology and immunology · 2024Review
- Recruitment strategies used to enrol healthy volunteers in the first pneumococcal human infection study in Africa: Lessons from Blantyre, Malawi.Wellcome open research · 2024Article
- Perceptions and acceptability of the controlled human malaria infection (CHMI) model in The Gambia: a qualitative study.Scientific reports · 2023Article
- Efficient infection of non-human primates with purified, cryopreserved Plasmodium knowlesi sporozoites.Malaria journal · 2022Article
- Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study.BMC medical ethics · 2022Article
- Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.Wellcome open research · 2022Article
- Ethical and practical considerations arising from community consultation on implementing controlled human infection studies usingGlobal bioethics = Problemi di bioetica · 2022Article
- Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt.Frontiers in public health · 2022Article
Corrections and comments
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Authors and funding
18 authors at 5 institutions in 4 countries.
Funding
Abstract
backgroundControlled human malaria infection (CHMI) studies, in which healthy volunteers are infected with Plasmodium falciparum to assess the efficacy of novel malaria vaccines and drugs, have become a vital tool to accelerate vaccine and drug development. CHMI studies provide a cost-effective and expeditious way to circumvent the use of large-scale field efficacy studies to deselect intervention candidates. However, to date few modern CHMI studies have been performed in malaria-endemic countries.
methodsAn open-label, randomized pilot CHMI study was conducted using aseptic, purified, cryopreserved, infectious P. falciparum sporozoites (SPZ) (Sanaria® PfSPZ Challenge) administered intramuscularly (IM) to healthy Kenyan adults (n = 28) with varying degrees of prior exposure to P. falciparum. The purpose of the study was to establish the PfSPZ Challenge CHMI model in a Kenyan setting with the aim of increasing the international capacity for efficacy testing of malaria vaccines and drugs, and allowing earlier assessment of efficacy in a population for which interventions are being developed. This was part of the EDCTP-funded capacity development of the CHMI platform in Africa. DISCUSSION: This paper discusses in detail lessons learnt from conducting the first CHMI study in Kenya. Issues pertinent to the African setting, including community sensitization, consent and recruitment are considered. Detailed reasoning regarding the study design (for example, dose and route of administration of PfSPZ Challenge, criteria for grouping volunteers according to prior exposure to malaria and duration of follow-up post CHMI) are given and changes other centres may want to consider for future studies are suggested.
conclusionsPerforming CHMI studies in an African setting presents unique but surmountable challenges and offers great opportunity for acceleration of malaria vaccine and drug development. The reflections in this paper aim to aid other centres and partners intending to use the CHMI model in Africa.
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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.