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As a result, Controlled Human Malaria Infection (CHMI) has become an important approach for accelerated development of malarial vaccines and drugs. We conducted a systematic review of the literature to establish aggregate evidence on the reproducibility of a malaria sporozoite challenge model.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A systematic review of research articles published between 1990 and 2018 on efficacy testing of malaria vaccines and drugs using sporozoite challenge and sporozoite infectivity studies was conducted using Pubmed, Scopus, Embase and Cochrane Library, ClinicalTrials.gov and Trialtrove. The inclusion criteria were randomized and non-randomized, controlled or open-label trials using <jats:italic>P. falciparum<\/jats:italic> or <jats:italic>P. vivax<\/jats:italic> sporozoite challenges. The data were extracted from articles using standardized data extraction forms and descriptive analysis was performed for evidence synthesis. The endpoints considered were infectivity, prepatent period, parasitemia and safety of sporozoite challenge.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Seventy CHMI trials conducted with a total of 2329 adult healthy volunteers were used for analysis. CHMI was induced by bites of mosquitoes infected with <jats:italic>P. falciparum<\/jats:italic> or <jats:italic>P. vivax<\/jats:italic> in 52 trials and by direct venous inoculation of <jats:italic>P. falciparum<\/jats:italic> sporozoites (PfSPZ challenge) in 18 trials. Inoculation with <jats:italic>P. falciparum<\/jats:italic>-infected mosquitoes produced 100% infectivity in 40 studies and the mean\/median prepatent period assessed by thick blood smear (TBS) microscopy was\u2009\u2264\u200912\u00a0days in 24 studies. On the other hand, out of 12 infectivity studies conducted using PfSPZ challenge, 100% infection rate was reproduced in 9 studies with a mean or median prepatent period of 11 to 15.3\u00a0days as assessed by TBS and 6.8 to 12.6\u00a0days by PCR. The safety profile of <jats:italic>P. falciparum<\/jats:italic> and <jats:italic>P.vivax<\/jats:italic> CHMI was characterized by consistent features of malaria infection.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>There is ample evidence on consistency of <jats:italic>P. falciparum<\/jats:italic> CHMI models in terms of infectivity and safety endpoints, which supports applicability of CHMI in vaccine and drug development. PfSPZ challenge appears more feasible for African trials based on current evidence of safety and efficacy.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12879-021-06953-4","type":"journal-article","created":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T12:02:48Z","timestamp":1640001768000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Reproducibility of malaria sporozoite challenge model in humans for evaluating efficacy of vaccines and drugs: a systematic review"],"prefix":"10.1186","volume":"21","author":[{"given":"Workineh","family":"Shibeshi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilhelmina","family":"Bagchus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00d6zkan","family":"Yalkinoglu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aliona","family":"Tappert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ephrem","family":"Engidawork","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claude","family":"Oeuvray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,12,20]]},"reference":[{"key":"6953_CR1","unstructured":"World Health Organization. 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