The candidate blood stage malaria vaccine P27A induces a robust humoral response in a fast track to the field phase I trial in exposed and non exposed volunteers

Steiner-Monard, Viviane and Kamaka, Kassim and Karoui, Olfa and Roethlisberger, Samuel and Audran, Régine and Daubenberger, Claudia and Fayet-Mello, Aurélie and Erdmann-Voisin, Aude and Felger, Ingrid and Geiger, Kristina and Govender, Lerisa and Houard, Sophie and Huber, Eric and Mayor, Carole and Mkindi, Catherine and Portevin, Damien and Rusch, Sebastian and Schmidlin, Sandro and Tiendrebeogo, Regis W. and Theisen, Michael and Thierry, Anne-Christine and Vallotton, Laure and Corradin, Giampietro and Leroy, Odile and Abdulla, Salim and Shekalaghe, Seif and Genton, Blaise and Spertini, François and Jongo, Said A.. (2019) The candidate blood stage malaria vaccine P27A induces a robust humoral response in a fast track to the field phase I trial in exposed and non exposed volunteers. Clinical Infectious Diseases, 68 (3). pp. 466-474.

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Official URL: https://edoc.unibas.ch/69743/

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P27A is an unstructured 104mer synthetic peptide from Plasmodium falciparum trophozoite exported protein 1 (TEX1), the target of human antibodies inhibiting parasite growth. The present project aimed at evaluating the safety and immunogenicity of P27A peptide vaccine in malaria-nonexposed European and malaria-exposed African adults.; This study was designed as a staggered, fast-track, randomized, antigen and adjuvant dose-finding, multicenter phase 1a/1b trial, conducted in Switzerland and Tanzania. P27A antigen (10 or 50 μg), adjuvanted with Alhydrogel or glucopyranosil lipid adjuvant stable emulsion (GLA-SE; 2.5 or 5 μg), or control rabies vaccine (Verorab) were administered intramuscularly to 16 malaria-nonexposed and 40 malaria-exposed subjects on days 0, 28, and 56. Local and systemic adverse events (AEs) as well as humoral and cellular immune responses were assessed after each injection and during the 34-week follow-up.; Most AEs were mild to moderate and resolved completely within 48 hours. Systemic AEs were more frequent in the formulation with alum as compared to GLA-SE, whereas local AEs were more frequent after GLA-SE. No serious AEs occurred. Supported by a mixed Th1/Th2 cell-mediated immunity, P27A induced a marked specific antibody response able to recognize TEX1 in infected erythrocytes and to inhibit parasite growth through an antibody-dependent cellular inhibition mechanism. Incidence of AEs and antibody responses were significantly lower in malaria-exposed Tanzanian subjects than in nonexposed European subjects.; The candidate vaccine P27A was safe and induced a particularly robust immunogenic response in combination with GLA-SE. This formulation should be considered for future efficacy trials.; NCT01949909, PACTR201310000683408.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
UniBasel Contributors:Daubenberger, Claudia and Felger, Ingrid and Huber, Eric and Mkindi, Catherine and Portevin, Damien and Schmidlin, Sandro and Genton, Blaise
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Oxford University Press
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:12 Mar 2019 12:54
Deposited On:12 Mar 2019 12:54

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