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http://hdl.handle.net/2445/148352
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DC Field | Value | Language |
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dc.contributor.author | Otieno, Lucas | - |
dc.contributor.author | Guerra Mendoza, Yolanda | - |
dc.contributor.author | Adjei, Samuel | - |
dc.contributor.author | Agbenyega, Tsiri | - |
dc.contributor.author | Agnandji, Selidji Todagbe | - |
dc.contributor.author | Aide, Pedro Carlos Paulino | - |
dc.contributor.author | Akoo, Pauline | - |
dc.contributor.author | Ansong, Daniel | - |
dc.contributor.author | Asante, Kwaku Poku | - |
dc.contributor.author | Berkley, James A. | - |
dc.contributor.author | Gesase, Samwel | - |
dc.contributor.author | Hamel, Mary J. | - |
dc.contributor.author | Hoffman, Irving | - |
dc.contributor.author | Kaali, Seyram | - |
dc.contributor.author | Kamthunzi, Portia | - |
dc.contributor.author | Kariuki, Simon | - |
dc.contributor.author | Kremsner, Simon | - |
dc.contributor.author | Lanaspa, Miguel | - |
dc.contributor.author | Lell, Bertrand | - |
dc.contributor.author | Lievens, Marc | - |
dc.contributor.author | Lusingu, John | - |
dc.contributor.author | Malabeja, Anangisye | - |
dc.contributor.author | Masoud, Nahya Salim | - |
dc.contributor.author | Mtoro, Ali Takadir | - |
dc.contributor.author | Njuguna, Patricia | - |
dc.contributor.author | Ofori-Anyinam, Opokua | - |
dc.contributor.author | Otieno, Godfrey Allan | - |
dc.contributor.author | Otieno, Walter | - |
dc.contributor.author | Owusu-Agyei, Seth | - |
dc.contributor.author | Schuerman, Lode | - |
dc.contributor.author | Sorgho, Hermann | - |
dc.contributor.author | Tanner, Marcel | - |
dc.contributor.author | Tinto, Halidou | - |
dc.contributor.author | Valea, Innocent | - |
dc.contributor.author | Vandoolaeghe, Pascale | - |
dc.contributor.author | Sacarlal, Jahit | - |
dc.contributor.author | Oneko, Martina | - |
dc.date.accessioned | 2020-01-21T13:35:58Z | - |
dc.date.available | 2020-01-21T13:35:58Z | - |
dc.date.issued | 2020-01-22 | - |
dc.identifier.issn | 0264-410X | - |
dc.identifier.uri | http://hdl.handle.net/2445/148352 | - |
dc.description.abstract | Background: We assessed the safety and immunogenicity of the RTS,S/AS01 malaria vaccine in a subset of children identified as HIV-infected during a large phase III randomized controlled trial conducted in seven sub-Saharan African countries. Methods: Infants 6–12 weeks and children 5–17 months old were randomized to receive 4 RTS,S/AS01 doses (R3R group), 3 RTS,S/AS01 doses plus 1 comparator vaccine dose (R3C group), or 4 comparator vaccine doses (C3C group) at study months 0, 1, 2 and 20. Infants and children with WHO stage III/IV HIV disease were excluded but HIV testing was not routinely performed on all participants; our analyses included children identified as HIV-infected based on medical history or clinical suspicion and confirmed by polymerase chain reaction or antibody testing. Serious adverse events (SAEs) and anticircumsporozoite (CS) antibodies were assessed. Results: Of 15459 children enrolled in the trial, at least 1953 were tested for HIV and 153 were confirmed as HIV-infected (R3R: 51; R3C: 54; C3C: 48). Among these children, SAEs were reported for 92.2% (95% CI: 81.1–97.8) in the R3R, 85.2% (72.9–93.4) in the R3C and 87.5% (74.8–95.3) in the C3C group over a median follow-up of 39.3, 39.4 and 38.3 months, respectively. Fifteen HIV-infected participants in each group (R3R: 29.4%, R3C: 27.8%, C3C: 31.3%) died during the study. No deaths were considered vaccinationrelated. In a matched case-control analysis, 1 month post dose 3 anti-CS geometric mean antibody concentrations were 193.3 EU/mL in RTS,S/AS01-vaccinated HIV-infected children and 491.5 EU/mL in RTS,S/ AS01-vaccinated immunogenicity controls with unknown or negative HIV status (p = 0.0001). Conclusions: The safety profile of RTS,S/AS01 in HIV-infected children was comparable to that of the comparator (meningococcal or rabies) vaccines. RTS,S/AS01 was immunogenic in HIV-infected children but antibody concentrations were lower than in children with an unknown or negative HIV status. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Elsevier | - |
dc.relation.isformatof | Reproducció del document publicat a: http://dx.doi.org/10.1016/j.vaccine.2019.10.077 | - |
dc.relation.ispartof | Vaccine, 2019, vol. 38, num. 4, p. 897-906 | - |
dc.relation.uri | http://dx.doi.org/10.1016/j.vaccine.2019.10.077 | - |
dc.rights | cc by (c) GlaxoSmithKline Biologicals S.A., 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.source | Articles publicats en revistes (ISGlobal) | - |
dc.subject.classification | Vacuna de la malària | - |
dc.subject.classification | Persones seropositives | - |
dc.subject.classification | Infants | - |
dc.subject.classification | Àfrica subsahariana | - |
dc.subject.other | Malaria vaccine | - |
dc.subject.other | HIV-positive persons | - |
dc.subject.other | Children | - |
dc.subject.other | Sub-Saharan Africa | - |
dc.title | Safety and immunogenicity of the RTS,S/AS01 malaria vaccine in infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2019-11-29T19:01:21Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
Appears in Collections: | Articles publicats en revistes (ISGlobal) |
Files in This Item:
File | Description | Size | Format | |
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OtienoL_Vaccine_2019.pdf | 1.09 MB | Adobe PDF | View/Open |
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