A Randomized, Observer-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of a Tetravalent Dengue Vaccine Candidate and a Yellow Fever YF-17D Vaccine Administered Concomitantly and Sequentially in Healthy Subjects Aged 18 to 60 Years in Non-Endemic Country(Ies)

The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.

开始日期2018-02-28

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与 YF-17D vaccine(Takeda) 相关的临床结果

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100 项与 YF-17D vaccine(Takeda) 相关的专利（医药）

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277

项与 YF-17D vaccine(Takeda) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Hydroxychloroquine is associated with lower seroconversion upon 17DD-Yellow fever primovaccination in patients with primary Sjögren’s syndrome

Article

作者: Maria Barbosa de Lima, Sheila ; Ribeiro Moulaz, Isac ; Gonçalves Rodrigues Aguiar, Laura ; Dias Schwarcz, Waleska ; Fontana Sutile Tardetti Fantinato, Francieli ; Assis Martins-Filho, Olindo ; da Costa-Rocha, Ismael Artur ; Valim, Valéria ; Libardi Lira Machado, Ketty Lysie ; Pedro Brito-de-Sousa, Joaquim ; da Penha Gomes Gouvea, Maria ; Espíndula Gianordoli, Ana Paula ; Campi-Azevedo, Ana Carolina ; Teixeira-Carvalho, Andréa ; Peruhype-Magalhães, Vanessa ; Maria Henrique da Mota, Licia ; de Souza Azevedo, Adriana ; Costa Martins, Priscila ; Vieira Serrano, Erica ; Coelho-Dos-Reis, Jordana Grazziela ; Fernandes Amorim da Silva, Juliana ; de Fatima Bissoli, Maria ; Tourinho Santos, Renata ; Tatiyama Miyamoto, Samira

The present study aimed at investigating whether the hydroxychloroquine (HCQ) treatment would impact the neutralizing antibody production, viremia levels and the kinetics of serum soluble mediators upon planned 17DD-Yellow Fever (YF) primovaccination (Bio-Manguinhos-FIOCRUZ) of primary Sjögren's syndrome (pSS). A total of 34 pSS patients and 23 healthy controls (HC) were enrolled. The pSS group was further categorized according to the use of HCQ (HCQ and Non-HCQ). The YF-plaque reduction neutralization test (PRNT ≥1:50), YF viremia (RNAnemia) and serum biomarkers analyses were performed at baseline and subsequent time-points (Day0/Day3-4/Day5-6/Day7/Day14-D28). The pSS group showed PRNT titers and seropositivity rates similar to those observed for HC (GeoMean = 238 vs 440, p = .11; 82% vs 96%, p = .13). However, the HCQ subgroup exhibited lower seroconversion rates as compared to HC (GeoMean = 161 vs 440, p = .04; 69% vs 96%, p = .02) and Non-HQC (GeoMean = 161 vs 337, p = .582; 69% vs 94%, p = .049). No differences in YF viremia were observed amongst subgroups. Serum biomarkers analyses demonstrated that HCQ subgroup exhibited increased levels of CCL2, CXL10, IL-6, IFN-γ, IL1-Ra, IL-9, IL-10, and IL-2 at baseline and displayed a consistent increase of several biomarkers along the kinetics timeline up to D14-28. These results indicated that HCQ subgroup exhibited a deficiency in assembling YF-specific immune response elicited by 17DD-YF primovaccination as compared to Non-HCQ subgroup. Our findings suggested that hydroxychloroquine is associated with a decrease in the humoral immune response after 17DD-YF primovaccination.

2024-11-01·The Lancet Global Health

Schistosome and malaria exposure and urban–rural differences in vaccine responses in Uganda: a causal mediation analysis using data from three linked randomised controlled trials

Article

作者: Webb, Emily L ; Tumusiime, Josephine ; Katushabe, Charity ; Nayebare, Doreen ; Kaleebu, Pontiano ; Kabali, Joel ; Amongin, Rebecca ; Namusobya, Loyce ; Kukundakwe, Christine ; Tumwesige, Pius ; Akello, Florence A ; van Dam, Govert J ; Mutebe, Alex ; Nkurunungi, Gyaviira ; Nassuuna, Jacent ; Kiwanuka, Samuel ; Wajja, Anne ; Onen, Caroline ; Kabuubi, Prossy N ; Zziwa, Christopher ; Serubanja, Joel ; Apule, Barbara ; Kiwudhu, Fred ; Zirimenya, Ludoviko ; Sewankambo, Moses ; Akurut, Hellen ; Akello, Mirriam ; Kizza, Moses ; Namutebi, Milly ; Kabami, Grace ; Walusimbi, Bridgious ; Driciru, Emmanuella ; Nakazibwe, Esther ; Corstjens, Paul L A M ; Elliott, Alison M ; Oduru, Gloria ; Ninsiima, Caroline ; Amongi, Susan ; Nyanzi, Ruth ; Natukunda, Agnes ; Nkangi, Ronald ; Cose, Stephen ; Kayiwa, John ; Nassanga, Beatrice ; Kakande, Ayoub ; Nankabirwa, Christine ; Kizindo, Robert ; Nsubuga, Denis ; Kabagenyi, Joyce

BACKGROUNDVaccine immunogenicity and effectiveness vary geographically. Chronic immunomodulating parasitic infections including schistosomes and malaria have been hypothesised to be mediators of geographical variations.METHODSWe compared vaccine-specific immune responses between three Ugandan settings (schistosome-endemic rural, malaria-endemic rural, and urban) and did causal mediation analysis to assess the role of Schistosoma mansoni and malaria exposure in observed differences. We used data from the control groups of three linked randomised trials investigating the effects of intensive parasite treatment among schoolchildren. All participants received the BCG vaccine (week 0); yellow fever (YF-17D), oral typhoid (Ty21a), human papillomavirus (HPV; week 4); and HPV booster and tetanus-diphtheria (week 28). Primary outcomes were vaccine responses at week 8 and, for tetanus-diphtheria, week 52. We estimated the total effect (TE) of setting on vaccine responses and natural indirect effect (NIE) mediated through current or previous infection with S mansoni or malaria, and baseline vaccine-specific responses.FINDINGSWe included 239 (43%) participants from the schistosomiasis-endemic setting, 171 (30%) from the malaria-endemic setting, and 151 (27%) from the urban setting. At week 8, vaccine responses were lower in rural settings: schistosomiasis-endemic versus urban settings (TE geometric mean ratio for YF-17D plaque reduction neutralisation at 50% (PRNT₅₀) titres 0·58 [95% CI 0·37 to 0·91], for S Typhi O-lipopolysaccharide-specific IgG 0·61 [0·40 to 0·93], and for tetanus-specific IgG 0·33 [0·22 to 0·51]); malaria-endemic versus urban settings (YF-17D 0·70 [0·49 to 0·99], S Typhi O-lipopolysaccharide-specific IgG 0·29 [0·20 to 0·43], and tetanus-specific IgG 0·53 [-0·35 to 0·80]). However, we found higher BCG-specific IFNγ responses in the malaria-endemic versus urban setting (1·54 [1·20 to 1·98]). The estimated NIEs of setting on vaccine responses mediated through previous and current S mansoni and malaria were not statistically significant. For malaria-endemic versus urban settings, baseline vaccine-specific responses contributed to some but not all differences: S Typhi O-lipopolysaccharide-specific IgG at week 8 (57.9% mediated [38·6 to 77·2]) and week 52 (70·0% mediated [49·4 to 90·6]) and BCG at week 52 (46.4% mediated [-4·8 to 97·7]).INTERPRETATIONWe found significant variation in vaccine response between urban and rural settings but could not confirm a causal role for schistosome or malaria exposure. Other exposures require consideration.FUNDINGUK Medical Research Council.

2024-10-01·eBioMedicine

Next generation yellow fever vaccine induces an equivalent immune and transcriptomic profile to the current vaccine: observations from a phase I randomised clinical trial

Article

作者: Aguirre, Marion ; Raynal, Franck ; Mantel, Nathalie ; Chautard, Emilie ; Carre, Christophe ; Modjarrad, Kayvon ; Feroldi, Emmanuel ; Vangelisti, Manuel ; Gimenez, Sophie ; Pagnon, Anke ; Scott, Paul

BACKGROUNDYellow fever (YF), a mosquito-borne acute viral haemorrhagic illness, is endemic to many tropical and subtropical areas of Africa and Central and South America. Vaccination remains the most effective prevention strategy; however, as repeated outbreaks have exhausted vaccine stockpiles, there is a need for improved YF vaccines to meet global demand. A live-attenuated YF vaccine candidate (referred to as vYF) cloned from a YF-17D vaccine (YF-VAX®) sub-strain, adapted for growth in Vero cells cultured in serum-free media, is in clinical development. We report the innate and adaptive immune responses and the transcriptome profile of selected genes induced by vYF.METHODSHealthy adults aged 18-60 years were randomised at a 1:1:1:1 ratio to receive one dose of vYF at 4, 5 or 6 Log CCID₅₀ or YF-VAX (reference vaccine), administered subcutaneously in the upper arm (ClinicalTrials.gov identifier: NCT04142086). Blood/serum samples were obtained at scheduled time points through 180 days (D180) post-vaccination. The surrogate endpoints assessed were: serum cytokine/chemokine concentrations, measured by bead-based Multiplex assay; peripheral blood vYF-specific IgG and IgM memory B cell frequencies, measured by FluoroSpot assay; and expression of genes involved in the immune response to YF-17D vaccination by RT-qPCR.FINDINGSThere was no increase in any of the cytokine/chemokine concentrations assessed through D14 following vaccination with vYF or YF-VAX, except for a slight increase in IP-10 (CXCL10) levels. The gene expression profiles and kinetics following vaccination with vYF and YF-VAX were similar, inclusive of innate (antiviral responses [type-1 interferon, IFN signal transduction; interferon-stimulated genes], activated dendritic cells, viral sensing pattern recognition receptors) and adaptive (cell division in stimulated CD4+ T cells, B cell and antibody) immune signatures, which peaked at D7 and D14, respectively. Increases in vYF-specific IgG and IgM memory B cell frequencies at D28 and D180 were similar across the study groups.INTERPRETATIONvYF-induced strong innate and adaptive immune responses comparable to those induced by YF-VAX, with similar transcriptomic and kinetic profiles observed.FUNDINGSanofi.

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适应症	最高研发状态	国家/地区	公司	日期
登革热	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2018-02-28
黄热病	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2018-02-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03342898 (CTgov)	临床3期	登革热 \| 黄热病	900	Placebo+TDV+YF-17D (Group 1: YF-17D + Placebo/TDV/TDV)	壓廠鹹範網選鏇醖餘繭(襯顧淵壓醖齋壓遞餘獵) = 繭艱鹹願鏇簾築鹽衊鏇餘簾簾淵製築鏇鹽製鬱 (選蓋構醖膚糧鹽網獵蓋, 衊窪構觸蓋築憲積鏇鏇 ~ 衊蓋網餘膚顧鹹製範鬱) 更多	-	2020-10-08
				Placebo+TDV+YF-17D (Group 2: TDV + Placebo/TDV/YF-17D)	壓廠鹹範網選鏇醖餘繭(襯顧淵壓醖齋壓遞餘獵) = 壓襯簾鏇餘鬱獵鹹製餘餘簾簾淵製築鏇鹽製鬱 (選蓋構醖膚糧鹽網獵蓋, 蓋餘範廠窪蓋窪膚襯範 ~ 淵齋選糧齋願齋簾鹽窪) 更多