Cargando…

Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine

BACKGROUND: A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an importa...

Descripción completa

Detalles Bibliográficos
Autores principales:	Swysen, Christine, Bruls, Myriam, Oyakhirome, Sunny, Drakeley, Chris, Okech, Brenda, Carter, Terrell, Duse, Adriano, Reijman, Andrea, Ingram, Charlotte, Frean, John, Ogutu, Bernhards
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2011
Materias:	Methodology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3220650/ https://www.ncbi.nlm.nih.gov/pubmed/21816032 http://dx.doi.org/10.1186/1475-2875-10-223

Ejemplares similares

Assessing the safety, impact and effectiveness of RTS,S/AS01(E) malaria vaccine following its introduction in three sub-Saharan African countries: methodological approaches and study set-up
por: Praet, Nicolas, et al.
Publicado: (2022)

Evaluation of RTS,S/AS02A and RTS,S/AS01B in Adults in a High Malaria Transmission Area
por: Polhemus, Mark E., et al.
Publicado: (2009)

A Randomized Trial Assessing the Safety and Immunogenicity of AS01 and AS02 Adjuvanted RTS,S Malaria Vaccine Candidates in Children in Gabon
por: Lell, Bertrand, et al.
Publicado: (2009)

Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient care
por: Vekemans, Johan, et al.
Publicado: (2011)

The thermostability of the RTS,S/AS01 malaria vaccine can be increased by co-lyophilizing RTS,S and AS01
por: Fortpied, Juliette, et al.
Publicado: (2020)

Induction of Plasmodium falciparum-Specific CD4(+) T Cells and Memory B Cells in Gabonese Children Vaccinated with RTS,S/AS01(E) and RTS,S/AS02(D)
por: Agnandji, Selidji T., et al.
Publicado: (2011)

Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS,S/AS01 malaria vaccine in African children
por: Lievens, Marc, et al.
Publicado: (2011)

Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa
por: Leach, Amanda, et al.
Publicado: (2011)

Effect of the Pre-erythrocytic Candidate Malaria Vaccine RTS,S/AS01(E) on Blood Stage Immunity in Young Children
por: Bejon, Philip, et al.
Publicado: (2011)

T Cell Responses to the RTS,S/AS01(E) and RTS,S/AS02(D) Malaria Candidate Vaccines Administered According to Different Schedules to Ghanaian Children
por: Ansong, Daniel, et al.
Publicado: (2011)

Safety of the Malaria Vaccine Candidate, RTS,S/AS01(E) in 5 to 17 Month Old Kenyan and Tanzanian Children
por: Lusingu, John, et al.
Publicado: (2010)

Randomized Controlled Trial of RTS,S/AS02(D) and RTS,S/AS01(E) Malaria Candidate Vaccines Given According to Different Schedules in Ghanaian Children
por: Owusu-Agyei, Seth, et al.
Publicado: (2009)

RTS,S malaria vaccine pilot studies: addressing the human realities in large-scale clinical trials
por: van den Berg, Machteld, et al.
Publicado: (2019)

A seven-year study on the effect of the pre-erythrocytic malaria vaccine candidate RTS,S/AS01 (E) on blood stage immunity in young Kenyan children
por: Ndungu, Francis M., et al.
Publicado: (2019)

The biological function of antibodies induced by the RTS,S/AS01 malaria vaccine candidate is determined by their fine specificity
por: Chaudhury, Sidhartha, et al.
Publicado: (2016)

Correction: Randomized Controlled Trial of RTS,S/AS02(D) and RTS,S/AS01(E) Malaria Candidate Vaccines Given According to Different Schedules in Ghanaian Children
por: Owusu-Agyei, Seth, et al.
Publicado: (2010)

Correction: Safety of the Malaria Vaccine Candidate, RTS,S/AS01(E) in 5 to 17 Month Old Kenyan and Tanzanian Children
por: Lusingu, John, et al.
Publicado: (2010)

Correction: Safety of the Malaria Vaccine Candidate, RTS,S/AS01(E) in 5 to 17 Month Old Kenyan and Tanzanian Children
por: Lusingu, John, et al.
Publicado: (2010)

Mosquirix™ RTS, S/AS01 Vaccine Development, Immunogenicity, and Efficacy
por: Nadeem, Aroosa Younis, et al.
Publicado: (2022)

The Future of the RTS,S/AS01 Malaria Vaccine: An Alternative Development Plan
por: Gosling, Roly, et al.
Publicado: (2016)

Immunogenicity of the RTS,S/AS01 malaria vaccine and implications for duration of vaccine efficacy: secondary analysis of data from a phase 3 randomised controlled trial
por: White, Michael T, et al.
Publicado: (2015)

Implementation strategies for the introduction of the RTS,S/AS01 (RTS,S) malaria vaccine in countries with areas of highly seasonal transmission: workshop meeting report
por: Merle, Corinne S.
Publicado: (2023)

Environmental modifiers of RTS,S/AS01 malaria vaccine efficacy in Lilongwe, Malawi
por: Bell, Griffin J., et al.
Publicado: (2020)

Towards Eradication of Malaria: Is the WHO’s RTS,S/AS01 Vaccination Effective Enough?
por: Arora, Navneet, et al.
Publicado: (2021)

Should India be considering deployment of the first malaria vaccine RTS, S/AS01?
por: Rahi, Manju, et al.
Publicado: (2022)

RTS,S/AS01 Malaria Vaccine - The Next Step for a Developing Country
por: ZEHRA, ASMAT, et al.
Publicado: (2022)

RTS,S/AS01 malaria vaccine (Mosquirix(®)): a profile of its use
por: Syed, Yahiya Y.
Publicado: (2022)

Acceptance, availability, and feasibility of RTS, S/AS01 malaria vaccine: A review
por: Mumtaz, Hassan, et al.
Publicado: (2023)

A Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01(E) and RTS,S/AS01(B) Delayed Fractional Dose Regimens in Malaria-Naive Adults
por: Moon, James E, et al.
Publicado: (2020)

Effect of ingested human antibodies induced by RTS, S/AS01 malaria vaccination in children on Plasmodium falciparum oocyst formation and sporogony in mosquitoes
por: Miura, Kazutoyo, et al.
Publicado: (2014)

Impact of RTS,S/AS02(A) and RTS,S/AS01(B) on Genotypes of P. falciparum in Adults Participating in a Malaria Vaccine Clinical Trial
por: Waitumbi, John N., et al.
Publicado: (2009)

Simulated Impact of RTS,S/AS01 Vaccination Programs in the Context of Changing Malaria Transmission
por: Brooks, Alan, et al.
Publicado: (2012)

Delayed fractional dose regimen of the RTS,S/AS01 malaria vaccine candidate enhances an IgG4 response that inhibits serum opsonophagocytosis
por: Chaudhury, Sidhartha, et al.
Publicado: (2017)

Sample-ready multiplex qPCR assay for detection of malaria
por: Kamau, Edwin, et al.
Publicado: (2014)

Avidity of Anti-Circumsporozoite Antibodies following Vaccination with RTS,S/AS01(E) in Young Children
por: Olotu, Ally, et al.
Publicado: (2014)

Impact of high human genetic diversity in Africa on immunogenicity and efficacy of RTS,S/AS01 vaccine
por: Tukwasibwe, Stephen, et al.
Publicado: (2023)

The effect of immunization schedule with the malaria vaccine candidate RTS,S/AS01(E) on protective efficacy and anti-circumsporozoite protein antibody avidity in African infants
por: Ajua, Anthony, et al.
Publicado: (2015)

Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5–17 months in Kenya and Tanzania: a randomised controlled trial
por: Olotu, Ally, et al.
Publicado: (2011)

Potential effect modification of RTS,S/AS01 malaria vaccine efficacy by household socio-economic status
por: Gyaase, Stephaney, et al.
Publicado: (2021)

Seven-year kinetics of RTS, S/AS01-induced anti-CSP antibodies in young Kenyan children
por: Mugo, Robert M., et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_e8nr4chg5d5thmuch2parqs7k7