Literature DB >> 28272979

Efficacy of phase 3 trial of RTS, S/AS01 malaria vaccine: The need for an alternative development plan.

Shima Mahmoudi1,2, Hossein Keshavarz2,3.   

Abstract

Although vaccines would be the ideal tool for control, prevention, elimination, and eradication of many infectious diseases, developing of parasites vaccines such as malaria vaccine is very complex. The most advanced malaria vaccine candidate RTS,S, a pre-erythrocytic vaccine, has been recommended for licensure by EMEA. The results of this phase III trial suggest that this candidate malaria vaccine has relatively little efficacy, and the vaccine apparently will not meet the goal of malaria eradication by itself. Since there are many vaccine candidates in the pipeline 1 that are being evaluated in vaccine trials, further study on using of alternative parasite targets and vaccination strategies are highly recommended.

Entities:  

Keywords:  RTS; S/AS01 malaria vaccine; efficacy; vaccine development

Mesh:

Substances:

Year:  2017        PMID: 28272979      PMCID: PMC5612527          DOI: 10.1080/21645515.2017.1295906

Source DB:  PubMed          Journal:  Hum Vaccin Immunother        ISSN: 2164-5515            Impact factor:   3.452


  31 in total

1.  First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children.

Authors:  Selidji Todagbe Agnandji; Bertrand Lell; Solange Solmeheim Soulanoudjingar; José Francisco Fernandes; Béatrice Peggy Abossolo; Cornelia Conzelmann; Barbara Gaelle Nfono Ondo Methogo; Yannick Doucka; Arnaud Flamen; Benjamin Mordmüller; Saadou Issifou; Peter Gottfried Kremsner; Jahit Sacarlal; Pedro Aide; Miguel Lanaspa; John J Aponte; Arlindo Nhamuave; Diana Quelhas; Quique Bassat; Sofia Mandjate; Eusébio Macete; Pedro Alonso; Salim Abdulla; Nahya Salim; Omar Juma; Mwanajaa Shomari; Kafuruki Shubis; Francisca Machera; Ali Said Hamad; Rose Minja; Ali Mtoro; Alma Sykes; Saumu Ahmed; Alwisa Martin Urassa; Ali Mohammed Ali; Grace Mwangoka; Marcel Tanner; Halidou Tinto; Umberto D'Alessandro; Hermann Sorgho; Innocent Valea; Marc Christian Tahita; William Kaboré; Sayouba Ouédraogo; Yara Sandrine; Robert Tinga Guiguemdé; Jean Bosco Ouédraogo; Mary J Hamel; Simon Kariuki; Chris Odero; Martina Oneko; Kephas Otieno; Norbert Awino; Jackton Omoto; John Williamson; Vincent Muturi-Kioi; Kayla F Laserson; Laurence Slutsker; Walter Otieno; Lucas Otieno; Otsyula Nekoye; Stacey Gondi; Allan Otieno; Bernhards Ogutu; Ruth Wasuna; Victorine Owira; David Jones; Agnes Akoth Onyango; Patricia Njuguna; Roma Chilengi; Pauline Akoo; Christine Kerubo; Jesse Gitaka; Charity Maingi; Trudie Lang; Ally Olotu; Benjamin Tsofa; Philip Bejon; Norbert Peshu; Kevin Marsh; Seth Owusu-Agyei; Kwaku Poku Asante; Kingsley Osei-Kwakye; Owusu Boahen; Samuel Ayamba; Kingsley Kayan; Ruth Owusu-Ofori; David Dosoo; Isaac Asante; George Adjei; George Adjei; Daniel Chandramohan; Brian Greenwood; John Lusingu; Samwel Gesase; Anangisye Malabeja; Omari Abdul; Hassan Kilavo; Coline Mahende; Edwin Liheluka; Martha Lemnge; Thor Theander; Chris Drakeley; Daniel Ansong; Tsiri Agbenyega; Samuel Adjei; Harry Owusu Boateng; Theresa Rettig; John Bawa; Justice Sylverken; David Sambian; Alex Agyekum; Larko Owusu; Francis Martinson; Irving Hoffman; Tisungane Mvalo; Portia Kamthunzi; Ruthendo Nkomo; Albans Msika; Allan Jumbe; Nelecy Chome; Dalitso Nyakuipa; Joseph Chintedza; W Ripley Ballou; Myriam Bruls; Joe Cohen; Yolanda Guerra; Erik Jongert; Didier Lapierre; Amanda Leach; Marc Lievens; Opokua Ofori-Anyinam; Johan Vekemans; Terrell Carter; Didier Leboulleux; Christian Loucq; Afiya Radford; Barbara Savarese; David Schellenberg; Marla Sillman; Preeti Vansadia
Journal:  N Engl J Med       Date:  2011-10-18       Impact factor: 91.245

2.  A phase I/IIa safety, immunogenicity, and efficacy bridging randomized study of a two-dose regimen of liquid and lyophilized formulations of the candidate malaria vaccine RTS,S/AS02A in malaria-naïve adults.

Authors:  Kent E Kester; Denise A McKinney; Nadia Tornieporth; Christian F Ockenhouse; D Gray Heppner; Ted Hall; Bruce T Wellde; Kate White; Peifang Sun; Robert Schwenk; Urszula Krzych; Martine Delchambre; Gerald Voss; Marie-Claude Dubois; Robert A Gasser; Megan G Dowler; Megan O'Brien; Janet Wittes; Robert Wirtz; Joe Cohen; W Ripley Ballou
Journal:  Vaccine       Date:  2007-05-30       Impact factor: 3.641

Review 3.  New horizons in adjuvants for vaccine development.

Authors:  Steven G Reed; Sylvie Bertholet; Rhea N Coler; Martin Friede
Journal:  Trends Immunol       Date:  2008-12-06       Impact factor: 16.687

4.  Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial.

Authors:  K A Bojang; P J Milligan; M Pinder; L Vigneron; A Alloueche; K E Kester; W R Ballou; D J Conway; W H Reece; P Gothard; L Yamuah; M Delchambre; G Voss; B M Greenwood; A Hill; K P McAdam; N Tornieporth; J D Cohen; T Doherty
Journal:  Lancet       Date:  2001-12-08       Impact factor: 79.321

5.  Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria.

Authors:  K E Kester; D A McKinney; N Tornieporth; C F Ockenhouse; D G Heppner; T Hall; U Krzych; M Delchambre; G Voss; M G Dowler; J Palensky; J Wittes; J Cohen; W R Ballou
Journal:  J Infect Dis       Date:  2001-01-24       Impact factor: 5.226

6.  Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation.

Authors:  Vasee Moorthy; Zarifah Reed; Peter G Smith
Journal:  Vaccine       Date:  2007-02-02       Impact factor: 3.641

7.  A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants.

Authors:  Selidji Todagbe Agnandji; Bertrand Lell; José Francisco Fernandes; Béatrice Peggy Abossolo; Barbara Gaelle Nfono Ondo Methogo; Anita Lumeka Kabwende; Ayola Akim Adegnika; Benjamin Mordmüller; Saadou Issifou; Peter Gottfried Kremsner; Jahit Sacarlal; Pedro Aide; Miguel Lanaspa; John J Aponte; Sonia Machevo; Sozinho Acacio; Helder Bulo; Betuel Sigauque; Eusébio Macete; Pedro Alonso; Salim Abdulla; Nahya Salim; Rose Minja; Maxmillian Mpina; Saumu Ahmed; Ali Mohammed Ali; Ali Takadir Mtoro; Ali Said Hamad; Paul Mutani; Marcel Tanner; Halidou Tinto; Umberto D'Alessandro; Hermann Sorgho; Innocent Valea; Biébo Bihoun; Issa Guiraud; Berenger Kaboré; Olivier Sombié; Robert Tinga Guiguemdé; Jean Bosco Ouédraogo; Mary J Hamel; Simon Kariuki; Martina Oneko; Chris Odero; Kephas Otieno; Norbert Awino; Meredith McMorrow; Vincent Muturi-Kioi; Kayla F Laserson; Laurence Slutsker; Walter Otieno; Lucas Otieno; Nekoye Otsyula; Stacey Gondi; Allan Otieno; Victorine Owira; Esther Oguk; George Odongo; Jon Ben Woods; Bernhards Ogutu; Patricia Njuguna; Roma Chilengi; Pauline Akoo; Christine Kerubo; Charity Maingi; Trudie Lang; Ally Olotu; Philip Bejon; Kevin Marsh; Gabriel Mwambingu; Seth Owusu-Agyei; Kwaku Poku Asante; Kingsley Osei-Kwakye; Owusu Boahen; David Dosoo; Isaac Asante; George Adjei; Evans Kwara; Daniel Chandramohan; Brian Greenwood; John Lusingu; Samwel Gesase; Anangisye Malabeja; Omari Abdul; Coline Mahende; Edwin Liheluka; Lincoln Malle; Martha Lemnge; Thor G Theander; Chris Drakeley; Daniel Ansong; Tsiri Agbenyega; Samuel Adjei; Harry Owusu Boateng; Theresa Rettig; John Bawa; Justice Sylverken; David Sambian; Anima Sarfo; Alex Agyekum; Francis Martinson; Irving Hoffman; Tisungane Mvalo; Portia Kamthunzi; Rutendo Nkomo; Tapiwa Tembo; Gerald Tegha; Mercy Tsidya; Jane Kilembe; Chimwemwe Chawinga; W Ripley Ballou; Joe Cohen; Yolanda Guerra; Erik Jongert; Didier Lapierre; Amanda Leach; Marc Lievens; Opokua Ofori-Anyinam; Aurélie Olivier; Johan Vekemans; Terrell Carter; David Kaslow; Didier Leboulleux; Christian Loucq; Afiya Radford; Barbara Savarese; David Schellenberg; Marla Sillman; Preeti Vansadia
Journal:  N Engl J Med       Date:  2012-11-09       Impact factor: 91.245

Review 8.  A review of malaria vaccine clinical projects based on the WHO rainbow table.

Authors:  Lauren Schwartz; Graham V Brown; Blaise Genton; Vasee S Moorthy
Journal:  Malar J       Date:  2012-01-09       Impact factor: 2.979

9.  Efficacy and safety of the RTS,S/AS01 malaria vaccine during 18 months after vaccination: a phase 3 randomized, controlled trial in children and young infants at 11 African sites.

Authors: 
Journal:  PLoS Med       Date:  2014-07-29       Impact factor: 11.069

10.  Assessment of Pfs25 expressed from multiple soluble expression platforms for use as transmission-blocking vaccine candidates.

Authors:  Shwu-Maan Lee; Chia-Kuei Wu; Jordan Plieskatt; David H McAdams; Kazutoyo Miura; Chris Ockenhouse; C Richter King
Journal:  Malar J       Date:  2016-08-11       Impact factor: 2.979

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  17 in total

1.  Analysis of gene expression profiles to study malaria vaccine dose efficacy and immune response modulation.

Authors:  Supantha Dey; Harpreet Kaur; Mohit Mazumder; Elia Brodsky
Journal:  Genomics Inform       Date:  2022-09-30

Review 2.  [Malarial antigens in the era of mRNA vaccines].

Authors:  Yannick Borkens
Journal:  Monatsschr Kinderheilkd       Date:  2022-07-14       Impact factor: 0.416

3.  Strain-transcending neutralization of malaria parasite by antibodies against Plasmodium falciparum enolase.

Authors:  Sneha Dutta; Aneesha Tewari; Chinthapalli Balaji; Reena Verma; Anasuya Moitra; Mamta Yadav; Prakhar Agrawal; Dinkar Sahal; Gotam K Jarori
Journal:  Malar J       Date:  2018-08-20       Impact factor: 2.979

Review 4.  Are malaria elimination efforts on right track? An analysis of gains achieved and challenges ahead.

Authors:  Sunil Dhiman
Journal:  Infect Dis Poverty       Date:  2019-02-13       Impact factor: 4.520

Review 5.  Immune Responses to the Sexual Stages of Plasmodium falciparum Parasites.

Authors:  Jonas A Kengne-Ouafo; Colin J Sutherland; Fred N Binka; Gordon A Awandare; Britta C Urban; Bismarck Dinko
Journal:  Front Immunol       Date:  2019-02-11       Impact factor: 7.561

6.  Concentration and avidity of antibodies to different circumsporozoite epitopes correlate with RTS,S/AS01E malaria vaccine efficacy.

Authors:  Carlota Dobaño; Hèctor Sanz; Hermann Sorgho; David Dosoo; Maximilian Mpina; Itziar Ubillos; Ruth Aguilar; Tom Ford; Núria Díez-Padrisa; Nana Aba Williams; Aintzane Ayestaran; Ousmane Traore; Augusto J Nhabomba; Chenjerai Jairoce; John Waitumbi; Selidji Todagbe Agnandji; Simon Kariuki; Salim Abdulla; John J Aponte; Benjamin Mordmüller; Kwaku Poku Asante; Seth Owusu-Agyei; Halidou Tinto; Joseph J Campo; Gemma Moncunill; Ben Gyan; Clarissa Valim; Claudia Daubenberger
Journal:  Nat Commun       Date:  2019-05-15       Impact factor: 14.919

7.  A Hetero-Multimeric Chitinase-Containing Plasmodium falciparum and Plasmodium gallinaceum Ookinete-Secreted Protein Complex Involved in Mosquito Midgut Invasion.

Authors:  Kailash P Patra; Hargobinder Kaur; Surendra Kumar Kolli; Jacob M Wozniak; Judith Helena Prieto; John R Yates; David J Gonzalez; Chris J Janse; Joseph M Vinetz
Journal:  Front Cell Infect Microbiol       Date:  2021-01-08       Impact factor: 5.293

Review 8.  Malaria Vaccine Development: The Need for Novel Approaches: A Review Article.

Authors:  Shima Mahmoudi; Hossein Keshavarz
Journal:  Iran J Parasitol       Date:  2018 Jan-Mar       Impact factor: 1.012

9.  OX40 Stimulation Enhances Protective Immune Responses Induced After Vaccination With Attenuated Malaria Parasites.

Authors:  Ahmad Syibli Othman; Blandine M Franke-Fayard; Takashi Imai; Esmé T I van der Gracht; Anke Redeker; Ahmed M Salman; Catherin Marin-Mogollon; Jai Ramesar; Séverine Chevalley-Maurel; Chris J Janse; Ramon Arens; Shahid M Khan
Journal:  Front Cell Infect Microbiol       Date:  2018-07-19       Impact factor: 5.293

10.  Epitope Mapping and Fine Specificity of Human T and B Cell Responses for Novel Candidate Blood-Stage Malaria Vaccine P27A.

Authors:  Kristina M Geiger; Daniel Guignard; Che Yang; Jean-Pierre Bikorimana; Bruno E Correia; Sophie Houard; Catherine Mkindi; Claudia A Daubenberger; François Spertini; Giampietro Corradin; Régine Audran
Journal:  Front Immunol       Date:  2020-03-10       Impact factor: 7.561

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