BACKGROUND: The development of a malaria vaccine remains a public health priority for sub-Saharan Africa. RTS,S/AS02A candidate malaria vaccine has been shown to be safe and immunogenic in previous studies in adults and staggered dose-escalation studies in children in The Gambia. However, genetic features and the intensity of malaria transmission may modify the safety and immune response of a vaccine. OBJECTIVE: We carried out a phase I, double-blind randomized controlled trial in 60 children aged 1-4 in Mozambique to evaluate thesafety, reactogenicity and immunogenicity of the paediatric vaccine dose (fixed 25 microg RTS,S in 0.25 ml) of RTS,S/AS02A, prior to undertaking a planned larger phase IIb proof-of-concept of efficacy study in the same population. METHOD: Children were randomized to receive either RTS,S/AS02A or Engerix-B vaccine. Monitoring of safety and reactogenicity included detailed clinical and laboratory analyses and assessment of adverse events (AEs). RESULTS: The RTS,S/AS02A was found to be safe and well tolerated. Serious adverse events were balanced between both groups and none was related to vaccination. The frequency of adverse events reported with RTS, S/AS02A was comparable to previous studies in children. Grade 3 AEs were infrequent (one case of pain, one of fever in each group and some swelling greater than 20 mm in diameter), transient and resolved without sequelae. RTS,S/AS02A was highly immunogenic for anti-circumsporozoite protein antibody response and induced a strong anti-hepatitis-B surface antigen response.
RCT Entities:
BACKGROUND: The development of a malaria vaccine remains a public health priority for sub-Saharan Africa. RTS,S/AS02A candidate malaria vaccine has been shown to be safe and immunogenic in previous studies in adults and staggered dose-escalation studies in children in The Gambia. However, genetic features and the intensity of malaria transmission may modify the safety and immune response of a vaccine. OBJECTIVE: We carried out a phase I, double-blind randomized controlled trial in 60 children aged 1-4 in Mozambique to evaluate the safety, reactogenicity and immunogenicity of the paediatric vaccine dose (fixed 25 microg RTS,S in 0.25 ml) of RTS,S/AS02A, prior to undertaking a planned larger phase IIb proof-of-concept of efficacy study in the same population. METHOD:Children were randomized to receive either RTS,S/AS02A or Engerix-B vaccine. Monitoring of safety and reactogenicity included detailed clinical and laboratory analyses and assessment of adverse events (AEs). RESULTS: The RTS,S/AS02A was found to be safe and well tolerated. Serious adverse events were balanced between both groups and none was related to vaccination. The frequency of adverse events reported with RTS, S/AS02A was comparable to previous studies in children. Grade 3 AEs were infrequent (one case of pain, one of fever in each group and some swelling greater than 20 mm in diameter), transient and resolved without sequelae. RTS,S/AS02A was highly immunogenic for anti-circumsporozoite protein antibody response and induced a strong anti-hepatitis-B surface antigen response.
Authors: Pedro Aide; John J Aponte; Montse Renom; Tacilta Nhampossa; Jahit Sacarlal; Inacio Mandomando; Quique Bassat; Maria Nélia Manaca; Amanda Leach; Marc Lievens; Johan Vekemans; Marie-Claude Dubois; Christian Loucq; W Ripley Ballou; Joe Cohen; Pedro L Alonso Journal: PLoS One Date: 2010-11-04 Impact factor: 3.240
Authors: Arnoldo Barbosa; Denise Naniche; John J Aponte; M Nelia Manaca; Inacio Mandomando; Pedro Aide; Jahit Sacarlal; Montse Renom; Sarah Lafuente; W Ripley Ballou; Pedro L Alonso Journal: Infect Immun Date: 2009-08-03 Impact factor: 3.441
Authors: Daniel Ansong; Kwaku P Asante; Johan Vekemans; Sandra K Owusu; Ruth Owusu; Naana A W Brobby; David Dosoo; Alex Osei-Akoto; Kingsley Osei-Kwakye; Emmanuel Asafo-Adjei; Kwadwo O Boahen; Justice Sylverken; George Adjei; David Sambian; Stephen Apanga; Kingsley Kayan; Michel H Janssens; Marc J J Lievens; Aurelie C Olivier; Erik Jongert; Patrice Dubois; Barbara M Savarese; Joe Cohen; Sampson Antwi; Brian M Greenwood; Jennifer A Evans; Tsiri Agbenyega; Philippe J Moris; Seth Owusu-Agyei Journal: PLoS One Date: 2011-04-27 Impact factor: 3.240
Authors: Seth Owusu-Agyei; Daniel Ansong; Kwaku Asante; Sandra Kwarteng Owusu; Ruth Owusu; Naana Ayiwa Wireko Brobby; David Dosoo; Alex Osei Akoto; Kingsley Osei-Kwakye; Emmanuel Asafo Adjei; Kwadwo Owusu Boahen; Justice Sylverken; George Adjei; David Sambian; Stephen Apanga; Kingsley Kayan; Johan Vekemans; Opokua Ofori-Anyinam; Amanda Leach; Marc Lievens; Marie-Ange Demoitie; Marie-Claude Dubois; Joe Cohen; W Ripley Ballou; Barbara Savarese; Daniel Chandramohan; John Owusu Gyapong; Paul Milligan; Sampson Antwi; Tsiri Agbenyega; Brian Greenwood; Jennifer Evans Journal: PLoS One Date: 2009-10-02 Impact factor: 3.240
Authors: Mark E Polhemus; Shon A Remich; Bernhards R Ogutu; John N Waitumbi; Lucas Otieno; Stella Apollo; James F Cummings; Kent E Kester; Christian F Ockenhouse; Ann Stewart; Opokua Ofori-Anyinam; Isabelle Ramboer; Conor P Cahill; Marc Lievens; Marie-Claude Dubois; Marie-Ange Demoitie; Amanda Leach; Joe Cohen; W Ripley Ballou; D Gray Heppner Journal: PLoS One Date: 2009-07-31 Impact factor: 3.240