Miller from the National Vaccine Evaluation Consortium (NVEC) for

Miller from the National Vaccine Evaluation Consortium (NVEC) for the HPV vaccine Cervarix® used in this study, Professor J.V. CH5424802 mw Parry (PHE) for helpful discussion and Nicky Jones and Kate Breed (NIBSC) for technical support. Conflict of

interest statement: The authors declare no conflicts of interest. “
“The RTS,S/AS01 candidate malaria vaccine targets the Plasmodium falciparum circumsporozoite (CS) protein, therefore acting at the pre-erythrocytic stage of the parasite life cycle [1]. This is a partially efficacious vaccine, which has shown protection against both clinical and severe malaria in young children and infants in a large phase 3 trial in Africa [2] and [3], and has an acceptable safety profile when co-administered with vaccines included in the routine Expanded Programme on Immunization [2], [3] and [4]. For regulatory approval of a new vaccine, it is necessary to demonstrate the quality of the manufacturing

process, including consistency in the manufacturing of vaccine lots [5], [6] and [7]. The assessment is expected to be performed in confirmatory immunogenicity studies using two-sided equivalence trials [8] and [9]. This study evaluated the consistency and safety of three different RTS,S/AS01 vaccine lots formulated from commercial-scale purified antigen bulk lots. The co-primary objectives were to demonstrate lot-to-lot consistency in terms of anti-CS antibody responses and, if reached, subsequently to demonstrate non-inferiority of the commercial-scale lots to a RTS,S/AS01 vaccine lot derived from pilot-scale purified

antigen bulk material. This was a phase III, randomized, double-blind study (, NCT01323972) conducted at two sites between May 2011 and May 2012: University of Nigeria Teaching Hospital in Enugu, which is located in south-east Nigeria, and Jos University Teaching Hospital in Jos, which of is in north-central Nigeria. The production scale of the RTS,S purified bulk antigen was increased from 20 litres-fermentation (pilot-plant scale, produced in January 2010; hereafter referred to as pilot-scale lot) to 1600 litres-fermentation (commercial-scale scale in commercial facilities, produced in October/November 2010; hereafter referred to as commercial-scale lots). The same starting material was used at both manufacturing scales, and the components of the final vaccine, including the adjuvant system, remained identical. Eligible children were randomized (1:1:1:1) to receive one of three different commercial-scale lots (lot 1, 2 or 3) or the pilot-scale lot (comparator) of RTS,S/AS01 vaccine according to a 0, 1 and 2 month schedule. A randomization list was generated by the study sponsor via an internet-based system, and treatment allocation at each site was performed using MATEX, a program developed for Statistical Analysis System (SAS®; Cary, NC, USA).

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