Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial

Idoko, Olubukola T.; Mboizi, Robert; Okoye, Michael; Ceesay, Bubacarr; Liang, John Z.; Dren-Narayanin, Natacha Le; Jansen, Kathrin U.; Gurtman, Alejandra; Scott, Daniel A.; Kampmann, Beate; Roca, Anna

doi:10.1016/j.vaccine.2017.04.049

Cited by 11 publications

(4 citation statements)

References 24 publications

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“…This study was nested within a phase III randomized, openlabel trial aimed at evaluating the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine (PCV13) formulated in multi-dose vials given with routine pediatric vaccinations in healthy infants. 16 The adult female literacy rate in this setting is about 30% 17 and health-seeking behavior is governed by traditions rather than modern health care norm. 18 We also assessed factors associated with decay of knowledge of key information relating to the parent trial 19 during the 3 month follow-up period using a descriptive study design.…”

Section: Introductionmentioning

confidence: 99%

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia

Mboizi

Afolabi

Okoye

et al. 2017

Human Vaccines & Immunotherapeutics

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Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

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Section: Introductionmentioning

confidence: 99%

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia

Mboizi

Afolabi

Okoye

et al. 2017

Human Vaccines & Immunotherapeutics

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“…Table 1 reports details of the study arms included in the systematic review: nine were studied in Africa (Dicko et al, 2011;Idoko et al, 2017;Jones et al, 2013;Madhi et al, 2017a;Madhi et al, 2017b;Moisi et al, 2018), 26 in the Americas (Black et al, 2000;Bryant et al, 2010;Gutierrez Brito et al, 2013;Lagos et al, 2014;Payton et al, 2013;Pichichero et al, 2007;Rennels et al, 1998;Ruiz-Palacios et al, 2011;Scheifele et al, 2006;Shinefield et al, 1999;Tapiero et al, 2013;Yeh et al, 2010), 56 in Europe (Bermal et al, 2009;Diez-Domingo et al, 2013;Esposito et al, 2005;Esposito et al, 2010;Gadzinowski et al, 2011;Givon-Lavi et al, 2010;Goldblatt et al, 2018;Grimprel et al, 2011;Iro et al, 2015;Kayhty et al, 2005;Kieninger et al, 2010;Knuf et al, 2006;Martinon-Torres et al, 2015;Martinon-Torres et al, 2012;Moss et al, 2010;Olivier et al, 2008;Reinert et al, 2008;Rodgers et 2013; Schmitt et al, 2003;Silfverdal et al, 2009;Snape e...…”

Section: Resultsmentioning

confidence: 99%

Associations between geographic region and immune response variations to pneumococcal conjugate vaccines in clinical trials: A systematic review and meta-analysis

Choe

Blatt

Lee

et al. 2020

International Journal of Infectious Diseases

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Geographic region can be an important source of variation in the immune response to pneumococcal conjugate vaccines (PCV). The aim of this study was to collate data from available PCV clinical trials in order to characterize the differences in antibody responses in different countries. Methods: A systematic review and meta-analysis was conducted to examine the difference in antibody responses after primary series of PCVs in infants, associated with geographic regions, compared with each other and with the different PCVs using random-effects models. Results: A total of 69 trials were included. Studies conducted in the Western Pacific Region (WPR) showed higher geometric mean concentrations (GMC) compared to studies conducted in Europe. The pooled GMC for serotype 4 after three doses of PCV7 in the WPR was 5.19 mg/ml (95% confidence interval 4.85-5.53 mg/ml), while for studies conducted in Europe this was 2.01 mg/ml (95% confidence interval 1.88-2.14 mg/ml). The IgG GMC ratios among the WPR versus European regions ranged from 1.51 to 2.87 for PCV7, 1.69 to 3.22 for PCV10, and 1.49 to 3.08 for PCV13. Conclusions: Studies conducted in the WPR generally showed greater antibody responses than the studies conducted in Europe. Indications of differences among geographic regions highlight the fact that further research is needed to compare the biological factors contributing to immune responses, which may affect vaccination schedules.

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“…A multidose vial presentation (MDV) of PCV13 (PCV13 MDV, Pfizer, New York City, USA) that contains four doses has been prequalified by WHO and is eligible for Gavi support and therefore available at a reduced cost per dose [ 4 ]. Benin introduced this new presentation into its EPI in April 2018 with the financial support of Gavi and the strategic and technical support from WHO, UNICEF (United Nations International Children’s Emergency Fund) and the Agence de Médecine Préventive bureau Afrique (AMP).…”

Section: Introductionmentioning

confidence: 99%

“…Here we describe and analyse the decision-making process and vaccinators’ experiences when a new presentation of an established vaccine was introduced into the EPI in Benin [ 4 ]. The lessons learnt from this experience could guide others considering changing the presentation of an existing vaccine.…”

Section: Introductionmentioning

confidence: 99%

Introduction of multi-dose PCV 13 vaccine in Benin: from the decision to vaccinators experience

Alfa

Houngnihin

Ilboudo³

et al. 2020

BMC Public Health

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Background: In 2011, Benin introduced the 13-valent pneumococcal conjugated vaccine (PCV13), in a single-dose vial, into its Expanded Programme for Immunisation (EPI) with support from Gavi. In April 2018, with the support of the Agence de Médecine Préventive Afrique (AMP) and other technical and financial partners, the single-dose vial was transitioned to a four-dose vial. Here we describe the decision-making process and the experience of the vaccinators during the change. Methods: We carried out semi-structured, individual interviews with 61 participants individuals involved in the EPI: 7 from central level, 5 from regional level, 7 from township level and 42 from district level. The interviews were recorded and transcribed, and the information categorised, using Nvivo software, and then analysed. Results: The Inter-agency Coordination Committee (ICC), the Benin National Advisory Committee for Vaccines and Vaccination, (BNACVV) and the World Health Organisation (WHO) (i.e., the traditional governance structures involved in vaccination decisions) were not involved in the decision to change to the four-dose vial for PCV13. The decision was taken by the EPI, supported by Gavi. The vaccination errors observed in the first months following the change in presentation were due to the absence of guidelines for changes in vaccine presentation and the central-level actors' perception that it was 'only a change in the vial', and therefore that the communication and training for a new vaccine were not required since the vaccine itself and its administration mode were unchanged.

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Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial

Cited by 11 publications

References 24 publications

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia

Associations between geographic region and immune response variations to pneumococcal conjugate vaccines in clinical trials: A systematic review and meta-analysis

Introduction of multi-dose PCV 13 vaccine in Benin: from the decision to vaccinators experience

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