Safety and immunogenicity of a novel 10-valent pneumococcal conjugate vaccine candidate in adults, toddlers, and infants in The Gambia—Results of a phase 1/2 randomized, double-blinded, controlled trial

Clarke, Ed; Bashorun, Adedapo Olufemi; Okoye, Michael; Umesi, Ama; Hydara, Mariama Badjie; Adigweme, Ikechukwu; Dhere, Rajeev; Sethna, Vistasp; Kampmann, Beate; Green, David; Tate, Andi; Weiner, Donald A.; Flores, Jorge; Alderson, Mark R.; Lamola, Steve

doi:10.1016/j.vaccine.2019.08.072

Cited by 22 publications

(20 citation statements)

References 35 publications

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“…In this study, one month after vaccination, PCV7 showed to induce an immune response greater than PPV23 in COPD, with lower efficacy rates in elderly subjects and previous PPV23 vaccinated [ 88 ]. An interesting and recent study evaluated the immunogenicity and safety of PCV13 in 74 PPV23 naïve patients and 58 previously immunized PPV23 patients (>1 year ago) with severe (stage 4–5) chronic kidney disease (CKD) [ 89 ]. The authors quantified specific serum IgG, IgM, and IgA for seven serotypes, at baseline, 4 weeks, and one year after vaccination.…”

Section: Immunological Features: the Immune Response To The Vaccinementioning

confidence: 99%

“…A very recent RCT performed in Gambia compared the immunogenicity and safety of a new ten-valent PCV (SIIPL-PCV) containing serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F with the PCV13 vaccine [ 89 ]. The immunogenicity of SIIPL-PCV was lower than that of PCV13, for which there are numerous data on efficacy and safety against pneumococcal disease.…”

Section: Immunological Features: the Immune Response To The Vaccinementioning

confidence: 99%

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Pneumonia and Invasive Pneumococcal Diseases: The Role of Pneumococcal Conjugate Vaccine in the Era of Multi-Drug Resistance

et al. 2021

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Streptococcus pneumoniae related diseases are a leading cause of morbidity and mortality, especially in children and in the elderly population. It is transmitted to other individuals through droplets and it can spread to other parts of the human host, causing a wide spectrum of clinical syndromes, affecting between 10 and 100 cases per 100,000 people in Europe and the USA. In order to reduce morbidity and mortality caused by this agent, pneumococcal vaccines have been developed over the years and have shown incredible effectiveness in reducing the spread of this bacterium and the development of related diseases, obtaining a significant reduction in mortality, especially in developing countries. However, considerable problems are emerging mainly due to the replacement phenomenon, multi-drug resistance, and the high production costs of conjugated vaccines. There is still a debate about the indications given by various countries to different age groups; this is one of the reasons for the diffusion of different serotypes. To cope with these problems, significant efforts have been made in the research field to further improve vaccination serotypes coverage. On the other hand, an equally important commitment by health care systems to all age group populations is needed to improve vaccination coverage.

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Section: Immunological Features: the Immune Response To The Vaccinementioning

confidence: 99%

Section: Immunological Features: the Immune Response To The Vaccinementioning

confidence: 99%

Pneumonia and Invasive Pneumococcal Diseases: The Role of Pneumococcal Conjugate Vaccine in the Era of Multi-Drug Resistance

et al. 2021

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“…IPA Diseases and Functions also showed reduced significance and z scores on day 7 for Inflammatory response (−log 10 p value 110.7 to 59.8, z-score 7.7 to 5.5) and Chronic inflammatory disorder (−log 10 p value 70.1 to 38.1, z-score −0.23 to −2.2) (S2L Table). These analyses again argue that inflammation at the injection site is abating on day 7, with persistent inflammation at the injection site generally deemed undesirable in most vaccination settings (Clarke et al ., 2020; Lee et al ., 2008; Wang et al ., 2014).…”

Section: Resultsmentioning

confidence: 96%

Systems vaccinology analysis of a recombinant vaccinia-based vector reveals diverse innate immune signatures at the injection site

Hazlewood

Dumenil

et al. 2020

Preprint

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Poxvirus systems have been extensively used as vaccine vectors. Herein a systems vaccinology analysis of intramuscular injection sites provides detailed insights into host innate immune responses, as well as expression of vector and recombinant immunogen genes, after vaccination with a new multiplication defective, vaccinia-based vector, Sementis Copenhagen Vector. Chikungunya and Zika virus immunogen mRNA and protein expression was associated with necrosing skeletal muscle cells surrounded by mixed cellular infiltrates. Adjuvant signatures at 12 hours post-vaccination were dominated by TLR3, 4 and 9, STING, MAVS, PKR and the inflammasome. Th1 cytokine signatures were dominated by IFNγ, TNF and IL1β, and chemokine signatures by CCL5 and CXCL12. Multiple signatures associated with dendritic cell stimulation were evident. By day seven, vaccine transcripts were absent, and cell death, neutrophil, macrophage and inflammation annotations had abated. No compelling arthritis signatures were identified. Such innate systems vaccinology approaches should inform refinements in poxvirus-based vector design.

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“…As far as we are aware, only one other study has reported on PCV safety and immunogenicity in adults living in a high endemicity setting. Seventeen adults aged 18-40 years old were vaccinated with a candidate 10-valent PCV as part of a phase 1/2 trial in the Gambia but whether, or how many of these adults were males or females was not reported [24]. Local and systemic side effects were reported to be mild but data itself were not shown.…”

Section: Discussionmentioning

confidence: 99%

An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea

et al. 2020

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Background Maternal immunization with pneumococcal conjugate vaccine (PCV) may protect young infants in high-risk settings against the high risk of pneumococcal infections in early life. The aim of this study was to determine the safety and immunogenicity of 13-valent PCV (PCV13) in healthy women of childbearing age in PNG. Methods As part of this observational study, 50 non-pregnant women of childbearing age (18-45 yrs. old) living in the highlands of PNG were vaccinated with a single dose of PCV13. Local and systemic reactogenicity were assessed 24–48 h after vaccination. Venous blood samples were collected before and 1 month after vaccination to measure PCV13 serotype-specific IgG antibody concentrations. Results No severe adverse effects were reported during the 1-month follow-up period. IgG antibody concentrations significantly increased after vaccination for all PCV13 serotypes. One month after vaccination IgG antibody levels ≥2.5 μg/mL were reached in at least 75% of women for all PCV13 serotypes, except serotype 3, and ≥ 5 μg/mL in at least 75% of women for 7 serotypes (serotypes 6B, 9 V, 14, 18C, 19A, 19F and 23F). Conclusion PCV13 is safe and immunogenic in women of childbearing age living in a high-risk setting in PNG. This supports the implementation of studies to investigate the safety and immunogenicity of maternal PCV vaccination in high-risk settings as a strategy to protect infants in these settings against the high risk of pneumococcal infections in early life. Trial registration NCT04183322. Registered 3 December 2019 - Retrospectively registered

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Safety and immunogenicity of a novel 10-valent pneumococcal conjugate vaccine candidate in adults, toddlers, and infants in The Gambia—Results of a phase 1/2 randomized, double-blinded, controlled trial

Cited by 22 publications

References 35 publications

Pneumonia and Invasive Pneumococcal Diseases: The Role of Pneumococcal Conjugate Vaccine in the Era of Multi-Drug Resistance

Pneumonia and Invasive Pneumococcal Diseases: The Role of Pneumococcal Conjugate Vaccine in the Era of Multi-Drug Resistance

Systems vaccinology analysis of a recombinant vaccinia-based vector reveals diverse innate immune signatures at the injection site

An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea

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