Safety profile of the 10-valent pneumococcal non-typeable <i>Haemophilus influenzae</i> protein D conjugate vaccine (PHiD-CV)

Silfverdal, Sven‐Arne; Coremans, Vanessa; François, Nancy; Borys, Dorota; Cleerbout, Jan

doi:10.1586/14760584.2016.1164044

Cited by 9 publications

(9 citation statements)

References 39 publications

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“…PHiD-CV was generally well tolerated with most adverse events being mild, self-limiting and within the ranges reported in other studies. 24 However, a higher proportion of children in the PHiD-CV group reported pain following both doses of vaccine compared to the MenACYW 135 group and it was the only reaction that increased in severity following the second vaccine dose. The most plausible explanation for this finding is that PHiD-CV contains an alum adjuvant, as do other PCVs (PCV7 and PCV13), and PPV23, while the MenACYW 135 vaccine used in this study does not.…”

Section: Discussionmentioning

confidence: 90%

The clinical, immunological and microbiological impact of the 10-valent pneumococcal-Protein D conjugate vaccine in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: A multi-centre, double-blind, randomised controlled trial

O'Grady

Chang

Cripps

et al. 2018

Human Vaccines & Immunotherapeutics

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We aimed to determine the efficacy of the 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in children aged 18-months to <18-years with recurrent protracted bacterial bronchitis (rPBB), chronic suppurative lung disease (CSLD) or bronchiectasis. In a multi-centre, double-blind randomised controlled trial, children received two doses, 2-months apart of the 10vPHiD-CV or quadrivalent meningococcal-ACYW conjugate vaccine. Active surveillance for acute exacerbations, respiratory symptoms and antibiotic use was undertaken through to 12-months after the second vaccine dose (clinical cohort only). Serum, saliva and nasopharyngeal swabs were collected to measure immunological and microbiological effects (immunology cohort). Between December 2012 and August 2015, 62 children were enrolled onto the clinical protocol (1 excluded from clinical analyses due to unblinding), while 74 contributed to the immunology cohort (overall mean age = 6.8-years (standard deviation = 3.7), 42 (56.8%) male). The absolute risk difference comparing the 10vPHiD-CV group (n = 31 children) to the MenACYW group (n = 30 children) for acute exacerbations was -0.5 exacerbations/100-weeks at risk (95% confidence interval (CI) -2.0, 0.9). Compared to the MenACYW group, children who received the 10vPHiD-CV were less likely to have respiratory symptoms in each fortnight of surveillance (incidence density ratio (IDR) 0.82, 95%CI 0.61, 1.10) and required fewer short-course (<14-days duration) antibiotics (IDR 0.81, 95% CI 0.61, 1.09). The vaccine was immunogenic and no serious adverse events related to the vaccine were reported. In conclusion, 10vPHiD-CV might have a future role in managing children with rPBB, CSLD and bronchiectasis, but larger multicentre trials are needed to confirm or refute findings from this preliminary study.

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Section: Discussionmentioning

confidence: 90%

The clinical, immunological and microbiological impact of the 10-valent pneumococcal-Protein D conjugate vaccine in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: A multi-centre, double-blind, randomised controlled trial

O'Grady

Chang

Cripps

et al. 2018

Human Vaccines & Immunotherapeutics

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“…Both vaccines are considered to have an acceptable safety profile and serious adverse events (SAE) are estimated to be rare [ 67 , 68 ]. Hence, we have not considered the impact of SAEs in our analysis.…”

Section: Methodsmentioning

confidence: 99%

A Cost-Effectiveness Analysis of the 10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Compared to the 13-Valent Pneumococcal Conjugate Vaccine (PCV13) for Universal Mass Vaccination Implementation in New Zealand

Varghese

Talbot²,

Govender³

et al. 2018

Appl Health Econ Health Policy

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ObjectivesInvasive pneumococcal disease (IPD), pneumonia and acute otitis media (AOM) still represent a significant medical burden in children < 5 years of age in New Zealand (NZ), with marked disparities across socio-economic and ethnic groups. This cost-effectiveness evaluation aims to compare the potential impact of two childhood universal immunisation strategies: vaccination with a 3 + 1 schedule of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, Synflorix, GSK) and the 13-valent pneumococcal conjugate vaccine (PCV13, Prevenar 13, Pfizer).MethodsA static Markov-process cohort model was used to simulate the epidemiological and economic burden of pneumococcal diseases on a single-birth cohort over its lifetime. Costs and outcomes were discounted annually at 3.5%. Epidemiological and cost inputs were extracted from the most recently available NZ data, or derived from the most relevant reference countries’ sources. The most updated evidence on the efficacies of the corresponding vaccines were used, particularly the significant effectiveness for PHiD-CV against IPD caused by serotype 19A.ResultsThe model estimated that both vaccines have a broadly comparable impact on IPD-related diseases and pneumonia. Due to the additional benefits possible through broader impact on AOM, PHiD-CV is estimated to potentially provide additional discounted cost offsets of approximately NZD 0.8 million over the lifetime of the birth cohort.ConclusionsTo ensure health equity in children, given the substantial burden of pneumonia and AOM, decision-makers should also take into account the impact of PCVs on these diseases for decisions relating to routine infant immunization.GSK study identifierHO-15-16775.Electronic supplementary materialThe online version of this article (10.1007/s40258-018-0387-5) contains supplementary material, which is available to authorized users.

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“…In clinical trials, both 11Pn-PD [68,69] and PHiD-CV [70,71] vaccines were shown to have acceptable safety profiles and induce robust immune responses against pneumococcal serotype-specific polysaccharides and protein D. In certain studies, efficacy of these formulations against NTHi AOM [72,73] and nasopharyngeal carriage [67,[74][75][76][77] was evaluated.…”

Section: Clinical Efficacy Of the Pneumococcal Nthi Protein D Conjugamentioning

confidence: 99%

Impact of protein D-containing pneumococcal conjugate vaccines on non-typeableHaemophilus influenzaeacute otitis media and carriage

Clarke

Bakaletz

Ruiz‐Guiñazú

et al. 2017

Expert Review of Vaccines

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Protein D-containing vaccines may decrease acute otitis media (AOM) burden and nasopharyngeal carriage of non-typeable Haemophilus influenzae (NTHi). Protein D-containing pneumococcal conjugate vaccine PHiD-CV (Synflorix, GSK Vaccines) elicits robust immune responses against protein D. However, the phase III Clinical Otitis Media and PneumoniA Study (COMPAS), assessing PHiD-CV efficacy against various pneumococcal diseases, was not powered to demonstrate efficacy against NTHi; only trends of protective efficacy against NTHi AOM in children were shown. Areas covered: This review aims to consider all evidence available to date from pre-clinical and clinical phase III studies together with further evidence emerging from post-marketing studies since PHiD-CV has been introduced into routine clinical practice worldwide, to better describe the clinical utility of protein D in preventing AOM due to NTHi and its impact on NTHi nasopharyngeal carriage. Expert commentary: Protein D is an effective carrier protein in conjugate vaccines and evidence gathered from pre-clinical, clinical and observational studies suggest that it also elicits immune response that can help to reduce the burden of AOM due to NTHi. There remains a need to develop improved vaccines for prevention of NTHi disease, which could be achieved by combining protein D with other antigens.

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Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Cited by 9 publications

References 39 publications

The clinical, immunological and microbiological impact of the 10-valent pneumococcal-Protein D conjugate vaccine in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: A multi-centre, double-blind, randomised controlled trial

The clinical, immunological and microbiological impact of the 10-valent pneumococcal-Protein D conjugate vaccine in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: A multi-centre, double-blind, randomised controlled trial

A Cost-Effectiveness Analysis of the 10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Compared to the 13-Valent Pneumococcal Conjugate Vaccine (PCV13) for Universal Mass Vaccination Implementation in New Zealand

Impact of protein D-containing pneumococcal conjugate vaccines on non-typeableHaemophilus influenzaeacute otitis media and carriage

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