Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States

Senders, Shelly; Klein, Nicola P.; Lamberth, Erik; Thompson, Allison; Drozd, Jelena; Trammel, James; Peng, Yahong; Giardina, Peter C.; Jansen, Kathrin U.; Gruber, William C.; Scott, Daniel A.; Watson, Wendy

doi:10.1097/inf.0000000000003277

Cited by 41 publications

(37 citation statements)

References 23 publications

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“…The response rates after a four-dose series for common serotype 6B and additional serotype 3 were lower than for other serotypes, which was consistent with our findings ( Ruiz-Aragón et al, 2013 ). It was also reported that in the immunogenicity of newly developed PCV20, the GMCs of 6B and 3 were lower than those in PCV13 ( Senders et al, 2021 ). However, we cannot completely understand the lower immunogenicity of serotypes 6B and 3.…”

Section: Discussionmentioning

confidence: 89%

Immunogenicity and Safety of a Novel 13-Valent Pneumococcal Vaccine in Healthy Chinese Infants and Toddlers

Zhao

Li²,

Xia

et al. 2022

Front. Microbiol.

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BackgroundTo determine the non-inferiority of the seven common serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in the 13-valent pneumococcal conjugate vaccine (PCV13) with each serotype conjugated to a tetanus toxoid carrier protein and adsorbed on aluminum phosphate and the superiority of its six additional serotypes (1, 3, 5, 6A, 7F, and 19A) to the serotypes in the PCV7.MethodsParticipants were evenly randomized in a 1:1 ratio into either the PCV13 or PCV7 groups, to receive three doses of the vaccine at the age of 3, 4, and 5 months, respectively, and a booster dose between 12 and 15 months of age. Serotype-specific antibodies were measured using a standardized enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic activity (OPA) microcolony assay method.ResultsA total of 1,040 healthy infants were enrolled. All the seven common serotypes in the PCV13 were non-inferior to those in the PCV7 in terms of the serotype-specific IgG production induced; however, non-inferiority was not shown for serotype 6B after the infant series. The proportion of subjects who reached OPA antibody titers ≥ 1:8 in the PCV13 group was 89.25% or higher. Local reactions and systemic events were mild or moderate in severity and similar between the two groups. No new safety signals were observed.ConclusionThe newly developed PCV13 was immunogenic for all serotypes and had a comparable safety profile to the marketed PCV7.

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Section: Discussionmentioning

confidence: 89%

Immunogenicity and Safety of a Novel 13-Valent Pneumococcal Vaccine in Healthy Chinese Infants and Toddlers

Zhao

Li²,

Xia

et al. 2022

Front. Microbiol.

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“…10,11,18-89 18 studies (20 publication records) were excluded from the analysis: 6 studies did not provide individual patient or aggregate data, [70][71][72][73] and 12 studies (14 publication records) were head-to-head studies with the vaccines of interest, but it was not possible to form a loop within the network meta-analysis to provide indirect evidence (See Supplementary Figure 1 and Supplementary Table 2). [74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89] Of these 12 studies, 8 reported results from different PCVs including a new Cuban PCV7, PCV10-SII, PCV11, PCV12, a Chinese PCV13, PCV14, PCV15, PCV20, PCV24 and PCV SP0202-VI. The remaining 27 studies (53 publication records) from 2009 to 2022 were included in the network meta-analyses.…”

Section: Search Resultsmentioning

confidence: 99%

Immunogenicity and seroefficacy of pneumococcal conjugate vaccines – a systematic review and network meta-analysis

Feng

McLellan

Pidduck

et al. 2023

Preprint

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Background Vaccination of infants with pneumococcal conjugate vaccines (PCV) is recommended by the World Health Organisation. Evidence is mixed regarding the differences in immunogenicity and efficacy of the different pneumococcal vaccines. Methods In this systematic-review and network meta-analysis, we searched the Cochrane Library, Embase, Global Health, Medline, clinicaltrials.gov and trialsearch.who.int up to July 2022 (Protocol PROSPERO ID CRD42019124580). Studies were eligible if they presented data comparing the immunogenicity of either PCV7, PCV10 or PCV13 in head-to-head randomised trials for young children, and provided at least one time point after the primary vaccination series and/or one-month after a booster dose. Individual participant level data were requested from publication authors and/or the relevant vaccine manufacturer; aggregate data were extracted if individual data were unavailable. Outcomes included the geometric mean ratio (GMR) of serotype-specific IgG and relative risk (RR) of seroinfection. Seroinfection is defined as a rise in antibody between the primary vaccination series and the booster dose, as evidence of subclinical infection. We also estimated the relationship between the GMR one month after priming and the RR of seroinfection by the time of the booster dose. Findings In total 45 studies were eligible from 38 countries across six continents. 27 and 12 studies with data available were included in immunogenicity and seroefficacy analyses respectively. GMRs comparing PCV13 vs PCV10 favoured PCV13 for serotypes 4, 9V, and 23F at 1 month after primary vaccination series, with 1.14- to 1.54- fold significantly higher IgG responses with PCV13. Risk of seroinfection prior to the time of booster dose was lower for PCV13 for serotype 4, 6B, 9V, 18C and 23F than for PCV10. Two-fold higher antibody after primary vaccination was associated with 54% decrease in risk of seroinfection (RR 0.46, 95%CI 0.23-0.96). Conclusion Serotype-specific differences were found in immunogenicity and seroefficacy between PCV10 and PCV13. Higher immunogenicity of PCVs are associated with lower risk of subsequent infection. These findings could be further used to compare PCVs and optimise vaccination strategy.

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“…Generally, other disease endpoints including non-bacteraemic pneumonia may also be important for vaccine choice e.g., PCV13 is shown to be more efficacious in preventing VT non-bacteraemic pneumonia than PPV23 (46% vs 21%) [2], and if included in this analysis, it may likely heighten PCV13 impact to similar levels or higher than PPV23 in England, albeit with higher vaccine cost. With the likely upcoming use of PCV15 and PCV20 in infants in the near future [39], the vaccine preventable fraction of adult disease is likely to diminish correspondingly because of the indirect effects of such infant programme, and thus reducing the benefit of adult programmes that target the same serotypes as those targeted in infants. On the other hand, PCV21 targets most serotypes not targeted by PPV23 or PCV20 [40], which could likely improve tackling the remaining burden of pneumococcal disease in older adults, in the long absence of vaccines that target surface proteins common to all serotypes [41].…”

Section: Discussionmentioning

confidence: 99%

Optimal age targeting for pneumococcal vaccination in older adults; a modelling study

Thindwa

Clifford

Kleynhans

et al. 2022

Preprint

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Background Invasive pneumococcal disease (IPD) risk increases with age for older adults whereas the population size benefiting from pneumococcal vaccines and the robustness of the immunogenic response to vaccination decline. This poses a conundrum for identifying the optimal age for vaccination. We estimate how demographics, vaccine efficacy/effectiveness (VE), and waning VE impact on optimal age for single-dose pneumococcal vaccination. Methods Age- and vaccine-serotype-stratified IPD incidence from routine surveillance of adults ≥55 years old (y) in Brazil, England, Blantyre (Malawi), and South Africa, ≥4-years after infant-pneumococcal vaccine introduction and before 2020, was used to parameterise exponential growth models of increasing IPD risk with age. A piecewise-constant model estimated VE and waning VE from prior studies. All estimates were then combined in a cohort model to assess the vaccine preventable IPD burden of delivering 13-, 15-, 20-valent conjugate or 23-valent polysaccharide vaccines at various ages. Findings In Brazil, Malawi, South Africa and England 51%, 51%, 54% and 39% of adults older than 55y were younger than 65y old. A smaller share of IPD was reported among adults <65y old in England (4,657 annual cases; 20% <65y) compared to Brazil (186; 45%), Malawi (4; 63%), or South Africa (134, 48%). PCV13- and PPV23-serotypes were estimated to cause 39% and 85% of IPD cases on average across settings. Vaccination at 55y in Brazil, Malawi, and South Africa, and at 70y in England had the greatest potential for IPD prevention with 38%, 31%, 27%, 8% of IPD preventable if using PCV13, 44%, 32%, 30%, 13% with PCV15, 65%, 69%, 53%, 37% with PCV20, and 30%, 29%, 20%, 14% with PPV23, respectively. Vaccination efficiency or cost effective use was optimal in 60-65y in Brazil, Malawi and South Africa, and in 80-85y in England. Interpretation In low/middle-income countries, pneumococcal vaccines may prevent a substantial proportion of the residual IPD burden if administered earlier in adulthood than is typical in high-income countries.

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Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States

Abstract: Supplemental Digital Content is available in the text.

Cited by 41 publications

References 23 publications

Immunogenicity and Safety of a Novel 13-Valent Pneumococcal Vaccine in Healthy Chinese Infants and Toddlers

Immunogenicity and Safety of a Novel 13-Valent Pneumococcal Vaccine in Healthy Chinese Infants and Toddlers

Immunogenicity and seroefficacy of pneumococcal conjugate vaccines – a systematic review and network meta-analysis

Optimal age targeting for pneumococcal vaccination in older adults; a modelling study

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