scholarly journals Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18–49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY)

2021 ◽  
Author(s):  
Laura L Hammitt ◽  
Dean Quinn ◽  
Ewa Janczewska ◽  
Francisco J Pasquel ◽  
Richard Tytus ◽  
...  
Keyword(s):  
Risk Factors ◽  
Conjugate Vaccine ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Geometric Mean ◽  
Behavioral Risk ◽  
Phase 3 ◽  
Increased Risk ◽  
Sequential Administration ◽  
Immunocompetent Adults

Abstract Background Adults with certain medical and behavioral factors are at increased risk for pneumococcal disease (PD). Sequential vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for at-risk adults in some countries. Methods This phase 3 trial evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 6 months later by PPSV23, in immunocompetent adults aged 18–49 years with or without pre-defined risk factors for PD (NCT03547167). Overall, 1515 participants were randomized 3:1 to receive either V114 or PCV13, followed by PPSV23. Results Most common solicited adverse events (AEs) following administration of V114 or PCV13 as well as PPSV23 were injection-site pain and fatigue. The proportion of participants with AEs was comparable in both groups. V114 and PCV13 were immunogenic based on opsonophagocytic activity (OPA) geometric mean titers (GMTs) 30 days post-vaccination for all serotypes contained in each respective vaccine. OPA GMTs to the 2 unique serotypes in V114 were robust in the V114 group. PPSV23 was immunogenic for all 15 serotypes contained in V114 in both vaccination groups, including 22F and 33F. Conclusions V114 administered alone or sequentially with PPSV23 is well tolerated and immunogenic for all 15 serotypes, including those not contained in PCV13, in immunocompetent adults aged 18–49 years with or without certain medical or behavioral risk factors for PD.

scholarly journals Schedules for Pneumococcal Vaccination of Preterm Infants: An RCT

2018 ◽  
pp. 18-32
Author(s):  
Alison Kent ◽  
Shamez N. Ladhani ◽  
Nick J. Andrews ◽  
Tim Scorrer ◽  
Andrew J. Pollard ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Premature Infants ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Geometric Mean ◽  
Pneumococcal Vaccination ◽  
Booster Vaccination ◽  
Vaccine Schedule

BACKGROUND AND OBJECTIVE Premature infants have a higher risk of invasive pneumococcal disease and are more likely to have lower vaccine responses compared with term infants. Increasingly, immunization schedules are including a reduced, 2-dose, pneumococcal conjugate vaccine priming schedule. Our goal was to assess the immunogenicity of 3 commonly used 13-valent pneumococcal conjugate vaccine (PCV13) priming schedules in premature infants and their response to a 12-month booster dose. METHODS Premature infants (<35 weeks’ gestation) were randomized to receive PCV13 at 2 and 4 months (reduced schedule); 2, 3, and 4 months (accelerated schedule); or 2, 4, and 6 months (extended schedule). All infants received a 12-month PCV13 booster. Serotype-specific pneumococcal immunoglobulin G (IgG) for PCV13 serotypes was measured by using enzyme-linked immunosorbent assay 1 month after the primary and booster vaccinations. RESULTS A total of 210 infants (median birth gestation, 29+6 weeks; range, 23+2–34+6 weeks) were included. After the primary vaccination, 75% (95% confidence interval [CI], 62–85), 88% (95% CI, 76–95), and 97% (95% CI, 87–99) of participants had protective antibody concentrations for at least one-half the PCV13 serotypes for the reduced, accelerated, and extended schedules, respectively. After the booster vaccination, participants receiving the extended schedule had significantly lower (P < .05) geometric mean concentrations compared with reduced (for 9 of 13 serotypes) and accelerated (for 4 of 13 serotypes) schedules, but nearly all participations, regardless of schedule or serotype, had seroprotective IgG concentrations. CONCLUSIONS A reduced priming schedule of PCV13 resulted in higher post-booster IgG concentrations but lower post-primary concentrations. The optimum vaccine schedule for preterm infants will therefore depend on when they are most at risk for invasive pneumococcal disease.

scholarly journals Changes in invasive pneumococcal disease among adults living with HIV following introduction of 13-valent pneumococcal conjugate vaccine, 2008–2014

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S57-S58
Author(s):  
Miwako Kobayashi ◽  
William Adih ◽  
Jianmin Li ◽  
Ryan Gierke ◽  
Olivia M Almendares ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Indirect Effects ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Census Data ◽  
People Living With Hiv ◽  
Childhood Immunization ◽  
Increased Risk ◽  
Living With Hiv

Abstract Background People living with HIV (PLHIV) are at increased risk of invasive pneumococcal disease (IPD). Introduction of 13-valent pneumococcal conjugate vaccine (PCV13) in children in 2010 reduced adult IPD burden (indirect effects). In 2012, PCV13 was recommended in series with 23-valent polysaccharide vaccine (PPSV23) for adults with immunocompromising conditions, including PLHIV. We evaluated changes in IPD incidence in adults ≥19 years old with and without HIV after PCV13 introduction for children in 2010 and for immunocompromised adults in 2012. PCV13 coverage for adults 19–64 years old with indications was 6% in 2014. Methods IPD cases, defined as pneumococcal isolation from sterile sites, were identified through CDC’s Active Bacterial Core surveillance, with counts projected nationally. HIV status was obtained from medical records. Isolates were serotyped by Quellung reaction or PCR and grouped into PCV13-types, PPV11-types (unique to PPSV23), or non-vaccine types. We estimated IPD incidence (cases per 100,000 people) using national case-based HIV surveillance (for PLHIV) or US Census data (for non-PLHIV) as denominators. We compared IPD incidence in 2011–12 and 2013–14 to the pre-PCV13 baseline (2008–09) by serotype groups. Results Overall IPD incidence at baseline was 354.0 for PLHIV and 15.5 for non-PLHIV. From baseline to 2013–14, IPD rates declined in both PLHIV (-36.3%; 95% CI: -38.8, -33.7%) and non-PLHIV (-27.3%; 95% CI: -28.2, -26.5%). The largest reductions were noted in PCV13-type IPD in both PLHIV (Figure 1) and non-PLHIV (Figure 2) for both periods (-46.8% for PLHIV and -45.9% for non-PLHIV in 2011–12; -60.3% for PLHIV and -65.8% for non-PLHIV in 2013–14). Overall IPD rates were 22.8 (95% CI: 22.2, 23.4) times as high in PLHIV compared with non-PLHIV at baseline, and 19.4 (95% CI: 18.8, 20.0) times as high in 2013–2014. Conclusion IPD rates declined significantly in both PLHIV and non-PLHIV during the study period due to reductions in PCV13-type IPD; however, IPD rates remained 20-fold in PLHIV compared with non-PLHIV. Similar magnitude reductions in PCV13-type IPD in both groups and low PCV13 coverage in immunocompromised adults suggest that most of the observed decline is due to PCV13 indirect effects from childhood immunization. Disclosures L. Harrison, GSK: Scientific Advisor, Consulting fee; W. Schaffner, Pfizer: Scientific Advisor, Consulting fee; Merck: Scientific Advisor, Consulting fee; Novavax: Consultant, Consulting fee; Dynavax: Consultant, Consulting fee; Sanofi-pasteur: Consultant, Consulting fee; GSK: Consultant, Consulting fee; Seqirus: Consultant, Consulting fee

scholarly journals 1436. Risk Factors for Invasive Pneumococcal Disease in Adults ≥65 Years Old Following Pneumococcal Conjugate Vaccine Recommendation

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S444-S444
Author(s):  
Olivia M Almendares ◽  
Wei Xing ◽  
Monica M Farley ◽  
William Schaffner ◽  
Ann Thomas ◽  
...  
Keyword(s):  
Risk Factors ◽  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Vaccine Recommendation

scholarly journals 70. Changes in Invasive Pneumococcal Disease among Adults Living with HIV Following Introduction of 13-Valent Pneumococcal Conjugate Vaccine, 2008–2018

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S46-S47
Author(s):  
Almea Matanock ◽  
Jianmin Li ◽  
William Adih ◽  
Wei Xing ◽  
William Schaffner ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Incidence Rates ◽  
People Living With Hiv ◽  
Hiv Status ◽  
Conjugate Vaccines ◽  
Increased Risk ◽  
Living With Hiv

Abstract Background People living with HIV (PLHIV) are at increased risk of invasive pneumococcal disease (IPD). The 13-valent pneumococcal conjugate vaccine (PCV13) was recommended for children in 2010, and for immunocompromised adults (including PLHIV) in series with 23-valent polysaccharide vaccine (PPSV23) in 2012. We evaluated changes in IPD incidence in adults ≥19 years old by HIV status after PCV13 introduction and proportion of remaining IPD due to serotypes included in the 15- (PCV15) and 20-valent (PCV20) conjugate vaccines expected to be licensed in 2021. Methods IPD cases were identified through CDC’s Active Bacterial Core surveillance (ABCs). HIV status was obtained from medical records. Isolates were serotyped by Quellung reaction, or whole-genome sequencing and grouped into PCV13-types, PPV11-types (unique to PPSV23), or non-vaccine types. We estimated IPD incidence (cases per 100,000 people) using national projections of ABCs cases as numerators and national case-based HIV surveillance (PLHIV) or US census data (non-PLHIV) as denominators. We compared IPD incidence in 2011–12 and 2017–18 to pre-PCV13 baseline (2008–09) by serotype groups. We assessed the proportion of IPD due to serotypes included in PCV15 and PCV20. Results Overall IPD incidence at baseline was 306.7 for PLHIV and 15.2 for non-PLHIV. From baseline to 2017–18, IPD incidence declined in PLHIV (-40.3%; 95% CI: -47.7, -32.3%) and non-PLHIV (-28.2%; 95% CI: -30.9, -25.5%). The largest reductions were in PCV13-type IPD during both periods (-44.2% for PLHIV and -42.2% for non-PLHIV in 2011–12; -72.5% for PLHIV and -62.2% for non-PLHIV in 2017–18) compared to baseline (Figures 1, 2). In 2017–2018, overall IPD and PCV13-type rates were 16.8 (95% CI: 15.1, 18.5) and 12.6 (95% CI: 9.9, 15.3) times as high in PLHIV vs non-PLHIV, respectively; PCV13, PCV15/non-PCV13, and PCV20/non-PCV15 serotypes comprised 21.5%, 11.2% and 16.5% of IPD in PLHIV. IPD incidence rates among adults aged ≥19 years old by serotype group in PLHIV, 2008–2018 IPD incidence rates among adults aged ≥19 years old by serotype group in non-PLHIV, 2008–2018 Conclusion IPD rates declined significantly in both PLHIV and non-PLHIV during the study period due to reductions in PCV13-type IPD; however, IPD rates remained 17-fold higher in PLHIV compared to non-PLHIV, mainly due to non-PCV13 types. Higher-valent pneumococcal conjugate vaccines provide opportunities to reduce some of the remaining IPD burden in PLHIV. Disclosures William Schaffner, MD, VBI Vaccines (Consultant) Lee Harrison, MD, GSK, Merck, Pfizer, Sanofi Pasteur (Consultant)

scholarly journals Modern Approaches to Vaccinal Prevention of a Pneumococcal Infection in Adults Patients with Diabetes Mellitus (Literature Review)

2018 ◽  
Vol 17 (2) ◽  
pp. 83-90
Author(s):  
J. A. Paramonova ◽  
L. B. Postnikova ◽  
M. P. Kostinov ◽  
A. A. Tarasova ◽  
V. A. Pogrebetzkaya
Keyword(s):  
Diabetes Mellitus ◽  
Conjugate Vaccine ◽  
Pneumococcal Conjugate Vaccine ◽  
Pneumococcal Disease ◽  
Pneumococcal Infection ◽  
Cost Effective ◽  
Morbidity Rate ◽  
Pneumococcal Infections ◽  
Increased Risk ◽  
Patients With Diabetes

At present, pneumococcal infections remain a major cause of morbidity and mortality around the world, being one of the ten leading causes of death worldwide. Some medical conditions, like  diabetes mellitus (DM) are associated with an increased risk of  pneumococcal infections and vaccination was calculated to be highly  cost-effective among those adults with an increased risk. The article  analyzes world data on pneumococcal infection morbidity rate among diabetes mellitus patients and possible ways of reducing it through  immunization. In December 2011, the Food and Drug Administration  (FDA) licensed 13-valent pneumococcal conjugate vaccine (PCV13)  for prevention of pneumonia and invasive pneumococcal disease in  adults aged ≥ 50 years. However, the efficacy of PCV in individuals  with specific comorbidities is yet unknown. The article presents the  findings of research which investigated the efficacy of  antipneumococcal vaccination among diabetes mellitus patients. It  also gives data of first-hand experience of 13-valent pneumococcal conjugate vaccine use (Prevenar 13, Pfizer).

scholarly journals 3. Phase 3 Pivotal Evaluation of 20-valent Pneumococcal Conjugate Vaccine (PCV20) Safety, Tolerability, and Immunologic Noninferiority in Participants 18 Years and Older

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S2-S2
Author(s):  
Brandon Essink ◽  
Charu Sabharwal ◽  
Xia Xu ◽  
Vani Sundaraiyer ◽  
Yahong Peng ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Pneumococcal Conjugate Vaccine ◽  
Geometric Mean ◽  
Pneumococcal Vaccination ◽  
Independent Contractor ◽  
Phase 3 ◽  
Pivotal Phase ◽  
Double Blind ◽  
Age Cohorts ◽  
Younger Age

Abstract Background PCV20 contains the 13-valent pneumococcal conjugate vaccine (PCV13) components, and 7 additional conjugates (for serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F), extending pneumococcal serotype coverage. Key data from the pivotal Phase 3 evaluation of PCV20 in adults are presented. Methods Adults naïve to pneumococcal vaccination were enrolled into 3 age cohorts (≥60, 50–59, and 18–49 years of age). Participants ≥60 years received either PCV20 and saline 1 month later, or PCV13 and 23-valent pneumococcal polysaccharide (PPSV23) 1 month later (1:1 randomization, double blind). Participants 50–59 and 18–49 years received either a dose of PCV20 or PCV13 (3:1 randomization, double blind). Tolerability, safety and immunogenicity (opsonophagocytic activity [OPA] responses) were assessed. Results 3889 participants received vaccine. 1507 and 1490 participants ≥60 years received PCV20 or control respectively. All 20 vaccine serotypes induced robust responses and OPA geometric mean titers (GMTs) to all 13 matched serotypes were noninferior to PCV13. In addition, the OPA GMTs to 6 of the 7 additional serotypes 1 month after PCV20 were noninferior compared to the same serotypes in PPSV23. The OPA GMT of serotype 8 missed noninferiority by a very narrow margin (2-sided 95% lower bound of GMT ratio [20vPnC/PPSV23] was 0.49, with noninferiority criterion of >0.5); this is unlikely to be clinically significant given the high geometric mean fold rise of OPA titers after PCV20 (22-fold above baseline). GMTs after PCV20 in each of the younger age cohorts (18–49 years, 50–59 years) were noninferior to adults 60–64 years. The tolerability and safety profile of PCV20 was similar to PCV13. Conclusion Based on the robust immune responses and comparability to licensed pneumococcal vaccines, as well as bridging to the younger age group, these data support that PCV20 will be protective against pneumococcal disease due to the 20 serotypes in adults. Disclosures Charu Sabharwal, MD, MPH, Pfizer (Employee, Shareholder) Xia Xu, PhD, Pfizer (Employee, Shareholder) Vani Sundaraiyer, PhD, MS, Pfizer (Independent Contractor) Yahong Peng, PhD, Pfizer (Employee, Shareholder) Lisa Moyer, BS, Pfizer (Employee, Shareholder) Michael W. Pride, PhD, Pfizer (Employee, Shareholder) Ingrid L. Scully, PhD, Pfizer Inc (Employee, Shareholder) Kathrin U. Jansen, PhD, Pfizer (Employee, Shareholder) William C. Gruber, MD, Pfizer (Employee, Shareholder) Daniel Scott, MD, Pfizer (Employee, Shareholder) Wendy Watson, MD, Pfizer (Employee, Shareholder)

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