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The European Respiratory Journal Feb 2022https://bit.ly/3q4skov
https://bit.ly/3q4skov
Topics: Germany; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Serogroup; Serotyping; Vaccines, Conjugate
PubMed: 34824055
DOI: 10.1183/13993003.02432-2021 -
Molecular Pharmaceutics Apr 2021We previously developed a safe and effective nasal vaccine delivery system using a self-assembled nanosized hydrogel (nanogel) made from a cationic cholesteryl pullulan....
We previously developed a safe and effective nasal vaccine delivery system using a self-assembled nanosized hydrogel (nanogel) made from a cationic cholesteryl pullulan. Here, we generated three pneumococcal surface protein A (PspA) fusion antigens as a universal pneumococcal nasal vaccine and then encapsulated each PspA into a nanogel and mixed the three resulting monovalent formulations into a trivalent nanogel-PspA formulation. First, to characterize the nanogel-PspA formulations, we used native polyacrylamide gel electrophoresis (PAGE) to determine the average number of PspA molecules encapsulated per nanogel molecule. Second, we adopted two methods-a densitometric method based on lithium dodecyl sulfate (LDS)-PAGE and a biologic method involving sandwich enzyme-linked immunosorbent assay (ELISA)-to determine the PspA content in the nanogel formulations. Third, treatment of nanogel-PspA formulations by adding methyl-β-cyclodextrin released each PspA in its native form, as confirmed through circular dichroism (CD) spectroscopy. However, when nanogel-PspA formulations were heat-treated at 80 °C for 16 h, CD spectroscopy showed that each PspA was released in a denatured form. Fourth, we confirmed that the nanogel-PspA formulations were internalized into nasal mucosa effectively and that each PspA was gradually released from the nanogel in epithelial cells in mice. Fifth, LDS-PAGE densitometry and ELISA both indicated that the amount of trivalent PspA was dramatically decreased in the heat-treated nanogel compared with that before heating. When mice were immunized nasally using the heat-treated formulation, the immunologic activity of each PspA was dramatically reduced compared with that of the untreated formulation; in both cases, the immunologic activity correlated well with the content of each PspA as determined by LDS-PAGE densitometry and ELISA. Finally, we confirmed that the trivalent nanogel-PspA formulation induced equivalent titers of PspA-specific serum IgG and mucosal IgA Abs in immunized mice. These results show that the specification methods we developed effectively characterized our nanogel-based trivalent PspA nasal vaccine formulation.
Topics: Administration, Intranasal; Animals; Bacterial Proteins; Drug Liberation; Female; Glucans; Humans; Hygroscopic Agents; Immunogenicity, Vaccine; Mice; Models, Animal; Nanogels; Nasal Mucosa; Pneumococcal Infections; Pneumococcal Vaccines; Recombinant Fusion Proteins; Streptococcus pneumoniae; beta-Cyclodextrins
PubMed: 33621107
DOI: 10.1021/acs.molpharmaceut.0c01003 -
Expert Review of Vaccines Jan 2022V114 (15-valent pneumococcal conjugate vaccine [PCV15]) and a 20-valent PCV (PCV20) are approved for adults (≥18 years) in the United States. We present methodologies...
BACKGROUND
V114 (15-valent pneumococcal conjugate vaccine [PCV15]) and a 20-valent PCV (PCV20) are approved for adults (≥18 years) in the United States. We present methodologies to indirectly compare immune responses to V114 versus PCV20.
RESEARCH DESIGN AND METHODS
Indirect treatment comparison and matching-adjusted indirect comparison (MAIC) were performed to estimate opsonophagocytic activity (OPA) geometric mean titer (GMT) ratios of V114/PCV20 at 30 days post-vaccination with PCV13 as common comparator for 13 serotypes (STs) shared with a 13-valent PCV (PCV13) among pneumococcal vaccine-naïve adults aged ≥60 years. Data from three V114 studies were pooled (V114, N = 2,196; PCV13, N = 843). In the MAIC analysis, data were reweighted, matching participant age and sex in NCT03760146 (PCV20, N = 1,507; PCV13, N = 1,490).
RESULTS
The lower bound of V114/PCV20 OPA GMT ratio for all PCV13 STs is greater than the prespecified 0.5 non-inferiority margin and those for five PCV13 STs (3, 6A, 6B, 18C, and 23F) are greater than the prespecified 1.2 superiority margin. V114 was associated with 77% greater OPA GMT for ST3 versus PCV20.
CONCLUSION
V114 was non-inferior to PCV20 for all PCV13 STs and statistically superior for five PCV13 STs.
Topics: Adult; Antibodies, Bacterial; Humans; Middle Aged; Pneumococcal Infections; Pneumococcal Vaccines; Serogroup; Vaccines, Conjugate
PubMed: 34672224
DOI: 10.1080/14760584.2021.1994858 -
Canadian Family Physician Medecin de... Sep 2019To describe the burden of pneumococcal disease and associated risk factors in the Canadian adult population, delineate available pneumococcal vaccines and associated... (Review)
Review
OBJECTIVE
To describe the burden of pneumococcal disease and associated risk factors in the Canadian adult population, delineate available pneumococcal vaccines and associated efficacy and effectiveness data, and review current pneumococcal vaccine recommendations and community-acquired pneumonia (CAP) prevention strategies in Canada.
QUALITY OF EVIDENCE
Pneumococcal vaccination guidelines from the Canadian National Advisory Committee on Immunization in 2013 and 2016 constitute level III evidence for CAP prevention in the Canadian adult population.
MAIN MESSAGE
It is recommended that immunosuppressed adults of all ages receive the 13-valent pneumococcal conjugate vaccine (PCV13) (grades A and B recommendations). In 2016, the National Advisory Committee on Immunization also recommended that all adults aged 65 years and older receive PCV13 (grade A recommendation) on an individual basis, followed by the 23-valent pneumococcal polysaccharide vaccine (grade B recommendation). This update is based on a large clinical study that demonstrated PCV13 efficacy against vaccine-type CAP in this population.
CONCLUSION
Physicians should focus on improving pneumococcal vaccination rates among adults, which remain low. Vaccination with PCV13 should also be considered for adults with chronic conditions, whose baseline risk is often higher than that for healthy individuals aged 65 years and older.
Topics: Advisory Committees; Canada; Community-Acquired Infections; Humans; Immunization Schedule; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Practice Guidelines as Topic; Streptococcus pneumoniae; Vaccines, Conjugate
PubMed: 31515311
DOI: No ID Found -
Expert Review of Pharmacoeconomics &... Apr 2021Pneumococcal diseases including invasive pneumococcal disease (IPD), pneumonia, and acute otitis media (AOM) impose a substantial public health burden. This study... (Comparative Study)
Comparative Study
Pneumococcal diseases including invasive pneumococcal disease (IPD), pneumonia, and acute otitis media (AOM) impose a substantial public health burden. This study performed a budget impact analysis of the use of pneumococcal conjugate vaccines (PCVs) in the National Immunization Program (NIP) in Colombia. We compared the direct medical cost of the scenario without and with PCV vaccination using either pneumococcal non-typeable protein D conjugate vaccine (PHiD-CV) or 13-valent pneumococcal conjugate vaccine (PCV-13) over 5 years (2020-2024) from the health-care system perspective. Vaccine efficacy estimates were obtained from published sources and vaccine prices were taken from the Pan-American Health Organization Revolving Fund. Vaccine coverage was assumed to be 90% based on Colombia data. Using PHiD-CV in the NIP in Colombia would reduce the estimated cost for treating pneumococcal disease by US$46.1 m over the 2020-2024 period (US$40.2 m using PCV-13), with a budget impact of US$100.1 m for PHiD-CV (US$121.4 m for PCV-13), and would cost US$3.1 m less per year on vaccine doses than using PCV-13. These findings are potentially valuable for the selection of vaccines for their national immunization programs under conditions of budgetary constraint.
Topics: Budgets; Colombia; Cost of Illness; Humans; Immunization Programs; Pneumococcal Infections; Pneumococcal Vaccines; Vaccination
PubMed: 33249948
DOI: 10.1080/14737167.2021.1855978 -
Expert Review of Vaccines Mar 2021: Immunogenicity studies evaluating sequential administration of pneumococcal conjugate vaccine (PCV) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23)... (Review)
Review
Immunogenicity following revaccination or sequential vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in older adults and those at increased risk of pneumococcal disease: a review of the literature.
: Immunogenicity studies evaluating sequential administration of pneumococcal conjugate vaccine (PCV) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) or revaccination with PPSV23 have raised concerns that PPSV23 may not elicit higher antibody levels than those measured following PCV or first PPSV23 dose.: Recent literature was evaluated for evidence of blunted immune response (hyporesponsiveness), focusing on studies using adequate intervals between doses in accordance with vaccination recommendations. In eight of nine studies that evaluated revaccination with PPSV23 at an interval of ≥5 years after the previous dose, immunoglobulin G geometric mean concentrations and/or opsonophagocytic assay geometric mean titers for most serotypes increased from pre- to post-repeat vaccination and were comparable between repeat and primary vaccination groups post-vaccination. In seven studies in which PPSV23 was administered after PCVs (8 weeks to 1 year apart), responses to PPSV23 were comparable to those seen after initial PCV dose for shared vaccine serotypes. Studies in which PCVs were administered after PPSV23 were not evaluated.: Published data suggest immune responses following repeat vaccination with PPSV23, or sequential PCV/PPSV23 vaccination, are robust, without evidence of hyporesponsiveness. PPSV23 vaccination of at-risk adults is essential to ensure broad protection against all 23 vaccine serotypes.
Topics: Aged; Antibodies, Bacterial; Humans; Immunization, Secondary; Immunogenicity, Vaccine; Pneumococcal Infections; Pneumococcal Vaccines; Streptococcus pneumoniae; Vaccination; Vaccines, Conjugate
PubMed: 33567914
DOI: 10.1080/14760584.2021.1889374 -
Clinical Obstetrics and Gynecology Dec 2019Streptococcus pneumoniae, a gram-positive diplococcus, is the most common cause of bacterial pneumonia. The diagnosis of pneumococcal pneumonia is usually confirmed by...
Streptococcus pneumoniae, a gram-positive diplococcus, is the most common cause of bacterial pneumonia. The diagnosis of pneumococcal pneumonia is usually confirmed by chest x-ray and gram stain. The most appropriate antibiotics for treatment pneumococcal infection are macrolides, beta-lactams, and quinolones. Two vaccines, PPSV23 and PCV13, are highly effective in preventing infection.
Topics: Anti-Bacterial Agents; Female; Humans; Pneumococcal Infections; Pneumococcal Vaccines; Pregnancy; Pregnancy Complications, Infectious; Streptococcus pneumoniae
PubMed: 31008732
DOI: 10.1097/GRF.0000000000000451 -
Vaccine Feb 2024Pneumococcal infections are associated with high disease burden in older individuals in Japan, South Korea, and Taiwan. The 20-valent pneumococcal conjugate vaccine... (Randomized Controlled Trial)
Randomized Controlled Trial
A phase 3 randomized trial of the safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults ≥ 60 years of age in Japan, South Korea, and Taiwan.
BACKGROUND
Pneumococcal infections are associated with high disease burden in older individuals in Japan, South Korea, and Taiwan. The 20-valent pneumococcal conjugate vaccine (PCV20) was developed to extend protection beyond earlier pneumococcal vaccines.
METHODS
This phase 3 randomized, double-blind study investigated the safety and immunogenicity of PCV20 in participants ≥ 60 years of age from Japan, South Korea, and Taiwan. Participants were randomized to receive PCV20 or 13-valent pneumococcal conjugate vaccine (PCV13). One month after vaccination, PCV20 recipients received a saline injection and PCV13 recipients received 23-valent polysaccharide vaccine (PPSV23). Primary immunogenicity objectives were to demonstrate noninferiority of PCV20 to PCV13 (13 matched serotypes) or PPSV23 (7 additional serotypes) for serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after vaccination with PCV20, PCV13, or PPSV23. Noninferiority for each serotype was declared if the lower bound of the 2-sided 95% CI for OPA geometric mean ratio (GMR) was > 0.5. Safety endpoints included local reactions, systemic events, adverse events (AEs), and serious AEs.
RESULTS
Overall, 1421 participants were vaccinated (median age [range]: 65 [60-85] years). PCV20 was noninferior to PCV13 for all 13 matched serotypes and to PPSV23 for 6 of 7 additional serotypes. Although statistical noninferiority was missed for serotype 8 (lower bound of the 2-sided 95% CI for OPA GMR = 0.5, thus not meeting the statistical noninferiority criterion of > 0.5), secondary immunogenicity endpoints for serotype 8 were supportive of a robust immune response. The incidence of AEs and the frequency and severity of local reactions and systemic events were generally similar after PCV20 and PCV13. No safety concerns were identified.
CONCLUSION
PCV20 generated robust immune responses to all vaccine serotypes in older adults in Japan, South Korea, and Taiwan. The safety and tolerability profile was similar to PCV13. PCV20 is expected to help protect against all 20 vaccine serotypes. NCT04875533.
Topics: Humans; Aged; Streptococcus pneumoniae; Vaccines, Conjugate; Japan; Taiwan; Antibodies, Bacterial; Pneumococcal Infections; Pneumococcal Vaccines; Double-Blind Method; Republic of Korea; Immunogenicity, Vaccine
PubMed: 38267330
DOI: 10.1016/j.vaccine.2024.01.004 -
Vaccine Nov 2020A lower conversion vaccination rate and a more rapid decline in antibody titers over time in dialysis patients raise concerns about the effectiveness of pneumococcal... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A lower conversion vaccination rate and a more rapid decline in antibody titers over time in dialysis patients raise concerns about the effectiveness of pneumococcal vaccination (PV) in this population, which has not been systematically reviewed.
METHODS
We searched PubMed, Cochrane Library, Embase and three Chinese databases from inception until February 29th, 2020 for interventional, cohort and case-control studies evaluating PV alone or combined with influenza vaccination (IV) on outcomes (all-cause mortality, pneumonia, cardiovascular events, antibody response and safety). Independent reviewers completed citation screening, data extraction, risk assessment, meta-analysis, and GRADE rating of the quality of evidence.
RESULTS
Five cohort studies and one quasirandomized control trial enrolling 394,299 dialysis patients with high to moderate quality were included. Compared with unvaccinated individuals, those receiving PV had lower risk of all-cause mortality [Adjusted relative risk (RR) 0.73, 95% CI 0.67-0.79, I = 31.1%, GRADE low certainty] and cardiovascular events (adjusted RR 0.80, 95% CI 0.69-0.93, I = 47.2%, GRADE low certainty) without serious adverse effect reported. Compared with no vaccination, lower all-cause mortality was observed in those receiving PV combined with IV (Adjusted RR 0.71, 95%CI 0.67-0.75, I = 63.3%), PV alone (Adjusted RR 0.86, 95% CI 0.78-0.94,I = 0%], and IV alone (Adjusted RR 0.76, 95% CI 0.73-0.79, I = 0%]. There was no difference between pneumococcal vaccinated patients vs non-vaccinated patients with respect to pneumonia. Immune response to pneumococcal conjugate vaccine-13 was weaker in polysaccharide pneumococcal vaccine-23-pre-vaccinated compared with vaccine-naive patients.
CONCLUSIONS
The use of pneumococcal vaccine especially combined with influenza vaccination is associated with lower risks of all-cause mortality but may be affected by residual confounding/healthy vaccinee bias.
Topics: Humans; Influenza Vaccines; Influenza, Human; Pneumococcal Vaccines; Renal Dialysis; Vaccination; Vaccines, Conjugate
PubMed: 33059969
DOI: 10.1016/j.vaccine.2020.09.080 -
Vaccine Jun 2024A U.S. case-control study (2010-2014) demonstrated vaccine effectiveness (VE) for ≥ 1 dose of the thirteen-valent pneumococcal conjugate vaccine (PCV13) against...
Effectiveness of 13-valent pneumococcal conjugate vaccine for prevention of invasive pneumococcal disease among children in the United States between 2010 and 2019: An indirect cohort study.
BACKGROUND
A U.S. case-control study (2010-2014) demonstrated vaccine effectiveness (VE) for ≥ 1 dose of the thirteen-valent pneumococcal conjugate vaccine (PCV13) against vaccine-type (VT) invasive pneumococcal disease (IPD) at 86 %; however, it lacked statistical power to examine VE by number of doses and against individual serotypes.
METHODS
We used the indirect cohort method to estimate PCV13 VE against VT-IPD among children aged < 5 years in the United States from May 1, 2010 through December 31, 2019 using cases from CDC's Active Bacterial Core surveillance, including cases enrolled in a matched case-control study (2010-2014). Cases and controls were defined as individuals with VT-IPD and non-PCV13-type-IPD (NVT-IPD), respectively. We estimated absolute VE using the adjusted odds ratio of prior PCV13 receipt (1-aOR x 100 %).
RESULTS
Among 1,161 IPD cases, 223 (19.2 %) were VT cases and 938 (80.8 %) were NVT controls. Of those, 108 cases (48.4 %; 108/223) and 600 controls (64.0 %; 600/938) had received > 3 PCV13 doses; 23 cases (17.6 %) and 15 controls (2.4 %) had received no PCV doses. VE ≥ 3 PCV13 doses against VT-IPD was 90.2 % (95 % Confidence Interval75.4-96.1 %), respectively. Among the most commonly circulating VT-IPD serotypes, VE of ≥ 3 PCV13 doses was 86.8 % (73.7-93.3 %), 50.2 % (28.4-80.5 %), and 93.8 % (69.8-98.8 %) against serotypes 19A, 3, and 19F, respectively.
CONCLUSIONS
At least three doses of PCV13 continue to be effective in preventing VT-IPD among children aged < 5 years in the US. PCV13 was protective against serotypes 19A and 19F IPD; protection against serotype 3 IPD did not reach statistical significance.
Topics: Humans; Pneumococcal Vaccines; Pneumococcal Infections; United States; Child, Preschool; Infant; Female; Male; Streptococcus pneumoniae; Case-Control Studies; Serogroup; Vaccines, Conjugate; Vaccine Efficacy; Cohort Studies; Infant, Newborn; Vaccination
PubMed: 38704263
DOI: 10.1016/j.vaccine.2024.04.061