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The Journal of Infection Jul 2024The last COVID-19 vaccine offered to all adults in England became available from November 2021. The most recent booster programme commenced in September 2023. Bivalent...
Effectiveness of autumn 2023 COVID-19 vaccination and residual protection of prior doses against hospitalisation in England, estimated using a test-negative case-control study.
INTRODUCTION
The last COVID-19 vaccine offered to all adults in England became available from November 2021. The most recent booster programme commenced in September 2023. Bivalent BA.4-5 or monovalent XBB.1.5 boosters were given. During the study period, the JN.1 variant became dominant in England.
METHODS
Vaccine effectiveness against hospitalisation was estimated throughout using the test-negative case-control study design where positive PCR tests from hospitalised individuals are cases and comparable negative PCR tests are controls. Multivariable logistic regression was used to assess vaccine effectiveness against hospitalisation with the test result as the outcome, vaccination status as the primary exposure variable of interest and confounder adjustment.
RESULTS
There was no evidence of residual protection for boosters given as part of previous campaigns. There were 28,916 eligible tests included to estimate the effectiveness of the autumn 2023 boosters in those aged 65 years and older. VE peaked at 50.6% (95% CI: 44.2-56.3%) after 2-4 weeks, followed by waning to 13.6% (95% CI: -11.7 to 33.2%). Estimates were generally higher for the XBB.1.5 booster than the BA.4-5 booster, but this difference was not statistically significant. Point estimates were highest against XBB sub-lineages. Effectiveness was lower against both JN.1 and EG.5.1 variants with confidence intervals non-overlapping with the effectiveness of the XBB sub-lineages at 2-4 weeks for EG.5.1 where VE was 44.5% (95% CI: 20.2-61.4%) and at 5-9 weeks for JN.1 where VE was 26.4% (95%CI: -3.4 to 47.6%).
CONCLUSIONS
The recent monovalent XBB.1.5 and bivalent BA.4-5 boosters provided comparable and good protection against hospitalisation, however there was evidence of lower VE against hospitalisation of these boosters against JN.1.
Topics: Humans; COVID-19; England; Hospitalization; Case-Control Studies; Aged; Male; SARS-CoV-2; Female; COVID-19 Vaccines; Vaccine Efficacy; Immunization, Secondary; Vaccination; Aged, 80 and over; Middle Aged; Adult
PubMed: 38719110
DOI: 10.1016/j.jinf.2024.106177 -
Vaccine Jul 2024Large health insurance claims databases can be used to estimate rates of rare safety outcomes. We measured incidence rates of rare outcomes that could be used to...
BACKGROUND
Large health insurance claims databases can be used to estimate rates of rare safety outcomes. We measured incidence rates of rare outcomes that could be used to contextualize adverse events among people receiving pneumococcal vaccines in clinical trials or clinical practice. However, algorithms used to identify outcomes in administrative databases are subject to error. Using two algorithms for each outcome, we assessed the influence of algorithm choice on the rates of the outcomes.
METHODS
We used closed administrative medical and pharmacy claims in the Healthcare Integrated Research Database (HIRD) to construct a broad cohort of individuals less than 100 years old (i.e., the target cohort) and a trial-similar cohort of individuals resembling those potentially eligible for a vaccine clinical trial (e.g., for a pneumococcal vaccine). We stratified by age and sex and used specific and sensitive algorithms to estimate rates of 39 outcomes including cardiac/cerebrovascular, metabolic, allergic/autoimmune, neurological, and hematologic outcomes. Specific algorithms intended to reduce false positive errors, while sensitive algorithms intended to reduce false negative errors, thereby providing lower and upper bounds for the "true" rates.
RESULTS
We followed approximately 40 million individuals in the target cohort for an average of 3 years. Of 39 outcomes, 14 (36 %) had a rate from the specific algorithm that was less than half the rate from the sensitive algorithm. Rates of cardiac/cerebrovascular outcomes were most consistent (mean ratio of rates from specific algorithms compared to rates from sensitive algorithms = 0.76), while the rates of neurological and hematologic outcomes were the least consistent (mean ratio of rates = 0.33 and 0.36, respectively).
CONCLUSIONS
For many cardiac/cerebrovascular outcomes, rates were similar regardless of the algorithm. For other outcomes, rates varied substantially by algorithm. Using multiple algorithms to ascertain outcomes in claims data can be informative about the extent of uncertainty due to outcome misclassification.
Topics: Humans; Algorithms; Male; Female; Middle Aged; Adult; Young Adult; Aged; Incidence; Adolescent; United States; Child, Preschool; Child; Pneumococcal Vaccines; Infant; Aged, 80 and over; Drug-Related Side Effects and Adverse Reactions; Insurance, Health; Infant, Newborn; Databases, Factual
PubMed: 38714442
DOI: 10.1016/j.vaccine.2024.04.095 -
Frontiers in Immunology 2024remains a significant global threat, with existing vaccines having important limitations such as restricted serotype coverage and high manufacturing costs. Pneumococcal...
remains a significant global threat, with existing vaccines having important limitations such as restricted serotype coverage and high manufacturing costs. Pneumococcal lipoproteins are emerging as promising vaccine candidates due to their surface exposure and conservation across various serotypes. While prior studies have explored their potential in mice, data in a human context and insights into the impact of the lipid moiety remain limited. In the present study, we examined the immunogenicity of two pneumococcal lipoproteins, DacB and MetQ, both in lipidated and non-lipidated versions, by stimulation of primary human immune cells. Immune responses were assessed by the expression of common surface markers for activation and maturation as well as cytokines released into the supernatant. Our findings indicate that in the case of MetQ lipidation was crucial for activation of human antigen-presenting cells such as dendritic cells and macrophages, while non-lipidated DacB demonstrated an intrinsic potential to induce an innate immune response. Nevertheless, immune responses to both proteins were enhanced by lipidation. Interestingly, following stimulation of dendritic cells with DacB, LipDacB and LipMetQ, cytokine levels of IL-6 and IL-23 were significantly increased, which are implicated in triggering potentially important Th17 cell responses. Furthermore, LipDacB and LipMetQ were able to induce proliferation of CD4+ T cells indicating their potential to induce an adaptive immune response. These findings contribute valuable insights into the immunogenic properties of pneumococcal lipoproteins, emphasizing their potential role in vaccine development against pneumococcal infections.
Topics: Humans; Streptococcus pneumoniae; Adaptive Immunity; Cytokines; Bacterial Proteins; Lipoproteins; Dendritic Cells; Antigen-Presenting Cells; Pneumococcal Vaccines; Pneumococcal Infections; Macrophages; Cells, Cultured
PubMed: 38711516
DOI: 10.3389/fimmu.2024.1392316 -
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 -
Vaccine May 2024Globally, cardiovascular disease (CVD) is the leading cause of death and illness. Vaccine-preventable infections may increase acute coronary vascular disease events and...
BACKGROUND
Globally, cardiovascular disease (CVD) is the leading cause of death and illness. Vaccine-preventable infections may increase acute coronary vascular disease events and the risk of complications. Low vaccine coverage has been reported among adults at high risk of complications from vaccine-preventable infections. There is a gap in research evidence around determinants of uptake of vaccines among adults with CVD. This study examined the uptake of influenza, pneumococcal and zoster vaccines and the determinants of uptake of the vaccines among cardiac patients.
METHOD
A prospective cross-sectional study was carried out among hospitalised cardiac patients through an interviewer-administered questionnaire. Descriptive statistics were used to investigate self-reported uptake of influenza, pneumococcal and zoster vaccines. Univariate and multivariate analyses of participants' social demographic and clinical characteristics were conducted to identify factors for receiving influenza vaccine.
RESULTS
Low vaccination rates among 104 participants were found for influenza (45.2%), pneumococcal (13.5%) and zoster (5.8%) vaccines. The most common reason for not receiving influenza vaccine was concern about side effects. Lack of awareness about the pneumococcal and zoster vaccines was the main reason for the poor uptake of these vaccines. Australia-born participants were more likely to receive influenza vaccine than overseas-born participants. Working-age participants and, interestingly, people living with a current smoker were less likely to receive influenza vaccine.
CONCLUSION
Influenza, pneumococcal and zoster vaccine uptake among cardiac patients was low. Encouraging physician recommendations for vaccination for cardiac patients under 65 years of age and addressing vaccination challenges among people from culturally and linguistically diverse backgrounds and pharmacy, workplace, and hospital vaccination may help increase vaccination uptake among cardiac patients.
Topics: Humans; Male; Female; Influenza Vaccines; Middle Aged; Cross-Sectional Studies; Pneumococcal Vaccines; Aged; Prospective Studies; Influenza, Human; Cardiovascular Diseases; Herpes Zoster Vaccine; Vaccination; Adult; Pneumococcal Infections; Surveys and Questionnaires; Vaccination Coverage; Australia; Aged, 80 and over
PubMed: 38704255
DOI: 10.1016/j.vaccine.2024.04.031 -
Vaccine Jun 2024This study investigates the association between parental attitudes towards mandatory and recommended vaccines in the National Immunization Plan (NIP) of Italy and their...
INTRODUCTION
This study investigates the association between parental attitudes towards mandatory and recommended vaccines in the National Immunization Plan (NIP) of Italy and their acceptance of the COVID-19 vaccine in children aged 5-11 years.
METHODS
Using data from approximately 42,000 children in Southern Italy, parental attitudes towards previous vaccinations were examined. Mandatory and recommended vaccinations were considered for the analysis, with the first shot of each schedule being considered relevant, regardless of when it was administered or whether the recommended number of doses was administered. A multivariate logistic regression was performed to analyze associations between the covariates of age, sex, adherence to mandatory vaccinations, number of recommended vaccinations, and COVID-19 vaccination.
RESULTS
The COVID-19 vaccine acceptance rate was 50.7% in our sample. We revealed a strong association between parental attitudes towards previous vaccinations and the acceptance of the COVID-19 vaccine. Mandatory vaccinations under the NIP showed the highest acceptance rates, and among non-mandatory vaccines, the pneumococcal conjugate vaccine had the highest acceptance rate, potentially due to its co-administration with the hexavalent vaccine. The study identified a trend of lower COVID-19 vaccine coverage in younger children.
CONCLUSIONS
The study underscores the importance of co-administration approaches and well-planned vaccination schedules in enhancing vaccine coverage. It suggests that integrating newer vaccines, like the COVID-19 vaccine, into established vaccination schedules could potentially increase acceptance and coverage. The findings highlight the urgency of addressing vaccine hesitancy, particularly in the pediatric population, to ensure high vaccination coverage and effective disease control. Further research is needed to explore the potential strategies to increase vaccine acceptance.
Topics: Humans; Italy; Male; Female; Parents; Child; Child, Preschool; COVID-19; COVID-19 Vaccines; Vaccination; Immunization Programs; SARS-CoV-2; Mandatory Programs; Vaccination Hesitancy; Vaccination Coverage; Patient Acceptance of Health Care; Health Knowledge, Attitudes, Practice
PubMed: 38704254
DOI: 10.1016/j.vaccine.2024.04.072 -
Expert Review of Vaccines 2024The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is used in the Japanese National Immunization Program for older adults and adults with increased risk for...
BACKGROUND
The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is used in the Japanese National Immunization Program for older adults and adults with increased risk for pneumococcal disease, however, disease incidence and associated burden remain high. We evaluated the cost-effectiveness of pneumococcal conjugate vaccines (PCVs) for adults aged 65 years and high-risk adults aged 60-64 years in Japan.
RESEARCH DESIGN AND METHODS
Using a Markov model, we evaluated lifetime costs using societal and healthcare payer perspectives and estimated quality-adjusted life-years (QALYs), and number of prevented cases and deaths caused by invasive pneumococcal disease (IPD) and non-IPD. The base case analysis used a societal perspective.
RESULTS
In comparison with PPSV23, the 20-valent PCV (PCV20) prevented 127 IPD cases 10,813 non-IPD cases (inpatients: 2,461, outpatients: 8,352) and 226 deaths, and gained more QALYs (+0.0015 per person) with less cost (-JPY22,513 per person). All sensitivity and scenario analyses including a payer perspective analysis indicated that the incremental cost-effectiveness ratios (ICERs) were below the cost-effectiveness threshold value in Japan (JPY5 million/QALY).
CONCLUSIONS
PCV20 is both cost saving and more effective than PPSV23 for adults aged 65 years and high-risk adults aged 60-64 years in Japan.
Topics: Humans; Cost-Benefit Analysis; Pneumococcal Vaccines; Japan; Pneumococcal Infections; Middle Aged; Aged; Vaccines, Conjugate; Male; Female; Quality-Adjusted Life Years; Markov Chains; Cost-Effectiveness Analysis
PubMed: 38703180
DOI: 10.1080/14760584.2024.2350246 -
Infectious Diseases and Therapy Jun 2024In Argentina, vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23; PCV13 → PPSV23)...
INTRODUCTION
In Argentina, vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23; PCV13 → PPSV23) has been recommended for all adults aged ≥ 65 years and younger adults with chronic medical ("moderate-risk") or immunocompromising ("high-risk") conditions since 2017. With the approval of a 20-valent PCV (PCV20), we evaluated the cost-effectiveness of PCV20 versus current recommendations for moderate-/high-risk adults aged 18-64 years and all adults 65-99 years.
METHODS
A probabilistic cohort model was used to project lifetime outcomes and costs associated with invasive pneumococcal disease (IPD) and all-cause non-bacteremic pneumonia (NBP), and the expected impact of vaccination. Clinical outcomes were projected annually based on Argentinean data. Economic costs were estimated based on cases and corresponding medical costs (adjusted to 2023 USD) and costs of vaccine and administration. Cost-effectiveness of PCV20 was evaluated versus the current strategy, PCV13 → PPSV23, and alternatively, versus sequentially administered 15-valent PCV and PPSV23 (PCV15 → PPSV23), and presented as cost per quality-adjusted life year gained; a healthcare system perspective was used. Costs and benefits were discounted at 3%/year.
RESULTS
PCV20 in lieu of PCV13 → PPSV23 among moderate-/high-risk adults aged 18-64 years and all adults 65-99 years (N = 13.4M) prevented 3838 IPD, 4377 inpatient NBP, and 6003 outpatient NBP cases, and 1865 disease-related deaths; relative to PCV15 → PPSV23 the corresponding reductions were 2775, 3285, 4518, and 1348. PCV20 was projected to be the dominant strategy versus PCV13 → PPSV23 and PCV15 → PPSV23 as overall costs were lower by $87.6M and $80.8M, respectively. In probabilistic sensitivity analyses, PCV20 was dominant (i.e., more effective, less costly) in 100% of 1000 simulations.
CONCLUSIONS
Analyses suggest implementing a PCV20 vaccination program in moderate-/high-risk adults aged 18-64 years and all adults ≥ 65 years-in lieu of PCV13 → PPSV23-would yield substantial reductions in pneumococcal disease and would be cost saving to the Argentinean healthcare system.
PubMed: 38700655
DOI: 10.1007/s40121-024-00972-9 -
IDCases 2024Given the high mortality rate of invasive pneumococcal disease (IPD) in hematopoietic stem cell transplant (HSCT) recipients, vaccination is recommended. These...
Given the high mortality rate of invasive pneumococcal disease (IPD) in hematopoietic stem cell transplant (HSCT) recipients, vaccination is recommended. These recipients respond to most vaccines; however, their immune response is typically weaker during the first months or years after transplantation, compared with that of healthy individuals. Here, we report a case of IPD with serotype 3 pneumonia and empyema in an HSCT recipient who had received three doses of the 13-valent pneumococcal conjugate vaccine (PCV) and one dose of the 23-valent pneumococcal polysaccharide vaccine; furthermore, the recipient had no relapse, graft-versus-host disease, or use of immunosuppressive agents after allogeneic HSCT for acute myeloid leukemia. Moreover, we discussed the characteristics of serotype 3 , a case series of breakthrough infections with in HSCT recipients who received pneumococcal vaccines, and the potential implications for the upcoming PCV15 and PCV20 vaccines for serotype 3.
PubMed: 38699526
DOI: 10.1016/j.idcr.2024.e01936 -
BMC Public Health May 2024Risk factors of infant mortality in Africa and south Asian countries have been broadly discussed. However, infant morbidity is largely underestimated. We analyzed the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Risk factors of infant mortality in Africa and south Asian countries have been broadly discussed. However, infant morbidity is largely underestimated. We analyzed the data from a randomized vaccine trial in Bangladesh to identify and assess the effect of risk factors on infant morbidity.
METHODS
Pregnant women were randomly assigned to receive either inactivated influenza vaccine or pneumococcal polysaccharide vaccine and the infants were randomly assigned to receive 7-valent pneumococcal conjugate vaccine or Hib conjugate vaccine at week 6, 10 and 14. The data were collected from August 2004 through December 2005. Each pair of infant and mother were followed for 24 weeks after birth with weekly visits. Generalized estimating equations (GEE) for repeated measurements and Poisson regression models were used to identify the risk factors and evaluate their effect on the longitudinal incidence and total number of episodes of respiratory illness with fever (RIF), diarrhea disease, ear problem and pneumonia.
RESULTS
A total of 340 pregnant women were randomized with mean age of 25 years. The baseline mother and infant characteristics were similar between two treatment groups. Exclusive breastfeeding and higher paternal education level were common factors associated with lower infant morbidity of RIF (adjusted OR = 0.40 and 0.94 with p < 0.01 and p = 0.02, respectively), diarrhea disease (adjusted OR = 0.39 and 0.95 with p < 0.01 and p = 0.04, respectively), and ear problem (adjusted OR = 0.20 and 0.76 with p < 0.01 and p < 0.01, respectively). Maternal influenza vaccine significantly reduced the incidence of RIF (adjusted OR = 0.54; p < 0.01) but not diarrhea disease or ear problem (p > 0.05). Female infants had lower incidence of diarrhea disease (adjusted OR = 0.67; p = 0.01) and ear problem (adjusted OR = 0.12; p = 0.01).
CONCLUSIONS
Maternal influenza vaccination, exclusive breastfeeding, female children, and higher paternal education level significantly reduced the infant morbidity within the 24 weeks after birth in Bangladesh.
Topics: Humans; Bangladesh; Female; Pregnancy; Adult; Infant; Influenza Vaccines; Pneumococcal Vaccines; Risk Factors; Infant, Newborn; Young Adult; Morbidity; Vaccination; Male
PubMed: 38698353
DOI: 10.1186/s12889-024-18486-x