Associations of influenza and pneumococcal vaccinations with burdens of older family caregivers: The Japan Gerontological Evaluation study (JAGES) cross-sectional study

BackgroundInfluenza and pneumonia tend to be severe in older adults; thus, vaccination is necessary to prevent these illnesses. Vaccination is especially important for older family caregivers (OFCs) not only to prevent them from becoming ill, but also to prevent secondary infections in the family care receivers (FCRs), who are mostly frail older adults and have a higher risk of severe illness. Thus, we investigated whether caregiving burdens were associated with the vaccinations among older adults.MethodsWe used cross-sectional data from the Japan Gerontological Evaluation Study (JAGES), which was conducted in 64 Japanese municipalities from November 2019 to January 2020. The target population consisted of 26,177 individuals aged 65 years or older who were independent and did not need public long-term care. The primary outcome was the uptakes of either or both influenza and pneumococcal vaccinations. Multinomial logistic regressions were performed, setting those who underwent neither vaccinations as the reference group.ResultsAmong the participants, 23.3 %, 25.8 %, 9.4 %, or 41.5 % underwent neither, only influenza, only pneumococcal, or the both vaccinations, respectively. The caregiving frequency, time length in a day, or dementia of FCR were negatively associated with influenza vaccination (caregiving almost every day: relative risk ratio {RRR}: 0.39, 95 % confident interval {95 % CI} [0.24–0.63]; caregiving almost all day: 0.44, 95 % CI: 0.23–0.85; caregiving for FCR: RRR:0.55, 95 % CI: 0.34–0.91). On the other hand, those caregiving burdens were not associated with pneumococcal only or the both vaccinations. Having a family physician mitigated all the negative effect of the caregiving burdens on the vaccinations.ConclusionOur results suggest that the caregiving burden is a barrier to influenza vaccination but not to pneumococcal vaccination and that having a physician mitigates the negative effect regardless of the burden kind.     

The burden of herpes zoster disease in Norway

BackgroundNo national vaccination program against herpes zoster (HZ) is currently in place in Norway. We aimed to quantify the burden of medically attended HZ to assess the need for a vaccination program.MethodsWe linked data from several health registries to identify medically attended HZ cases during 2008–2014 and HZ-associated deaths during1996–2012 in the entire population of Norway. We calculated HZ incidences for primary and hospital care by age, sex, type of health encounter, vaccination status, and co-morbidities among hospital patients. We also estimated HZ-associated mortality and case-fatality.ResultsThe study included 82,064 HZ patients, of whom none were reported as vaccinated against HZ. The crude annual incidence of HZ was 227.1 cases per 100,000 in primary healthcare and 24.8 cases per 100,000 in hospitals. Incidence rates were higher in adults aged ≥50 years (461 per 100,000 in primary care and 57 per 100,000 in hospitals), and women than in men both in primary healthcare (267 vs 188 per 100,000), and hospitals (28 vs 22 per 100,000). Among hospital patients, 47% had complicated zoster and 25% had comorbidities, according to the Charlson comorbidity index. The duration of hospital stay (median 4 days) increased with the severity of comorbidities. The estimated mortality rate was 0.18 per 100,000; and in-hospital case-fatality rate was 1.04%.ConclusionsMedically attended HZ poses a substantial burden in the Norwegian healthcare sector. The majority of the zoster cases occurred among adults aged ≥50 years – the group eligible for zoster vaccination – and increased use of zoster vaccination may be warranted, especially among persons with co-morbidities.     

Pneumococcal vaccination coverage among adults newly diagnosed with underlying medical conditions and regional variation in the U.S.

BackgroundThe Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends pneumococcal vaccination for adults with chronic or immunocompromising conditions to prevent pneumococcal disease, yet vaccination rates are low and have limited information on regional variation. This study examines factors associated with pneumococcal vaccination in adults with underlying conditions and describes regional variation in vaccination across the U.S.MethodsUsing IBM MarketScan Commercial Database and Medicare Supplemental Database, this retrospective cohort study included adults ages 19–64 newly diagnosed with chronic (i.e. diabetes, chronic heart, lung, or liver disease, alcohol or tobacco dependence) or immunocompromising (i.e. cancer, chronic renal disease, organ transplant, HIV/AIDS, and asplenia) conditions in 2013. Adults were followed up until the time of pneumococcal vaccination, death, or December 31, 2019, whichever came first. Cox proportional hazards model was used to examine factors associated with vaccination. Vaccination rate was calculated by metropolitan statistical area (MSA) and visually represented on a U.S. map.Results255,330 adults were included. Vaccination rate increased from 6.0% to 21.1% among adults with one year and five years of follow-up, respectively. It took 2.4 years on average for adults to receive vaccination after initial diagnosis. Adults ages 50–64, 35–49 (relative to 19–34) or receiving influenza vaccination were more likely to receive pneumococcal vaccinations. Adults with HIV/AIDS were more likely and those with other conditions were less likely to be vaccinated than those with diabetes. Adults being diagnosed by other providers were less likely to be vaccinated than those diagnosed by primary care providers. Vaccination rate varied largely across MSAs, ranging from 0.0% (Ames, IA; Cheyenne, WY) to 34.0% (Ann Arbor, MI).ConclusionPneumococcal vaccination remains low and most adults with underlying conditions are unvaccinated. Insights into factors associated with vaccination, including regional variability, can help to increase pneumococcal vaccination.     

Seroprevalence of anti-tetanus antibodies in mothers and cord blood and associated factors in health-care settings in Lao People’s Democratic Republic

BackgroundMaternal neonatal tetanus (MNT) was eliminated from Lao People’s Democratic Republic (PDR) in 2014. WHO recommends 80% coverage of 2 or more tetanus vaccinations (TT2+) in pregnancy to maintain MNT control. Vaccination coverage in Lao PDR varies among regions although the reasons are not clear.Methods185 pregnant women giving birth in three district hospitals in Savannakhet province, Lao PDR were recruited. A questionnaire was administered to determine factors associated with seroprotection and blood was taken from mother and cord blood to be tested for anti-tetanus antibodies by ELISA.Results77% of mothers and 79% of newborns had sufficiently protective antibody titres (>0.5 IU/ml) against tetanus. Only 70% of the mothers received one dose of TT vaccination during antenatal care (ANC) consultation and 45% received the recommended two injections. Although most of the vaccination took place during ANC 1 and 2, many were missed at these time-points. Anti-tetanus seroprotection in the mothers was associated with maternal age, number of ANC visits, number of TT vaccinations during and before pregnancy and gestational age.ConclusionSeroprevalence of anti-tetanus antibodies in mothers and newborns was intermediate but TT2+ coverage was low in healthcare settings in Lao PDR. TT2+ coverage during ANC is likely to be significantly lower in settings with less robust ANC practices. Missed opportunities to vaccinate in ANC 1 and 2 suggest a need to promote vaccine awareness and vaccination at first ANC visit. A booster dose of TT containing vaccine should be considered for children aged between 4 and 7 years old.     

Vaccine exposure during pregnancy among privately and publicly insured women in the United States, 2016–2018

BackgroundVaccine use during pregnancy affects maternal and infant health. Many women do not receive vaccines recommended during pregnancy; conversely, inadvertent exposure to vaccines contraindicated or not recommended during pregnancy may occur. We assessed exposure to two recommended vaccines and two vaccines not recommended during pregnancy among privately and Medicaid-insured women in the United States.MethodsThis study includes a retrospective cohort of pregnancies in women aged 12–55 years resulting in live birth, spontaneous abortion, or stillbirth identified in the IBM® MarketScan® Commercial, Blue Health Intelligence® (BHI®) Commercial, and IBM MarketScan Multi-State Medicaid Databases from August 1, 2016, to December 31, 2018. Gestational age at vaccination was determined using a validated algorithm. We examined vaccines (1) recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) (tetanus, diphtheria, and acellular pertussis [Tdap]; inactivated influenza) and (2) not recommended (human papillomavirus [HPV]) or contraindicated (measles, mumps, and rubella [MMR]).ResultsWe identified 496,771 (MarketScan Commercial), 858,961 (BHI), and 289,573 (MarketScan Medicaid) pregnancies (approximately 75% aged 20–34 years). Across these three databases, 52.1%, 50.3%, and 31.3% of pregnancies, respectively, received Tdap, most often at a gestational age of 28 weeks, and influenza vaccination occurred in 32.1%, 30.8%, and 18.0% of pregnancies, respectively. HPV vaccination occurred in < 0.2% of pregnancies, mostly in the first trimester among women aged 12–19 years, and MMR was administered in < 0.1% of pregnancies. Use of other contraindicated vaccines per ACIP (e.g., varicella, live attenuated influenza) was rare.ConclusionMaternal vaccination with ACIP-recommended vaccines was suboptimal among privately and Medicaid-insured patients, with lower vaccination coverage among Medicaid-insured pregnancies than their privately insured counterparts. Inadvertent exposure to contraindicated vaccines during pregnancy was rare. This study evaluated only vaccinations reimbursed among insured populations and may have limited generalizability to uninsured populations.     

Immunogenicity,transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized,placebo-controlled trial

BackgroundPertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach.MethodsThis phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27–36 weeks’ gestation with crossover ≤ 72-hour-postpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (CIs) of the pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood were ≥ 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest were recorded.Results687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5–19.2) for anti-filamentous hemagglutinin, 20.7 (15.9–26.9) for anti-pertactin and 8.5 (7.0–10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination.ConclusionsTdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease.Clinical Trial Registration. ClinicalTrials.gov: NCT02377349.     

Pneumococcal vaccination in older adults: An initial analysis of social determinants of health and vaccine uptake

ObjectivesTo examine the potential influence of social determinants of health on pneumococcal vaccination in older American adults.MethodsThis study used nationwide, US Medicare claims data from 2013 to 2016 to assess uptake of pneumococcal vaccination among adults in the first year after turning age 65. Patients were followed from the point of being 65 years of age and initially enrolled in traditional fee-for-service Medicare or a Medicare Advantage plan through the subsequent year and observed for pneumococcal vaccination in outpatient clinics and pharmacies. Publicly-available data on select social determinants of health were incorporated and guided by the World Health Organization vaccine hesitancy matrix. Logistic regression determined predictors of vaccination while controlling clinical and demographic characteristics.ResultsA total of 307,488 and 74,995 adults aged 65 years were identified from Medicare Advantage and Medicare fee-for-service claims, respectively, and 21.1% of Medicare Advantage and 38.2% of Medicare fee-for-service patients received a pneumococcal vaccine in the first year after turning 65. Those residing in urban areas had a higher likelihood of pneumococcal vaccination in both the Medicare Advantage (OR: 1.31; 95% CI: 1.267–1.344) and Medicare fee-for-service (OR: 1.53; 95% CI: 1.450–1.615) cohorts. Additionally, residing in areas of higher health literacy or communities with more democratic voters were consistently associated with a higher odds of pneumococcal vaccination regardless of Medicare type. Results also pointed to a synergistic relationship between receiving the influenza vaccine and also being vaccinated against pneumococcal disease.ConclusionSocial determinants of health, including local health literacy, poverty, residing in more liberal areas, and access to information, may be influencing the pneumococcal vaccine-related decisions of older adults. However, additional factors associated with the vaccine hesitancy matrix and more granular data (e.g., zip code-level) are needed to fully determine the impact in this and other vaccines recommended in older adults.     

An observational study of antibody responses to a primary or subsequent pertussis booster vaccination in Australian healthcare workers

Adult pertussis vaccination is increasingly recommended to control pertussis in the community. However, there is little data on the duration and kinetics of immunity to pertussis boosters in adults. We compared IgG responses to vaccination with a tetanus, low-dose diphtheria, low-dose acellular pertussis (Tdap) booster at 1 week, 1 month and 1 year post-vaccination in whole-cell (wP)-primed Australian paediatric healthcare workers who had received an adult Tdap booster 5–12 years previously, to those who received their first Tdap booster.Tdap vaccination was well tolerated in both groups. Previously boosted adults had significantly higher pre-vaccination IgG concentrations for all vaccine-antigens, and more were seropositive for pertussis toxin (PT)-specific IgG (≥ 5 IU/mL) (69.5%; 95% confidence interval (CI) 59.5–79.5) than adults in the naïve group (45.2%; 95% CI 32.8-57.5). Tdap vaccination significantly increased IgG responses 1 month post-vaccination in both groups. This increase was more rapid in previously boosted than in naïve adults, with geometric mean fold-increases in PT-IgG at 1 week post vaccination of 3.6 (95% CI 2.9–4.3) and 2.6 (95% CI 2.2–3.2), respectively. Antibody waning between 1 month and 1 year post-vaccination was similar between groups for IgG specific to PT and filamentous haemagglutinin (FHA), but was faster for IgG against pertactin (PRN) in the naïve group (GMC ratio 0.36; 95% CI 0.31–0.42) than the previously boosted group (GMC ratio 0.45; 95% CI 0.39–0.50). At baseline, all but one adult had protective IgG titres against tetanus toxin (TT) (≥ 0.1 IU/mL), and 75.6% in the previously boosted and 61.3% in the naïve group had protective IgG titres against diphtheria toxoid (DT) of ≥ 0.1 IU/mL.This study shows that pertussis immune memory is maintained up to 12 years after Tdap vaccination in wP-primed Australian adults. There was no evidence that pertussis immune responses waned faster after a booster dose. These findings support current recommendations of repeating Tdap booster vaccination in paediatric healthcare workers at least every 10 years. Clinical trials registry: ACTRN12615001262594.     

Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial

BackgroundPertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization.MethodsThis phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6–14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (27^0/7–36^6/7 weeks’ gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination.Results601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5–77.1%) versus placebo (90.0–99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related.ConclusionsPertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant’s ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience.Clinical Trial Registration: ClinicalTrials.gov: NCT02422264.     

Impact of the adolescent pertussis booster dose on the incidence of pertussis in British Columbia and Quebec,Canada

Impact of an adolescent tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine program was assessed in the provinces of British Columbia and Quebec, Canada. In both provinces, the Tdap booster has been in place since 2004, targeting Grade 9 students (14–15-years-of-age). Incidence rate ratios (IRRs) standardizing notification rates among teens 15–19-years-old to infants <1-year-old decreased following introduction of the Tdap program and were significantly halved during the 2009–2012 post-Tdap versus 2000–2003 pre-Tdap period. This program impact, however, is tempered by the observation that pertussis incidence among 15–19-year-olds was already lower than any other pediatric age group, following gradual decline from pre-teen rates even before the Tdap program. The risk of hospitalization among adolescents 15–19-years-old was also low throughout at <1/100,000. Furthermore, IRRs increased in 2013–2017 when an increasing proportion of 15–19-year-olds were primed with acellular pertussis vaccine only, suggesting short-lived Tdap booster-dose effectiveness that warrants further monitoring.     

The changing epidemiology of herpes zoster over a decade in South Korea, 2006–2015

BackgroundIn South Korea, the population is rapidly aging and the prevalence of comorbidities has increased. We investigated longitudinal changes in the herpes zoster (HZ) considering demographic changes and comorbidities in the era of universal single-dose varicella vaccination.MethodsWe used the population-based database of the National Health Insurance Service in South Korea, with approximately 50 million subscribers during 2006–2015. HZ cases were identified using ICD-10 codes and comorbid conditions were also collected. Incidence rates (IRs) and incidence rate ratios (IRRs) per year were calculated adjusting for age, sex, comorbidities and socioeconomic status, and the temporal trends were examined using segmented negative binomial regression analysis.ResultsOver a decade, the adjusted HZ IR increased significantly from 4.23 to 9.22 per 1000 person-years (adjusted IRR 1.05, 95% confidence interval [CI] 1.04–1.06). However, during 2012–2015, the increasing trends decelerated (adjusted IRR per year 1.01, 95% CI 0.98–1.04) and slope changes differed by age. There was a declining trend in children under 9 years, sustained increase in adults aged 30–39 years, and near-plateau in those aged 50–69 years. Nonetheless, the age distribution of HZ incidence did not change over a decade, with the peak in adults aged 60–79 years. HZ-associated hospitalization rates also increased, with a deceleration in the increasing trends during 2012–2015.ConclusionsThe HZ burden increased independently of demographic changes and prevalence of comorbidities. However, different trajectories by age group necessitate continuous HZ surveillance for better understanding of these changes, and to provide evidence for development of preventive strategies.     

Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings

ObjectiveTo test the effectiveness of a multimodal intervention in obstetrics/gynecology (ob-gyn) clinics to increase uptake of influenza and tetanus-diphtheria-acellular pertussis (Tdap) vaccines in pregnant women and these vaccines plus human papillomavirus (HPV) vaccine in non-pregnant women.MethodsA cluster randomized controlled trial among 9 private ob-gyn practices in Colorado from 9/2011 to 5/2014. The intervention consisted of: designation of immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials. Control practices continued usual care. Primary outcomes were receipt of influenza and Tdap vaccines among pregnant women and these vaccines plus HPV vaccine among non-pregnant women, comparing a Baseline period (Year 0/Year 1) to Year 2, intervention versus control. With an estimated sample size of 32,590 per arm, there would be >80% power to detect a 10% difference between groups.ResultsIn the Baseline period, 27% of pregnant women in both intervention and control practices received influenza vaccine. In Year 2, 29% of pregnant women in intervention practices received influenza vaccine versus 41% in control practices. In the Baseline period, 18% of pregnant women in intervention practices received Tdap vaccine versus 22% in control practices. Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations. Relatively few HPV, influenza or Tdap vaccines (≤6% of eligible patients) were given to non-pregnant patients in either intervention or control practices at any time during the study.ConclusionIn this cluster randomized trial designed to increase vaccination uptake, both intervention and control practices showed improved vaccination of pregnant but not non-pregnant patients. Future work should focus on tailoring evidence-based immunization practices or developing new approaches to specifically fit busy ob-gyn offices.     

Safety and efficacy of recombinant and live herpes zoster vaccines for prevention in at-risk adults with chronic diseases and immunocompromising conditions

Compared with the general population, older adults with immune senescence and individuals who are immunocompromised (IC) due to disease or immunosuppressive therapy are at increased risk for herpes zoster (HZ) and its associated complications, which can be debilitating and life-threatening. Vaccination can be an effective strategy against HZ and studies have shown that HZ vaccination in IC individuals can elicit immune responses and provide protection from infection. Recently, the first approvals have been granted in the United States and the European Union for the recombinant HZ vaccine (RZV) in adults ≥ 18 years of age at risk of HZ due to immunodeficiency or immunosuppression. Existing systematic reviews have highlighted the risks for HZ in limited immunocompromising conditions and have only examined clinical data for RZV. This review details the risks and burden of HZ in a broad range of clinically relevant IC populations and summarizes key efficacy and safety data for RZV and live HZ vaccine in these individuals. Research has shown IC individuals can benefit from HZ vaccination; however, these insights have yet to be fully incorporated into vaccination guidelines and clinical care. Clinicians should consider HZ vaccination in eligible at-risk populations to protect against HZ and its associated complications and thereby, reduce the burden that HZ poses on the healthcare system. Electronic health records and linked personal health records could be used to identify and contact patients eligible for HZ vaccination and provide clinical decision support-generated alerts for missing or delayed vaccinations. This review will help clinicians identify eligible IC individuals who may benefit from HZ vaccination.A video abstract linked to this article is available on Figshare https://doi.org/10.6084/m9.figshare.21517605.     

Patient report of herpes zoster pain: Incremental benefits of zoster vaccine live

IntroductionPain following herpes zoster (HZ) can persist for months and negatively impact quality of life. To evaluate the effect of zoster vaccine live (ZVL) on progression of pain following HZ, we conducted a prospective cohort study of HZ cases at Kaiser Permanente Southern California.MethodsZVL vaccinated and unvaccinated members aged ≥60 years with laboratory-confirmed HZ from January 18, 2012 to February 26, 2015 were followed up within 5 days of HZ diagnosis, and at 30, 60, and 90 days after diagnosis. Pain was assessed with the Zoster Brief Pain Inventory (ZBPI) on a 0–10 scale, using cut-points of ≥3, ≥5, and ≥7, with postherpetic neuralgia (PHN) defined as pain ≥3 at 90 days. Log binomial regression was used to estimate adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) associated with pain, comparing vaccinated versus unvaccinated HZ patients.ResultsWe interviewed 509 vaccinated and 509 unvaccinated HZ patients. ZVL was associated with significantly lower risks of HZ-related pain at all time-points. The risk of PHN in vaccinated and unvaccinated patients, respectively, was 9.2% and 15.4% (aRR = 0.594, 95% CI: 0.413, 0.854); 2.0% and 4.8% of these patients reported pain ≥7 (aRR = 0.332, 95% CI: 0.153, 0.721). Irrespective of vaccination, the risk of PHN was lower in adults aged <70 years versus those ≥70 years and was similar or lower in females versus males.ConclusionWe used laboratory confirmation of HZ cases and patient survey to show that aside from preventing HZ, ZVL reduced HZ-related pain and prevented PHN among vaccine recipients who experienced HZ. Observational studies will be needed to evaluate long-term effectiveness of the new recombinant zoster vaccine and its benefits in protecting patients against PHN.     

The adjuvanted recombinant zoster vaccine co-administered with a tetanus,diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial

BackgroundThis study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years.MethodsIn this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed.ResultsVRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.ConclusionsCo-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.     

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination

IntroductionA 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults ≥65 years of age with prior pneumococcal vaccination.MethodsThis phase 3, multicenter, randomized, open-label study was conducted in the United States and Sweden. Adults ≥65 years of age were enrolled into 1 of 3 cohorts based on their prior pneumococcal vaccination history (23-valent pneumococcal polysaccharide vaccine [PPSV23], PCV13, or both PCV13 and PPSV23). Participants were randomized 2:1 within their cohort to receive a single dose of PCV20 or PCV13 in those with prior PPSV23 only, and PCV20 or PPSV23 in those with prior PCV13 only; all participants with prior PCV13 and PPSV23 received PCV20. Safety was assessed by prompted local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. Immune responses 1 month after PCV20 were assessed.ResultsThe percentages of participants reporting local reactions, systemic events, and AEs after PCV20 administration were similar across cohorts and comparable with the PCV13 and PPSV23 control groups. SAE and NDCMC rates were low in all groups. Robust immune responses, including opsonophagocytic antibody responses, to the 20 vaccine serotypes were observed 1 month after PCV20 regardless of prior pneumococcal vaccination.ConclusionsPCV20 was well tolerated and immunogenic in adults ≥65 years of age previously vaccinated with different pneumococcal vaccine regimens.Clinicaltrials.gov NCT03835975.     

Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against community-acquired pneumonia in older individuals after the introduction of childhood 13-valent pneumococcal conjugate vaccine: A multicenter hospital-based case-control study in Japan

BackgroundIn the era of childhood pneumococcal conjugate vaccine (PCV) immunization, especially 13-valent pneumococcal conjugate vaccine (PCV13) immunization, serotype replacement of Streptococcus pneumoniae and herd immunity in adults have been reported worldwide. Therefore, continuous evaluation of the effectiveness of the pneumococcal vaccine in adults is crucial because vaccine effectiveness may change owing to these factors. The purpose of this study was to evaluate the effectiveness of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) against all-cause pneumonia and pneumococcal pneumonia in older individuals with community-acquired pneumonia (CAP) after the introduction of childhood PCV13 in Japan, a topic that has remained largely unexplored.MethodsWe evaluated pneumococcal vaccine effectiveness in this multicenter, matched case-control study conducted in hospitals and clinics. Cases included patients (aged ≥ 65 years) newly diagnosed with CAP between October 2016 and September 2019. A maximum of five non-pneumonia control patients matched for sex, school grade, date of outpatient visit, and medical institution were selected for each case. Conditional logistic regression models were used to calculate the odds ratios (ORs) and 95% confidence intervals (CIs) of pneumococcal vaccines for the occurrence of all-cause CAP and pneumococcal CAP.ResultsThe analysis included 740 individuals (142 patients and 598 controls). The median age of participants was 75 years (men: 54%). The adjusted OR for pneumococcal vaccination against all-cause CAP was 1.31 (95% CI: 0.84–2.06), while that for PPSV23 vaccination in the previous 5 years was 1.33 (95% CI: 0.85–2.09). The adjusted OR for PPSV23 vaccination in the previous 5 years against pneumococcal CAP was 0.93 (95% CI: 0.35–2.50).ConclusionsThis study was unable to demonstrate the effectiveness of PPSV23 against all-cause and pneumococcal pneumonia after the introduction of childhood PCV13 in Japan. Nonetheless, additional studies are needed to validate these results.