Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Research Articles

Bell's palsy and SARS-CoV-2 vaccines

Bell's palsy and SARS-CoV-2 vaccines

Post-Marketing Surveillance Observational Study of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (MenACWY-DT, MCV4/Menactra®) in the Republic of Korea, 2014–2019

BackgroundInvasive meningococcal disease is a notifiable disease in the Republic of Korea. The meningococcal (groups A, C, Y, and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-DT, Menactra®) was licensed in the Republic of Korea in 2014. This post-marketing surveillance (PMS) observational study aims to assess the safety of MenACWY-DT administration of routine clinical care to individuals aged 9–23 months as a two-dose series at least 3 months apart and to individuals 2–55 years as a single dose.MethodsThe PMS observational study (NCT02864927) included participants aged 9 months to 55 years and who were given MenACWY-DT during routine healthcare visits. The study participants were followed-up for up to 30 days following vaccination (additional time was allowed for the visit or phone call to be conducted). Study outcomes included solicited and unsolicited adverse reactions, unexpected adverse events, and serious adverse events (SAEs).ResultsA total of 640 participants 9–23 months of age and 671 participants 2–55 years of age were eligible for safety analysis. Overall, AEs were reported by 35.3% of participants aged < 2 years and 45% of participants aged 2–55 years. Solicited adverse reactions were reported by 21.4% and 17.4% of participants aged < 2 years and 2–55 years, respectively. Unsolicited adverse reactions were reported by 26.1% and 37.9%, respectively. No vaccine-related SAEs occurred during the study. The AEs reported in Korean population were consistent with the known safety profile of MenACWY-DT, and most were of grade 1–2 in severity.ConclusionsThis study did not detect any unanticipated or new safety findings of concern with MenACWY-DT in either of the study age groups, and provides reassurance that MenACWY-DT can be used as part of routine immunization care for the prevention of invasive meningococcal disease.Trial RegistrationClinicalTrials.gov Identifier, NCT02864927

Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005–2016

BackgroundPost marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM197 conjugate vaccine (MenACWY-CRM). To provide an updated general safety assessment, we reviewed reports of AEs following MenACWY-D submitted to the Vaccine Adverse Event Reporting System (VAERS). MethodsVAERS is a national spontaneous reporting vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. We searched the VAERS database for U.S. reports of AEs after administration of MenACWY-D from January 2005 through June 2016. We conducted clinical reviews of serious reports after MenACWY-D administered alone, reports of MenACWY-D use during pregnancy, and reports of selected pre-specified outcomes. We screened for disproportionate reporting of AEs after MenACWY-D using empirical Bayesian data mining. ResultsVAERS received 13,075 U.S. reports after receipt of MenACWY-D; most (86%) described vaccination in adolescents, were classified as non-serious (94%), and described AEs consistent with pre-licensure studies. We did not find any evidence that reported deaths were related to vaccination. In serious reports, GBS and meningococcal infection were the most commonly reported medical conditions. Many reports of MenACWY-D use during pregnancy described inadvertent vaccination; most (61%) did not report any AE. ConclusionsFindings from our comprehensive review of reports to VAERS following MenACWY-D are consistent with data from pre-licensure studies and provide further reassurance on the safety of MenACWY-D.

Persistence of bactericidal antibodies 4 years after a booster dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D)

One dose of quadrivalent meningococcal conjugate vaccine (MenACWY) was first recommended for US adolescents (ages 11–12 years) in 2005 to protect against invasive meningococcal disease (IMD). In 2010, after evidence emerged about waning protection within 5 years after MenACWY vaccination, the US Advisory Committee on Immunization Practices (ACIP) recommended a MenACWY booster at age 16 years. We used a serum bactericidal assay with human complement (hSBA) to evaluate antibody persistence after a MenACWY-D booster in a sample of 110 participants who received the booster 4 years earlier in a phase 2 study. High proportions (89.9–98.2%) of participants maintained hSBA titers (≥1:4) associated with protection against IMD; a majority (81.7–97.2%) also had hSBA titers ≥1:8, a more conservative threshold. These findings support ACIP recommendations regarding MenACWY booster vaccination, which are aimed at protecting adolescents and young adults throughout the period in which they are at increased risk of IMD.

Observational Safety Study of Meningococcal Conjugate Vaccine Against Serogroups A, C, W and Y (Menactra) Used in Routine Healthcare Practice for Persons Aged 2 to 55 Years in Russian Federation

Although incidence of invasive meningococcal disease (IMD) in the Russian Federation is low, children younger 15 years of age are significantly affected. Serogroups A, B, and C are frequently implicated. The quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) is approved in Russia for immunization of individuals 9 months to 55 years of age. Goals . We evaluated the safety of a single dose of MenACWY-D administered to individuals 2–55 years of age in routine clinical practice in the Russian Federation. Materials and Methods . Using diary cards filled by participants or their parents, this prospective multicenter observational study quantified the occurrence of solicited injection site and systemic reactions up to 7 days after vaccination as well as unsolicited non-serious adverse events (AEs), and serious adverse events (SAEs) for 28 days. Results . The systemicrate of solicited injection site and systemic reactions during the 7-day observation period was 52.0% (95% CI: 41.8; 62.2). Rates of solicited injection site reactions and systemic reactions of any severity were 49% (95% CI: 38.9; 59.2) and 20% (95% CI: 12.7; 29.2), respectively. The rate of unsolicited AEs was 9% (95% CI: 4.2; 16.4). Rates of solicited grade 3 injection site and systemic reactions ranged between 1–3% and 0–1%, respectively. There were no unsolicited adverse reactions (ARs), SAEs, or deaths. Conclusions . These findings corroborate those of pre-licensure and post-registration studies and confirm the safety and good tolerability of MenACWY-D when used in routine clinical practice in individuals 2–55 years of age in the Russian Federation.

Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children

BackgroundMenactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11–55 years of age, in 2007 for children 2–10 years of age, and in 2011 for infants/toddlers 9–23 months of age. We conducted two studies at Kaiser Permanente Northern California (KPNC), an integrated health care organization, to assess the safety of MenACWY-D in 2–10-year-olds and 9–23-month-olds receiving the vaccine during routine clinical care. MethodsWe conducted observational, retrospective studies of MenACWY-D in 2–10-year-olds (October 2007–October 2010) and in 9–23-month-olds (June 2011–June 2014). We monitored all subjects for non-elective hospitalizations, emergency department visits, and selected outpatient outcomes (specified neurological conditions, hypersensitivity reactions and new-onset autoimmune diseases) up to 6 months after vaccination, depending on the study. Using a self-control risk-interval design, we calculated incidence rate ratios (IRRs) comparing outcomes during the post-vaccination risk interval (0–30 days) with those during more remote post-vaccination comparison intervals (31–60 and 31–180 days [children] or 31–75 days [infants/toddlers]). ResultsThere were 1421 children aged 2–10 years and 116 infants/toddlers aged 9–23 months who received MenACWY-D. Approximately 30% of the 2–10-year-olds and 67% of the 9–23-month-olds were considered at increased risk of meningococcal disease. Among 2–10-year-olds, there was 1 hospitalization on post-vaccination day 5 for fever, which was considered possibly related to vaccination. The only significantly elevated outcome among 2–10-year-olds was cellulitis/abscess (2 cases occurred during the risk interval versus 0 during comparison interval; IRR not evaluable [NE], 95% CI: 1.42, NE). After medical record review, the 2 cases were considered unrelated to vaccination. Among 9–23-month-olds, no outcomes were significantly elevated after vaccination and there were no hospitalizations. There were no deaths observed during the three-year accrual and subsequent six-month surveillance period for either study. ConclusionsImmunization of infants and young children with MenACWY-D vaccine was not associated with any new safety concerns; however, these small studies had limited power to detect rare or uncommon safety events.ClinicalTrials.gov Identifiers are NCT00728260 and NCT01689155.

Safety and Immunogenicity of a Meningococcal Quadrivalent Conjugate Vaccine in Five- to Eight-Year-Old Saudi Arabian Children Previously Vaccinated with Two Doses of a Meningococcal Quadrivalent Polysaccharide Vaccine

Saudi Arabian children respond poorly to 2 doses of meningococcal quadrivalent polysaccharide vaccine (MPSV4) when given before 2 years of age. This study examined whether such children were able to respond to 1 dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MCV4) when they were older. Saudi Arabian children 5 to 8 years of age who had previously been vaccinated with 2 doses of MPSV4 when they were under 2 years of age (termed the prior-MPSV4 group) were enrolled in a controlled, open-label, multicenter study. In the prior-MPSV4 group, children (n = 153) received 1 dose of MCV4, as did a group of age-matched meningococcal vaccine-naïve children (n = 85). Blood samples collected prevaccination and 28 days postvaccination were measured for serogroup-specific serum bactericidal antibody (SBA) levels in the presence of baby rabbit complement (rSBA) and for IgG antibody levels. Vaccine tolerability and safety were also evaluated. For all of the measured serogroups (A, C, Y, and W-135), the meningococcal vaccine-naïve participants achieved higher postvaccination rSBA geometric mean titers (GMTs) than did those in the prior-MPSV4 group. This was statistically significant for serogroup C (512 versus 167). Percentages of participants with postvaccination titers of ≥8 and with ≥4-fold increases in prevaccination to postvaccination titers appeared to be quite similar in the 2 groups. No worrisome safety signals were detected. MCV4 induced robust immune responses and was well tolerated in Saudi Arabian children who previously received 2 doses of MPSV4 as well as in those who were previously meningococcal vaccine naïve.