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0%), II (35.0%), and III (25.0%). Most cases occurred in the mandible (65.0%), followed by the maxilla (30.0%). The success rate of surgical intervention for MRONJ secondary to denosumab was in 16 of 20 (80.0%) patients. Stage I MRONJ lesions achieved mucosal closure in 100% of patients, stage II in 71.4%, and stage III in 60.0%. The surgical success rate was 83.3% in the maxilla and 76.9% in the mandible.
The surgical success rate for MRONJ secondary to denosumab was 80.0%, similar to that reported in bisphosphonates of 85 to 95%; however, more evidence must be reported and analyzed.
The surgical success rate for MRONJ secondary to denosumab was 80.0%, similar to that reported in bisphosphonates of 85 to 95%; however, more evidence must be reported and analyzed.The indications for use of programed cell death receptor (PD-1) inhibitors to treat cancer continues to expand rapidly. Treatment with PD-1 inhibitors has been associated with numerous immune-mediated mucocutaneous side effects. Here, we report 2 cases of severe mucositis caused by the PD-1 inhibitor pembrolizumab and review the defining features of similar cases. Recognition of mucocutaneous toxicities of PD-1 inhibitors is increasingly important as their use continues to expand. A stepwise approach to diagnosis and management is also reviewed.
The evaluation of immune responses to RTS,S/AS01 has traditionally focused on immunoglobulin (Ig) G antibodies that are only moderately associated with protection. The role of other antibody isotypes that could also contribute to vaccine efficacy remains unclear. Here we investigated whether RTS,S/AS01
elicits antigen-specific serum IgA antibodies to the vaccine and other malaria antigens, and we explored their association with protection.
Ninety-five children (age 5-17months old at first vaccination) from the RTS,S/AS01
phase 3 clinical trial who received 3 doses of RTS,S/AS01
or a comparator vaccine were selected for IgA quantification 1month post primary immunization. Two sites with different malaria transmission intensities (MTI) and clinical malaria cases and controls, were included. Measurements of IgA against different constructs of the circumsporozoite protein (CSP) vaccine antigen and 16 vaccine-unrelated Plasmodium falciparum antigens were performed using a quantitative suspension array asS,S/AS01
immunization is necessary for the design of improved second-generation vaccines.
ClinicalTrials.gov NCT008666191.
ClinicalTrials.gov NCT008666191.
In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the United States for adults aged ≥18years. A quadrivalent version (ccIIV4) was later approved in 2016 and replaced ccIIV3. The safety of ccIIV3 or ccIIV4 (ccIIV) was not assessed for pregnant women or their infants during pre-licensure studies.
To assess the safety of ccIIV administered during pregnancy in pregnant women and their infants whose reports were submitted to VAERS during 2013-2020.
We searched VAERS for United States reports of adverse events (AEs) in pregnant women who received ccIIV from 1 July 2013 through 31 May 2020. Clinicians reviewed reports and available medical records and assigned a primary clinical category for each report. Reports were coded as serious based on the Code of Federal Regulations definition.
VAERS received 391 reports following ccIIV administered to pregnant women. Twenty-four (6.1%) were serious. Two neonatal deaths were reported. No maternal deaths occurred. Among reports with trimester information (n=340), ccIIV was administered during the second trimester in 170 (50%). The most frequent pregnancy-specific AE was premature delivery in 85 (21.7%) reports, followed by dysmature placenta in 13 (3.3%) and pre-eclampsia/eclampsia in ten (2.3%). The most common non-pregnancy specific conditions were infectious conditions in 32 (8.2%). Among infant conditions, low birth weight was reported in 62 (15.9%) reports. Fifteen birth defects were reported; in 12 with gestational age information, administration of the vaccine occurred late in the second trimester or later.
Review of maternal ccIIV reports in VAERS was not unexpectedly different from other maternal influenza vaccine safety VAERS reviews.
Review of maternal ccIIV reports in VAERS was not unexpectedly different from other maternal influenza vaccine safety VAERS reviews.Individuals with chronic kidney disease (CKD) are at high risk of pneumococcal infections and recommended to receive the 23-valent pneumococcal polysaccharide vaccine (PPV23). Although the 13-valent pneumococcal conjugate vaccine (PCV13) has been found to have higher immunogenicity compared to PPV23 in adults with some immunocompromising conditions, previous PPV23 immunization may decrease the immunogenicity of PCV13. We assessed immunogenicity and safety of PCV13 in 74 PPV23-naïve and 58 previously PPV23-immunized (>1 year ago) patients with severe (stage 4-5) CKD. Serum IgG, IgM, and IgA specific to seven serotypes, i.e. 3, 6B, 9V, 14, 19A, 19F, 23F were quantified pre- and 4 weeks and one year post-immunization. Baseline concentrations for most serotype-specific IgG and IgM, and serotype 3-specific IgA were higher in previously PPV23-immunized compared to PPV23-naïve patients. Immunization with PCV13 significantly increased almost all serotype-specific IgG, all IgA and some IgM; an increase in some serotype-specific IgG and IgM lasted for one year. Fold increases in antibody concentrations and the proportion of individuals with >2-fold increase post-immunization were generally larger in PPV23-naïve than previously immunized patients for most serotype-specific IgG and some IgA. The data show that in patients with CKD who received previous PPV23 immunization over one year ago, the antibody response to PCV13 was inferior compared to pneumococcal vaccine naïve study participants. In both groups, the lowest response to PCV13 was found for serotype 3. Alvespimycin Patients of Indigenous ethnic background demonstrated a superior immune response to PCV13 compared to the non-Indigenous counterpart that could partially be related to Indigenous study participants' younger age. Although we found that previous PPV23 immunization could contribute to the more frequent occurrence of systemic adverse events post PCV13 immunization, those did not exceed the mild to moderate range.
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