Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study.

Background: In a parallel-group, international, phase 3 study (ClinicalTrials.govNCT04762680), we evaluated prototype (D614) and Beta (B.1.351) variant recombinant spike protein booster vaccines with AS03-adjuvant (CoV2 preS dTM-AS03). Methods: Adults, previously primed with mRNA (BNT162b2, mRNA-1273), adenovirus-vectored (Ad26.CoV2.S, ChAdOx1nCoV-19) or protein (CoV2 preS dTM-AS03 [monovalent D614; MV(D614)]) vaccines were enrolled between 29 July 2021 and 22 February 2022. Participants were stratified by age (18-55 and ≥ 56 years) and received one of the following CoV2 preS dTM-AS03 booster formulations: MV(D614) (n = 1285), MV(B.1.351) (n = 707) or bivalent D614 + B.1.351 (BiV; n = 625). Unvaccinated adults who tested negative on a SARS-CoV-2 rapid diagnostic test (control group, n = 479) received two primary doses, 21 days apart, of MV(D614). Anti-D614G and anti-B.1.351 antibodies were evaluated using validated pseudovirus (lentivirus) neutralization (PsVN) assay 14 days post-booster (day [D]15) in 18-55-year-old BNT162b2-primed participants and compared with those pre-booster (D1) and on D36 in 18-55-year-old controls (primary immunogenicity endpoints). PsVN titers to Omicron BA.1, BA.2 and BA.4/5 subvariants were also evaluated. Safety was evaluated over a 12-month follow-up period. Planned interim analyses are presented up to 14 days post-last vaccination for immunogenicity and over a median duration of 5 months for safety. Findings: All three boosters elicited robust anti-D614G or -B.1.351 PsVN responses for mRNA, adenovirus-vectored and protein vaccine-primed groups. Among BNT162b2-primed adults (18-55 years), geometric means of the individual post-booster versus pre-booster titer ratio (95% confidence interval [CI]) were: for MV (D614), 23.37 (18.58-29.38) (anti-D614G); for MV(B.1.351), 35.41 (26.71-46.95) (anti-B.1.351); and for BiV, 14.39 (11.39-18.28) (anti-D614G) and 34.18 (25.84-45.22 (anti-B.1.351). GMT ratios (98.3% CI) versus post-primary vaccination GMTs in controls, were: for MV(D614) booster, 2.16 (1.69; 2.75) [anti-D614G]; for MV(B.1.351), 1.96 (1.54; 2.50) [anti-B.1.351]; and for BiV, 2.34 (1.84; 2.96) [anti-D614G] and 1.39 (1.09; 1.77) [anti-B.1.351]. All booster formulations elicited cross-neutralizing antibodies against Omicron BA.2 (across priming vaccine subgroups), Omicron BA.1 (BNT162b2-primed participants) and Omicron BA.4/5 (BNT162b2-primed participants and MV D614-primed participants). Similar patterns in antibody responses were observed for participants aged ≥56 years. Reactogenicity tended to be transient and mild-to-moderate severity in all booster groups. No safety concerns were identified. Interpretation: CoV2 preS dTM-AS03 boosters demonstrated acceptable safety and elicited robust neutralizing antibodies against multiple variants, regardless of priming vaccine. Funding: Sanofi and Biomedical Advanced Research and Development Authority (BARDA).

Missed Opportunity: The Unseen Driver for Low Coronavirus Disease 2019 Vaccination Rates in Underserved Patients.

Background: Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus have been available since December 2020. Vaccination rates among hospitalized patients at our institution remained low at approximately 40%, thus we sought to understand the drivers of vaccine hesitancy in our patient population. Methods: All unvaccinated adult patients admitted to our hospital were asked to participate in a survey to assess coronavirus disease 2019 (COVID-19) vaccine hesitancy. Updated vaccination status was collected at the end of the study. Results: Ninety-seven patients agreed to participate, 34% of which were SARS-CoV-2 positive based on results from polymerase chain reaction tests. Of the 64 participants eligible to receive the vaccine, 57.8% were agreeable but only 27% received the vaccine before discharge. Conclusion: Many patients are willing to receive the vaccine, and hospitalization provides a unique opportunity to interact with patients who have been otherwise unaware, unable, or unwilling to pursue vaccination outside of the hospital.

Promoting Health Literacy About Cancer Screening Among Muslim Immigrants in Canada: Perspectives of Imams on the Role They Can Play in Community.

Purpose: Immigrants tend to have lower rates of cancer screening than non-immigrants in Canada. Inequity in screening rates may stem from religious factors, which religious leaders can influence. This study aimed to explore the knowledge and attitudes held by Muslim religious leaders about cancer screening, as well as the role religious leaders perceive they can play in improving cancer screening health literacy among South Asian Muslim immigrant women. Methods: We conducted interviews with 8 Muslim religious leaders in Calgary, Canada. Participants' knowledge and attitudes were inductively summarized using descriptive analysis, while practices were deductively thematically analyzed using the Socioecological Model and the Communication for Development approaches. Results: We found participants mostly had some knowledge of cancer, but lesser knowledge of different screening tests and of low screening rates among immigrants. Participants proposed that their role as a speaker, access to facilities and community networks, and collaboration with universities and healthcare professionals could help overcome religious misinterpretations and promote cancer screening among South Asian Muslim immigrant women. Conclusion: Religious leaders were highly supportive of incorporating health messaging into faith-based messaging. Future work should focus on implementing the practices recommended in this study with South Asian Muslim immigrant women's voices at their center.

Alcohol reduction in the first trimester is unrelated to smoking, patient or pregnancy characteristics.

INTRODUCTION: Studies show alcohol-preferring mice reduce their alcohol intake during pregnancy; this study questions if the same is true for humans. The current investigation compares women's pre-pregnancy and first trimester alcohol consumption, examines if women with problem drinking diminish their alcohol intake during pregnancy, and determines if prenatal alcohol reduction is associated with characteristics of pregnancy, patients or smoking. METHODS: 126 participants in weeks 1-12 of pregnancy, recruited from Obstetric and Family Practices, completed a survey during their initial prenatal visit including two gender-specific AUDITs (Alcohol Use Disorders Identification Tests) querying current and pre-pregnancy alcohol use. AUDIT-C (AUDIT items 1-3) scores measuring pre-pregnancy and first trimester alcohol consumption were compared, analyzed and tested using general linear model repeated. A p ≤ 0.05 was accepted as significant. RESULTS: Most participants were multiparous, Caucasian high school graduates experiencing nausea and vomiting. Pre-pregnancy alcohol use was significantly (p = 0.019, Fisher's exact) higher among women seeing obstetricians. Pre-pregnancy AUDIT-C scores (m (mean) = 2.22, sd (standard deviation) = 2.19) were significantly higher (p < 0.001) than first trimester scores (m = 0.143, sd = 0.532). Among 49 with pre-pregnancy AUDIT-C scores ≥ 3, 45/49 (92%) reduced their alcohol use to zero during the first trimester. Age, race, education, marital status, parity, nausea and vomiting, gestational age and smoking were non-factors in score reduction. CONCLUSIONS: Women reported reducing their alcohol consumption during pregnancy, including those screening positive for pre-pregnancy problem drinking. First trimester alcohol reduction cannot be accounted for by smoking, patient or pregnancy characteristics; public health initiatives, psychological factors and hormonal mechanisms may be implicated.

Is toxoplasmosis prophylaxis necessary in cardiac transplantation? Long-term follow-up at two transplant centers.

Cardiac transplant recipients are often given prophylactic treatments to prevent opportunistic infections such as Pneumocystis carinii. Toxoplasmosis prophylaxis is commonly prescribed for transplant recipients who have not been exposed to this disease but receive a heart from an exposed donor. We reviewed the collective 28-year experience at two urban transplant programs with 596 patients, and found no cases of toxoplasmosis, but all patients received trimethoprim-sulfamethoxazole to prevent Pneumocystis pneumonia. We conclude that specific anti-toxoplasmosis prophylaxis is unnecessary in heart transplant recipients.