Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial.

The mRNA-1273 vaccine for coronavirus disease 2019 (COVID-19) demonstrated 93.2% efficacy in reduction of symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in the blinded portion of the Phase 3 Coronavirus Efficacy (COVE) trial. While mRNA-1273 demonstrated high efficacy in prevention of COVID-19, including severe disease, its effect on the viral dynamics of SARS-CoV-2 infections is not understood. Here, in exploratory analyses, we assessed the impact of mRNA-1273 vaccination in the ongoing COVE trial (number NCT04470427) on SARS-CoV-2 copy number and shedding, burden of disease and infection, and viral variants. Viral variants were sequenced in all COVID-19 and adjudicated COVID-19 cases (n = 832), from July 2020 in the blinded part A of the study to May 2021 of the open-label part B of the study, in which participants in the placebo arm started to receive the mRNA-1273 vaccine after US Food and Drug Administration emergency use authorization of mRNA-1273 in December 2020. mRNA-1273 vaccination significantly reduced SARS-CoV-2 viral copy number (95% confidence interval) by 100-fold on the day of diagnosis compared with placebo (4.1 (3.4-4.8) versus 6.2 (6.0-6.4) log10 copies per ml). Median times to undetectable viral copies were 4 days for mRNA-1273 and 7 days for placebo. Vaccination also substantially reduced the burden of disease and infection scores. Vaccine efficacies (95% confidence interval) against SARS-CoV-2 variants circulating in the United States during the trial assessed in this post hoc analysis were 82.4% (40.4-94.8%) for variants Epsilon and Gamma and 81.2% (36.1-94.5%) for Epsilon. The detection of other, non-SARS-CoV-2, respiratory viruses during the trial was similar between groups. While additional study is needed, these data show that in SARS-CoV-2-infected individuals, vaccination reduced both the viral copy number and duration of detectable viral RNA, which may be markers for the risk of virus transmission.

Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis.

The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study ( NCT04405076 ) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P < 0.0001) relative to peak titers against wild-type D614G measured 1 month after the primary series, and neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) VOCs were either low or undetectable. Both the mRNA-1273 booster and variant-modified boosters were safe and well-tolerated. All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001). In addition, all boosters increased neutralization titers against key VOCs and VOIs, including B.1.351, P.1. and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing.

Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents.

BACKGROUND: The incidence of coronavirus disease 2019 (Covid-19) among adolescents between 12 and 17 years of age was approximately 900 per 100,000 population from April 1 through June 11, 2021. The safety, immunogenicity, and efficacy of the mRNA-1273 vaccine in adolescents are unknown. METHODS: In this ongoing phase 2-3, placebo-controlled trial, we randomly assigned healthy adolescents (12 to 17 years of age) in a 2:1 ratio to receive two injections of the mRNA-1273 vaccine (100 µg in each) or placebo, administered 28 days apart. The primary objectives were evaluation of the safety of mRNA-1273 in adolescents and the noninferiority of the immune response in adolescents as compared with that in young adults (18 to 25 years of age) in a phase 3 trial. Secondary objectives included the efficacy of mRNA-1273 in preventing Covid-19 or asymptomatic severe acute respiratory syndrome coronavirus 2 infection. RESULTS: A total of 3732 participants were randomly assigned to receive mRNA-1273 (2489 participants) or placebo (1243 participants). In the mRNA-1273 group, the most common solicited adverse reactions after the first or second injections were injection-site pain (in 93.1% and 92.4%, respectively), headache (in 44.6% and 70.2%, respectively), and fatigue (in 47.9% and 67.8%, respectively); in the placebo group, the most common solicited adverse reactions after the first or second injections were injection-site pain (in 34.8% or 30.3%, respectively), headache (in 38.5% and 30.2%, respectively), and fatigue (in 36.6% and 28.9%, respectively). No serious adverse events related to mRNA-1273 or placebo were noted. The geometric mean titer ratio of pseudovirus neutralizing antibody titers in adolescents relative to young adults was 1.08 (95% confidence interval [CI], 0.94 to 1.24), and the absolute difference in serologic response was 0.2 percentage points (95% CI, -1.8 to 2.4), which met the noninferiority criterion. No cases of Covid-19 with an onset of 14 days after the second injection were reported in the mRNA-1273 group, and four cases occurred in the placebo group. CONCLUSIONS: The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19. (Funded by Moderna and the Biomedical Advanced Research and Development Authority; Teen COVE ClinicalTrials.gov number, NCT04649151.).

The effect of health-care Qigong Baduanjin combined with auricular point sticking on athletes' pre-competition anxiety: A protocol for systematic review and meta-analysis.

BACKGROUND: Competition anxiety is also known as pre-competition anxiety (PCA), because this anxiety state often occurs before the athletes face the competition. If it is not adjusted in time, which will greatly affect the performance of athletes, even the mental health and physical health of athletes. Therefore, the selection of appropriate methods to intervene the athletes, reducing the PCA of athletes, and it has an important effect on the competition performance of athletes. Therefore, based on the basic theory of traditional Chinese medicine and sports psychology principles, this study adopts a way of systematic evaluation to study the effect of health-care Qigong Baduanjin (HCQB) combined with auricular point sticking (APS)in the treatment of athletes' PCA (APA), the purpose is to help the majority of athletes to eliminate the PCA. METHODS: Two searchers independently retrieve CNKI, WANFANG databases, VIP, CBM, Web of Science, Embase, PubMed, The Cochran Library and other Chinese and English databases. It is supplemented by manual retrieval to comprehensively collect the relevant literature data of the clinical controlled study of HCQB combined with APS in the treatment of APA. The retrieval time is from January 1, 1990 to October 1, 2020, using the subject word and keywords to retrieve, developing a retrieval style according to the characteristics of the database. The two evaluators independently use the above-mentioned retrieval methods to retrieve the main literature database, summarizing and removing the duplicate literature, then reading the title and abstract of the literature separately, excluding the literature that clearly does not meet the inclusion criteria, and finally reading the literature, and finally including the literature in line with the study, in case of disagreement, with the third researcher to decide. The quality evaluation of the literature is independently evaluated using the bias risk assessment criteria for randomized controlled trials in Cochrane Manual 5.1.0. Using the RevMan 5.3 software for meta-analysis. RESULTS: This study will study the effect of HCQB combined with APS on reducing APA, and the results of the study will be published in high-impact academic journals. CONCLUSION: The quality of athletes' mental state is related to whether athletes can play their true level of sports in the competition, and good mental state is also the prerequisite to ensure that athletes get better results. The conclusions reached by this study will provide quantifiable reference for coaches and athletes, with the aim of providing theoretical basis for helping the athletes eliminate PCA. ETHICS AND DISSEMINATION: The type of this study belongs to the category of systematic evaluation, the data in this study are derived from published research papers and public data in the Internet, so ethical review is not suitable for this study. PROSPERO REGISTRATION NUMBER: 2021 CRD42021228254.

Homo-epitaxial secondary growth of ZnO nanowire arrays for a UV-free warm white light-emitting diode application.

The warm white homojunction light-emitting diode (LED) was fabricated by a doped ZnO nanowire array homojunction with homo-epitaxial secondary grown on a GaN substrate by the chemical vapor deposition method. Due to the high quality of the nanosized ZnO homojunction, the I-V characteristic curve of the ZnO homojunction shows good pn junction rectification characteristics, and the turn-on voltage is about 6 V. Under forward bias, bright yellow light was emitting from the homojunction LED. From the electroluminescence spectrum, the main luminescence peak is divided into a small part of blue light of about 420 nm and dominated yellow-green light of about 570 nm. The CIE color space chromaticity survey shows that the chromaticity coordinates of the homojunction LED are at (0.3358, 0.3341), which indicate that fabricated white LEDs have potential applications in efficient and healthy lighting and displaying fields.