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This is a comprehensive report on immunogenicity of COVAXIN ® booster dose against ancestral and Variants of Concern (VOCs) up to 12 months. It is well known that neutralizing antibodies induced by COVID-19 vaccines wane within 6 months of vaccination leading to questions on the effectiveness of two-dose vaccination against breakthrough infections. Therefore, we assessed the persistence of immunogenicity up to 6 months after a two or three-dose with BBV152 and the safety of a booster dose in an ongoing phase 2, double-blind, randomized controlled trial (ClinicalTrials.gov: NCT04471519). We report persistence of humoral and cell mediated immunity up to 12 months of vaccination, despite decline in the magnitude of antibody titers. Administration of a third dose of BBV152 increased neutralization titers against both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) with a slight increase in B cell memory responses. Thus, seronversion rate remain high in boosted recipients compared to non-booster, even after 6 months, post third dose against variants. No serious adverse events observed, except pain at the injection site, itching and redness. Hence, these results indicate that a booster dose of BBV152 is safe and necessary to ensure persistent immunity to minimize breakthrough infections of COVID-19, due to newly emerging variants. Trial registration: Registered with the Clinical Trials Registry (India) No. CTRI/2021/04/032942, dated 19/04/2021 and on Clinicaltrials.gov: NCT04471519.

One of the most preferable characteristics for a COVID-19 vaccine candidate is the ability to reduce transmission and infection of SARS-CoV-2, in addition to disease prevention. Unlike intramuscular vaccines, intranasal COVID-19 vaccines may offer this by generating mucosal immunity. In this open-label, randomised, multicentre, phase 3 clinical trial (CTRI/2022/02/40065; ClinicalTrials.gov: NCT05522335), healthy adults were randomised to receive two doses, 28 days apart, of either intranasal adenoviral vectored SARS-CoV-2 vaccine (BBV154) or licensed intramuscular vaccine, Covaxin®. Between April 16 and June 4, 2022, we enrolled 3160 subjects of whom, 2971 received 2 doses of BBV154 and 161 received Covaxin. On Day 42, 14 days after the second dose, BBV154 induced significant serum neutralization antibody titers against the ancestral (Wuhan) virus, which met the pre-defined superiority criterion for BBV154 over Covaxin®. Further, both vaccines showed cross protection against Omicron BA.5 variant. Salivary IgA titers were found to be higher in BBV154. In addition, extensive evaluation of T cell immunity revealed comparable responses in both cohorts due to prior infection. However, BBV154 showed significantly more ancestral specific IgA-secreting plasmablasts, post vaccination, whereas Covaxin recipients showed significant Omicron specific IgA-secreting plasmablasts only at day 42. Both vaccines were well tolerated. Overall reported solicited reactions were 6.9% and 25.5% and unsolicited reactions were 1.2% and 3.1% in BBV154 and Covaxin® participants respectively.

Background The stillbirth rate is an indicator of quality of care during pregnancy and delivery. Good quality care is supported by a functional heath system. The objective of this study was to explore the risk factors for stillbirths, particularly those related to a health system. Methods This case-control study was conducted in two districts of Bihar, India. Information on cases (stillbirths) were obtained from facilities as reported by Health Management Information System; controls were consecutive live births from the same population as cases. Data were collected from 400 cases and 800 controls. The risk factors were compared using a hierarchical approach and expressed as odds ratio, attributable fractions and population attributable fractions. Results Of all the factors studied, 22 risk factors were independently associated with stillbirths. Health system-related factors were: administration of two or more doses of oxytocics to augment labour before reaching the facilities (OR 1.6; 95% CI 1.2–2.1), any complications during labour (OR 2.3;1.7–3.1), >30 min to reach a facility from home (OR 1.4;1.05–1.8), >10 min to attend to the pregnant woman after reaching the facility (OR 2.8;1.7–4.5). In the final regression model, modifiable health system-related risk factors included: >10 min taken to attend to women after they reach the facilities (AOR 3.6; 95% CI 2.5–5.1), untreated hypertension during pregnancy (AOR 2.9; 95% CI 1.5–5.6) and presence of any complication during labour, warranting treatment (AOR 1.7; 95% CI 1.2–2.4). Among mothers who reported complications during labour, time taken to reach the facility was significantly different between stillbirths and live births (2nd delay; 33.5 min v/s 25 min; p  < 0.001). Attributable fraction for any complication during labour was 0.56 (95% CI 0.42–0.67), >30 min to reach the facility 0.48 (95% CI 0.31–0.60) and institution of management 10 min after reaching the facility 0.68 (95% CI 0.58–0.75). Reaching a facility within 30 min, initiation of management within 10 min of reaching the facility and timely management of complications during labour could have prevented 17%, 37% and 20% of stillbirths respectively. Conclusion A pro-active health system with accessible, timely and quality obstetric services can prevent a considerable proportion of stillbirths in low and middle income countries.

Coronary artery disease is the leading cause of death for both men and women in the United States. Percutaneous coronary intervention with drug-eluting stents (DES) has been a major advance in treatment. In-stent restenosis (ISR) occurs in up to 10% of patients, and is often managed with repeat DES placement. However, when DES-ISR occurs, treatment options remain limited. Angioplasty followed by intravascular brachytherapy (IVBT) is one option for such patients. Outcomes of 78 patients (91 vessels) treated with angioplasty followed by strontium-90 IVBT from 2016-2024 were reviewed. Following vessel preparation with angioplasty, an intravascular catheter was introduced into the index lesion. Radiation was prescribed to an area encompassing the angioplasty injury length with a minimum 10 mm margin. Radiation dose delivered was 23 Gy or 18.4 Gy according to protocol standard. Major adverse cardiac events (MACE), including myocardial infarction and stroke as well as all causes of death were analyzed, as was the need for repeat angioplasty or intervention. All patients had at least 2 drug-eluting stents previously deployed in the affected vessel, and were not technically suitable for additional stenting. One patient expired while receiving intervention due to cardiac arrest, with no other intraprocedural toxicities reported. Median follow-up was 22.8 months (range, 0.9-60.6 months), and forty-four percent of patients experienced symptomatic relief. Major cardiac adverse events rates at interval follow-up of IVBT included myocardial infarction (18%) and stroke (5%). Death from any cause occurred in 16% of patients at a median time of 9.3 months post-treatment (range, 0.5-29.5 months). Angioplasty followed by intravascular brachytherapy is a safe and effective therapy for patients with complex coronary artery lesions experiencing stent-in-stent restenosis, who have few other treatment options.

Introduction: Polycystic ovarian syndrome (PCOS) constitutes most cases of endocrine disorder among females. Objectives: This study was done to assess the proportion of university students with PCOS and to study its risk factors. Materials and Methods: Data were collected from students of a private medical, dental, and nursing college using a self-administered questionnaire. Height and weight of all participants were recorded by standard procedures. Results: The mean age of students was 20.4 ΁ 1.5 years. Of the 480 participants, 39 (8.1%) were already diagnosed with PCOS. Out of the remaining 441 participants, 40 (9.1%) were at high risk, and 401 (90.9%) were at low risk for PCOS. Greater proportion of PCOS cases was seen in the age group 23-25 years (P = 0.026), among those with family history of PCOS (P = 0.002), among those who were permanent residents of urban areas (P = 0.048), and among those who were overweight or obese (P = 0.004). About 90% of PCOS cases and those at high risk for PCOS, each had difficulty in controlling excess weight or were experiencing difficulty in maintaining ideal weight. About 36 (92.3%) of PCOS cases and all those at high risk had emotional problems such as feeling moody or experiencing fatigability over the previous 2 weeks. Conclusion: PCOS is a common disorder among young women in this settings and this warrants periodic screening activities. A multidisciplinary approach is required to bring about lifestyle modification and help those with emotional problems due to this endocrine disorder.

Immunogenic cell death (ICD) is an immunostimulatory process that can be induced by light‐activated photosensitizers, but its mechanisms remain unclear, especially with lipid nanoparticle (LNP) formulations. In this study, a multivariate, data‐driven analysis was conducted using a panel of five verteporfin(V)‐LNPs to identify the attributes that lead to the greatest photochemically‐induced exposure of ICD markers in pancreatic cancer cells. These attributes include varying production of Type I (radicals) or Type II (singlet oxygen) reactive oxygen species (ROS) upon 690 nm activation, localization in different organelles, variable cellular uptake efficiencies, and different phototoxicity levels. Using principal component analysis, we identified that, unexpectedly, Type I ROS is most strongly associated with ICD marker exposure, which leads to dendritic cell activation ex vivo, while Type II ROS shows the weakest association. Furthermore, V‐LNP localization in the endoplasmic reticulum and mitochondria is most strongly associated with exposure of ICD markers, while lysosomal localization shows the weakest association. ICD marker exposure is proportional to the degree of phototoxicity and cellular uptake efficiency for all V‐LNPs. These findings provide critical insights into the multiparametric mechanism underlying photochemical ICD induced by V‐LNPs and can inform the rational design of photochemical LNP constructs for augmenting anticancer immune responses. The relationship between the attributes of verteporfin‐lipid nanoparticles and the exposure of immunogenic cell death markers (HSP‐70, HMGB1, and calreticulin) following 690 nm light activation in murine pancreatic cancer cells.

Purpose In response to the evolving COVID-19 pandemic, many universities have transitioned to online instruction. With learning promising to be online, at least in part, for the near future, instructors may be thinking of providing online collaborative learning opportunities to their students who are increasingly isolated from their peers because of social distancing guidelines. This paper aims to provide design recommendations for online collaborative project-based learning exercises based on this research in a software engineering course at the university level. Design/methodology/approach Through joint work between learning scientists, course instructors and software engineering practitioners, instructional design best practices of alignment between the context of the learners, the learning objectives, the task and the assessment are actualized in the design of collaborative programming projects for supporting learning. The design, first segments a short real-time collaborative exercise into tasks, each with a problem-solving phase where students participate in collaborative programming, and a reflection phase for reflecting on what they learned in the task. Within these phases, a role-assignment paradigm scaffolds collaboration by assigning groups of four students to four complementary roles that rotate after each task. Findings By aligning each task with granular learning objectives, significant pre- to post-test learning from the exercise as well as each task is observed. Originality/value The roles used in the paradigm discourage divide-and-conquer tendencies often associated with collaborative projects. By requiring students to discuss conflicting ideas to arrive at a consensus implementation, their ideas are made explicit, thus providing opportunities for clarifying misconceptions through discussion and learning from the collaboration.

Sannino, A., Sarti, M., Reddy, S. B., Prihoda, T. J., Vijayalaxmi and Scarfì, M. R. Induction of Adaptive Response in Human Blood Lymphocytes Exposed to Radiofrequency Radiation. Radiat. Res. 171, 735–742 (2009). The incidence of micronuclei was evaluated to assess the induction of an adaptive response to non-ionizing radiofrequency (RF) radiation in peripheral blood lymphocytes collected from five different human volunteers. After stimulation with phytohemagglutinin for 24 h, the cells were exposed to an adaptive dose of 900 MHz RF radiation used for mobile communications (at a peak specific absorption rate of 10 W/kg) for 20 h and then challenged with a single genotoxic dose of mitomycin C (100 ng/ml) at 48 h. Lymphocytes were collected at 72 h to examine the frequency of micronuclei in cytokinesis-blocked binucleated cells. Cells collected from four donors exhibited the induction of adaptive response (i.e., responders). Lymphocytes that were pre-exposed to 900 MHz RF radiation had a significantly decreased incidence of micronuclei induced by the challenge dose of mitomycin C compared to those that were not pre-exposed to 900 MHz RF radiation. These preliminary results suggested that the adaptive response can be induced in cells exposed to non-ionizing radiation. A similar phenomenon has been reported in cells as well as in animals exposed to ionizing radiation in several earlier studies. However, induction of adaptive response was not observed in the remaining donor (i.e., non-responder). The incidence of micronuclei induced by the challenge dose of mitomycin C was not significantly different between the cells that were pre-exposed and unexposed to 900 MHz RF radiation. Thus the overall data indicated the existence of heterogeneity in the induction of an adaptive response between individuals exposed to RF radiation and showed that the less time-consuming micronucleus assay can be used to determine whether an individual is a responder or non-responder.

Background: A functional newborn care corner (NBCC) is critical to provide immediate care to newborns including resuscitation, warmth, and initial care to sick newborns. NBCC provides an acceptable environment for all infants at birth, and it is mandatory for all delivery points at all levels in the health system including operation theaters. Objective: The objective of this study was to find the status of availability of NBCCs and service provision in selected public health facilities of Bihar. Methods: A total of 57 NBCCs, having high delivery load (>100 deliveries/month), across 25 high-priority districts in Bihar, were selected purposively in consultation with the State Health Society, Bihar, for the assessment. These facilities were assessed for the availability and/or functioning of infrastructure, equipment maintenance, human resource, supply of drugs and consumables, adherence to protocols, and record keeping. Results: Only 22.8% of the NBCCs were found to be fully functional, majority (68.4%) were partially functional, and 9% were nonfunctional. Thirty-seven (64.9%) NBCCs were located inside the labor room premises. Approximately, one-third of the neonates delivered were kept in NBCCs. Equipment though available lacked the provision of annual maintenance contract. Essential drugs such as adrenaline (24.6%) and Vitamin K injection (42.1%) were not available in many facilities. Only 6.2% of the newborns had low birth weight, indicating underreporting. Majority of the health-care staff available were trained but possessed poor skills. Data recording and reporting was also suboptimal. Conclusion: The network of NBCCs needs to be strengthened across the state and linked with higher facilities to achieve the desired reduction in neonatal morbidity and mortality.

To mitigate the effects of COVID-19, a vaccine is urgently needed. BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 at 11 hospitals across India. Healthy adults aged 18–55 years who were deemed healthy by the investigator were eligible. Individuals with positive SARS-CoV-2 nucleic acid and/or serology tests were excluded. Participants were randomly assigned to receive either one of three vaccine formulations (3 μg with Algel-IMDG, 6 μg with Algel-IMDG, or 6 μg with Algel) or an Algel only control vaccine group. Block randomisation was done with a web response platform. Participants and investigators were masked to treatment group allocation. Two intramuscular doses of vaccines were administered on day 0 (the day of randomisation) and day 14. Primary outcomes were solicited local and systemic reactogenicity events at 2 h and 7 days after vaccination and throughout the full study duration, including serious adverse events. Secondary outcome was seroconversion (at least four-fold increase from baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. The trial is registered at ClinicalTrials.gov (NCT04471519). Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). After both doses, solicited local and systemic adverse reactions were reported by 17 (17%; 95% CI 10·5–26·1) participants in the 3 μg with Algel-IMDG group, 21 (21%; 13·8–30·5) in the 6 μg with Algel-IMDG group, 14 (14%; 8·1–22·7) in the 6 μg with Algel group, and ten (10%; 6·9–23·6) in the Algel-only group. The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 μg with Algel group, unrelated to the vaccine. Seroconversion rates (%) were 87·9, 91·9, and 82·8 in the 3 μg with Algel-IMDG, 6 μg with Algel-IMDG, and 6 μg with Algel groups, respectively. CD4+ and CD8+ T-cell responses were detected in a subset of 16 participants from both Algel-IMDG groups. BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted. Bharat Biotech International.