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The ultra-thin heterostructure of Pr0.6Sr0.4MnO3(15 nm)/Pr0.5Ca0.5MnO3(15 nm)/SrTiO3 fabricated using pulsed laser deposition technique exhibits the phase-segregated nature wherein the ferromagnetism of Pr0.6Sr0.4MnO3, and the antiferromagnetic state of Pr0.5Ca0.5MnO3 coexist in proximity. The observation of two exciting phenomena in the grown ultra-thin heterostructure, namely, the kinetic arrest and training effect, confirms its phase-segregated nature. The melting of the antiferromagnetic state in Pr0.5Ca0.5MnO3 into a ferromagnetic state due to the interfacial interaction arising from the magnetic proximity of the ferromagnetic clusters of Pr0.6Sr0.4MnO3 have been observed. A metal–insulator transition (TMIT) found at 215 K, close to its Curie temperature (TCurie) observed at 230 K, reveals a strong correlation between the electrical transport and the magnetization of the ultra-thin heterostructure. The electrical conduction in the high-temperature regime is explained in terms of the adiabatic small polaron hopping model. While the resistance in the metallic regime for temperatures above 100 K is contributed by the inelastic scattering due to the two-magnons, in the metallic regime below 100 K, the one-magnon inelastic scattering contribution is prevalent. An enhanced colossal magnetoresistance property near room temperature is obtained in the ultra-thin heterostructure arising from the proximity-driven interfacial interaction, making it a suitable candidate for technological applications near room temperature.

Background Displaced Gartland type III and IV supracondylar fractures are difficult to reduce and invariably require closed pining. After closed reduction, taking the anteroposterior (AP) view does not present any problem but when the elbow is placed in flexion and the limb is rotated internally to take a lateral view, the reduction is invariably lost. However, the reduction stays when the arm is rotated outwards, keeping the medial condyle up. This stimulates the idea of whether the medial pin can be placed first and then the two lateral pins to stabilize the fracture. It is very frustrating for young orthopedic surgeons to see reduction getting lost during internal rotation after first doing lateral pinning. There is no clear guideline on which side should be fixed first. Hypothesis We hypothesized that placing the medial pin first maintains the reduction and facilitates the subsequent placing of lateral pins without the loss of reduction. Materials and methods A total of 170 children with displaced supracondylar humerus fractures were included in the study. A total of 120 children were grouped in the medial wire first group, and 50 were placed in the lateral wire first group, which was the control group. The mean age of the children was 7.5 years (range 2-13 years). The gender ratio (M: F) was 5:3; the left elbow was involved in 68% of the injuries, whereas the right elbow was involved in 32% of the injuries. All 170 children had an extension-type injury, with 91 (53.5%) fractures being Gartland type III and 79 (46.45%) fractures being type IV. Results Results were recorded as per Flynn's criteria. At the end of two years of follow-up, the children in the medial wire first group 117 (97.5%) showed excellent results and three (2.5%) children showed good results, whereas, in the lateral wire first group, 48 (96%) children showed excellent results and two (3.8%) children showed good results. There was a significant difference in the mean surgical time of 20.11±15.43 minutes in the medial wire first group vs 41.23±19.65 minutes in the lateral first group (p = 0.0021). None of the children developed permanent ulnar nerve palsy. Conclusions Placing the medial K-wire first rather than the conventional placing of the lateral wire first helps in maintaining the reduction and allows for the subsequent placement of lateral K-wires without losing the reduction, thus minimizing fixation time and producing good results.

Summary Background BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine (3 μg or 6 μg) formulated with a toll-like receptor 7/8 agonist molecule (IMDG) adsorbed to alum (Algel). We previously reported findings from a double-blind, multicentre, randomised, controlled phase 1 trial on the safety and immunogenicity of three different formulations of BBV152 (3 μg with Algel-IMDG, 6 μg with Algel-IMDG, or 6 μg with Algel) and one Algel-only control (no antigen), with the first dose administered on day 0 and the second dose on day 14. The 3 μg and 6 μg with Algel-IMDG formulations were selected for this phase 2 study. Herein, we report interim findings of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28. Methods We did a double-blind, randomised, multicentre, phase 2 clinical trial to evaluate the immunogenicity and safety of BBV152 in healthy adults and adolescents (aged 12–65 years) at nine hospitals in India. Participants with positive SARS-CoV-2 nucleic acid and serology tests were excluded. Participants were randomly assigned (1:1) to receive either 3 μg with Algel-IMDG or 6 μg with Algel-IMDG. Block randomisation was done by use of an interactive web response system. Participants, investigators, study coordinators, study-related personnel, and the sponsor were masked to treatment group allocation. Two intramuscular doses of vaccine were administered on day 0 and day 28. The primary outcome was SARS-CoV-2 wild-type neutralising antibody titres and seroconversion rates (defined as a post-vaccination titre that was at least four-fold higher than the baseline titre) at 4 weeks after the second dose (day 56), measured by use of the plaque-reduction neutralisation test (PRNT50) and the microneutralisation test (MNT50). The primary outcome was assessed in all participants who had received both doses of the vaccine. Cell-mediated responses were a secondary outcome and were assessed by T-helper-1 (Th1)/Th2 profiling at 2 weeks after the second dose (day 42). Safety was assessed in all participants who received at least one dose of the vaccine. In addition, we report immunogenicity results from a follow-up blood draw collected from phase 1 trial participants at 3 months after they received the second dose (day 104). This trial is registered at ClinicalTrials.gov , NCT04471519 . Findings Between Sept 5 and 12, 2020, 921 participants were screened, of whom 380 were enrolled and randomly assigned to the 3 μg with Algel-IMDG group (n=190) or 6 μg with Algel-IMDG group (n=190). Geometric mean titres (GMTs; PRNT50) at day 56 were significantly higher in the 6 μg with Algel-IMDG group (197·0 [95% CI 155·6–249·4]) than the 3 μg with Algel-IMDG group (100·9 [74·1–137·4]; p=0·0041). Seroconversion based on PRNT50 at day 56 was reported in 171 (92·9% [95% CI 88·2–96·2] of 184 participants in the 3 μg with Algel-IMDG group and 174 (98·3% [95·1–99·6]) of 177 participants in the 6 μg with Algel-IMDG group. GMTs (MNT50) at day 56 were 92·5 (95% CI 77·7–110·2) in the 3 μg with Algel-IMDG group and 160·1 (135·8–188·8) in the 6 μg with Algel-IMDG group. Seroconversion based on MNT50 at day 56 was reported in 162 (88·0% [95% CI 82·4–92·3]) of 184 participants in the 3 μg with Algel-IMDG group and 171 (96·6% [92·8–98·8]) of 177 participants in the 6 μg with Algel-IMDG group. The 3 μg with Algel-IMDG and 6 μg with Algel-IMDG formulations elicited T-cell responses that were biased to a Th1 phenotype at day 42. No significant difference in the proportion of participants who had a solicited local or systemic adverse reaction in the 3 μg with Algel-IMDG group (38 [20·0%; 95% CI 14·7–26·5] of 190) and the 6 μg with Algel-IMDG group (40 [21·1%; 15·5–27·5] of 190) was observed on days 0–7 and days 28–35; no serious adverse events were reported in the study. From the phase 1 trial, 3-month post-second-dose GMTs (MNT50) were 39·9 (95% CI 32·0–49·9) in the 3μg with Algel-IMDG group, 69·5 (53·7–89·9) in the 6 μg with Algel-IMDG group, 53·3 (40·1–71·0) in the 6 μg with Algel group, and 20·7 (14·5–29·5) in the Algel alone group. Interpretation In the phase 1 trial, BBV152 induced high neutralising antibody responses that remained elevated in all participants at 3 months after the second vaccination. In the phase 2 trial, BBV152 showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses compared with the phase 1 trial. The 6 μg with Algel-IMDG formulation has been selected for the phase 3 efficacy trial. Funding Bharat Biotech International. Translation For the Hindi translation of the abstract see Supplementary Materials section.

Background Several methodological tests are available to detect SARS-CoV-2 antibody. Tests are mostly used in the aid of diagnosis or for serological assessment. No tests are fully confirmatory and have variable level of diagnostic ability. We aimed at assessing agreement with three serological tests: quantitative anti receptor binding domain ELISA (Q-RBD), qualitative ELISA (WANTAI SARS-CoV-2 Ab) and qualitative chemiluminiscence assays (CLIA). Methods This study was a part of a large population based sero-epidemiological cohort study. Participants aged 1 year or older were included from 25 randomly selected clusters each in Delhi urban (urban resettlement colony of South Delhi district) and Delhi rural (villages in Faridabad district, Haryana). Three type of tests were applied to all the baseline blood samples. Result of the three tests were evaluated by estimating the total agreement and kappa value. Results Total 3491 blood samples collected from March to September, 2021, out of which 1700 (48.7%) from urban and 1791 (51.3%) from rural. Overall 44.1% of participants were male. The proportion of sero-positivity were 78.1%, 74.1% and 31.8% by Wantai, QRBD and CLIA tests respectively. The total agreement between Wantai and QRBD was 94.2%, 53.1% between Wantai and CLIA, and 56.6% between QRBD and CLIA. The kappa value between these three tests were 0.84 (95% CI: 0.80–0.87), 0.22 (95% CI: 0.19–0.24) and 0.26 (95% CI: 0.23–0.28). Conclusions There was strong concordance between Wantai and QRBD test. Agreement between CLIA with other two tests was low. Wantai and QRBD may be used interchangeably.

Introduction India is the biggest contributor to the global incidence of tuberculosis (TB). A major reason behind the persistently high incidence of TB in India is treatment loss-to-follow-up (LTFU). The consequences of LTFU include continuous transmission to uninfected individuals, drug resistance, and a higher rate of death in incompletely treated patients. It is a significant hurdle to making India 'TB-Free' by 2025. Hence, we conducted a community-based qualitative study to understand the determinants of treatment of LTFU in TB patients in the Faridabad district of Haryana, India. Methodology We enrolled TB patients who had completed treatment as well as those who had been LTFU. We also enrolled National Tuberculosis Elimination Programme (NTEP) functionaries, healthcare providers, family members, and community members. In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted to understand stakeholders' perceptions of reasons for LTFU. The grounded theory approach was used with inductive analysis. Data were triangulated from stakeholders' interviews. Themes and sub-themes were identified. A Health Belief Model for TB treatment completion was developed. Results Fifty-eight IDIs and four FGDs were conducted between May-June 2018. The major themes influencing the treatment of LTFU which emerged from the analyses were - the role of external motivators, regular use of alcohol, lack of/or inappropriate knowledge related to treatment, lack of family support, and side effects of anti-tubercular drugs, and a poor experience with the health system. Stigma was not found to be a major determinant - in the few cases that it affected treatment, it spurred treatment completion rather than LTFU. "

Background: Quality of HIV sentinel surveillance (HSS) depends on preparedness of the site and adherence to the standard operating procedures (SOPs) for HSS. A designated sentinel site is considered prepared for the round of sentinel surveillance based on the availability of infrastructure, human resource, and consumables. Objectives: The study objectives were to describe the site level preparedness and adherence to SOP of antenatal care clinic (ANC) sites during the 16th round of HSS in India. Methods: This was a cross-sectional study based on the findings of the supervisory visits conducted by public health specialists in ANC sites during the 16th round of HSS from January to March 2019. Semi-structured checklists were used to assess site-preparedness and adherence to the SOP for HSS. All supervisors were expected to upload the filled pro forma to the HSS management information system (MIS). We present here a descriptive analysis of the uploaded visit reports. Results: Of 870 HSS sites, 783 (90%) were visited, and 479 (61.2%) reports were uploaded to MIS. Preround HSS training was not attended by one-fifth (22.6%) of the site in-charges; 35.8% of them had never received any HSS training. SOP was followed at most (94%) of the sites. The most frequently reported problem at the sites was inadequate or delayed availability of consumables. Conclusion: The overall quality of site-level preparedness at antenatal clinic sites in India was good. Attention needs to be given to timely and adequate availability of consumables at sentinel sites along with proper administrative support and preround training of site in-charges.

Background The Joint United Nations Programme on AIDS (UNAIDS) has emphasized on the incidence-prevalence ratio (IPR) and incidence-mortality ratio (IMR) to measure the progress in HIV epidemic control. In this paper, we describe the status of epidemic control in India and in various states in terms of UNAIDS’s recommended metrices. Method The National AIDS Control Programme (NACP) of India spearheads work on mathematical modelling to estimate HIV burden based on periodically conducted sentinel surveillance for providing guidance to program implementation and policymaking. Using the results of the latest round of HIV Estimations in 2019, IPR and IMR were calculated. Results National level IPR was 0.029 [0.022–0.037] in 2019 and ranged from 0.01 to 0.15 in various States and Union Territories (UTs). Corresponding Incidence-Mortality Ratio was at 0.881 [0.754–1.014] nationally and ranged between 0.20 and 12.90 across the States/UTs. Conclusions Based on UNAIDS recommended indicators for HIV epidemic control, namely IPR and IMR; national AIDS response in India appears on track. However, the program success is not uniform and significant heterogeneity as well as expanding epidemic was observed at the level of States or UTs. Reinforcing States/UTs specific and focused HIV prevention, testing and treatment initiatives may help in the attainment of 2030 Sustainable Development Goals of ending AIDS as a public health threat by 2030.

Background: Hydrogen peroxide (H2O2) is used as a topical antiseptic in contaminated wounds caused by road traffic accidents. It kills bacteria by producing oxidation through local, nascent, free oxygen radicals. It also removes dirt from the wound due to its frothing action. H2O2 is synthesized by various cells as an active biochemical agent that affects cell biological behavior through complex chemical reactions. H2O2 has also been used as a wound cleaning agent, removing debris, preventing infection, and causing hemostasis due to its exothermic reaction with blood. Despite its widespread use, there is scanty literature on its use to promote granulation tissue formation. Objective: In the orthopaedics literature, studies on H2O2 use are very limited and its potential is underestimated. In the present study, we would like to report our protocol of use of H2O2 for its tremendous potential for stimulating granulation and early wound healing. Material and Methods: A total of 53 patients with large acute extensive lower limb contaminated wounds reported to the emergency department have been included with and without lower limb fracture. In group A (43 patients) wound management was done using 7% H2O2 and group B (10 patients) was treated by only saline dressing as a control group. Results: In the present study, daily dressing by 7% H2O2 solution and provide solution gives excellent results compared to the Saline group. Granulation tissue appeared much earlier with a mean SD 6.3 ± 6.8 days in the hydrogen peroxide group as compared to the Saline group where granulation tissue appeared in 9.3 ± 8.4 days. Conclusion: Spontaneous wound healing is a controlled balance between destructive and healing processes. It is mandatory to remove damaged tissue to promote healing by secondary intention and minimize infection. The dynamic effect of H2O2 promotes faster healing, stimulates granulation, and minimizes infection by oxidative stress.

BackgroundWe report the clinical efficacy against COVID-19 infection of BBV152, a whole-virion inactivated SARS-CoV-2 vaccine formulated with a Toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG).MethodsWe did a double-blind, randomised, multicentre, phase 3 clinical trial in 25 Indian hospitals to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Healthy adults (age 18–98 years) randomised 1:1 using a computer-generated randomisation scheme received two intramuscular doses of vaccine or placebo administered four weeks apart. The primary outcome was laboratory-confirmed symptomatic COVID-19, occurring at least 14 days after the second dose. Secondary outcomes were efficacy in sub-groups for age (18–< 60 years and ≥ 60 years) and in participants with pre-existing stable medical conditions. We also evaluated safety, reactogenicity, and consistency of immune responses for three consecutive manufacturing lots.FindingsBetween November 16, 2020 and January 7, 2021 we recruited 25,798 participants who were randomised to BBV152 or placebo groups; 24,419 received two doses of BBV152 (n = 12,221) or placebo (n = 12,198). In a case-driven analysis, 130 cases of symptomatic COVID-19 were reported in 16,973 (0·77%) participants with follow-up at least two weeks after the second vaccination; 24 occurred in the vaccine group and 106 in placebo recipients giving an overall vaccine efficacy of 77·8% (95% CI: 65·2–86·4). Sixteen cases, one vaccinee and 15 placebo recipients, met the severe symptomatic COVID-19 case definition giving a vaccine efficacy of 93·4% (57·1–99·8). Efficacy against asymptomatic COVID-19 was 63·6% (29·0–82·4). BBV152 conferred 65·2% (95% CI: 33·1–83·0) protection against the SARS-CoV-2 Variant of Concern, B.1.617.2 (Delta). BBV152 was well tolerated with no clinically or statistically significant differences in the distributions of solicited, unsolicited, or serious adverse events between vaccine and placebo groups. No cases of anaphylaxis or vaccine-related deaths were reported.InterpretationBBV152 was immunogenic and highly efficacious against symptomatic and asymptomatic COVID-19 variant associated disease, particularly against severe disease in adults. Vaccination was well tolerated with an overall incidence of adverse events observed over a median of 146 days that was lower than that observed with other COVID-19 vaccines.FundingThis work was supported and funded by Bharat Biotech International Limited and partly co-funded by the Indian Council of Medical Research.Clinicaltrials.gov:NCT04641481

Decentralized response has been the hallmark of the National AIDS Control Programme in India. District-level HIV burden estimates quantifying the distribution of the epidemics are needed to enhance this decentralized response further to monitor the progress on prevention, testing, and treatment interventions. In this paper, we describe the methodology and results of district-level estimates using the Spectrum model piloted in 5 states of India under National AIDS Control Programme. Using state spectrum model for HIV estimations 2017, we disaggregated state results by the district in pilot states. Each district was considered a subepidemic and HIV epidemic configuration was carried out in its general population as well as in key population. We used HIV surveillance data from antenatal clinics and routine pregnant women testing to model the general population's epidemic curve. We used HIV prevalence data available from HIV sentinel surveillance and integrated biological and behavioral surveys to inform the epidemic curve for key population. Estimation and projection packgage classic platform was used for the curve fitting. District-wide estimates extracted from subpopulation summary in Spectrum results section were used to calculate relative burden for each district and applied to approved State HIV Estimations 2017 estimates. No district in Tamil Nadu had an adult HIV prevalence of higher than 0.5% except for one, and the epidemic seems to be declining. In Maharashtra, the epidemic has shown a decline, with all except 5 districts showing an adult prevalence of less than 0.50%. In Gujarat and Uttar Pradesh, few districts showed rising HIV prevalence. However, none had an adult prevalence of higher than 0.50%. In Mizoram, 6 of 8 districts showed a rising HIV trend with an adult prevalence of 1% or more in 5 districts. Disaggregation of state-level estimates by districts provided insights on epidemic diversity within the analyzed states. It also provided baseline evidence to measure the progress toward the goal of end of AIDS by 2030.

The number of secondary cases from each primary case determines how fast an epidemic grows. It is known that all cases do not spread the infection equally; super spreaders play an important role as they contribute disproportionately to a much larger number of cases including in the ongoing COVID-19 pandemic. Super spreaders have been reported for more than a century, but limited information is available in scientific literature. An epidemic containment strategy needs to include early identification of super spreaders to limit an explosive growth. Super spreaders tend to get stigmatized, resulting in late reporting and hiding of cases. It is important for program managers to be sensitive to the manner in which related information is shared with media and general public.

Summary Objective Morel-Lavallee lesions are posttraumatic soft tissue closed degloving injuries in which the subcutaneous tissue is torn away from the underlying fascia, creating a cavity filled with a hematoma and liquefied fat. The lesion goes undetected unless high index of suspicion and MRI is the gold standard for diagnosis. We present our experiences while managing 10 cases. Methods Study includes ten cases of Morel-Lavallee lesions involving knee, hip and thigh. After confirming on MRI each patient was managed by incision and drainage of hematomas. Results Nine patients were improved without any morbidity; one patient who presented late because of late diagnosis developed fever and skin necrosis and managed by debridement and flap cover. Conclusion Morel-Lavallee lesions are post-traumatic usually following contact sports, closed degloving injuries occurring in the subcutaneous plane due to disruption of capillaries resulting in an effusion containing hemolymph and necrotic fat. There should be high index of suspicion in order to diagnose such cases and MRI is the modality of choice. Early diagnosis and management is vital. Involvement of joint capsule indicates surgery intervention over conservative management of such lesion.

Background: Idiopathic adhesive capsulitis of shoulder is common cause of pain and restriction of shoulder motion between the ages of 30 and 65. The prevalence of adhesive capsulitis is as high as 10% to 22% in diabetes mellitus as compared normal population which is 02% and 04%. Therefore, the doubt arises whether patients developed adhesive capsulitis are at greater risk to develop diabetes mellitus and should be screen for diabetes so that it can be detected early. Purpose: To compare the prevalence of prediabeties and diabetes mellitus among patients with features of idiopathic adhesive capsulitis of shoulder who are otherwise healthy. Methods: Patients between 30-65 years of age who attended Orthopaedics OPD with features of idiopathic adhesive capsulitis of shoulder were included. Participated underwent a 2 hour long oral glucose tolerance test and based on fasting and 2-hour plasma glucose levels, patients were diagnosed as normal glucose tolerance, prediabetic, or diabetic and the results were matched with previous published data. Results: 135 patients as participated and completed the test. 21 (15.5%) patients with idiopathic adhesive capsulitis of shoulder were found to be prediabetic, and 37 (27.4%) patients were found to be diabetic. However, 31 patients had family history of diabetes. Conclusion: Based on our study, we can recommend that patients with features of idiopathic adhesive capsulitis of shoulder should be screened at least for fasting and post prandial blood sugar so that diabetes can be detected early.

Historical specimens collected from hospitalized children were tested for the following 13 viruses: influenza A and B; respiratory syncytial virus (RSV); parainfluenza viruses 1–3; human metapneumovirus; rhinovirus; coronaviruses 229E, OC43, NL63 and HKU1 and Adenovirus using monoplex real-time reverse transcriptase polymerase chain reaction (rRT-PCR). They were retested using TaqMan Array Card (TAC), a micro-fluidic system, capable of simultaneous multi-pathogen testing, to evaluate its sensitivity and specificity against monoplex rRT-PCR. TAC showed high sensitivity (71%–100%) and specificity (98%–100%) for these viruses in comparison to monoplex rRT-PCR. Multi-specimen detection with high sensitivity and specificity makes TAC a potentially useful tool for both surveillance and outbreak investigations.

BackgroundConcern has been raised in India regarding the probable third wave of COVID-19 where children and young age group is thought to get affected the most. There is a lack of serological prevalence data in this age group. We have some interim data from our research for WHO unity protocol, which might help policymakers and the research community to answer such questions based on evidence. Hence, we conducted a study to compare the COVID -19 sero-positivity rate between children and adultsMethods/MaterialsThis is part of an ongoing large multi-centric population-based sero-epidemiological study. The study is being conducted in five selected states with a proposed total sample size of 10,000. We have data of 4,500 participants at the time of midterm analysis from four states of India. Total serum antibody against SARS-CoV-2 virus was assessed qualitatively by using a standard ELISA kit. Here we are reporting the interim data of serological prevalence among children aged between 2 to 17 years along with a comparison with ≥18-year old participants.ResultsThe data collection period was from 15th March 2021 to 10th June 2021. Total available data was of 4,509 participants out of which ConclusionSARS-CoV-2 sero-positivity rate among children was high and were comparable to the adult population. Hence, it is unlikely that any future third wave by prevailing COVID-19 variant would disproportionately affect children two years or older.

Summary Background 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). Methods 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). Findings 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. Interpretation 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. Funding Bharat Biotech International.

Background: India introduced BBV152/Covaxin and AZD1222/Covishield vaccines from January 2021. We estimated effectiveness of these vaccines against severe Coronavirus disease 2019 (COVID-19) among individuals aged >=45 years. Methods: We did a multi-centric, hospital-based, case–control study between May and July 2021. Cases were severe COVID-19 patients and controls were COVID-19 negative individuals from 11 hospitals. Vaccine effectiveness (VE) was estimated for full (2 doses ≥14days) and partial (1 dose ≥21 days) vaccination; duration between two vaccine doses and against the Delta variant. We used a random effects logistic regression model to calculate adjusted odds ratios (aOR) with 95% CI after adjusting for relevant known confounders. Findings: We enrolled 1,143 cases and 2,541 controls. The VE of full vaccination was 80% (95% CI: 73%-86%) with AZD1222/Covishield and 69% (95% CI: 54%-79%) with BBV152/Covaxin. The VE was highest for a gap of 6-8 weeks between two doses of AZD1222/Covishield (92%, 95% CI: 82%-96%) and BBV152/Covaxin (92%, 95% CI: 26%-99%). The VE estimates were similar against the Delta strain and sub-lineages. Interpretation: BBV152/Covaxin and AZD1222/Covishield were effective against severe COVID-19 among the Indian population during the period of dominance of highly transmissible Delta variant in second wave of pandemic. An escalation of two-dose coverage with COVID-19 vaccines is critical to control the pandemic in the country. Funding Information: Indian Council of Medical Research Declaration of Interests: None to declare. Ethics Approval Statement: We obtained written informed consent from all the participants or their legally authorized representatives. Study procedures were approved by the Institutional Human Ethics Committees of all participating institutions.

Aim and Objective: Our study's objective is to determine the level of awareness in postmenopausal women in Guwahati, Northeast part of India, using the Osteoporosis Health Belief Scale (OHBS). Settings and Design: Osteoporosis is the most common silent health problem in postmenopausal Indian women. An awareness level among this subset of women needs to study. The present study is based on a self-explanatory questionnaire. Methods: We conducted a self-explanatory questionnaire study on 2000 postmenopausal women in Guwahati, North East region of India. The bone mineral density (BMD) was measured using calcaneum Quantitative ultrasound (QUS) to assess BMD. Baseline characteristics were noted and analyzed. Results: The awareness level was noted only in757 (37.85%). Women with education level 12th standard and above have some awareness regarding osteoporosis. Conclusions: Based on the present study, we can conclude that there is a lack of awareness in postmenopausal women regarding osteoporosis in India's North-East region. This subset of women is unaware of the condition that can leads to fragility fracture if not address in time. The study emphasizes that health care professionals should conduct frequent awareness programs in the community to prevent this silent disease, and morbidities so arise from osteoporosis can be minimized.

Background: Nutritional anemia due to iron deficiency is the most common cause of anemia in India. The average diet in India is low in iron and mostly of vegetable origin. This can be improved by increasing awareness of foodstuffs that are rich in iron and ensuring their availability. Objective: The objective of the study was to assess the quality of information available on iron-rich foods and to assess their production and consumption in India. Methods: This was a review of common textbooks for medical, nursing, and home science students; related policy and program documents; and government publications on production and consumption of various foodstuffs in India. Results: Details of specific foods that are rich in iron have not been provided. Instead, food groups such as pulses, cereals, nuts, and green leafy vegetables (GLVs) have been mentioned that are good sources of non-heme iron. This is in spite of the fact that all the foodstuffs in these groups are not uniformly iron rich. Among cereals and pulses, rice and red gram dal (arhar) are the most commonly produced and consumed, though they have the lowest iron content. Spinach and mustard leaves believed to be iron rich and commonly consumed are among those GLVs having lowest iron content. Conclusion: Details of 5–10 foodstuffs which have the highest iron content within each food group should be available in relevant books and documents meant for education, production, and consumption data.

Background: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine (3 μg or 6 μg) formulated with a Toll-Like Receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or 6 μg with alum (Algel). Methods: We conducted a double-blind, randomised, multicentre, controlled phase 1 clinical trial to evaluate the safety and immunogenicity of BBV152. A total of 375 healthy adults Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation were randomised equally to receive three vaccine formulations (n=100 each) prepared with 3 μg with Algel-IMDG, 6 μg with Algel-IMDG, and 6 μg with Algel, and an Algel only control arm (n=75). Two intramuscular doses of vaccines were administered (twoweeks apart). Primary outcomes were reactogenicity and safety. Secondary outcome was seroconversion (≥4-fold above baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. Findings: Among 827 participants screened between July 13 and July 30, 2020, 375 participants were randomised. After both doses, the proportion (95%CI) of solicited local and systemic adverse reactions were 17% (10·5, 26·1), 21% (13·8, 30·5), 14% (8·1, 22·7), and 10% (6·9, 23·6) in the 3 μg with Algel-IMDG, 6 μg with Algel-IMDG, 6 μg with Algel, and control groups, respectively . The most common solicited adverse events were injection site pain, headache, and fatigue. All solicited adverse events were mild (43, 69·3%) or moderate (19, 30·7%) and were more frequent after the first dose. One serious adverse event 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 AlgelIMDG, 6 μg with Algel-IMDG and 6 μg with Algel groups, respectively. CD4 + and CD8 + T cell responses were detected in a subset from both Algel-IMDG groups. Interpretations: 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. Trial Registration Number: Clinicaltrials.gov : NCT04471519 Funding: This work was supported and funded by Bharat Biotech International Limited. Conflict of Interest: This work was supported and funded by Bharat Biotech International Limited. All authors are employees of one of the above-mentioned organisations, with no stock options or incentives. Co-author- K.E is the Chairman and Managing Director of Bharat Biotech. Ethical Approval: The trial was conducted across 11 sites in 9 states in India. The trial was approved by the National Regulatory Authority (India) and the respective Ethics Committees and was conducted in compliance with all International Council for Harmonization 114 (ICH) Good Clinical Practice guidelines.

The COVID-19 pandemic has swept the entire world in a few months' time, much faster than any epidemic before. The scientist, doctors, and politicians worldwide are fervently working round the clock to bring an end to this pandemic which has otherwise stalled the lives of the populations. In the absence of any reliable treatment or vaccine, nonpharmaceutical interventions are presently are the mainstay to prevent and possibly end the COVID-19 pandemic. The development of herd immunity either through natural infection or induced through vaccine can bring down the epidemic. However, it may take a few more months before the normalcy returns.