To leave no one behind: Assessing utilization of maternal newborn and child health services by all the 13 particularly vulnerable tribal groups (PVTGs) of Odisha, India.

BACKGROUND: Indigenous tribal people experience lower coverage of maternal, newborn and child healthcare (MNCH) services worldwide, including in India. Meanwhile, Indian tribal people comprise a special sub-population who are even more isolated, marginalized and underserved, designated as particularly vulnerable tribal groups (PVTGs). However, there is an extreme paucity of evidence on how this most vulnerable sub-population utilizes health services. Therefore, we aimed to estimate MNCH service utilization by all the 13 PVTGs of the eastern Indian state of Odisha and compare that with state and national rates. METHODS: A total of 1186 eligible mothers who gave birth to a live child in last 5 years, were interviewed using a validated questionnaire. The weighted MNCH service utilization rates were estimated for antenatal care (ANC), intranatal care (INC), postnatal care (PNC) and immunization (for 12-23-month-old children). The same rates were estimated for state (n = 7144) and nationally representative samples (n = 176 843) from National Family Health Survey-5. RESULTS: The ANC service utilization among PVTGs were considerably higher than national average except for early pregnancy registration (PVTGs 67% versus national 79.9%), and 5 ANC components (80.8% versus 82.3%). However, their institutional delivery rates (77.9%) were lower than averages for Odisha (93.1%) and India (90.1%). The PNC and immunization rates were substantially higher than the national averages. Furthermore, the main reasons behind greater home delivery in the PVTGs were accessibility issues (29.9%) and cultural barriers (23.1%). CONCLUSION: Ours was the first study of MNCH service utilization by PVTGs of an Indian state. It is very pleasantly surprising to note that the most vulnerable subpopulation of India, the PVTGs, have achieved comparable or often greater utilization rates than the national average, which may be attributable to overall significantly better performance by the Odisha state. However, PVTGs have underperformed in terms of timely pregnancy registration and institutional delivery, which should be urgently addressed.

Quality of Life Assessment in Diabetic Patients Using a Validated Tool in a Patient Population Visiting a Tertiary Care Center in Bhubaneswar, Odisha, India.

Odisha has 4.2 million diabetic patients against the country's 70 million with an urban prevalence of nearly 15.4%. Diabetes is affecting younger age groups, thus having a crucial impact on quality of life of the affected. A qualitative endeavour was attempted at the diabetic clinic of a tertiary care set up in the capital city of Bhubaneswar to create a diabetic surveillance data assembly, wherein subjects above 18 years of age and newly diagnosed or on follow-up, after obtaining informed consent, were made to respond to a quality of life (QOLID) validated tool. The pretested tool has 8-domain role limitation due to physical health, physical endurance, general health, treatment satisfaction, symptom botherness, financial worries, emotional/mental health, and diet advice tolerance. The validated tool had 34 items (questions) that were selected to represent these domains on the basis of extraction communality, factor loading, and interitem and item-total correlations. The final questionnaire had an overall Cronbach's alpha value of 0.894 (subscale: 0.55 to 0.85), showing high internal consistency in the current study population. A score for each domain was calculated by simple addition of items scores. Each individual domain score was then standardized by dividing by maximum possible domain score and multiplying by 100. All individual standardized domain scores were then added and divided by 8 (number of domain) to obtain an overall score. The data collection was done for 400 patients as an interim analysis. Univariate and subsequently multivariate analysis was performed to decide the predictors that affected quality of life. Age over 50 years (OR = 1.81, CI 1.12-2.93; p=0.014), female gender (OR = 2.05, CI 1.26-3.35; p=0.004), having foot complications (OR = 2.81, CI 1.73-4.55; p < 0.001), and having depression (OR = 1.88, CI 1.15-3.06, p=0.011) emerged as predictors of poor QOLID scores. The tool can be made a subtle part of chronic case management of diabetes to ensure patient's participation in the treatment of the disease and to create a database that can redefine diabetic care in India to suit the diverse regional settings in the country.

Family and facility care variables attributing to postnatal depression among women in two tribal-dominated districts of Odisha: Log model analysis to suggest intervention.

Introduction: It is a proven fact that women are affected by poor mental health predominantly in the postnatal period. This is authenticated by the use of a validated and tested Edinburg Postnatal Depression scale (EPNS), which is a simple tool to measure depression among women after delivery by posing 10 questions and this is also validated in Odia language. Odisha has made laudable progress in delivering Maternal and Child Health care to women even in tribal-dominated districts through its robust Comprehensive Obstetrics care network restricting home delivery almost to a mere 4%-5% and reducing maternal deaths by 60%-70% as per the National Family Health Survey (NFHS-5). As a part of an Indian Council of Medical Research (ICMR) extramural project to enhance contraceptive acceptance among males in districts that had a total fertility rate (TFR) higher than 3, a qualitative objective to measure mean postnatal depression in the early postpartum period (who are also the target to advocate contraceptive acceptance) was undertaken. A secondary objective was to compare family care vs. facility care as greater attributing factors for higher EPNS scores. Materials and Methods: Due to time constraints, the study was done on a fast-track mode wherein two villages each from the sampled blocks of Koraput and Boudh (with one of the highest birth rates) were selected. All women in villages who had a baby aged between 1 and 6 months, were the sampling frame and only those were selected who consented. A questionnaire was used that elicited information on familial sociodemographic details and also facility-based antenatal care (ANC) and postdelivery services that were availed for the last-born child. General Health Questionnaire-12 (GHQ-12) scores were used as an independent variable and a proxy measure of cumulative familial stress. Descriptives and log regression were used to measure the odds of family vs. facility-based services. Results: A total of 98 women, 50 from Boudh and 48 from Koraput, participated in the study. Koraput's mean EPNS scores were 6 points higher than Boudh indicating much higher postnatal poor mental health. Log models showed that there was no difference between facility-based care in both districts as both reported 96%-97.3% institutional delivery, with out-of-pocket expenditure (OOP) being less than 520 Indian rupees on average and nearly 100% reported receipt of iron folic acid and calcium as well as streamlined Janani Suraksha Yojana (JSY) services. However, the odds of men's participation in Family planning was 2.77 times less in Koraput (SD = 2.582), fourth birth order 1.33 odds, and female gender 5.66 odds higher for the district as a result of which GHQ 12 score mean was 21.00 (CI: 19.18-22.82) hinting very high psychological stress as compared with Boudh where the mean was 17 (CI: 14.59-19.41). Conclusion: This clearly indicates that a robust healthcare delivery alone will not be able to address the holistic health of women in the childbearing age group. Familial stressors compound poor mental health and hence counseling of the family as a whole is necessary to achieve sound mental health in women in the postnatal period. The spousal role is emerging as a strong determinant, especially in terms of nonacceptance or casual approach to contraceptive use. Interestingly, a skewed gender bias is noted for the female child, which is also a contributor to postnatal depression (PND) in both districts, though a bigger sample would be needed to statistically prove it.

A Pilot Study to Show Longitudinal Trends in Health-Related Quality of Life (HRQOL) in a Cohort of Breast Cancer Patients Under Treatment at a Tertiary Healthcare Facility in Bhubaneswar, India.

Introduction: Breast cancer incidence has overtaken that of cervical cancer among women in India according to the Globacon 2020 reports. Cancer management is also being streamlined at the Center and district levels, such that comprehensive integrated management is offered to cases to optimize the best results. In breast cancer, there are two modes of surgery namely Breast Conservation Surgery(BCS) and Modified Radical Mastectomy (MRM) now over 2 decades, with recommended Chemo radiation depending on the extent of the disease. HRQOL (Health-related Quality of Life) studies have been done in these groups of patients, due to their added relevance in terms of the loss of a vital organ like the breast. EORTC 30 and BR23 are standardized and detailed tools that have been seen to estimate QOL, keeping in mind a whole array of domains that are affected by the disease. Objective: To evaluate the "Body Image" and "Quality of life" (QOL) in operated breast cancer patients using BR -23 and EORTC - QLQ- questionnaire at 1month (after surgery) and then 3 to 4 months after surgery. Methods: This article attempts to draw a comparison among of EORTC30 and BR 23 scores calculated for 46 breast cancer patients operated during the pandemic time in one center and consenting to repeat the measures at pre-decided three time periods during the course of management. Results: No significant differences are noted in the mean scores for EORTC 30 and BR23 for the two types of surgeries. Visit 1 scores for both modes of surgery are over 75 and by Visit 3 become less than 55 for EORTC. BR 23 (which measures the symptoms core to Breast cancer) at all 3 visits are between 45 to 55. Friedman's test shows that the scores are not significant for age groups, the number of living children, or lifestyle factors like alcohol or tobacco chewing, though quadratic graphs depict the distinct variations in the scores at the 3 times reinforcing the need for follow-up of mental health in these subjects at intervals. The study largely brings out a strong need for repeated follow-up and counseling at regular and short intervals, post-surgery in breast cancer patients. EORTC 30 and BR 23 tools are excellent to use to essay information on the mental health of patients with breast cancer.

Antibiotic-resistant bacteria in bovine milk in India.

Antibiotic resistance (ABR) is a global issue that draws the attention of all healthcare experts in the veterinary and medical fields. Of various factors, indiscriminate and unregulated antibiotic usage in the animals reared for food production, especially in cows and buffaloes suffering from mastitis, contribute significantly to the rising incidence of resistant bacteria. A literature survey reveals the spread of resistant strains of mastitis-causing bacteria, like Staphylococcus aureus and Escherichia coli, to humans. In addition, antibiotic residues detected in milk samples against all major groups of antibiotics are likely to enter the human body through the food chain and aggravate the condition. The cumulative effects of ABR have emerged as a silent killer. The benefits of systematic surveillance on ABR in India are yet to be available. Here is an attempt to understand the ABR burden in India associated with bovine milk and its mitigation strategies.

Community-friendly tool to assess patient satisfaction in tuberculosis programme in the covid pandemic period; Bhubaneswar; India.

National Tuberculosis Elimination Programme (NTEP) is a priority programme for India, given that India is one of the 20 countries with high burden of TB. Odisha (a state in Eastern India) in 2017 reported 159/lakh/year cases as against a national average incidence of 138.33/lakh/year. Thus, the state, under an encouraging political milieu went to vigorously implement the newer initiatives outlined in the National Strategic Plan 2020-25, the result of which in 2021 Odisha was ranked second in the country for its efforts on TB elimination. The current article attempts to take community feedback on the programmatic endeavours, by using a tool for client satisfaction. 350 consecutive subjects, adults aged 18 years and above consented among the 465 who were diagnosed and started on treatment between 5/4/21 to 5/4/22. The selected subjects were interviewed after confirmation of diagnosis at one DOTS centre in an urban city, using a pre-designed and pretested tool after taking requisite ethical permission from the institute as well as after consent from the participating subjects. The tool had 10 items on structure; 10 items on the process and 3 on outcome each rated on a Likert scale of 1-5 (very satisfied to very dissatisfied) and lastly a score on 10 scale for overall satisfaction. For all the 24 items; alpha Cronbach coefficient was 0.928 (bootstrap 95% CI); for subscales infrastructure, process and outcome isolatedly was 0.931, 0.912 and 0.959 respectively. This shows that the questionnaire had very good reliability. Infrastructure mean score for all 10 questions was above 4.5; for processes, it was <4.05 for a few questions and mainly these referred to Out of pocket expenditures and waiting time; outcome again for all three questions mean score was near or above 4.4. The overall score was between 5 and 10; maximally at 8. This simple tool gave clear-cut hints at the best picture scenario, as the study was done at a single DOTS service centre in the capital city of the state, which ran effectively even during the pandemic. However, it brings out the weak points in the processes like the cost incurred to come to the centre and communication with ancillary staff. No difference in satisfaction levels was reported among pulmonary and extrapulmonary cases (ratio 8.4:1.5) in this study in the covid period; with overall satisfaction being 4.45 ± 0.44 and 4.41 ± 0.25 respectively. The promptness in the programmatic services at the DOTS centre under study is encouraging but warrants conformity with DOTS centres in rural and far-to-reach areas. Best evaluation of achievements of programme can be determined by word of mouth of the beneficiaries. Hence, this tool if replicated at all service centres can help programme managers plug any disconnects in service delivery and assure good satisfaction from all quarters.

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants-A randomized study.

BACKGROUND: Pentavalent vaccines (DTP-HepB-Hib) have been introduced in many countries in their routine public immunization programmes to protect against diphtheria (D), tetanus (T), pertussis (P), hepatitis B (Hep B) and Hemophilus influenzae type b (Hib) diseases. This study compared the safety and immunogenicity of a new formulation of a whole-cell Bordetella pertussis (wP) based pentavalent vaccine (DTwP-HepB-Hib). The new formulation was developed using well-characterized hepatitis B and pertussis whole cell vaccine components. METHODS: This was a phase III, observer-blind, randomized, non-inferiority, multi-center study conducted in India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator formulations at 6-8, 10-12 and 14-16 weeks of age. RESULTS: The investigational formulation of DTwP-HepB-Hib vaccine was non-inferior to the licensed formulation in terms of hepatitis B seroprotection rate (% of subjects with HepB antibodies ≥10mIU/mL were 99.1% versus 99.0%, respectively, corresponding to a difference of 0.1% (95% CI, -2.47 to 2.68)) and pertussis immune responses (adjusted geometric mean concentrations of antibodies for anti-PT were 76.7 EU/mL versus 63.3 EU/mL, with a ratio of aGMTs of 1.21 (95% CI, 0.89-1.64), and for anti-FIM were 1079 EU/mL versus 1129 EU/mL, with a ratio of aGMTs of 0.95 (95% CI, 0.73-1.24), respectively). The immune responses to other valences (D, T, and Hib) in the two formulations were also similar. The safety profile of both formulations was found to be similar and were well tolerated. CONCLUSIONS: The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry India number: CTRI/2018/12/016692.

Assessment of Blood Lead Level of School Children in 10 Cities of India: A Cross-Sectional Study.

OBJECTIVES: To assess the blood lead level (BLL) of school children in 10 cities of India. METHODS: This multi-centric cross-sectional study enrolled participants from randomly selected schools. Data on demographic details, socioeconomic status (SES) and anthropometric indicators was collected. Samples were collected for assessment of lead level in blood. Inductively coupled plasma-optical emission spectrometry technique was used to assess BLL. RESULTS: From April 2019 through February 2020, 2247 participants were recruited from sixty schools (62.6% government schools) with equal gender distribution. The overall median (interquartile range) BLL was 8.8 (4.8, 16.4) µg/dl. The highest median (interquartile range) BLL was in Manipal 30.6 (23.0, 46.7) and lowest in Dibrugarh 4.8 (3.2, 7.0). Overall, 82.5% of participants had BLL above ≤4 µg/dl. Significant negative correlation was observed between BLL and SES (correlation= -0.24, p <0.001), anthropometric indicators (correlation= -0.11, p <0.001), hemoglobin level (correlation= -0.045, p = 0.03) and multivariate regression model showed association with gender, SES and anthropometric indicators. CONCLUSIONS: BLL are elevated in urban school going children and there is intercity variation. Hence, urgent focus is needed to reduce exposure to lead in India.

Association of dietary intake with micronutrient deficiency in Indian school children: a cross-sectional study.

Adequate nutrition is necessary during childhood and early adolescence for adequate growth and development. Hence, the objective of the study was to assess the association between dietary intake and blood levels of minerals (calcium, iron, zinc, and selenium) and vitamins (folate, vitamin B12, vitamin A, and vitamin D) in urban school going children aged 6-16 years in India, in a multicentric cross-sectional study. Participants were enrolled from randomly selected schools in ten cities. Three-day food intake data was collected using a 24-h dietary recall method. The intake was dichotomised into adequate and inadequate. Blood samples were collected to assess levels of micronutrients. From April 2019 to February 2020, 2428 participants (50⋅2 % females) were recruited from 60 schools. Inadequate intake for calcium was in 93⋅4 % (246⋅5 ± 149⋅4 mg), iron 86⋅5 % (7⋅6 ± 3⋅0 mg), zinc 84⋅0 % (3⋅9 ± 2⋅4 mg), selenium 30⋅2 % (11⋅3 ± 9⋅7 mcg), folate 73⋅8 % (93⋅6 ± 55⋅4 mcg), vitamin B12 94⋅4 % (0⋅2 ± 0⋅4 mcg), vitamin A 96⋅0 % (101⋅7 ± 94⋅1 mcg), and vitamin D 100⋅0 % (0⋅4 ± 0⋅6 mcg). Controlling for sex and socioeconomic status, the odds of biochemical deficiency with inadequate intake for iron [AOR = 1⋅37 (95 % CI 1⋅07-1⋅76)], zinc [AOR = 5⋅14 (95 % CI 2⋅24-11⋅78)], selenium [AOR = 3⋅63 (95 % CI 2⋅70-4⋅89)], folate [AOR = 1⋅59 (95 % CI 1⋅25-2⋅03)], and vitamin B12 [AOR = 1⋅62 (95 %CI 1⋅07-2⋅45)]. Since there is a significant association between the inadequate intake and biochemical deficiencies of iron, zinc, selenium, folate, and vitamin B12, regular surveillance for adequacy of micronutrient intake must be undertaken to identify children at risk of deficiency, for timely intervention.

Micronutrients and cognitive functions among urban school-going children and adolescents: A cross-sectional multicentric study from India.

BACKGROUND: Micronutrient deficiency (MD) is associated with deficits in cognitive functioning of children. However, no comprehensive multicentric study has been conducted in India to explore the role of multiple MD in cognition of children and adolescents. The present study aimed to explore association of MD with level of general intelligence and specific cognitive functions, in urban school-going children and adolescents across ten cities of India. METHOD: Cross-sectional multicentric study, enrolled participants aged 6-16 years. Blood samples were collected for biochemical analysis of calcium, iron, zinc, selenium, folate, vitamin A, D and B12. Colored Progressive Matrices / Standard Progressive Matrices (CPM/SPM), Coding, Digit Span and Arithmetic tests were used for the assessment of cognitive functions of participants. Height and weight measures were collected along with socio-economic status. RESULTS: From April-2019 to February-2020, 2428 participants were recruited from 60 schools. No MD was found in 7.0% (134/1918), any one MD in 23.8% (457/1918) and ≥ 2 MD in 69.2% (1327/1918) participants. In presence of ≥ 2 MD, adjusted odds ratio (OR) for borderline or dull normal in CPM/SPM was 1.63, (95% CI: 1.05-2.52), coding was 1.66 (95% CI: 1.02-2.71), digit span was 1.55 (95% CI: 1.06-2.25) and arithmetic was 1.72 (95% CI: 1.17-2.53), controlling for gender, socioeconomic status and anthropometric indicators. CONCLUSION: Since ≥ 2 MD were found in more than 2/3rd of participants and was associated with impairment in cognitive function, attempts must be made to ameliorate them on priority in school going children in India. TRIAL REGISTRATION NUMBER: CTRI/2019/02/017783.

Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India: A Phase 2-3 Randomized Clinical Trial.

Importance: The recombinant COVID-19 vaccine NVX-CoV2373 has demonstrated efficacy of approximately 90% in adults; however, its safety and efficacy in children is unknown. Objective: To assess the noninferiority of SII-NVX-CoV2373 in children and adolescents compared to adults and to evaluate its safety in comparison with placebo. Design, Setting, and Participants: This phase 2-3 observer-blind randomized clinical trial was conducted in 2 cohorts, children (aged 2 to 11 years) and adolescents (aged 12 to 17 years) between August 2021 and August 2022. Participants were randomized 3:1 to SII-NVX-CoV2373 or placebo and monitored for 179 days. The participants, study team, and laboratory staff were blinded. This was a multicenter study conducted across 10 tertiary care hospitals in India. Exclusion criteria included previous COVID-19 infection or vaccination, immunocompromised condition, and immunosuppressive medications. Interventions: Two doses of 0.5-mL SII-NVX-CoV2373 or placebo were administered intramuscularly on days 1 and 22. Main Outcomes and Measures: Primary outcomes were geometric mean titer ratio of both anti-spike (anti-S) IgG and neutralizing antibodies (NAbs) between both pediatric age groups to that of adults on day 36. Noninferiority was concluded if the lower bound of 95% CI of this ratio was greater than 0.67 for each age group. Both the antibodies were assessed for the index strain and for selected variants at various time points. Solicited adverse events (AEs) were recorded for 7 days after each vaccination, unsolicited AEs were recorded for 35 days, and serious AEs and AEs of special interest were recorded for 179 days. Results: A total of 460 children in each age cohort were randomized to receive vaccine or placebo. The mean (SD) age was 6.7 (2.7) years in the child cohort and 14.3 (1.6) years in the adolescent cohort; 231 participants (50.2%) in the child cohort and 218 in the adolescent cohort (47.4%) were female. Both anti-S IgG and NAb titers were markedly higher in the SII-NVX-CoV2373 group than in the placebo group on both day 36 and day 180. The geometric mean titer ratios compared to those in adults were 1.20 (95% CI, 1.08-1.34) and 1.52 (95% CI, 1.38-1.67) for anti-S IgG in adolescents and children, respectively; while for NAbs, they were 1.33 (95% CI, 1.17-1.50) and 1.93 (95% CI, 1.70-2.18) in adolescents and children, respectively, indicating noninferiority. SII-NVX-CoV2373 also showed immune responses against variants studied. Injection site reactions, fever, headache, malaise, and fatigue were common solicited AEs. There were no AEs of special interest and no causally related serious AEs. Conclusions and Relevance: SII-NVX-CoV2373 was safe and well tolerated in children and adolescents in this study. The vaccine was highly immunogenic and may be used in pediatric vaccination against COVID-19. Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2021/02/031554.

Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants.

The WHO pre-qualified rotavirus vaccine, ROTAVAC®, is derived naturally from the neonatal 116E rotavirus strain, and stored at -20°C. As refrigerator storage is preferable, immunogenicity and safety of liquid formulations kept at 2-8°C, having excipients to stabilize the rotavirus, with or without buffers, were compared with ROTAVAC® in different clinical studies. Study-1, the pivotal trial for this entire product development work, was a randomized, single-blind trial with two operationally seamless phases: (i) an exploratory phase involving 675 infants in which two formulations, ROTAVAC 5C (LnHRV-1.5 mL and LnHRV-2.0 mL) containing buffer and excipients to stabilize the virus against gastric acidity and temperature, were compared with ROTAVAC®. As the immune response of ROTAVAC 5C (LnHRV-2.0 mL) was non-inferior to ROTAVAC®, it was selected for (ii) confirmatory phase, involving 1,302 infants randomized 1:1:1:1 to receive three lots of LnHRV-2.0 mL, or ROTAVAC®. Primary objectives were the evaluation of non-inferiority and lot-to-lot consistency. The secondary objectives were to assess the safety and interference with the concomitant pentavalent vaccine. As it was separately established that buffers are not required for ROTAVAC®, in Study-2, the safety and immunogenicity of ROTAVAC 5D® (with excipients) were compared with ROTAVAC® and lot-to-lot consistency was assessed in another study. All lots elicited consistent immune responses, did not interfere with UIP vaccines, and had reactogenicity similar to ROTAVAC®. ROTAVAC 5C and ROTAVAC 5D® were immunogenic and well tolerated as ROTAVAC®. ROTAVAC 5D® had comparable immunogenicity and safety profiles with ROTAVAC® and can be stored at 2-8°C, leading to WHO pre-qualification.Clinical Trials Registration: Clinical Trials Registry of India (CTRI): CTRI/2015/02/005577CTRI/2016/11/007481 and CTRI/2019/03/017934.

A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults.

Due to waning immunity following primary immunization with COVID-19 vaccines, booster doses may be required. The present study assessed a heterologous booster of SII-NVX-CoV2373 (spike protein vaccine) in adults primed with viral vector and inactivated vaccines. In this Phase 3, observer-blind, randomized, active controlled study, a total of 372 adults primed with two doses of ChAdOx1 nCoV-19 (n = 186) or BBV152 (n = 186) at least six months ago, were randomized to receive a booster of SII-NVX-CoV2373 or control vaccine (homologous booster of ChAdOx1 nCoV-19 or BBV152). Anti-S IgG and neutralizing antibodies (nAbs) were assessed at days 1, 29, and 181. Non-inferiority (NI) of SII-NVX-CoV2373 to the control vaccine was assessed based on the ratio of geometric mean ELISA units (GMEU) of anti-S IgG and geometric mean titers (GMT) of nAbs (NI margin > 0.67) as well as seroresponse (≥ 2 fold-rise in titers) (NI margin -10%) at day 29. Safety was assessed throughout the study period. In both the ChAdOx1 nCoV-19 prime and BBV152 prime cohorts, 186 participants each received the study vaccines. In the ChAdOx1 nCoV-19 prime cohort, the GMEU ratio was 2.05 (95% CI 1.73, 2.43) and the GMT ratio was 1.89 (95% CI 1.55, 2.32) whereas the difference in the proportion of seroresponse was 49.32% (95% CI 36.49, 60.45) for anti-S IgG and 15% (95% CI 5.65, 25.05) for nAbs on day 29. In the BBV152 prime cohort, the GMEU ratio was 5.12 (95% CI 4.20, 6.24) and the GMT ratio was 4.80 (95% CI 3.76, 6.12) whereas the difference in the proportion of seroresponse was 74.08% (95% CI 63.24, 82.17) for anti-S IgG and 24.71% (95% CI 16.26, 34.62) for nAbs on day 29. The non-inferiority of SII-NVX-CoV2373 booster to the control vaccine for each prime cohort was met. SII-NVX-CoV2373 booster showed significantly higher immune responses than BBV152 homologous booster. On day 181, seroresponse rates were ≥ 70% in all the groups for both nAbs and anti-S IgG. Solicited adverse events reported were transient and mostly mild in severity in all the groups. No causally related SAE was reported. SII-NVX-CoV2373 as a heterologous booster induced non-inferior immune responses as compared to homologous boosters in adults primed with ChAdOx1 nCoV-19 and BBV152. SII-NVX-CoV2373 showed a numerically higher boosting effect than homologous boosters. The vaccine was also safe and well tolerated.

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study.

Background: NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study. Methods: This was an observer-blind, randomised, phase 2/3 study in 1600 adults. In phase 2, 200 participants were randomized 3:1 to SII-NVX-CoV2373 or placebo. In phase 3, 1400 participants were randomized 3:1 to SII-NVX-CoV2373 or NVX-CoV2373 (940 safety cohort and 460 immunogenicity cohort). Two doses of study products (SII-NVX-CoV2373, NVX-CoV2373 or placebo) were given 3 weeks apart. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 to NVX-CoV2373 in terms of geometric mean ELISA units (GMEU) ratio of anti-S IgG antibodies 14 days after the second dose (day 36) and to determine the incidence of causally related serious adverse events (SAEs) through 180 days after the first dose. Anti-S IgG response was assessed using an Enzyme-Linked Immunosorbent Assay (ELISA) and neutralizing antibodies (nAb) were assessed by a microneutralization assay using wild type SARS CoV-2 in participants from the immunogenicity cohort at baseline, day 22, day 36 and day 180. Cell mediated immune (CMI) response was assessed in a subset of 28 participants from immunogenicity cohort by ELISpot assay at baseline, day 36 and day 180. The total follow-up was for 6 months. Trial registration: CTRI/2021/02/031554. Findings: Total 1596 participants (200 in Phase 2 and 1396 in Phase 3) received the first dose. SII-NVX-CoV2373 was found non-inferior to NVX-CoV2373 (anti-S IgG antibodies GMEU ratio 0.91; 95% CI: 0.79, 1.06). At day 36, there was more than 58-fold rise in anti-S IgG and nAb titers compared to baseline in both the groups. On day 180 visit, these antibody titers declined to levels slightly lower than those after the first dose (13-22 fold-rise above baseline). Incidence of unsolicited and solicited AEs was similar between the SII-NVX-CoV2373 and NVX-CoV2373 groups. No adverse event of special interest (AESI) was reported. No causally related SAE was reported. Interpretation: SII-NVX-CoV2373 induced a non-inferior immune response compared to NVX-CoV2373 and has acceptable safety profile. Funding: SIIPL, Indian Council of Medical Research, Novavax.

Review on public private mix TB control strategy in India.

In India, around 70% of health care services are offered by the private sector. National strategic plan (NSP) has emphasized private sector engagement to TB program. Public private mix strategy along with web based mandatory notification of TB cases were established in 2002. However, feasibility of consulting an informal provider first was seen to be associated with significant increases in total delay (absolute increase 22.8 days, 95%CI 6.2-39.5) and in the risk of prolonged delay >90 days. STUDY DESIGN: A mixed method literature review, descriptive information and evaluative outcomes data extracted and analysed. OBJECTIVE: This review aimed to systematically review public private mix strategy in TB control in Indian tuberculosis disease burden and efforts towards elimination. METHODS: Available published literatures were searched with key words, articles related with objectives were selected, analysed and systematically synthesized. Overall 30 studies were reviewed. RESULT: Available literatures were selected based on study objective and analysed. The modes of PPM strategy its success and problems of implementation and shortcomings were synthesized. DISCUSSION: After implementing PPM from 2002, case detection is seen to have significantly increased for smear positive cases and high detection rate and better treatment outcomes achieved. However, implementation of PPM has been challenged to fully deliver the intended services. Interestingly, seeking initial care from PPs is significant risk factor for diagnostic delay. CONCLUSION: PPM is a proven and tested strategy to achieve End TB goal globally and even in India. However, studies indicated there is the need to strengthen and motivate public sector to engage private practitioners in specific districts and sync their activities into the mainstream programme. Conflict of interest and mistrust between private practitioners and public sector has to be well addressed to build sustainable relationship among the sectors. Routine and institutionalized systematic monitoring and evaluation of the system is required to meet the End TB goal by 2025.

Prevalence of specific micronutrient deficiencies in urban school going children and adolescence of India: A multicenter cross-sectional study.

INTRODUCTION: Childhood and adolescence require adequate amount of micronutrients for normal growth and development. The primary objective of study was to assess the prevalence of deficiencies of Vitamins (Vitamin A, 25 Hydroxy Vitamin D, Vitamin B12 and Folate) and minerals (Calcium, Zinc, Selenium and Iron), among urban school going children aged 6-11 and 12-16 years in ten cities of India. Secondary objective was to find the association between micronutrient deficiencies with sociodemographic and anthropometric indicators. METHODS: A multi-center cross-sectional study was conducted across India. Participants in the age groups of 6 to 11 years (group 1) and 12 to 16 years (group 2) were selected from randomly chosen schools from each center. Data on socio economic status, anthropometric measures was collected. Blood samples were collected for biochemical analysis of micronutrients. Point estimates and 95% confidence intervals was used to assess the prevalence of deficiencies. Associations were observed using chi square, student t test and ANOVA test. RESULTS: From April 2019 to February 2020, 2428 participants (1235 in group 1 and 1193 group 2) were recruited from 60 schools across ten cites. The prevalence of calcium and iron deficiency was 59.9% and 49.4% respectively. 25 Hydroxy Vitamin D deficiency was seen in 39.7% and vitamin B12 in 33.4% of subjects. Folate, Selenium and Zinc were deficient in 22.2%, 10.4% and 6.8% of subjects respectively. Vitamin A deficiency least (1.6%). Anemia was prevalent in 17.6% subjects and was more common among females. CONCLUSION: One or more micronutrient deficiencies are found in almost one half of school going children in urban area. Hence efforts must be made to combat these on priority. TRIAL REGISTRATION NUMBER: CTRI/2019/02/017783.

Effect of pandemic on Quality of life in Diabetics (QOLID) assessment: Data from a teaching hospital in Bhubaneswar, Odisha, India.

BACKGROUND: Quality of life in Diabetics (QOLID) questionnaire is a validated tool to assess the quality of life affected by diagnosed diabetic patients and has 8 sub domains, which are essential factors that have proven effect on the management. In a state of art Diabetic clinic in Bhubaneswar city, the tool was used to add more quality to diabetic management. METHODS: The ongoing assessment through the months of 2020 (study period being from December 2019 to August 2020), offered an opportunity to assess the effect of the pandemic on QOLID scores and review some nascent or strong factors which may be affecting chronic disease management. RESULTS: Complete data could be collected from 599 subjects, 343 from pre pandemic and 256 from pandemic period. The overall scores which were on 100, did not show any significant difference for pre covid and the Covid period, interestingly nearly 1.93 points better in Covid period (69.69±11.10 vs71.62±8.49; p=0.396). Mild difference in overall scores of 4.82 points is seen in females in Covid period; and as seen in age group data maximum gain in sub domains, more for females is seen in the emotional and mental health. Though women reporting to the clinic in both periods are usually in 1:2 ratios, as against men; but QOLID scores in both men and women in Covid period was 71 to 80 points. After the univariate analysis for significant factors, it was that Covid (1.50; 1.08 - 2.07) ; compliance to medications (2.27; 1.48 - 3.50) and reporting of all diabetic complications especially that of eye and depression are coming out to be strong associative factors to affect QOLID scores. Interestingly, rising education has a protective effect on QOLID scores that was significant as higher awareness and better job or earning opportunities may be a contributor for higher QOLID scores for the well educated. CONCLUSION: This brings out a strong emphasis on QOL assessments to be made an inbuilt part of Diabetic management at all centers to maximize treatment outcomes.

Knowledge and practice of mothers of school-going children regarding iodized salt and its association with the psychology testing of the students.

CONTEXT: Iodized salt is the mainstay intervention to tackle iodine-related disorders. In spite of the government's efforts to make iodized salt available in more than 90% of the households across the country, there are sketchy details on its use. Since the main propagators of this intervention are the mothers cooking in kitchen, this study was conceived, as a corollary to a larger micronutrient assessment study among school-going children. AIMS: The aim of this was to assess knowledge, practice of mothers of school-going children (6-16 years) regarding use of iodized salt, and to see any association between the simple psychological testing of the children and the iodine content of the salt used in home kitchen and the contributing factors thereof. METHODS AND MATERIALS: A cross-sectional study was conducted by interviewing mothers of 240 school-going children of age groups 6-11 years and 12-16 years from six schools of Bhubaneswar using a semi-structured questionnaire regarding their knowledge on iodine and its deficiency and the practice of using iodized salt. MBI kit was used to assess the iodine content of salt used at home. The psychology adeptness of students was assessed using the standardized and validated coding, standard progressive matrices, and colored progressive matrices tests. STATISTICAL ANALYSIS: Analysis was done using SPSS version 16, wherein the sociodemographic data were shown in proportions, and the iodine content was taken as the dependent continuous variable and means reported. For the sake of associations with intelligence and cognition, a binary logistic regression model was drawn. RESULTS: It reports that 47.5% of mothers knew that iodized salt is good for health and iodine content measured using MBI kit was 15 ppm and above for 71.7% of the sample. Further, iodine content in salt is seen as protective for cognition and also for IQ. CONCLUSIONS: The knowledge of the mothers' needs reinforcement regarding iodine and related disorders and the benefits of iodized salt. The aim of the National Iodine Deficiency Disorders Control Program can only be achieved by generating awareness, regular follow-up, and improving the iodization of salt.

Osteoarthritis in women reporting to tertiary care hospital in Eastern India: Associated factors determining management.

INTRODUCTION: Osteoarthritis (OA) is a painful joint condition that is left heavily underdiagnosed, as it is also related to advancing age. Hence, those affected, tend to live with it, until the condition becomes excruciating or disabling. The women in our society are a section, who have very poor health seeking behavior. However, in today's era, tertiary care hospitals offer definitive management for OA in the form of Joint Replacement Surgery (JRS). This again is taken up often as a last resort and is heavily dependent on the socioeconomic condition of the family. The surgery offers proven better quality of life. OBJECTIVES: This study discusses a public health hypothesis regarding the disease presentations of OA in women visiting a tertiary care hospital and endeavors to develop a model based on some predictors that increase the predilection of recommendation of surgery among these women, These studies have been done for general populations, but here we chose to study women, as the society in eastern part of the country is male dominated and the decision to go for a surgery in case of the women is dependent on several issues. This model perhaps will bring to light the need of surgery in the women with OA and help take some policy decisions to offer some subsidized care to this section of the society. The results were derived from 350 women coming to an orthopedic tertiary care center during a 6-month study period with joint pain in any of the big joints and then finally given a definitive diagnosis of OA based on radiological KL score and clinical presentations. RESULTS: Women above age 40 years were taken up; mean age in study being 55.94 SD 6.648 (maximum 83, minimum 43). A semi structured questionnaire was used to compare the sociodemographic parameters like type of residence, type of family, attained menopause, occupation, duration of OA, etc., In the sample, which gave multiple responses, right and left knee were maximally inflicted by OA i.e. 59.1% and 57.1% of cases, followed by hip (28.9%) and lower back (26.1%). 75% were offered conservative treatment, only 24.6% were on physiotherapy. CONCLUSION: Menopause, increased age, comorbidities, and preobese were seen to be significantly associated with recommendations of JRS. This can help develop a screening method for women and encourage them to undergo assessment for OA as a targeted intervention and address this growing burden of disease at the earliest.