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.
Pregnancy-related Acute kidney injury (PR-AKI) accounts for approximately 15% of maternal mortality, with 10–30% progressing to end stage renal disease (ESRD). However, there are no comparative studies of obstetric and non-obstetric AKI. This study compares the outcomes of both groups with short-term follow-up to day 90. This prospective observational study was conducted over 1.5 years, enrolling 260 cases divided into non-obstetric and obstetric AKI groups. Inclusion criteria: Non-obstetric group - patients > 18 years with AKI; Obstetric group - pregnant or up to 42 days postpartum with AKI, as per KDIGO criteria. Patients with known Chronic kidney disease (CKD) or transplant were excluded. Demographics, clinical profiles and relevant investigations (including renal biopsy) were analysed. Outcomes assessed at days 7, 30, and 90 for complete recovery, dialysis dependency, CKD progression, and mortality. Of 260 patients, 83.4% were in non-obstetric group while 16.6% were in the obstetric group. Sepsis was leading cause of AKI (51.5%), affecting 47.7% of non-obstetric and 74.4% of obstetric patients. Renal biopsies (12.3% of cases) predominantly showed acute tubular injury, lupus nephritis, Minimal change disease, Focal segmental glomerulosclerosis, ANCA-associated Glomerulonephritis (GN), IgA nephropathy, and Membranoproliferative GN. In Obstetric AKI, acute cortical necrosis and thrombotic microangiopathy (TMA) were common biopsy findings. At 3-months follow-up, complete recovery was higher in the non-obstetric group (40.5% vs. 33.3%), with the obstetric group having more progression to CKD and dialysis dependency. Mortality was higher in non-obstetric AKI (50.4% vs. 33.3%), likely due to underlying comorbidities. Non-obstetric AKI showed higher early mortality but better long-term recovery, while obstetric AKI had poorer renal outcomes and a higher risk of progression to CKD. Early detection and intervention are critical for improving outcomes.
The physiological changes in the thyroid gland during pregnancy are well understood but only a few reports provide information about thyroid function in complicated pregnancies.The present study evaluates thyroid hormonal levels in cases of preeclampsia in the third trimester of pregnancy.A case-control study was conducted in the antenatal clinic of a public hospital of Delhi.Thyroid hormones, namely triiodothyronine (Free T3), thyroxine (Free T4) and thyroid stimulating hormone (TSH) were evaluated at the time of diagnosis of preeclampsia in 82 pregnant women and equal number of matched controls.The demographic data and hormone levels were analyzed using students' t test, Mann-Whitney test and chi-square test. Pearson two-tailed analysis was used for correlation.Mean TSH levels were significantly higher in preeclamptic group as compared to controls (p< 0.001). However, mean values of thyroid hormones were in the normal range. Approximately 40% preeclamptic women had TSH titres > 5 mIU/ml in the study group as compared to 12.2% in the controls. Approximately 76.7% of 43 pregnant women with abnormal TSH titres and 40% of 121 pregnant women with normal TSH titres belonged to the study group (p< 0.001). The odd ratio corresponding to TSH titres > 5 mIU/ml in preeclamptic women was 4.85 (95% CI 2.19-10.74).Mean serum TSH levels were significantly increased without concomitant changes in free T3 and T4, in preeclampsia compared to normal pregnancy. Abnormal TSH titres might be associated with a risk for occurrence of preeclampsia.
Summary Hepatitis E virus ( HEV ) infection can be vertically transmitted, but the factors that transmit the disease to foetuses are still unclear. We studied a total of 144 pregnant women with HEV infection. Cord blood and newborn samples were taken for analysis. Nutritional factors were evaluated on the basis of anthropometric parameters and biochemical factors, and HEV viral load was quantified by real‐time PCR . Sequencing of HEV ‐positive samples was performed. Approximately 14.63% (6/41) of pregnant patients with acute liver failure ( ALF ) died before delivery. Vertical transmission was observed in 46.09% (59/128) of HEV ‐IgM‐positive mothers. Approximately 23.80% (10/42) of newborns in the acute viral hepatitis group and 29.41% (5/17) in the ALF group were positive for HEV ‐ RNA . No significant difference was observed in the occurrence of vertical transmission in HEV groups. Viral load was found to be a significant predictor for vertical transmission of HEV infection adjusted with haemoglobin and folate in derivation cohort group. Incorporating these variables, a new score predicting vertical transmission of HEV was derived. Using these significant predictors, the probability for vertical transmission of HEV was well stratified in the validation group ( P >.05). In conclusion, viral load was associated with vertical transmission of HEV infection. A valid prediction score model was generated that was verified in a validation cohort group.
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