A phase III randomized double-blind placebo-controlled trial was conducted in the urban neighborhoods of Delhi to assess whether Oral Rotavirus Vaccine ROTAVAC® interferes with the immune response to childhood vaccines when coadministered. Infants aged 6 weeks were randomized to receive three doses of either ROTAVAC® or placebo along with childhood vaccines: Oral Polio Vaccine and vaccines against Diphtheria, Pertussis, Tetanus, Hepatitis B and Haemophilus influenza type b given as Pentavalent at 6, 10, 14 weeks of age. Blood specimens were collected from all infants at baseline and 4 weeks post dose 3 to assess the immune response to antigens in Oral Polio Vaccine, Pentavalent and ROTAVAC® vaccines. Non-inferiority of immune response to all vaccine components of the childhood vaccines when ROTAVAC® was administered concurrently was demonstrated. Non-inferior immune responses to childhood vaccines were evaluated based on the seroprotective levels of antibodies against polio types 1, 2, and 3, Diphtheria toxoid, Tetanus toxoid, Haemophilus influenza type b anti- polyribosyl ribitol phosphate antibodies and Hepatitis B antibodies; and the Geometric Mean Concentration for Pertussis. The proportion of infants who seroconverted (≥4 fold rise) was 38.6% in the ROTAVAC® group and 12.2% in the placebo group. The frequency and severity of immediate adverse events, adverse events and serious adverse events were similar in both groups. None of the five reported deaths were considered to be related to the ROTAVAC® and no case of intussusception meeting Brighton Diagnostic Certainty Level I criteria was reported.This study demonstrated that ROTAVAC® can be safely administered with childhood vaccines without interfering with the immune response to the antigens contained in these vaccines.
IMPORTANCE Approximately 1 in 5 women in low-and middle-income countries experience postpartum depression, and the risk is higher among mothers of low-birth-weight (LBW) infants.Kangaroo mother care (KMC) is effective in improving survival among LBW infants, but the benefits of KMC for mothers are not well described. OBJECTIVETo estimate the effects of community-initiated KMC (ciKMC) on maternal risk of moderate-to-severe postpartum depressive symptoms and on salivary cortisol concentration, a biomarker of stress. DESIGN, SETTING, AND PARTICIPANTS This was an unmasked, parallel-group, individually randomized clinical trial. Participants included 1950 mothers of stable LBW infants (weighing 1500-2250 g) in rural and semiurban low-income populations in North India enrolled between April 2017 and March 2018. Data analysis was performed from January to July 2020. INTERVENTIONS Eligible participants were randomly assigned to the intervention or control group by block randomization. The mothers in the intervention group were supported to practice ciKMC until 28 days after birth or until the infant wriggled out of the KMC position (ie, was no longer staying in the KMC position). The intervention included promotion and support of skin-to-skin contact and exclusive breastfeeding through home visits. MAIN OUTCOMES AND MEASURESPostpartum depressive symptoms at the end of the neonatal period were measured using the Patient Health Questionnaire-9, with a score of 10 or higher used to identify moderate-to-severe depressive symptoms. Salivary cortisol concentration was measured in a subsample of 550 mothers before and after breastfeeding on day 28 after birth. RESULTSOf the 1950 participants (mean [SD] age, 23 [3.5] years), outcome assessment was completed for 974 of 1047 participants (93%) in the intervention group and 852 of 903 participants (94%) in the control group. Sixty-four percent of participants (1175 of 1826 participants) belonged to the lowest 3 wealth quintiles. The proportion of mothers with moderate-to-severe postpartum depressive symptoms was 10.8% (95% CI, 8.9%-12.9%; 105 of 974 mothers) in the intervention group vs 13.6% (95% CI, 11.4%-16.1%; 116 of 852 mothers) in the control group. The adjusted relative risk of moderate-to-severe maternal postpartum depressive symptoms was 0.75 (95% CI, 0.59-0.96), or an efficacy of 25%. There was no difference in day-28 salivary cortisol concentration between the ciKMC and control group mothers before or after breastfeeding. The analysis estimated that supporting 36 mothers to perform KMC at home would prevent 1 mother from experiencing moderate-to-severe postpartum depressive symptoms. (continued) Key Points Question Does the practice of community-initiated kangaroo mother care (ciKMC), an intervention encompassing skin-to-skin-contact and exclusive breastfeeding, during the neonatal period reduce the risk of moderate-to-severe postpartum depressive symptoms among mothers of low-birth-weight (LBW) infants? Findings In a randomized clinical trial that included 1950 mothers ...
The occurrence of DNA synthesis in mouse peritoneal macrophages was estimated autoradiographically in cells cultured on glass in the presence of tritiated thymidine. Subcutaneous injection of a soluble antigen, human serum albumin (HSA) into mice previously immunized with HSA in Freund’s complete adjuvant was followed, after a lag of at least 16 h, by the onset of DNA synthesis in peritoneal macrophages. This effect was immunologically specific and was accompanied by morphological changes indicating activation. The ability to respond in this way was passively transferable by means of spleen cells, but not serum, from immunized mice. DNA synthesis in macrophages was induced in vivo by Concanavalin A, phytohaemagglutinin-P, anti-lymphocyte globulin, bacterial endotoxin and normal mouse serum. The number of macrophages synthesizing DNA was also increased in mice with graft-versus-host reactions and in mice bearing a syngeneic methylcholanthrene-induced tumour.
Background Systematic studies to estimate the disease burden of typhoid and paratyphoid in India are limited. Therefore, a multicenter study on the Surveillance of Enteric Fever in India was carried out to estimate the incidence, clinical presentation, and antimicrobial resistance (AMR) trend. The data presented here represent the national burden of AMR in Salmonella Typhi and Salmonella Paratyphi A. Methods Antimicrobial susceptibility testing was performed for S. Typhi and S. Paratyphi A (n = 2373) isolates collected prospectively during a 2-year period from November 2017 to January 2020. Results Of 2373 Salmonella isolates, 2032 (85.6%) were identified as S. Typhi and 341 (14.4%) were S. Paratyphi A. Approximately 2% of S. Typhi were multidrug-resistant (MDR), whereas all 341 (100%) of S. Paratyphi A isolates were sensitive to the first-line antimicrobials. Among 98% of ciprofloxacin nonsusceptible isolates, resistance (minimum inhibitory concentration [MIC] >0.5 µg/mL) was higher in S. Typhi (37%) compared with S. Paratyphi A (20%). Azithromycin susceptibility was 99.9% and 100% with a mean MIC of 4.98 μg/mL for S. Typhi and 7.39 μg/mL for S. Paratyphi A respectively. Ceftriaxone was the only agent that retained 100% susceptibility. Moreover, beta-lactam/beta-lactamase inhibitors showed potent in vitro activity against the study isolates. Conclusions Data obtained from this systematic surveillance study confirms the declining trend of MDR Salmonella isolates from India. The higher prevalence of ciprofloxacin nonsusceptibility enforces to limit its use and adhere to the judicious usage of azithromycin and ceftriaxone for enteric fever management.
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