Comparison of a Novel Human Rabies Monoclonal Antibody to Human Rabies Immunoglobulin for Postexposure Prophylaxis: A Phase 2/3, Randomized, Single-Blind, Noninferiority, Controlled Study.

Background: Lack of access to rabies immunoglobulin (RIG) contributes to high rabies mortality. A recombinant human monoclonal antibody (SII RMAb) was tested in a postexposure prophylaxis (PEP) regimen in comparison with a human RIG (HRIG)-containing PEP regimen. Methods: This was a phase 2/3, randomized, single-blind, noninferiority study conducted in 200 participants with World Health Organization category III suspected rabies exposures. Participants received either SII RMAb or HRIG (1:1 ratio) in wounds and, if required, intramuscularly on day 0, along with 5 doses of rabies vaccine intramuscualarly on days 0, 3, 7, 14 and 28. The primary endpoint was the ratio of the day 14 geometric mean concentration (GMC) of rabies virus neutralizing activity (RVNA) as measured by rapid fluorescent focus inhibition test for SII RMAb recipients relative to HRIG recipients. Results: One hundred ninety-nine participants received SII RMAb (n = 101) or HRIG (n = 98) and at least 1 dose of vaccine. The day 14 GMC ratio of RVNA for the SII RMAb group relative to the HRIG group was 4.23 (96.9018% confidence interval [CI], 2.59-6.94) with a GMC of of 24.90 IU/mL (95% CI, 18.94-32.74) for SII RMAb recipients and 5.88 IU/mL (95% CI, 4.11-8.41) for HRIG recipients. The majority of local injection site and systemic adverse reactions reported from both groups were mild to moderate in severity. Conclusions: A PEP regimen containing SII RMAb was safe and demonstrated noninferiority to HRIG PEP in RVNA production. The novel monoclonal potentially offers a safe and potent alternative for the passive component of PEP and could significantly improve the management of bites from suspected rabid animals. Clincical Trials Registration: CTRI/2012/05/002709.

An assessment of admission pattern and treatment outcomes of neonates admitted in centers under facility-based newborn care program in Maharashtra, India.

Background: Newborn period is the most vulnerable period of life. As the rate of decline in neonatal mortality was slow compared to infant mortality rate, improved neonatal health-care services were started in existing facilities under facility-based newborn care program. Materials and Methods: A total of six special newborn care units at the district hospitals and 12 newborn stabilization units at the subdistrict/rural hospitals were included in the study. The outcome parameters were analyzed in the admitted babies using statistical tests. RESULTS: The mortality pattern was higher among low-birth-weight and preterm babies. The lower health-care centers had less neonatal deaths, as the neonates were referred. The common causes of admission were neonatal jaundice, respiratory distress syndrome, birth asphyxia, and so on. Conclusion: The focus on the high-risk babies needs to be strengthened, as these babies are at a high risk for neonatal mortality.

Photovoice: a novel approach to improving antituberculosis treatment adherence in pune, India.

We compared antituberculosis treatment (ATT) adherence and outcomes among patients exposed to Photovoice (video of previously cured TB patients sharing experiences about TB treatment) versus those not exposed. The odds of successful outcome (i.e., cured or completing treatment) for the 135 patients who watched Photovoice were 3 times greater (odds ratio: 2.8; 95% CI: 1.3-6.1) than for patients who did not watch Photovoice. The comparison group, on average, missed more doses (10.9 doses; 95% CI: 6.6-11.1) than the intervention group who saw Photovoice (5.5 doses; 95% CI: 3.7-6.1). Using Photovoice at initiation of ATT has the potential to improve treatment adherence and outcomes.