Browsing by Author "Sudhir Babji"

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Intussusception after rotavirus vaccine introduction in India
(Massachussetts Medical Society, 2020) Samarasimha N. Reddy; Nayana P. Nair; Jacqueline E. Tate; Varunkumar Thiyagarajan; Sidhartha Giri; Ira Praharaj; Venkata R. Mohan; Sudhir Babji; Mohan D. Gupte; Rashmi Arora; Sunita Bidari; Sowmiya Senthamizh; Suhasini Mekala; Krishna B. Goru; Bhaskar Reddy; Padmalatha Pamu; Rajendra P. Gorthi; Manohar Badur; Vittal Mohan; Saroj Sathpathy; Hiranya Mohanty; Mrutunjay Dash; Nirmal K. Mohakud; Rajib K. Ray; Prasantajyoti Mohanty; Geeta Gathwala; Suraj Chawla; Madhu Gupta; Rajkumar Gupta; Suresh Goyal; Pramod Sharma; Mannancheril A. Mathew; Tarun J.K. Jacob; Balasubramanian Sundaram; Girish K.C. Purushothaman; Priyadarishini Dorairaj; Muthukumaran Jagannatham; Kulandaivel Murugiah; Hemanthkumar Boopathy; Raghul Maniam; Rajamani Gurusamy; Sambandan Kumaravel; Ashwitha Shenoy; Hemant Jain; Jayanta K. Goswami; Ashish Wakhlu; Vineeta Gupta; Gopinath Vinayagamurthy; Umesh D. Parashar; Gagandeep Kang
BACKGROUND A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case–control analysis was performed, with matching for age, sex, and location. RESULTS From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case–control analysis. CONCLUSIONS The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.) Copyright © 2020 Massachusetts Medical Society.
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
(Taylor and Francis Ltd., 2023) Krishna Kumari P; Siddharth Reddy Chiteti; Vinay K. Aileni; Sudhir Babji; William C. Blackwelder; Ashok Kumar; Jayant Vagha; Uma Nayak; Monjori Mitra; Narayanaappa D; Sonali Kar; Sangeeta Yadav; Swamy Naidu; Niranjan Mahantshetti; Vasant Khalatkar; Satyajit Mohapatra; P.K. Purthi; Pawan Sharma; A. Kannan; Ramchandra Keshav Dhongade; Sai D. Prasad; Raches Ella; Krishna Mohan Vadrevu
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. © 2023 The Author(s). Published with license by Taylor & Francis Group, LLC.