AI Article Synopsis

  • ROTAVAC® (nHRV), a rotavirus vaccine derived from the human 116E strain, was approved in India in 2015 and needed comparison to the WHO-prequalified Rotarix® to meet WHO prequalification standards.
  • A phase 4 clinical trial involving 464 infants was conducted to assess the immunogenicity and safety of ROTAVAC® by comparing it to Rotarix®, focusing on antibody responses measured via ELISA.
  • Results confirmed that ROTAVAC® was immunologically non-inferior to Rotarix® with similar safety profiles, making it a promising option for increasing access to rotavirus vaccination in more countries.

Article Abstract

Background: ROTAVAC® (nHRV), derived naturally from the human 116E rotavirus (RV) neonatal strain, was licensed in India in 2015 based on promising results of a phase 3, safety and efficacy vaccine trial. As a pre-requisite for WHO prequalification, we compared the immunogenicity and safety of ROTAVAC® to those of a WHO-prequalified, Rotarix®.

Methods: We conducted a multicentre, open-labeled, randomized phase 4 clinical trial where 464 infants, 6-8 weeks of age were equally randomized to receive as licensed, the complete regimen of ROTAVAC® (3 doses; Group I) or Rotarix® (2 doses; Group II). Antibody responses (serum anti-RV Immunoglobulin A [IgA]) were measured by enzyme-linked immunosorbent assay (ELISA). The primary analysis was an assessment of non-inferiority of ROTAVAC® to Rotarix® for geometric mean concentration (GMC) for infants who received the complete regimen of either vaccine.

Results: The GMC for Group I was 20.4 (95%CI: 17.6, 23.6) and that for Group II was 24.8 (95%CI: 20.3, 30.3), the GMC ratio was 0.82 (95% CI: 0.64, 1.05), thus meeting the non-inferiority criterion. Site-wise analysis of GMC titres revealed that one site had a peculiar pre-vaccination titre affecting only ROTAVAC® post-vaccination GMCs. Seroconversion rates were 35.3% (95%CI: 29.0, 41.9) and 31.0% (95%CI: 25.1, 37.4) for Groups I and Group II, respectively. There was no substantive difference in safety profiles between both vaccines.

Conclusions: The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile. Because the demand for RV vaccines is increasing as more countries are expanding their immunization schedules, the lack of need of a buffering agent, low dose volume (0.5 mL), non-interference with other concomitantly administered vaccines, and conformance with WHO-prequalification requirements provide ROTAVAC® the potential for widespread global usage. Post completion of this study, ROTAVAC® is now a WHO-prequalified vaccine.

Clinical Trials Registration: (CTRI Number: CTRI/2015/12/006428).

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Source
http://dx.doi.org/10.1016/j.vaccine.2019.05.069DOI Listing

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