Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data: A Secondary Cross-Protocol Analysis of 5 Randomized Clinical Trials. (PubMed, JAMA Netw Open) - May 28, 2025 - "This secondary cross-protocol analysis constructed TND study datasets from study sites in 16 countries across 5 continents using the blinded phase cohorts of 5 harmonized phase 3 COVID-19 Prevention Network RCTs: COVE (Coronavirus Vaccine Efficacy and Safety), AZD1222, ENSEMBLE, PREVENT-19 (Prefusion Protein Subunit Vaccine Efficacy Novavax Trial COVID-19), and VAT00008...Participants received vaccines consisting of messenger RNA-1273 (COVE; 2 doses 28 days apart), ChAdOx1 nCoV-19 (AZD1222; 2 doses 28 days apart), Ad26.COV2.S (ENSEMBLE; 1 dose), NVX-CoV2373 (PREVENT-19; 2 doses 21 days apart), CoV2 preS dTM-AS03 (VAT00008; D614) (2 doses 21 days apart), or CoV2 preS dTM-AS03 (D614 plus B.1.351) (VAT00008; 2 doses 21 days apart) or placebo...In this cross-protocol analysis, the TND provided reliable inferences on COVID-19 vaccine effectiveness in health care-seeking populations for multiple vaccines and symptom definitions when confounding and selection bias were..."
Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
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; Ann R Falsey; Benjamin Luft; Brendan Flannery; Carla Truyers; Catherine Mary Healy; Colleen F Kelley; Dean Follmann; Deborah A Theodore; Frances Priddy; Guy de Bruyn; Hana M El Sahly; Holly Janes; Hong-Van Tieu; Ian Hirsch; Jessica Andriesen; Kathleen M Neuzil; Kelsey M Sumner; Lars Van Der Laan; Leah I B Andrews; Leigh H Fisher; Lilly Immergluck; Lindsey R Baden; M Elizabeth Halloran; Magdalena Sobieszczyk; Mayur Patel; Nadine Rouphael; Peter B Gilbert; Stephen R Walsh; Thomas B Campbell; Yunda Huang
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