Terry L. Poling

Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data

Leah I. B. Andrews, M. Elizabeth Halloran, Lars van der Laan, Yunda Huang et autres

Importance: The test-negative design (TND) has been widely used to assess postmarketing COVID-19 vaccine effectiveness but requires further evaluation for this application. Objective: To determine whether the TND reliably evaluates vaccine effectiveness against symptomatic COVID-19 using placebo-controlled vaccine efficacy randomized clinical trials …

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SARS-CoV-2 Viral Load in the Nasopharynx at Time of First Infection Among Unvaccinated Individuals

Leigh H. Fisher, Jia Jin Kee, Albert Liu, Claudia Espinosa et autres

Importance: SARS-CoV-2 viral load (VL) in the nasopharynx is difficult to quantify and standardize across settings, but it may inform transmission potential and disease severity. Objective: To characterize VL at COVID-19 diagnosis among previously uninfected and unvaccinated individuals by evaluating the association …

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Risk of COVID-19 after natural infection or vaccination

Anne-Marie Rick, Matthew B. Laurens, Ying Huang, Chenchen Yu et autres

BACKGROUND: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample …

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Clinical and Demographic Factors Associated With COVID-19, Severe COVID-19, and SARS-CoV-2 Infection in Adults

Deborah Theodore, Angela R Branche, Lily Zhang, Daniel S. Graciaa et autres

Importance: Current data identifying COVID-19 risk factors lack standardized outcomes and insufficiently control for confounders. Objective: To identify risk factors associated with COVID-19, severe COVID-19, and SARS-CoV-2 infection. Design, Setting, and Participants: This secondary cross-protocol analysis included 4 multicenter, international, randomized, blinded, …

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Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents

Germán Áñez, Lisa M. Dunkle, Cynthia L. Gay, Karen L. Kotloff et autres

Importance: Greater than 20% of cases and 0.4% of deaths from COVID-19 occur in children. Following demonstration of the safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial immediately expanded to adolescents. Objective: To evaluate …

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Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination

Ana Strezova, Javier Díez‐Domingo, Kamal Al Shawafi, Juan Carlos Tinoco et autres

Approximately 10 years after vaccination with the recombinant zoster vaccine (RZV), an interim analysis of this follow-up study of the ZOE-50/70 trials demonstrated that efficacy against herpes zoster remained high. Moreover, the safety profile remained clinically acceptable, suggesting that the clinical benefit …

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The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70

Céline Boutry, Andrew Hastie, Javier Díez‐Domingo, Juan Carlos Tinoco et autres

BACKGROUND: This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). …

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Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients

Josephine C Ocran-Appiah, Céline Boutry, Caroline Hervé, Jyoti Soni et autres

BACKGROUND: Efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster (HZ) was demonstrated in pivotal trials ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). This study was designed to offer RZV to placebo recipients of these parent studies. METHODS: Vaccine safety and suspected …

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Three-Year Follow Up for Safety and Immunogenicity of a Candidate Clostridium difficile Toxoid Vaccine

Guy de Bruyn, Richard Glover, Terry L. Poling, Xiaohua Sheng et autres

Background. Sanofi Pasteur is evaluating a toxoid vaccine for the prevention of Clostridium difficile infection (CDI) in a Phase III efficacy trial in at-risk individuals. The data reported here constitute the extension (up to three years after the last dose) phase of …

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Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study

Casey Johnson, Matthew J. Hohenboken, Terry L. Poling, Peter Jaehnig et autres

BACKGROUND: A/H3N2 variant (H3N2v) influenza may sustain human-to-human transmission, and an available candidate vaccine would be important. METHODS: In this phase I, randomized, observer-blind, dose-ranging study, 627 healthy subjects ≥ 3 years of age were randomized to receive 2 vaccinations with H3N2c …

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Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18–64 years of age

Geoffrey J. Gorse, Ann Regina Falsey, John A. Fling, Terry L. Poling et autres

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Dose-Sparing H5N1 A/Indonesia/05/2005 Pre-pandemic Influenza Vaccine in Adults and Elderly Adults: A Phase III, Placebo-Controlled, Randomized Study

Joanne Marie Langley, George Risi, Michael S. Caldwell, Larry Gilderman et autres

BACKGROUND: Highly pathogenic avian influenza H5N1 viruses remain a threat to human health, with potential to become pandemic agents. METHODS: This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03(A)) adjuvanted H5N1 …

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