Catherine A. Cosgrove

220. Safety and Immunogenicity of mRNA-1018, a candidate vaccine for the prevention of H5N1 pandemic influenza, in healthy adults ≥18 years of age in a dose-ranging Phase 1/2 clinical study

Natalia V. Voge, Catherine A. Cosgrove, Andrei Avanesov, Kingston Kang et autres

Abstract Background Influenza A viruses pose a persistent pandemic threat due to their zoonotic potential and capability of antigenic shift, enabling the emergence of novel strains with pandemic potential. Methods This parallel design, dose-ranging, blinded study, assessed the safety and immunogenicity of …

us, gb (code pays fourni par la source)

Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial

Spyros Chalkias, Patrick Dennis, Dena Petersen, Leroy Vaughan et autres

us, gb, ca (code pays fourni par la source)

Risk of invasive meningococcal disease in people with sickle cell disease: A systematic review

Catherine Isitt, Helen Campbell, Catherine A. Cosgrove, Mary Ramsay et autres

BACKGROUND: Asplenia and splenic dysfunction is associated with an increased risk of severe and fatal infections, especially due to encapsulated bacteria including Streptococcus pneumoniae, Haemophilus influenzae serotype b (Hib) and Neisseria meningitidis. People with sickle cell disease (SCD) develop recurrent splenic infarcts …

se, gb (code pays fourni par la source)

The predictive role of symptoms in COVID-19 diagnostic models: A longitudinal insight

Olivia Bird, Eva Galiza, D. N. Baxter, Marta Boffito et autres

To investigate the symptoms of SARS-CoV-2 infection, their dynamics and their discriminatory power for the disease using longitudinally, prospectively collected information reported at the time of their occurrence. We have analysed data from a large phase 3 clinical UK COVID-19 vaccine trial. …

gb, us, au, at, ca (code pays fourni par la source)

Propositive follow‐up: Long‐term immune responses to the 4CMenB and MenACWY vaccines in people living with HIV

Alberto San Francisco Ramos, Catherine Isitt, Shehnaz Athaide, Shamez Ladhani et autres

BACKGROUND: People living with HIV have an increased risk of meningococcal disease. The Propositive trial evaluated co-administration of two doses of a four-component recombinant protein-based MenB vaccine (4CMenB) and a quadrivalent conjugate polysaccharide MenACWY vaccine (MenACWY-CRM197) given 1 month apart in people …

gb, us (code pays fourni par la source)

2363. Three-Month Safety and Immunogenicity of Bivalent SARS-CoV-2 Omicron-Containing Booster Vaccines: Interim Results From a Phase 3, Randomized, Observer-Blind, Active-Controlled Trial

Ivan T. Lee, Catherine A. Cosgrove, Patrick Moore, Marcin Bula et autres

Abstract Background Updated COVID-19 vaccines have been developed to help broaden protection against circulating SARS-CoV-2 variants. Here we present a 3-month interim analysis from a phase 3, randomized, observer-blind, active-controlled study of 2 omicron BA.1-containing vaccines: BA.1-monovalent mRNA-1273.529 (BA.1 variant only) and …

us, gb (code pays fourni par la source)

Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial

Ivan T. Lee, Catherine A. Cosgrove, Patrick Moore, Claire Bethune et autres

us, gb (code pays fourni par la source)

The propositive study: Immunogenicity and safety of a four‐component recombinant protein‐based vaccine against MenB and a quadrivalent conjugate MenACWY vaccine in people living with HIV

Catherine Isitt, Angela Bartolf, Nick Andrews, Shehnaz Athaide et autres

BACKGROUND: People living with HIV have been shown to have an increased risk of invasive meningococcal disease. In some countries, meningococcal vaccines are now routinely recommended to all people living with HIV, but no study has yet assessed the immunogenicity and safety …

gb, us (code pays fourni par la source)

A Randomized Trial Comparing Omicron-Containing Boosters with the Original Covid-19 Vaccine mRNA-1273

Ivan T. Lee, Catherine A. Cosgrove, Patrick Moore, Claire Bethune et autres

Abstract Background Omicron-containing bivalent boosters are available worldwide. Results of a large, randomized, active-controlled study are presented. Methods This phase 3, randomized, observer-blind, active-controlled trial in the United Kingdom evaluated the immunogenicity and safety of 50-µg doses of omicron-BA.1-monovalent mRNA-1273.529 and bivalent …

us, gb, fr, au, Zambie (code pays fourni par la source)

COVAC1 phase 2a expanded safety and immunogenicity study of a self-amplifying RNA vaccine against SARS-CoV-2

Alex J. Szubert, Katrina M. Pollock, Hannah M. Cheeseman, Jasmini Alagaratnam et autres

Background: Lipid nanoparticle (LNP) encapsulated self-amplifying RNA (saRNA) is well tolerated and immunogenic in SARS-CoV-2 seronegative and seropositive individuals aged 18-75. Methods: A phase 2a expanded safety and immunogenicity study of a saRNA SARS-CoV-2 vaccine candidate LNP-nCoVsaRNA, was conducted at participating centres …

gb (code pays fourni par la source)

Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial

Paul T. Heath, Eva Galiza, D. N. Baxter, Marta Boffito et autres

BACKGROUND: The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended to include a blinded crossover. Data to the end of the placebo-controlled …

gb, us (code pays fourni par la source)

Group B Streptococcus (GBS) colonization is dynamic over time, whilst GBS capsular polysaccharides-specific antibody remains stable

I L Haeusler, Olwenn Daniel, Catherine Isitt, Rheana Watts et autres

Group B Streptococcus (GBS) is a leading cause of adverse pregnancy outcomes due to invasive infection. This study investigated longitudinal variation in GBS rectovaginal colonization, serum and vaginal GBS capsular polysaccharide (CPS)-specific antibody levels. Non-pregnant women were recruited in the UK and …

gb, fr, us, Ouganda (code pays fourni par la source)