Elissa Malkin
A5085318317- SARS-CoV-2 and COVID-19 Research
- Viral gastroenteritis research and epidemiology
- COVID-19 Clinical Research Studies
- Respiratory viral infections research
- Immunotherapy and Immune Responses
- SARS-CoV-2 detection and testing
- Animal Virus Infections Studies
- Viral Infections and Immunology Research
- vaccines and immunoinformatics approaches
- RNA Interference and Gene Delivery
- Neonatal Respiratory Health Research
- Vaccine Coverage and Hesitancy
George Washington University
2022-2025
The best assay or marker to define mRNA-1273 vaccine–induced antibodies as a correlate of protection (CoP) is unclear. In the COVE trial, participants received two doses COVID-19 vaccine placebo. We previously assessed IgG binding spike protein (spike IgG) receptor domain (RBD and pseudovirus neutralizing antibody 50 80% inhibitory dilution titer measured on day 29 57, correlates risk (CoRs) CoPs against symptomatic over 4 months after dose. Here, we new marker, live virus 50%...
Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of second boost monovalent or bivalent variant vaccines from mRNA protein-based platforms targeting wild-type, Beta, Delta Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers 50%...
ABSTRACT Background Protection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety immunogenicity of variant vaccines. Methods phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a primary series single boost. Eligible participants were to one six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), BA.1+Beta (1 or doses), BA.1+Delta, BA.1 monovalent,...
Background/Objectives: Individuals with immunocompromising conditions are at high risk of developing severe respiratory syncytial virus (RSV) illness. This phase 3, single-arm study assessed the safety and immunogenicity bivalent RSV prefusion F protein−based (RSVpreF) 120-µg vaccine in immunocompromised renally impaired adults. Methods: Participants were stratified by age group (18−<60-year-olds; ≥60-year-olds) received two RSVpreF doses 1 month apart (i.e., Dose 2, respectively)....
Vaccine protection against COVID-19 wanes over time and has been impacted by the emergence of new variants with increasing escape neutralization. The Variant Immunologic Landscape (COVAIL) randomized clinical trial (clinicaltrials.gov NCT05289037) compares breadth, magnitude durability antibody responses induced a second vaccine boost mRNA (Moderna mRNA-1273 Pfizer-BioNTech BNT162b2), or adjuvanted recombinant protein (Sanofi CoV2 preS DTM-AS03) monovalent bivalent candidates targeting...
For COVAIL recipients of a coronavirus disease 2019 (COVID-19) Sanofi booster vaccine, neutralizing antibody titers were assessed as correlate risk (CoR) COVID-19. Peak and exposure-proximal inverse CoRs with covariate-adjusted hazard ratios (95% confidence intervals) 0.30 (0.11, 0.78) 0.25 (0.07, 0.85) per 10-fold increase in weighted average titer.
Abstract Background Older individuals and adults with certain chronic or immunocompromising health conditions are at increased risk of severe respiratory syncytial virus (RSV) disease. Methods In this phase 3 randomized trial RSVpreF safety immunogenicity in 18–59-year-olds high RSV disease, participants were 2:1 to 1 (120 µg) placebo dose. Primary endpoints included reactogenicity events adverse (AEs) through 7 days month after vaccination, respectively, serious AEs (SAEs) newly diagnosed...
We compared the serologic responses of 1 dose versus 2 doses a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. A 2-dose boosting regimen with did not increase magnitude or durability serological to single boost.