Publications by authors named "A I Gurtman"
Objective: To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).
Methods: MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose.
Objective: To describe preterm birth frequency and newborn and infant outcomes overall and among preterm children in the MATISSE (Maternal Immunization Study for Safety and Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVpreF) to protect infants against severe RSV-associated illness.
Methods: MATISSE was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections of RSVpreF or placebo.
Article Synopsis
- Older adults and those with chronic health conditions are particularly vulnerable to severe RSV disease, prompting research into the vaccine RSVpreF for high-risk individuals aged 18-59.
- In a phase 3 trial, participants received either RSVpreF or a placebo, with safety and immunogenicity monitored through various endpoints, revealing no serious adverse effects tied to the vaccine.
- Results showed that RSVpreF was well tolerated and met efficacy benchmarks, indicating it could be effectively used to prevent RSV-related illnesses in younger high-risk populations, similar to findings in older adults.
We report neutralization titer data against contemporary SARS-CoV-2 sublineages from an ongoing, phase 2/3, open-label, clinical trial of a single dose (30 μg) of an Omicron XBB.1.5-adapted BNT162b2 monovalent mRNA vaccine.
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