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Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 μg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth. A lower boundary of the confidence interval for vaccine efficacy (99.5% confidence interval [CI] at 90 days; 97.58% CI at later intervals) greater than 20% was considered to meet the success criterion for vaccine efficacy with respect to the primary end points. At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. Overall, 3682 maternal participants received vaccine and 3676 received placebo; 3570 and 3558 infants, respectively, were evaluated. Medically attended severe lower respiratory tract illness occurred within 90 days after birth in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3); 19 cases and 62 cases, respectively, occurred within 180 days after birth (vaccine efficacy, 69.4%; 97.58% CI, 44.3 to 84.1). Medically attended RSV-associated lower respiratory tract illness occurred within 90 days after birth in 24 infants of women in the vaccine group and 56 infants of women in the placebo group (vaccine efficacy, 57.1%; 99.5% CI, 14.7 to 79.8); these results did not meet the statistical success criterion. No safety signals were detected in maternal participants or in infants and toddlers up to 24 months of age. The incidences of adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively). RSVpreF vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, and no safety concerns were identified. (Funded by Pfizer; MATISSE ClinicalTrials.gov number, NCT04424316.).

In a phase 3 trial, adults (≥60 years of age) received one 120-μg dose of RSVpreF vaccine (17,215) or placebo (17,069). Vaccine efficacy against RSV-associated lower respiratory tract illness was 67 to 86%.

In a placebo-controlled, phase 2–3 trial, one dose of mRNA-1345 led to a lower incidence of RSV disease among adults 60 years of age or older. Solicited local and systemic adverse reactions occurred more often with the vaccine.

Respiratory syncytial virus causes clinically significant illness in children and adults. In a placebo-controlled trial, a prefusion stabilized F protein vaccine led to an 83% lower risk of RSV infection.

A combination of adenovirus 26 and protein vaccines was used to deliver a prefusion stabilized RSV protein. RSV-related lower respiratory tract illness developed in fewer vaccine recipients than placebo recipients.

Respiratory syncytial virus is a major cause of illness in infants. In this randomized, double-blind, placebo-controlled trial, the safety and immunogenicity of a bivalent RSV prefusion F protein–based vaccine was assessed in pregnant women and their infants. Anti-RSV antibodies were elicited with efficient transplacental transfer.

An RSV prefusion F maternal vaccine was assessed for efficacy against RSV disease in infants. The trial was stopped early owing to a higher incidence of preterm birth in the vaccine group than in the placebo group.

In a randomized, placebo-controlled, phase 2b clinical trial, an adjuvanted vaccine containing the respiratory syncytial virus (RSV) fusion protein was immunogenic but did not protect older adults from disease caused by RSV. Abstract Background Respiratory syncytial virus (RSV) is an important cause of illness in older adults. This study assessed efficacy of a vaccine for prevention of RSV-associated acute respiratory illness (ARI), defined by specified symptoms with virologic confirmation. Methods This phase 2b study evaluated RSV postfusion F protein (120 µg) with glucopyranosyl lipid adjuvant (5 µg) in 2% stable emulsion. Subjects aged ≥60 years were randomly assigned at a ratio of 1:1 to receive vaccine or placebo (all received inactivated influenza vaccine). Ill subjects recorded symptoms and provided blood and nasal swab samples. Results In the per-protocol population (n = 1894), the incidence of RSV-associated ARI occurring ≥14 days after dosing was 1.7% and 1.6% in the vaccine and placebo groups, respectively, for a vaccine efficacy (VE) of –7.1% (90% confidence interval [CI], –106.9%–44.3%). Efficacy was not observed in secondary analyses that included seroresponse to nonvaccine RSV antigens (VE, 8.9%; 90% CI, –28.5%–35.4%) or symptoms combined with seroresponse (VE, 10.0%; 90% CI, –45.4%–44.4%). On day 29, 92.9% of vaccinees had an anti-F immunoglobulin G antibody seroresponse. Overall, 48.5% and 30.9% of RSV vaccine recipients reported local and systemic solicited symptoms, respectively. Conclusion The RSV vaccine was immunogenic but did not protect older adults from RSV illness. Clinical Trials Registration NCT02508194.

Reductions in antimicrobial consumption are needed to mitigate the burden of antimicrobial resistance. Vaccines may have an important role to play in reducing antimicrobial consumption by preventing infections for which treatment is often prescribed, whether appropriately or inappropriately. However, limited understanding of the volume of antimicrobial treatment attributable to specific pathogens—and to viruses, in particular—presently hinders efforts to prioritize vaccines with the greatest potential to reduce antimicrobial consumption. In a double-blind trial undertaken across 11 countries, infants born to mothers who were randomized to receive an experimental vaccine against respiratory syncytial virus (RSV) experienced 12.9% (95% CI: 1.3 to 23.1%) lower incidence of antimicrobial prescribing over the first 3 mo of life than infants whose mothers were randomized to receive placebo. Vaccine efficacy against antimicrobial prescriptions associated with acute lower respiratory tract infections (LRTIs) was 16.9% (95% CI: 1.4 to 29.4%). Over the first 3 mo of life, maternal vaccination prevented 3.6 antimicrobial prescription courses for every 100 infants born in high-income countries and 5.1 courses per 100 infants in low- and middle-income countries, representing 20.2 and 10.9% of all antimicrobial prescribing in these settings, respectively. While LRTI episodes accounted for 69 to 73% of all antimicrobial prescribing prevented by maternal vaccination, striking vaccine efficacy (71.3% [95% CI: 28.1 to 88.6%]) was also observed against acute otitis media–associated antimicrobial prescription among infants in high-income countries. Our findings implicate RSV as a cause of substantial volumes of antimicrobial prescribing among young infants and demonstrate the potential for prevention of such prescribing through use of maternal vaccines against RSV.

Background Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life‐threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV‐ARI and 82.6% against RSV‐LRTD (AReSVi‐006/NCT04886596). We present the patient‐reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient‐Reported Outcome (FLU‐PRO), Short Form‐12 (SF‐12), and EuroQol‐5 Dimension (EQ‐5D) questionnaires. Peak FLU‐PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF‐12 physical functioning (PF) and EQ‐5D health utility scores were estimated using mixed effects models. Results In the RSVPreF3 OA group (N = 12,466), 27 first RSV‐ARI episodes were observed versus 95 in the Placebo group (N = 12,494). Median peak FLU‐PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ‐5D health utility score were 7.00 (95% confidence interval [CI]: −9.86, 23.85; p = 0.4125) and 0.0786 (95% CI: −0.0340, 0.1913; p = 0.1695). Conclusions The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV‐associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.