scholarly journals Phase 2b Study of an Ad26.RSV.preF Vaccine for Prevention of RSV-mediated Respiratory Tract Disease in Older Adults

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 1050-1051
Author(s):  
Ann Falsey ◽  
Kristi Williams ◽  
Efi Gymnopoulou ◽  
Stephan Bart ◽  
John Ervin ◽  
...  

Abstract Respiratory syncytial virus (RSV) may cause serious lower respiratory tract disease (LRTD) in older adults, and there is currently no licensed vaccine. CYPRESS (NCT03982199) is a randomized, double-blind, placebo-controlled Phase 2b proof-of-concept trial of an Ad26.RSV.preF-based vaccine for the prevention of RSV-mediated LRTD in older adults. Adults aged ≥65 years were randomized 1:1 before the RSV season to receive Ad26.RSV.preF-based vaccine or placebo. Acute respiratory infection symptoms were collected through a patient eDiary and/or clinician assessment until the end of the RSV season. The primary endpoint was the first occurrence of RTPCR-confirmed RSV-mediated LRTD according to any of 3 case definitions: (1) ≥3 symptoms of lower respiratory tract infection (LRTI), (2) ≥2 symptoms of LRTI, or (3) ≥2 symptoms of LRTI or ≥1 symptom of LRTI with ≥1 systemic symptom. Immunogenicity was assessed in a subset of approximately 200 participants. A total of 2891 participants in each study arm received study treatment. Vaccine efficacy was 80% (94.2% CI, 52.2-92.9%), 75% (50.1-88.5%), and 69.8% (43.7-84.7%) for case definition 1, 2, and 3, respectively (all P <0.001). In the vaccine arm, geometric mean fold increase in antibody titers 14 days after vaccination was 13.5 for RSV neutralizing antibodies and 8.6 for RSV prefusion F-specific binding antibodies, and median frequency of RSV-F-specific INFγ T-cells increased from 34 to 444 SFC/10^6 PBMC; no relevant changes were observed in the placebo arm. The Ad26.RSV.preF-based vaccine was highly effective against RSV-mediated LRTD through the first RSV season and elicited robust immune responses in older adults.

PEDIATRICS ◽  
1979 ◽  
Vol 63 (2) ◽  
pp. 192-197
Author(s):  
Margaret A. Tipple ◽  
Marc O. Beem ◽  
Evelyn M. Saxon

Respiratory tract colonization with Chlamydia trachomatis commonly occurs in natally acquired chlamydial infection and is sometimes associated with a chronic, afebrile pneumonia that has relatively distinctive clinical characteristics. To further define the frequency and clinical characteristics of lower respiratory tract disease associated with C trachomatis, we grouped 56 infants aged less than 6 months with afebrile pneumonia according to nasopharyngeal shedding of Chlamydia and viruses and compared their illnesses. Forty-one (73%) were positive for C trachomatis (23 had C trachomatis only, while 18 had C trachomatis plus a virus [cytomegalovirus, respiratory synctial virus, adenovirus, rhinovirus, or enterovirus]), and 15 were C trachomatis negative (nine had a virus only, and six had neither C trachomatis nor virus). The 41 infants with C trachomatis alone or C trachomatis plus a virus were similar clinically and differed significantly from other infants in several ways: (1) onset of symptoms before 8 weeks of age; (2) gradually worsening symptoms; (3) presentation for care at 4 to 11 weeks of age; (4) presence of conjunctivitis and ear abnormalities; (5) chest roentgenograms showing bilateral, symmetrical, interstitial infiltrates and hyperexpansion; (6) peripheral blood eosinophils ≥300/cu mm; and (7) elevated values for serum immunoglobulins M, G, and A.


Author(s):  
Elizabeth E. Halvorson ◽  
Amit Saha ◽  
Christopher B. Forrest ◽  
Hanieh Razzaghi ◽  
Suchitra Rao ◽  
...  

OBJECTIVES To identify associations between weight category and hospital admission for lower respiratory tract disease (LRTD), defined as asthma, community-acquired pneumonia, viral pneumonia, or bronchiolitis, among children evaluated in pediatric emergency departments (PEDs). METHODS We performed a retrospective cohort study of children 2 to <18 years of age evaluated in the PED at 6 children’s hospitals within the PEDSnet clinical research network from 2009 to 2019. BMI percentile of children was classified as underweight, healthy weight, overweight, and class 1, 2, or 3 obesity. Children with complex chronic conditions were excluded. Mixed-effects multivariable logistic regression was used to assess associations between BMI categories and hospitalization or 7- and 30-day PED revisits, adjusted for covariates (age, sex, race and ethnicity, and payer). RESULTS Among 107 446 children with 218 180 PED evaluations for LRTD, 4.5% had underweight, 56.4% had healthy normal weight, 16.1% had overweight, 14.6% had class 1 obesity, 5.5% had class 2 obesity, and 3.0% had class 3 obesity. Underweight was associated with increased risk of hospital admission compared with normal weight (odds ratio [OR] 1.76; 95% confidence interval [CI] 1.69–1.84). Overweight (OR 0.87; 95% CI 0.85–0.90), class 1 obesity (OR 0.88; 95% CI 0.85–0.91), and class 2 obesity (OR 0.91; 95% CI 0.87–0.96) had negative associations with hospital admission. Class 1 and class 2, but not class 3, obesity had small positive associations with 7- and 30-day PED revisits. CONCLUSIONS We found an inverse relationship between patient weight category and risk for hospital admission in children evaluated in the PED for LRTD.


2017 ◽  
Vol 15 (7) ◽  
pp. 703-711 ◽  
Author(s):  
Miguel Lanaspa ◽  
Quique Bassat ◽  
Marcia Melo Medeiros ◽  
Camen Muñoz-Almagro

Sign in / Sign up

Export Citation Format

Share Document