Two double-blind randomised controlled studies (phase I and I/II) were performed to assess for the first time the safety and immunogenicity of a recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine in 148 healthy adult volunteers. All candidate vaccine formulations had a good safety profile and were well tolerated, with the incidence of solicited and unsolicited symptoms within a clinically acceptable range. One serious adverse event was reported in the phase I trial which was considered to be of suspected relationship to vaccination. The gp350 vaccine formulations were immunogenic and induced gp350-specific antibody responses (including neutralising antibodies).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.vaccine.2007.04.008 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Phase I-II study of prone hypofractionated accelerated breast and nodal intensity modulated radiation therapy.
Int J Radiat Oncol Biol Phys
January 2025
Department of Radiation Oncology, New York University Langone Health and Perlmutter Cancer Center, New York, NY.
Background: In patients with breast cancer, prone radiation therapy (RT) has been shown to reduce heart and lung dose. Though prone positioning is routinely used for whole breast RT, its use when treating the regional lymph nodes (RLNs) is not widespread.
Methods: In this phase I-II trial for stage IB-IIA breast cancer treated with lumpectomy or mastectomy, patients received 40.
Bayesian item response theory to estimate power in clinical trials with patient-reported outcomes as endpoints.
Qual Life Res
January 2025
Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, KS, USA.
Purpose: Patient-Reported Outcomes (PROs) are widely used in clinical trials, epidemiological research, quality of life (QOL) studies, routine clinical care, and medical surveillance. The Patient Reported Outcomes Measurement Information System (PROMIS) is a system of reliable and standardized measures of PROs developed with Item Response Theory (IRT) using latent scores. Power estimation is critical to clinical trials and research designs.
View Article and Find Full Text PDFEnhanced D614G and Omicron Variants Antibody Persistence in Infants at 2 Months of Age Following Maternal mRNA Booster Vaccination During Pregnancy or Postpartum.
Pediatr Infect Dis J
November 2024
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD.
Background: Following maternal COVID-19 vaccination, the persistence of antibodies in sera and breast milk for mothers and infants is not well characterized. We sought to describe the persistence of antibodies through 2 months after delivery in maternal and infant serum and breast milk following maternal COVID-19 mRNA vaccination and to examine differences by receipt of booster dose during pregnancy or postpartum.
Methods: This is a prospective cohort study with enrollment from July 2021 to January 2022 at 9 US academic sites.
Durvalumab and tremelimumab in combination with metronomic oral vinorelbine for recurrent advanced cervical cancer: an open-label phase I/II study.
J Immunother Cancer
January 2025
Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France.
Background: The MOVIE phase I/II trial (NCT03518606) evaluated the safety and antitumor activity of durvalumab and tremelimumab combined with metronomic oral vinorelbine in patients with advanced tumors. We present the results of the recurrent advanced cervical cancer cohort.
Methods: Patients received tremelimumab (intravenously, 75 mg, every four weeks (Q4W); four cycles max) plus durvalumab (intravenously, 1,500 mg, Q4W; 26 cycles max) and metronomic oral vinorelbine (40 mg, every three weeks (3QW)) until disease progression.
Pharmacodynamic Model of the Hemodynamic Effects of Propofol and Remifentanil and Their Interaction with Noxious Stimulation.
Pharmaceutics
December 2024
Department of Pharmaceutical Sciences, School of Pharmacy and Nutrition, University of Navarra, 31008 Pamplona, Spain.
: Despite the known impact of propofol and remifentanil on hemodynamics and patient outcomes, there is a lack of comprehensive quantitative analysis, particularly in surgical settings, considering the influence of noxious stimuli. The aim of this study was to develop a quantitative semi-mechanistic population model that characterized the time course changes in mean arterial pressure (MAP) and heart rate (HR) due to the effects of propofol, remifentanil, and different types of noxious stimulation related to the clinical routine. : Data from a prospective study were used; the study analyzed the effects of propofol and remifentanil general anesthesia on female patients in physical status of I-II according to the American Society of Anesthesiologists (ASA I-II) undergoing gynecology surgery.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!