A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine
| العنوان: | A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine |
|---|---|
| المؤلفون: | Edward E Walsh, Ann R Falsey, Daniel A Scott, Alejandra Gurtman, Agnieszka M Zareba, Kathrin U Jansen, William C Gruber, Philip R Dormitzer, Kena A Swanson, David Radley, Emily Gomme, David Cooper, Beate Schmoele-Thoma |
| المصدر: | The Journal of Infectious Diseases. 225:1357-1366 |
| بيانات النشر: | Oxford University Press (OUP), 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Infectious Diseases, Immunology and Allergy |
| الوصف: | Background Protection against human respiratory syncytial virus (RSV) remains an unmet need potentially addressable by maternal immunization. This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B. Methods Adults 18–49 years old (N = 618) were randomized to receive placebo or 60, 120, or 240 µg RSVpreF with or without Al(OH)3. Safety and immunogenicity were evaluated. Results RSVpreF recipients more frequently reported local reactions and systemic events than placebo recipients; these were mostly mild or moderate. No vaccine-related serious adverse events occurred through 12 months postvaccination. All RSVpreF formulations induced 1-month postvaccination virus-neutralizing titers higher than those associated with protection of high-risk infants by palivizumab, the only prophylactic currently available for RSV. Geometric mean fold rises (GMFRs) across RSVpreF doses/formulations were 10.6–16.9 for RSV A and 10.3–19.8 for RSV B at 1 month postvaccination, greater than those historically elicited by postfusion F vaccines. GMFRs were 3.9–5.2 and 3.7–5.1, respectively, at 12 months postvaccination. Conclusions RSVpreF formulations were safe, well tolerated, and induced robust neutralizing responses in adults. These findings support development of RSVpreF, which is being evaluated in a pivotal phase 3 study for maternal immunization. Clinical Trials Registration NCT03529773. |
| تدمد: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/jiab612 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::db31eddd0942954dada73b35a5b5d7bd https://doi.org/10.1093/infdis/jiab612 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi...........db31eddd0942954dada73b35a5b5d7bd |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15376613 00221899 |
|---|---|
| DOI: | 10.1093/infdis/jiab612 |