Safety and Immunogenicity of 3 Formulations of an Investigational Respiratory Syncytial Virus Vaccine in Nonpregnant Women: Results From 2 Phase 2 Trials
| العنوان: | Safety and Immunogenicity of 3 Formulations of an Investigational Respiratory Syncytial Virus Vaccine in Nonpregnant Women: Results From 2 Phase 2 Trials |
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| المؤلفون: | Laurence Fissette, Pierre Van Damme, Laurence Chu, Alexander Schmidt, Marta Picciolato, Jason D Lickliter, Marie-Pierre David, Ilse Dieussaert, Casey P. Johnson, Joseph B. Domachowske, Jiři Beran, Kanchanamala Withanage, Koen Maleux, Tino F. Schwarz |
| المصدر: | The Journal of Infectious Diseases The journal of infectious diseases |
| بيانات النشر: | Oxford University Press, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | 0301 basic medicine, Whooping Cough, viruses, Respiratory syncytial virus, Antibodies, Viral, 0302 clinical medicine, Immunogenicity, Vaccine, vaccine, Immunology and Allergy, Medicine, 030212 general & internal medicine, Neutralizing antibody, biology, Tetanus, Immunogenicity, Vaccination, Antibody titer, virus diseases, RSV, respiratory system, Middle Aged, Antibodies, Bacterial, Infectious Diseases, Viruses, Female, women, Adult, Adolescent, Respiratory Syncytial Virus Infections, Diphtheria-Tetanus-acellular Pertussis Vaccines, 03 medical and health sciences, Major Articles and Brief Reports, Young Adult, Adjuvants, Immunologic, Respiratory Syncytial Virus Vaccines, Humans, Biology, Diphtheria-Tetanus-Pertussis Vaccine, Reactogenicity, business.industry, Diphtheria, medicine.disease, Antibodies, Neutralizing, 030104 developmental biology, maternal antibodies, Bronchiolitis, Respiratory Syncytial Virus, Human, Immunology, biology.protein, Human medicine, business |
| الوصف: | A single dose of either 30 µg or 60 µg of nonadjuvanted respiratory syncytial virus prefusion F protein antigen boosts humoral immune responses in women of childbearing age. The investigational vaccine was well tolerated and had a safety profile similar to that of the widely used combined Tdap vaccine. Background Respiratory syncytial virus (RSV) causes bronchiolitis and pneumonia in neonates and infants. RSV vaccination during pregnancy could boost preexisting neutralizing antibody titers, providing passive protection to newborns. Methods Two observer-blinded, controlled studies (RSV F-020 [clinical trials registration NCT02360475] and RSV F-024 [NCT02753413]) evaluated immunogenicity and safety of an investigational RSV vaccine in healthy, nonpregnant 18–45-year-old women. Both studies used a licensed adult formulation of combined tetanus toxoid-diphtheria toxoid-acellular pertussis (Tdap) vaccine as a control. RSV F-020 evaluated immunogenicity and safety: participants were randomized (1:1:1:1) to receive 1 dose of RSV–prefusion F protein (PreF) vaccine containing 30 µg or 60 µg of nonadjuvanted RSV-PreF, 60 µg of aluminum-adjuvanted RSV-PreF, or Tdap. RSV F-024 evaluated safety: participants were randomized 1:1 to receive 1 dose of 60 µg of nonadjuvanted RSV-PreF or Tdap. Results Both studies showed similar reactogenicity profiles for RSV-PreF and Tdap. No serious adverse events were considered vaccine related. In RSV F-020, geometric mean ratios of RSV-A neutralizing antibody levels at day 30 versus prevaccination were 3.1–3.9 in RSV-PreF recipients and 0.9 in controls. Palivizumab-competing antibody concentrations increased >14-fold in RSV-PreF recipients on day 30. RSV antibody titers waned after day 30 but remained well above baseline through day 90. Conclusions All formulations of RSV-PreF boosted preexisting immune responses in 18–45-year old women with comparable immunogenicity. The RSV-PreF safety profile was similar to that of Tdap vaccine. |
| وصف الملف: | |
| اللغة: | English |
| تدمد: | 1537-6613 0022-1899 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::47987956cff2caa871629940384c5445 http://europepmc.org/articles/PMC5913599 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....47987956cff2caa871629940384c5445 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15376613 00221899 |
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