A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age
| Autor: | D. Nigel Thomas, David Flyer, Eloi Kpamegan, Pedro A. Piedra, Dewal Jani, Somia P. Hickman, Gale Smith, Gregory M. Glenn, Hanxin Lu, Louis Fries |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
0301 basic medicine Palivizumab Adolescent Recombinant Fusion Proteins medicine.medical_treatment Dose-Response Relationship Immunologic Respiratory Syncytial Virus Infections Antibodies Viral medicine.disease_cause Young Adult 03 medical and health sciences 0302 clinical medicine Adjuvants Immunologic medicine Humans Immunology and Allergy 030212 general & internal medicine Adverse effect business.industry Immunogenicity Viral Vaccine Viral Vaccines Dose-ranging study Virology Respiratory Syncytial Viruses 030104 developmental biology Infectious Diseases Respiratory syncytial virus (RSV) Immunization Immunoglobulin G Immunology Nanoparticles Female business Adjuvant medicine.drug |
| Zdroj: | Journal of Infectious Diseases. 213:411-422 |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/jiv406 |
| Popis: | Background Respiratory syncytial virus (RSV) is a leading cause of infant morbidity and mortality. A recombinant RSV fusion protein nanoparticle vaccine (RSV F vaccine) candidate for maternal immunization was tested for safety and immunogenicity in women of childbearing age. Methods Three hundred thirty women (18-35 years) were randomized to receive 1 or 2 doses of RSV F vaccine (60 or 90 µg) with or without aluminum phosphate adjuvant, or placebo at days 0 and 28. Safety was evaluated over 180 days; immunogenicity and RSV infection rates were evaluated over 112 days. Results All vaccine formulations were well tolerated, without vaccine-related serious adverse events. Anti-F immunoglobulin G antibodies rose 6.5-15.6-fold, with significantly higher levels in 2-dose, adjuvanted regimens at day 56. Palivizumab-competitive antibody levels were undetectable at day 0 but increased up to 325 µg/mL at day 56. A 2.7- and 3.5-fold rise in RSV/A and RSV/B microneutralization antibodies were noted at day 56. Between days 56 and 112, 21% (12/56) of placebo recipients and 11% of vaccinees (26/244) showed evidence of a recent RSV infection (P = .04). Conclusions The vaccine appeared safe, immunogenic, and reduced RSV infections. Further development as a vaccine for use in maternal immunization is warranted. Clinical trials registration NCT01704365. |
| Databáze: | OpenAIRE |
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