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A Randomized, Controlled, Observer-Blinded Phase 1 Study of the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine With or Without Alum Adjuvant
- Source :
- The Journal of Infectious Diseases
- Publication Year :
- 2016
- Publisher :
- Oxford University Press, 2016.
-
Abstract
- Background. Respiratory syncytial virus (RSV) is a leading cause of childhood bronchiolitis and pneumonia, particularly in early infancy. Immunization of pregnant women could boost preexisting immune responses, providing passive protection to newborns through placental transfer of anti-RSV antibody. Methods. In this first-in-humans clinical trial of a purified recombinant RSV protein F vaccine engineered to preferentially maintain prefusion conformation (RSV-PreF), 128 healthy men 18–44 years old were randomized to one dose of a RSV-PreF vaccine containing 10, 30, or 60 µg of RSV-PreF antigen, with or without alum adjuvant, or control, and followed for one year for safety and immunogenicity outcomes. Results. Injection site pain was the most common adverse event, reported by up to 81.3% of participants. The highest RSV neutralizing antibody responses were in the 30 µg RSV-PreF/alum, 60 µg RSV-PreF/alum, and 60 µg RSV-PreF/nonadjuvant groups. Responses were evident on day 7, and 30 days after vaccination these participants had RSV-A neutralizing antibody titers of ≥1:512, and >70% had titers of 1:1024, with titers increasing by 3.2–4.9 fold. Responses remained high on day 60 but waned on days 180 and 360. Conclusions. The RSV-PreF vaccine elicited rapid RSV neutralizing antibody responses in healthy young men, with an acceptable adverse event profile.
- Subjects :
- Adult
Male
0301 basic medicine
Adolescent
viruses
respiratory syncytial virus
Respiratory Syncytial Virus Infections
Antibodies, Viral
Young Adult
03 medical and health sciences
Major Articles and Brief Reports
0302 clinical medicine
Adjuvants, Immunologic
Antigen
Pregnancy
vaccine
medicine
Respiratory Syncytial Virus Vaccines
Humans
Immunology and Allergy
030212 general & internal medicine
Alum adjuvant
Neutralizing antibody
Antigens, Viral
Vaccines, Synthetic
biology
business.industry
Immunogenicity
virus diseases
respiratory system
medicine.disease
Antibodies, Neutralizing
Virology
3. Good health
Vaccination
030104 developmental biology
Infectious Diseases
Bronchiolitis
vaccine safety and immunogenicity
Respiratory Syncytial Virus, Human
Viruses
biology.protein
Alum Compounds
Female
maternal immunization
Antibody
business
Viral Fusion Proteins
Subjects
Details
- Language :
- English
- ISSN :
- 15376613 and 00221899
- Volume :
- 215
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- The Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....bb5dc52c1d253d4d4f6773a879160805