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Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses
- Source :
- Clinical and Vaccine Immunology : CVI
- Publication Year :
- 2017
- Publisher :
- American Society for Microbiology, 2017.
-
Abstract
- This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double-blind study, 261 subjects aged ≥60 years received inactivated influenza vaccine (IIV), a vaccine containing 120 μg sF with escalating doses of GLA (1, 2.5, or 5 μg) in SE, or a vaccine containing 80 μg sF with 2.5 μg GLA in SE. Subjects receiving 120 μg sF with 2.5 or 5 μg GLA were also randomized to receive IIV or placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma interferon enzyme-linked immunosorbent spot assay T-cell responses. Higher adjuvant doses increased injection site discomfort, but at the highest dose, the reactogenicity was similar to that of IIV. Significant humoral and cellular immune responses were observed. The 120 μg sF plus 5.0 μg GLA formulation resulted in the highest responses in all subjects and in older subjects. These results confirm previous observations of vaccine tolerability, safety, and immunogenicity and were used to select the 120 μg sF plus 5.0 μg GLA formulation for phase 2 evaluation. (This study has been registered at ClinicalTrials.gov under registration no. NCT02289820.)
- Subjects :
- Male
0301 basic medicine
Enzyme-Linked Immunospot Assay
respiratory syncytial virus
T-Lymphocytes
medicine.medical_treatment
Clinical Biochemistry
Antibodies, Viral
Immunoglobulin G
Immunogenicity, Vaccine
0302 clinical medicine
Glucosides
vaccine
Immunology and Allergy
Medicine
030212 general & internal medicine
Aged, 80 and over
Vaccines
Immunity, Cellular
biology
Immunogenicity
Middle Aged
Lipid A
Influenza Vaccines
Female
Antibody
Adjuvant
Adult
Microbiology (medical)
Influenza vaccine
Immunology
Dose-Response Relationship, Immunologic
Respiratory Syncytial Virus Infections
Interferon-gamma
03 medical and health sciences
Immune system
adjuvant
Adjuvants, Immunologic
Double-Blind Method
Immunity
Influenza, Human
Respiratory Syncytial Virus Vaccines
cell-mediated immunity
Humans
Aged
TLR-4 agonist
Reactogenicity
business.industry
Antibodies, Neutralizing
Immunity, Humoral
030104 developmental biology
Respiratory Syncytial Virus, Human
biology.protein
business
Viral Fusion Proteins
Subjects
Details
- ISSN :
- 1556679X and 15566811
- Volume :
- 24
- Database :
- OpenAIRE
- Journal :
- Clinical and Vaccine Immunology
- Accession number :
- edsair.doi.dedup.....c473a02247be3fd76c449829e3595e1d