Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses
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 in...
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| Published in | Clinical and vaccine immunology Vol. 24; no. 9 |
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| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
American Society for Microbiology
01.09.2017
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1556-6811 1556-679X 1556-679X |
| DOI | 10.1128/CVI.00157-17 |
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| 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.) |
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| AbstractList | 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.).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.). 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.) |
| Author | Falloon, Judith Takas, Therese Esser, Mark T. Lambert, Stacie L. Ervin, John Yu, Jing Krieger, Diane Yu, Li Curtis, Craig Talbot, H. Keipp Dubovsky, Filip Villafana, Tonya |
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| Cites_doi | 10.1016/j.smim.2013.04.011 10.1056/NEJMoa043951 10.1093/infdis/jis309 10.1093/infdis/jit839 10.1371/journal.pone.0119509 10.1093/infdis/jiv281 10.1186/s12879-015-1218-z 10.1371/journal.pone.0051618 10.1016/j.virusres.2011.09.020 10.1371/journal.pone.0016333 10.1016/j.vaccine.2015.07.025 10.1086/517376 10.1128/CVI.00736-13 10.1086/650486 10.1128/CVI.00580-12 10.1086/380907 10.1016/j.vaccine.2016.04.002 10.1016/j.antiviral.2004.04.005 10.1086/511986 10.1111/j.1750-2659.2008.00035.x 10.1007/978-3-642-38919-1_4 10.1542/peds.102.3.531 10.1371/journal.pone.0054445 10.1007/978-3-642-38919-1_11 10.1371/journal.pone.0153019 10.1002/jmv.20724 10.1056/NEJMoa1501184 10.1016/S0264-410X(03)00355-4 10.1093/cid/cir955 10.1086/592168 10.1056/NEJMoa1315727 10.1093/infdis/163.4.693 |
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| Copyright | Copyright © 2017 Falloon et al. Copyright © 2017 Falloon et al. 2017 Falloon et al. |
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| Keywords | vaccine adult adjuvant respiratory syncytial virus TLR-4 agonist cell-mediated immunity |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Citation Falloon J, Talbot HK, Curtis C, Ervin J, Krieger D, Dubovsky F, Takas T, Yu J, Yu L, Lambert SL, Villafana T, Esser MT. 2017. Dose selection for an adjuvanted respiratory syncytial virus F protein vaccine for older adults based on humoral and cellular immune responses. Clin Vaccine Immunol 24:e00157-17. https://doi.org/10.1128/CVI.00157-17. |
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| SubjectTerms | Adjuvants, Immunologic Adult Aged Aged, 80 and over Antibodies, Neutralizing - blood Antibodies, Viral - blood Dose-Response Relationship, Immunologic Double-Blind Method Enzyme-Linked Immunospot Assay Female Glucosides Glucosides - immunology Humans Immunity, Cellular Immunity, Humoral Immunogenicity, Vaccine Immunoglobulin G - blood Influenza Vaccines - administration & dosage Influenza Vaccines - immunology Influenza, Human - immunology Interferon-gamma - biosynthesis Interferon-gamma - immunology Lipid A Lipid A - immunology Male Middle Aged Respiratory Syncytial Virus Infections - immunology Respiratory Syncytial Virus Infections - prevention & control Respiratory Syncytial Virus Vaccines Respiratory Syncytial Virus Vaccines - administration & dosage Respiratory Syncytial Virus Vaccines - chemistry Respiratory Syncytial Virus Vaccines - genetics Respiratory Syncytial Virus Vaccines - immunology Respiratory Syncytial Virus, Human Respiratory Syncytial Virus, Human - immunology T-Lymphocytes - immunology Vaccines Viral Fusion Proteins Viral Fusion Proteins - administration & dosage Viral Fusion Proteins - genetics Viral Fusion Proteins - immunology |
| Title | Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/28679495 https://journals.asm.org/doi/10.1128/CVI.00157-17 https://www.proquest.com/docview/1916709984 https://pubmed.ncbi.nlm.nih.gov/PMC5585697 |
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