TY - JOUR
T1 - Broad Antibody and Cellular Immune Response from a Phase 2 Clinical Trial with a Novel Multivalent Poxvirus-Based Respiratory Syncytial Virus Vaccine
AU - Jordan, Elke
AU - Lawrence, Steven J.
AU - Meyer, Thomas P.H.
AU - Schmidt, Darja
AU - Schultz, Stephanie
AU - Mueller, Jutta
AU - Stroukova, Daria
AU - Koenen, Brigitte
AU - Gruenert, Robert
AU - Silbernagl, Guenter
AU - Vidojkovic, Sanja
AU - Chen, Liddy M.
AU - Weidenthaler, Heinz
AU - Samy, Nathaly
AU - Chaplin, Paul
N1 - Publisher Copyright:
© 2020 The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].
PY - 2021/3/15
Y1 - 2021/3/15
N2 - Background: Respiratory syncytial virus (RSV) is a major cause of severe respiratory disease in young children and the elderly. Protective immunity is not generated after repeated infections, but vaccination may hopefully prove effective. Methods: This phase 2 clinical study investigated a multivalent RSV vaccine (MVA-BN-RSV) designed to induce broad antibody and cellular immune responses by encoding RSV surface proteins F, G (for both A and B subtypes), and internal antigens (M2, N). This study evaluated the immune response in adults aged ≥55 years to identify the optimal MVA-BN-RSV dose and vaccination schedule. Results: A single dose increased the levels of neutralizing (plaque reduction neutralization test to RSV A and B) and total (IgG and IgA ELISA) antibodies (1.6 to 3.4-fold increase from baseline) and induced a broad Th1-biased cellular immune response (interferon-γELISPOT) to all 5 vaccine inserts (5.4 to 9.7-fold increases). Antibody responses remained above baseline for 6 months. A 12-month booster dose elicited a booster effect in antibody and T-cell responses (up to 2.8-fold from preboost levels). No drug-related serious adverse events were reported. Conclusions: MVA-BN-RSV induces a broad immune response that persists at least 6 months and can be boosted at 12 months, without significant safety findings. Clinical Trials Registration: NCT02873286
AB - Background: Respiratory syncytial virus (RSV) is a major cause of severe respiratory disease in young children and the elderly. Protective immunity is not generated after repeated infections, but vaccination may hopefully prove effective. Methods: This phase 2 clinical study investigated a multivalent RSV vaccine (MVA-BN-RSV) designed to induce broad antibody and cellular immune responses by encoding RSV surface proteins F, G (for both A and B subtypes), and internal antigens (M2, N). This study evaluated the immune response in adults aged ≥55 years to identify the optimal MVA-BN-RSV dose and vaccination schedule. Results: A single dose increased the levels of neutralizing (plaque reduction neutralization test to RSV A and B) and total (IgG and IgA ELISA) antibodies (1.6 to 3.4-fold increase from baseline) and induced a broad Th1-biased cellular immune response (interferon-γELISPOT) to all 5 vaccine inserts (5.4 to 9.7-fold increases). Antibody responses remained above baseline for 6 months. A 12-month booster dose elicited a booster effect in antibody and T-cell responses (up to 2.8-fold from preboost levels). No drug-related serious adverse events were reported. Conclusions: MVA-BN-RSV induces a broad immune response that persists at least 6 months and can be boosted at 12 months, without significant safety findings. Clinical Trials Registration: NCT02873286
KW - MVA-BN
KW - RSV
KW - antibody immune response
KW - cellular immune response
KW - poxvirus
KW - recombinant RSV vaccine
KW - respiratory syncytial virus
KW - vaccine
KW - viral vector
UR - http://www.scopus.com/inward/record.url?scp=85103683126&partnerID=8YFLogxK
U2 - 10.1093/infdis/jiaa460
DO - 10.1093/infdis/jiaa460
M3 - Article
C2 - 32726422
AN - SCOPUS:85103683126
SN - 0022-1899
VL - 223
SP - 1062
EP - 1072
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 6
ER -