A randomized phase 1 study of the safety and immunogenicity of 2 novel pneumococcal conjugate vaccines in healthy Japanese adults in the United States
| Title: | A randomized phase 1 study of the safety and immunogenicity of 2 novel pneumococcal conjugate vaccines in healthy Japanese adults in the United States |
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| Authors: | David Fitz-Patrick, Mariano Young Jr, Daniel A. Scott, Ingrid L. Scully, Gary Baugher, Yahong Peng, Kathrin U. Jansen, William Gruber, Wendy Watson |
| Source: | Human Vaccines & Immunotherapeutics, Vol 17, Iss 7, Pp 2249-2256 (2021) |
| Publisher Information: | Taylor & Francis Group, 2021. |
| Publication Year: | 2021 |
| Collection: | LCC:Immunologic diseases. Allergy LCC:Therapeutics. Pharmacology |
| Subject Terms: | streptococcus pneumoniae, clinical trial, pneumococcal conjugate vaccine, immunogenicity, safety, pcv20, cpcv7, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950 |
| More Details: | Expanding serotype coverage of pneumococcal conjugate vaccines (PCVs) to target prevailing disease-causing serotypes could further reduce disease burden. To address this need, 2 different PCVs have been investigated: a 20-valent PCV (PCV20; includes the 13 serotypes in the 13-valent PCV [PCV13] plus 7 additional serotypes [8, 10A, 11A, 12F, 15B, 22F, 33F]) and a complementary 7-valent PCV (cPCV7; contains only the 7 additional serotypes). This phase 1b, randomized, controlled, double-blind study evaluated PCV20 and cPCV7 safety and immunogenicity in healthy Japanese adults 18–49 years of age residing in the United States for ≤5 years. Participants (n = 104) were randomized equally to receive a single dose of PCV20, cPCV7, or PCV13. Immunogenicity was assessed at baseline and 1 month after vaccination using serotype-specific opsonophagocytic activity (OPA) titers and serotype-specific immunoglobulin G (IgG) concentrations. Prompted local reactions and systemic events; adverse events (AEs); and serious AEs and newly diagnosed chronic disease were assessed 14 days, through 1 month, and upto 6 months following vaccination, respectively. OPA immune responses were robust for all 20 serotypes in the PCV20 group and for the 7 serotypes in the cPCV7 group 1 month after vaccination. IgG immune response showed similar trends. Injection site pain and muscle pain were the most common local reaction and systemic event; the majority were mild or moderate in severity. Few AEs and no severe AEs, serious AEs, or safety-related withdrawals were reported. Taken together, administration of PCV20 or cPCV7 in Japanese adults was well tolerated and induced robust serotype-specific functional immune responses. NCT03642847. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 2164-5515 2164-554X 21645515 |
| Relation: | https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X |
| DOI: | 10.1080/21645515.2020.1863177 |
| Access URL: | https://doaj.org/article/0b3347e2452941a9b4e2d5703b0f8e80 |
| Accession Number: | edsdoj.0b3347e2452941a9b4e2d5703b0f8e80 |
| Database: | Directory of Open Access Journals |
| ISSN: | 21645515 2164554X |
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| DOI: | 10.1080/21645515.2020.1863177 |
| Published in: | Human Vaccines & Immunotherapeutics |
| Language: | English |