Safety, Tolerability, and Immunogenicity of Booster Dose with MVC-COV1901 or MVC-COV1901-Beta SARS-CoV-2 Vaccine in Adults: A Phase I, Prospective, Randomized, Open-Labeled Study
Author:
Lien Chia En12, Liu Ming-Che34, Wang Ning-Chi5, Liu Luke Tzu-Chi1, Wu Chung-Chin1, Tang Wei-Hsuan1, Lian Wei-Cheng1, Huang Kuan-Ying A.67, Chen Charles18
Affiliation:
1. Medigen Vaccine Biologics Corporation, Taipei 114, Taiwan 2. Institute of Public Health, National Yang-Ming Chiao Tung University, Taipei 112, Taiwan 3. Clinical Research Centre, Taipei Medical University Hospital Taipei, Taipei 110, Taiwan 4. School of Dental Technology, College of Oral Medicine, Taipei Medical University, Taipei 110, Taiwan 5. Tri-Service General Hospital, Taipei 114, Taiwan 6. Graduate Institute of Immunology, College of Medicine, National Taiwan University, Taipei 100, Taiwan 7. Department of Pediatrics, National Taiwan University Hospital, Taipei 100, Taiwan 8. College of Science and Technology, Temple University, Philadelphia, PA 19122, USA
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines based on variant strains have been in use as booster doses to update immunity against circulating variants. Here we present the results of a phase one prospective, randomized, and open-labeled trial to study the safety and immunogenicity of a booster dose consisting of a subunit vaccine based on the stabilized prefusion SARS-CoV-2 spike protein, MVC-COV1901, or its Beta version, MVC-COV1901-Beta. Participants aged ≥18 and <55 years who received two or three prior doses of MVC-COV1901 vaccines were enrolled and were to receive a booster dose of either 15 mcg of MVC-COV1901, 15 mcg, or 25 mcg of MVC-COV1901-Beta in a 1:1:1 ratio. Adverse reactions after either MVC-COV1901 or MVC-COV1901-Beta booster doses after two or three doses of MVC-COV1901 were comparable and mostly mild and transient. At four weeks after the booster dose, participants with two prior doses of MVC-COV1901 had higher levels of neutralizing antibodies against ancestral SARS-CoV-2, Beta, and Omicron variants than participants with three prior doses of MVC-COV1901, regardless of the type of booster used. MVC-COV1901 and MVC-COV1901-Beta can both be effectively used as booster doses against SARS-CoV-2, including the BA.4/BA.5 Omicron variants.
Funder
Medigen Vaccine Biologics Corporation
Subject
Pharmacology (medical),Infectious Diseases,Drug Discovery,Pharmacology,Immunology
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