Safety and immunogenicity of a homologous booster dose of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: 12 months follow-up result of an open-label, nonrandomized extension of a phase 1/2 trial
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: OBJECTIVES: This study evaluated the safety and immunogenicity of a homologous GBP510/AS03 booster given 6-12 months after a primary two-dose series. METHODS: In an open-label extension of a phase 1/2 trial in Korea, healthy adults aged 19-85 years who had completed two doses received a single GBP510/AS03 booster. The primary objective was to assess safety and reactogenicity. Secondary objectives included assessment of humoral and cellular immunogenicity against the ancestral D614G strain and Omicron variants. RESULTS: Between December 2021 and January 2022, 81 participants received the booster and 56 completed 12-month follow-up. No immediate systemic reactions were reported. The most common local adverse event was injection site pain, while systemic events such as myalgia, fatigue, and chills were mostly mild to moderate. No serious adverse events related to vaccination occurred. Neutralizing antibody titres and seroconversion rates against D614G following the booster were noninferior to those observed after the primary series. Cross-neutralization responses to Omicron variants improved after boosting, and neutralizing antibody titres to early Omicron variants and the ancestral strain were sustained for up to 12 months. CONCLUSIONS: A homologous GBP510/AS03 booster was well tolerated and induced robust, durable neutralizing antibody responses against SARS-CoV-2, including Omicron variant.
Authors: Joon Young Song, Won Suk Choi, Jung Yeon Heo, Young Rong Kim, Jin Soo Lee, Dong Sik Jung, Shin-Woo Kim, Kyung-Hwa Park, Joong Sik Eom, Su Jin Jeong, Jacob Lee, Ki Tae Kwon, Hee Jung Choi, Jang Wook Sohn, Young Keun Kim, Yoonyeong Lee, Ho Keun Park, Ji Hwa Ryu, Su Jeen Lee, Yong Wook Park, Hun Kim, Francesca Solmi, Maria Angeles Ceregido, Marguerite Koutsoukos, Neil King, David Veesler, Hee Jin Cheong
Institutions: Korea University, Korea University Guro Hospital, Korea University Ansan Hospital, Ajou University, Yonsei University, Wonju Severance Christian Hospital, Hallym University, Inha University, Inha University Hospital, Dong-A University, Kyungpook National University Hospital, Kyungpook National University, Chonnam National University, Gachon University, Gachon University Gil Medical Center, Gachon University Medical Center, Severance Hospital, Yonsei University Health System, Kyungpook National University Chilgok Hospital, Ewha Womans University, Ewha Womans University Mokdong Hospital, Korea University Anam Hospital, SK bioscience Co., Ltd. (South Korea), GlaxoSmithKline (Belgium), University of Washington
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,900
OpenAlex ID: W4414975010