Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial
Issued Date
2023-01-01
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85162241589
Journal Title
Vaccine
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine (2023)
Suggested Citation
Muangnoicharoen S., Wiangcharoen R., Nanthapisal S., Kamolratakul S., Lawpoolsri S., Jongkaewwattana A., Thitithanyanont A., Luvira V., Chinwangso P., Thanthamnu N., Chantratita N., Lim J.K., Anh Wartel T., Excler J.L., Ryser M.F., Leong C., Mak T.K., Pitisuttithum P. Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial. Vaccine (2023). doi:10.1016/j.vaccine.2023.06.043 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/87669
Title
Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial
Author's Affiliation
Faculty of Tropical Medicine, Mahidol University
Duke-NUS Medical School
International Vaccine Institute, Seoul
Faculty of Medicine, Thammasat University
Vaccine and Infectious Disease Organization - International Vaccine Centre
Mahidol University
Thailand National Center for Genetic Engineering and Biotechnology
Phaholpolpayuhasena Hospital
Janssen Global Medical Affairs
Janssen Asia Pacific Medical Affairs Operations
Duke-NUS Medical School
International Vaccine Institute, Seoul
Faculty of Medicine, Thammasat University
Vaccine and Infectious Disease Organization - International Vaccine Centre
Mahidol University
Thailand National Center for Genetic Engineering and Biotechnology
Phaholpolpayuhasena Hospital
Janssen Global Medical Affairs
Janssen Asia Pacific Medical Affairs Operations
Other Contributor(s)
Abstract
Background: The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S booster dose given at different intervals after 2 doses of BBIBP-CorV are presented. Methods: This open-label phase 1/2 trial was conducted in healthy adults in Thailand who had completed 2-dose primary vaccination with BBIBP-CorV. Participants received a single booster dose of Ad26.COV2.S (5 × 1010 virus particles) 90–240 days (Group A1; n = 360) or 45–75 days (Group A2; n = 66) after the second BBIBP-CorV dose. Safety and immunogenicity were assessed over 28 days. Binding IgG antibodies to the full-length pre-fusion Spike and anti-nucleocapsid proteins of SARS-CoV-2 were measured by enzyme-linked immunosorbent assay. The SARS-CoV-2 pseudovirus neutralization assay and live virus microneutralization assay were used to quantify the neutralizing activity of antibodies against ancestral SARS-CoV-2 (Wuhan-Hu-1) and the delta (B.1.617.2) and omicron (B.1.1.529/BA.1 and BA.2) variants. The cell-mediated immune response was measured using a quantitative interferon (IFN)-γ release assay in whole blood. Results: Solicited local and systemic adverse events (AEs) on days 0–7 were mostly mild, as were unsolicited vaccine-related AEs during days 0–28, with no serious AEs. On day 28, anti-Spike binding antibodies increased from baseline by 487- and 146-fold in Groups A1 and A2, and neutralizing antibodies against ancestral SARS-CoV-2 by 55- and 37-fold, respectively. Humoral responses were strongest against ancestral SARS-CoV-2, followed by the delta, then the omicron BA.2 and BA.1 variants. T-cell–produced interferon-γ increased approximately 10-fold in both groups. Conclusions: A single heterologous Ad26.COV2.S booster dose after two BBIBP-CorV doses was well tolerated and induced robust humoral and cell-mediated immune responses measured at day 28 in both interval groups. Clinical Trials Registration. NCT05109559.
