Heterologous Ad26.COV2.S booster after primary BBIBP-CorV vaccination against SARS-CoV-2 infection: 1-year follow-up of a phase 1/2 open-label trial
Issued Date
2024-01-01
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85192886363
Journal Title
Vaccine
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine (2024)
Suggested Citation
Muangnoicharoen S., Wiangcharoen R., Lawpoolsri S., Nanthapisal S., Jongkaewwattana A., Duangdee C., Kamolratanakul S., Luvira V., Thanthamnu N., Chantratita N., Thitithanyanont A., Anh Wartel T., Excler J.L., Ryser M.F., Leong C., Mak T.K., Pitisuttithum P. Heterologous Ad26.COV2.S booster after primary BBIBP-CorV vaccination against SARS-CoV-2 infection: 1-year follow-up of a phase 1/2 open-label trial. Vaccine (2024). doi:10.1016/j.vaccine.2024.05.010 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/98403
Title
Heterologous Ad26.COV2.S booster after primary BBIBP-CorV vaccination against SARS-CoV-2 infection: 1-year follow-up 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
Hospital for Tropical Diseases, Bangkok
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
Hospital for Tropical Diseases, Bangkok
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
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: Inactivated whole-virus vaccination elicits immune responses to both SARS-CoV-2 nucleocapsid (N) and spike (S) proteins, like natural infections. A heterologous Ad26.COV2.S booster given at two different intervals after primary BBIBP-CorV vaccination was safe and immunogenic at days 28 and 84, with higher immune responses observed after the longer pre-boost interval. We describe booster-specific and hybrid immune responses over 1 year. Methods: This open-label phase 1/2 study was conducted in healthy Thai adults aged ≥ 18 years who had completed primary BBIBP-CorV primary vaccination between 90–240 (Arm A1; n = 361) or 45–75 days (Arm A2; n = 104) before enrolment. All received an Ad26.COV2.S booster. We measured anti-S and anti-N IgG antibodies by Elecsys®, neutralizing antibodies by SARS-CoV-2 pseudovirus neutralization assay, and T-cell responses by quantitative interferon (IFN)-γ release assay. Immune responses were evaluated in the baseline-seronegative population (pre-booster anti-N < 1.4 U/mL; n = 241) that included the booster-effect subgroup (anti-N < 1.4 U/mL at each visit) and the hybrid-immunity subgroup (anti-N ≥ 1.4 U/mL and/or SARS-CoV-2 infection, irrespective of receiving non-study COVID-19 boosters). Results: In Arm A1 of the booster-effect subgroup, anti-S GMCs were 131-fold higher than baseline at day 336; neutralizing responses against ancestral SARS-CoV-2 were 5-fold higher than baseline at day 168; 4-fold against Omicron BA.2 at day 84. IFN-γ remained approximately 4-fold higher than baseline at days 168 and 336 in 18–59-year-olds. Booster-specific responses trended lower in Arm A2. In the hybrid-immunity subgroup at day 336, anti-S GMCs in A1 were 517-fold higher than baseline; neutralizing responses against ancestral SARS-CoV-2 and Omicron BA.2 were 28- and 31-fold higher, respectively, and IFN-γ was approximately 14-fold higher in 18–59-year-olds at day 336. Durable immune responses trended lower in ≥ 60-year-olds. Conclusion: A heterologous Ad26.COV2.S booster after primary BBIBP-CorV vaccination induced booster-specific immune responses detectable up to 1 year that were higher in participants with hybrid immunity. Clinical Trials Registration. NCT05109559.