PMID- 35818701 OWN - NLM STAT- MEDLINE DCOM- 20220713 LR - 20221207 IS - 1598-6357 (Electronic) IS - 1011-8934 (Print) IS - 1011-8934 (Linking) VI - 37 IP - 27 DP - 2022 Jul 11 TI - Immunogenicity and Reactogenicity of Ad26.COV2.S in Korean Adults: A Prospective Cohort Study. PG - e210 LID - 10.3346/jkms.2022.37.e210 [doi] LID - e210 AB - BACKGROUND: As the coronavirus disease 2019 (COVID-19) pandemic continues, there are concerns regarding waning immunity and the emergence of viral variants. The immunogenicity of Ad26.COV2.S against wild-type (WT) and variants of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) needs to be evaluated. METHOD: This prospective cohort study was conducted between June 2021 and January 2022 at two university hospitals in South Korea. Healthy adults who were scheduled to be vaccinated with Ad26.COV2.S were enrolled in this study. The main outcomes included anti-spike (S) IgG antibody and neutralizing antibody responses, S-specific T-cell responses (interferon-gamma enzyme-linked immunospot assay), solicited adverse events (AEs), and serious AEs. RESULTS: Fifty participants aged >/= 19 years were included in the study. Geometric mean titers (GMTs) of anti-S IgG were 0.4 U/mL at baseline, 5.2 +/- 3.0 U/mL at 3-4 weeks, 55.7 +/- 2.4 U/mL at 5-8 weeks, and 81.3 +/- 2.5 U/mL at 10-12 weeks after vaccination. GMTs of 50% neutralizing dilution (ND50) against WT SARS-CoV-2 were 164.6 +/- 4.6 at 3-4 weeks, 313.9 +/- 3.6 at 5-8 weeks, and 124.4 +/- 2.6 at 10-12 weeks after vaccination. As for the S-specific T-cell responses, the median number of spot-forming units/10(6) peripheral blood mononuclear cell was 25.0 (5.0-29.2) at baseline, 60.0 (23.3-178.3) at 5-8 weeks, and 35.0 (13.3-71.7) at 10-12 weeks after vaccination. Compared to WT SARS-CoV-2, ND50 against Delta and Omicron variants was attenuated by 3.6-fold and 8.2-fold, respectively. The most frequent AE was injection site pain (82%), followed by myalgia (80%), fatigue (70%), and fever (50%). Most AEs were grade 1-2, and resolved within two days. CONCLUSION: Single-dose Ad26.COV2.S was safe and immunogenic. NAb titer and S-specific T-cell immunity peak at 5-8 weeks and rather decrease at 10-12 weeks after vaccination. Cross-reactive neutralizing activity against the Omicron variant was negligible. CI - (c) 2022 The Korean Academy of Medical Sciences. FAU - Hyun, Hakjun AU - Hyun H AUID- ORCID: 0000-0002-1193-8948 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. FAU - Choi, Min Joo AU - Choi MJ AUID- ORCID: 0000-0002-2739-0948 AD - Department of Internal Medicine, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, Korea. FAU - Heo, Jung Yeon AU - Heo JY AUID- ORCID: 0000-0002-6548-1939 AD - Department of Infectious Diseases, Ajou University School of Medicine, Suwon, Korea. FAU - Seo, Yu Bin AU - Seo YB AUID- ORCID: 0000-0001-5183-1996 AD - Division of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea. FAU - Nham, Eliel AU - Nham E AUID- ORCID: 0000-0001-7509-4863 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. FAU - Yoon, Jin Gu AU - Yoon JG AUID- ORCID: 0000-0003-3283-1880 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. FAU - Seong, Hye AU - Seong H AUID- ORCID: 0000-0002-5633-7214 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. FAU - Noh, Ji Yun AU - Noh JY AUID- ORCID: 0000-0001-8541-5704 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. AD - Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Korea. AD - Vaccine Innovation Center-KU Medicine (VIC-K), Seoul, Korea. FAU - Cheong, Hee Jin AU - Cheong HJ AUID- ORCID: 0000-0002-2532-1463 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. FAU - Kim, Woo Joo AU - Kim WJ AUID- ORCID: 0000-0002-4546-3880 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. AD - Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Korea. AD - Vaccine Innovation Center-KU Medicine (VIC-K), Seoul, Korea. FAU - Choi, Ju-Yeon AU - Choi JY AUID- ORCID: 0000-0003-3477-8569 AD - Division of Vaccine Clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, Cheongju, Korea. FAU - Lee, Young Jae AU - Lee YJ AUID- ORCID: 0000-0002-4902-2281 AD - Division of Vaccine Clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, Cheongju, Korea. FAU - Lee, Hye Won AU - Lee HW AUID- ORCID: 0000-0001-8391-1165 AD - Division of Vaccine Clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, Cheongju, Korea. FAU - Kim, Sung Soon AU - Kim SS AUID- ORCID: 0000-0003-2774-6710 AD - Division of Vaccine Clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, Cheongju, Korea. FAU - Kim, Byoungguk AU - Kim B AUID- ORCID: 0000-0001-9084-4490 AD - Division of Vaccine Clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, Cheongju, Korea. kimbg10@korea.kr. FAU - Song, Joon Young AU - Song JY AUID- ORCID: 0000-0002-0148-7194 AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. AD - Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Korea. AD - Vaccine Innovation Center-KU Medicine (VIC-K), Seoul, Korea. infection@korea.ac.kr. LA - eng GR - 2021-ER2603-01/Korea Disease Control and Prevention Agency/Korea PT - Journal Article DEP - 20220711 PL - Korea (South) TA - J Korean Med Sci JT - Journal of Korean medical science JID - 8703518 RN - JT2NS6183B (Ad26COVS1) RN - 0 (Antibodies, Neutralizing) RN - 0 (Antibodies, Viral) RN - SARS-CoV-2 variants SB - IM MH - Ad26COVS1 MH - Adult MH - Antibodies, Neutralizing MH - Antibodies, Viral MH - *COVID-19 MH - Humans MH - Leukocytes, Mononuclear MH - Prospective Studies MH - *SARS-CoV-2 PMC - PMC9274104 OTO - NOTNLM OT - Adenovirus Vector OT - Adverse Events OT - COVID-19 OT - Cellular Immunity OT - Humoral Immunity OT - SARS-CoV-2 OT - Vaccines COIS- The authors have no potential conflicts of interest to disclose. EDAT- 2022/07/13 06:00 MHDA- 2022/07/14 06:00 PMCR- 2022/07/11 CRDT- 2022/07/12 02:44 PHST- 2022/04/29 00:00 [received] PHST- 2022/06/08 00:00 [accepted] PHST- 2022/07/12 02:44 [entrez] PHST- 2022/07/13 06:00 [pubmed] PHST- 2022/07/14 06:00 [medline] PHST- 2022/07/11 00:00 [pmc-release] AID - 37.e210 [pii] AID - 10.3346/jkms.2022.37.e210 [doi] PST - epublish SO - J Korean Med Sci. 2022 Jul 11;37(27):e210. doi: 10.3346/jkms.2022.37.e210.