PMID- 37515078 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230801 IS - 2076-393X (Print) IS - 2076-393X (Electronic) IS - 2076-393X (Linking) VI - 11 IP - 7 DP - 2023 Jul 20 TI - Serologic Response and Safety after a Third Dose of the COVID-19 BNT162b2 Vaccine in Patients with Inflammatory Bowel Diseases. LID - 10.3390/vaccines11071263 [doi] LID - 1263 AB - Vaccines are pivotal for control of the coronavirus disease (COVID-19) pandemic. Patients with inflammatory bowel diseases (IBDs) treated with antitumor necrosis factor (TNF)-alpha have lower serologic response after two COVID-19 vaccine doses. Data regarding a third vaccine dose are scarce. An Israeli multicenter prospective observational study recruited 319 subjects: 220 with IBD (79 treated with anti-TNFalpha) and 99 healthy control (HC) participants. All patients received two mRNA-BNT162b2 vaccines (Pfizer/BioNTech), 80% of whom received a third vaccine dose. Evaluation included disease activity, anti-spike (S) and nucleocapsid (N) antibody levels, anti-TNFalpha drug levels, and adverse events (AEs). All participants showed significant serologic response one month after receiving a third dose. However, three months later, the anti-S levels decreased significantly in patients treated with anti-TNFalpha compared with the non-anti-TNFalpha and HC groups. A correlation between serologic response to the third vaccine dose and anti-TNF drug levels was not found. No significant AE or IBD exacerbation was observed. Importantly, lower serologic response after the third vaccine dose predicted infection. A third dose of BNT162b2 is effective and safe in patients with IBD. Lower serologic response predicted infection, even in seropositive subjects. Lower serologic responses and their rapid decline suggest a fourth vaccine dose in this patient population. FAU - Edelman-Klapper, Hadar AU - Edelman-Klapper H AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Rabinowitz, Keren Masha AU - Rabinowitz KM AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Felsenstein Medical Research Center, Sackler School of Medicine, Tel Aviv 6997801, Israel. FAU - Zittan, Eran AU - Zittan E AD - The Abraham and Sonia Rochlin IBD Unit, Department of Gastroenterology, HaEmek Medical Center, Faculty of Medicine, Israel Institute of Technology, Afula 1834111, Israel. AD - Rappaport Faculty of Medicine Technion-Israel Institute of Technology, Haifa 3109601, Israel. FAU - Bar-Gil Shitrit, Ariella AU - Bar-Gil Shitrit A AD - IBD MOM Unit, Shaare Zedek Medical Center, Digestive Diseases Institute, Jerusalem 9103102, Israel. AD - Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 9112102, Israel. FAU - Goren, Idan AU - Goren I AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Avni-Biron, Irit AU - Avni-Biron I AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Ollech, Jacob E AU - Ollech JE AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Lichtenstein, Lev AU - Lichtenstein L AD - Clalit Health Services, Petah Tikva 4933355, Israel. AD - Adelson School of Medicine, Ariel University, Ariel 4077625, Israel. FAU - Banai-Eran, Hagar AU - Banai-Eran H AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Yanai, Henit AU - Yanai H AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Snir, Yifat AU - Snir Y AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Pauker, Maor H AU - Pauker MH AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Friedenberg, Adi AU - Friedenberg A AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. FAU - Levy-Barda, Adva AU - Levy-Barda A AD - Biobank, Rabin Medical Center, Department of Pathology, Petah Tikva 4941492, Israel. FAU - Broitman, Yelena AU - Broitman Y AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Ben Zvi, Haim AU - Ben Zvi H AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. AD - Microbiology Laboratory, Rabin Medical Center, Petah Tikva 4941492, Israel. FAU - Perets, Tsachi-Tsadok AU - Perets TT AD - Gastroenterology Laboratory, Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Holon Institute of Technology, Department of Digital Medical Technologies, Holon 5810201, Israel. FAU - Eliakim, Rami AU - Eliakim R AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. AD - Department of Gastroenterology, Sheba Medical Center, Ramat Gan 52621, Israel. FAU - Barkan, Revital AU - Barkan R AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. FAU - Goren, Sophy AU - Goren S AD - School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Cohen, Dani AU - Cohen D AUID- ORCID: 0000-0003-2664-2303 AD - School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. FAU - Dotan, Iris AU - Dotan I AD - Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel. CN - REsponses to COVid-19 vaccinE IsRaeli IBD group [RECOVERI] LA - eng GR - # G-2101-04950/Leona M. and Harry B. Helmsley Charitable Trust/ PT - Journal Article DEP - 20230720 PL - Switzerland TA - Vaccines (Basel) JT - Vaccines JID - 101629355 PMC - PMC10386081 OTO - NOTNLM OT - BNT162b2 vaccine OT - COVID-19 OT - anti-TNFalpha OT - inflammatory bowel diseases COIS- I.D.: consultation/advisory board: Abbvie, Athos, Arena, Cambridge Healthcare, Celltrion, Celgene/BMS, DSM, Ferring, Food Industries Organization, Iterative Scopes, Integra Holdings, Janssen, MSD, Neopharm, Pfizer, Rafa laboratories, Roche/Genentech, Sangamo, Sublimity, Takeda, and Wildbio; speaking/teaching: Abbvie, Altman, Celltrion, Celgene/BMS, Ferring, Falk Pharma, Janssen, MSD, Neopharm, Nestle, Pfizer, Rafa laboratories, Roche/Genentech, Sandoz, and Takeda. A.B.G.S.; grant support from Takeda and Janssen; consultancy and lecture fees from Takeda, Janssen, Abbvie, Pfizer, Neopharm, and BMS. E.Z. has received research support and consulting fees from Janssen, Abbvie, Takeda, Neopharm, Celgene, and Pfizer. All other authors declare they have no conflicts of interest. EDAT- 2023/07/29 11:47 MHDA- 2023/07/29 11:48 PMCR- 2023/07/20 CRDT- 2023/07/29 01:44 PHST- 2023/05/19 00:00 [received] PHST- 2023/06/29 00:00 [revised] PHST- 2023/07/14 00:00 [accepted] PHST- 2023/07/29 11:48 [medline] PHST- 2023/07/29 11:47 [pubmed] PHST- 2023/07/29 01:44 [entrez] PHST- 2023/07/20 00:00 [pmc-release] AID - vaccines11071263 [pii] AID - vaccines-11-01263 [pii] AID - 10.3390/vaccines11071263 [doi] PST - epublish SO - Vaccines (Basel). 2023 Jul 20;11(7):1263. doi: 10.3390/vaccines11071263.