COVID19 Vaccine in SOT Adult Recipients

NCT05116748 | Completed DMC FDA Drug

• 1 other identifier: COVID19_VaxSOT
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only. Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19 Visits and timepoints:

• T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status
• Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination
• T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity
• Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

Conditions

COVID-19; Vaccine Adverse Reaction; Vaccine Response Impaired; Vaccine Reaction; Lung Transplant; Complications; Liver Transplant; Complications; Vaccination

Keywords

COVID19; Vaccination; Vaccine; Transplant; Solid organ transplant; Lung transplant; Liver transplant

Outcome Measures

Primary Outcomes (1)

• Safety and reactogenicity

  Primary endpoints: * Incidence of systemic and local adverse events (and their degree) in the subsequent 7 days after each vaccine administration in this population * Incidence of unusual adverse events (and their degree) in the subsequent 28 days after each vaccine administration in this population * Incidence of serious adverse events (SAEs) and sentinel events (NOCMCs, new onset chronic medical conditions, and MAAEs, medically-attended adverse events) over a 1-year follow-up period after administration of the first vaccine dose in this population

  365 days

Secondary Outcomes (5)

• Immunogenicity - antibody response, using ImmunoAssay in ECLIA for the quantitative detection of anti-protein S1 (spike) antibodies (including IgG)

  365 days

• Immunogenicity - Tcell response, using IGRA interferon-γ ELISpot, performed 60 days after the administration of the first vaccine dose

  60 days

• Prevention of COVID19

  365 days

• Prevention of severe COVID19

  365 days

• Immunogenicity and immunosuppression level

  365 days

Study Arms (2)

LuTx recipients

Lung Transplant recipients

Biological: COVID19 mRNA vaccine

OLT recipients

Orthotopic Liver Transplant recipients

Biological: COVID19 mRNA vaccine

Interventions

COVID19 mRNA vaccine BIOLOGICAL

Administration of COVID19 mRNA vaccine

LuTx recipients; OLT recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lung and liver transplant recipients

You may qualify if:

• Age \> 18 years
• Patient's written informed consent

You may not qualify if:

• Lung transplant being performed in the previous 6 months
• Liver transplant being performed in the previous 3 months

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

Related Publications (17)

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  PMID: 33378609 BACKGROUND

• Blumenthal KG, Robinson LB, Camargo CA Jr, Shenoy ES, Banerji A, Landman AB, Wickner P. Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. 2021 Apr 20;325(15):1562-1565. doi: 10.1001/jama.2021.3976.

  PMID: 33683290 BACKGROUND

• Boyarsky BJ, Ou MT, Greenberg RS, Teles AT, Werbel WA, Avery RK, Massie AB, Segev DL, Garonzik-Wang JM. Safety of the First Dose of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients. Transplantation. 2021 May 1;105(5):e56-e57. doi: 10.1097/TP.0000000000003654. No abstract available.

  PMID: 33560728 BACKGROUND

• Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, Garonzik-Wang JM. Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. JAMA. 2021 May 4;325(17):1784-1786. doi: 10.1001/jama.2021.4385.

  PMID: 33720292 BACKGROUND

• Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, Hernan MA, Lipsitch M, Reis B, Balicer RD. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med. 2021 Apr 15;384(15):1412-1423. doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24.

  PMID: 33626250 BACKGROUND

• Fernandez-Ruiz M, Andres A, Loinaz C, Delgado JF, Lopez-Medrano F, San Juan R, Gonzalez E, Polanco N, Folgueira MD, Lalueza A, Lumbreras C, Aguado JM. COVID-19 in solid organ transplant recipients: A single-center case series from Spain. Am J Transplant. 2020 Jul;20(7):1849-1858. doi: 10.1111/ajt.15929. Epub 2020 May 10.

  PMID: 32301155 BACKGROUND

• Fung M, Chiu CY, DeVoe C, Doernberg SB, Schwartz BS, Langelier C, Henrich TJ, Yokoe D, Davis J, Hays SR, Chandran S, Kukreja J, Ng D, Prostko J, Taylor R, Reyes K, Bainbridge E, Bond A, Chin-Hong P, Babik JM. Clinical outcomes and serologic response in solid organ transplant recipients with COVID-19: A case series from the United States. Am J Transplant. 2020 Nov;20(11):3225-3233. doi: 10.1111/ajt.16079. Epub 2020 Jul 17.

  PMID: 32476258 BACKGROUND

• Grasselli G, Greco M, Zanella A, Albano G, Antonelli M, Bellani G, Bonanomi E, Cabrini L, Carlesso E, Castelli G, Cattaneo S, Cereda D, Colombo S, Coluccello A, Crescini G, Forastieri Molinari A, Foti G, Fumagalli R, Iotti GA, Langer T, Latronico N, Lorini FL, Mojoli F, Natalini G, Pessina CM, Ranieri VM, Rech R, Scudeller L, Rosano A, Storti E, Thompson BT, Tirani M, Villani PG, Pesenti A, Cecconi M; COVID-19 Lombardy ICU Network. Risk Factors Associated With Mortality Among Patients With COVID-19 in Intensive Care Units in Lombardy, Italy. JAMA Intern Med. 2020 Oct 1;180(10):1345-1355. doi: 10.1001/jamainternmed.2020.3539.

  PMID: 32667669 BACKGROUND

• Kates OS, Haydel BM, Florman SS, Rana MM, Chaudhry ZS, Ramesh MS, Safa K, Kotton CN, Blumberg EA, Besharatian BD, Tanna SD, Ison MG, Malinis M, Azar MM, Rakita RM, Morilla JA, Majeed A, Sait AS, Spaggiari M, Hemmige V, Mehta SA, Neumann H, Badami A, Goldman JD, Lala A, Hemmersbach-Miller M, McCort ME, Bajrovic V, Ortiz-Bautista C, Friedman-Moraco R, Sehgal S, Lease ED, Fisher CE, Limaye AP; UW COVID-19 SOT Study Team. Coronavirus Disease 2019 in Solid Organ Transplant: A Multicenter Cohort Study. Clin Infect Dis. 2021 Dec 6;73(11):e4090-e4099. doi: 10.1093/cid/ciaa1097.

  PMID: 32766815 BACKGROUND

• Long L, Zeng X, Zhang X, Xiao W, Guo E, Zhan W, Yang X, Li C, Wu C, Xu T, Zhan C, Chen Y, Jiang M, Zhong N, Lai K. Short-term outcomes of COVID-19 and risk factors for progression. Eur Respir J. 2020 May 27;55(5):2000990. doi: 10.1183/13993003.00990-2020. Print 2020 May.

  PMID: 32312863 BACKGROUND

• Morlacchi LC, Rossetti V, Gigli L, Amati F, Rosso L, Aliberti S, Nosotti M, Blasi F. COVID-19 in lung transplant recipients: A case series from Milan, Italy. Transpl Infect Dis. 2020 Dec;22(6):e13356. doi: 10.1111/tid.13356. Epub 2020 Jun 26.

  PMID: 32510771 BACKGROUND

• Pereira MR, Mohan S, Cohen DJ, Husain SA, Dube GK, Ratner LE, Arcasoy S, Aversa MM, Benvenuto LJ, Dadhania DM, Kapur S, Dove LM, Brown RS Jr, Rosenblatt RE, Samstein B, Uriel N, Farr MA, Satlin M, Small CB, Walsh TJ, Kodiyanplakkal RP, Miko BA, Aaron JG, Tsapepas DS, Emond JC, Verna EC. COVID-19 in solid organ transplant recipients: Initial report from the US epicenter. Am J Transplant. 2020 Jul;20(7):1800-1808. doi: 10.1111/ajt.15941. Epub 2020 May 10.

  PMID: 32330343 BACKGROUND

• Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

  PMID: 33301246 BACKGROUND

• Sette A, Crotty S. Adaptive immunity to SARS-CoV-2 and COVID-19. Cell. 2021 Feb 18;184(4):861-880. doi: 10.1016/j.cell.2021.01.007. Epub 2021 Jan 12.

  PMID: 33497610 BACKGROUND

• Shimabukuro TT, Cole M, Su JR. Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US-December 14, 2020-January 18, 2021. JAMA. 2021 Mar 16;325(11):1101-1102. doi: 10.1001/jama.2021.1967. No abstract available.

  PMID: 33576785 BACKGROUND

• Tschopp J, L'Huillier AG, Mombelli M, Mueller NJ, Khanna N, Garzoni C, Meloni D, Papadimitriou-Olivgeris M, Neofytos D, Hirsch HH, Schuurmans MM, Muller T, Berney T, Steiger J, Pascual M, Manuel O, van Delden C; Swiss Transplant Cohort Study (STCS). First experience of SARS-CoV-2 infections in solid organ transplant recipients in the Swiss Transplant Cohort Study. Am J Transplant. 2020 Oct;20(10):2876-2882. doi: 10.1111/ajt.16062. Epub 2020 Jun 9.

  PMID: 32412159 BACKGROUND

• Xiang F, Wang X, He X, Peng Z, Yang B, Zhang J, Zhou Q, Ye H, Ma Y, Li H, Wei X, Cai P, Ma WL. Antibody Detection and Dynamic Characteristics in Patients With Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 5;71(8):1930-1934. doi: 10.1093/cid/ciaa461.

  PMID: 32306047 BACKGROUND

Related Links

• Agenzia Italiana del Farmaco.
• Ministero della Salute del Governo Italiano
• Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
• World Health Organization
• NY Times vaccine tracker

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Letizia Corinna Morlacchi, MD

  Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Respiratory Consultant, attending Lung Transplant clinic

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 11, 2021
• Study Start: October 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)