Immunocompromised Swiss Cohorts Based Trial Platform

Summary

This study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study \[SHCS\] and Swiss Transplant Cohort Study \[STCS\]) to assess the comparative effectiveness and safety of approved SARS-CoV-2 vaccines in immunocompromised patients. This platform will be tested in the frame of an exploratory pilot trial and a framework will be set up to conduct a larger, flexible, randomized controlled trial (RCT) to test approved SARS-CoV-2 vaccines to prevent SARS-CoV-2 infections. The first sub-protocol for a pilot trial is to investigate the operability of a platform trial that is nested into two existing cohort studies and compare immune response, safety and clinical efficacy of the first two mRNA vaccines (Comirnaty® by Pfizer / BioNTech and COVID-19 mRNA Vaccine Moderna®, by Moderna) in immune compromised patients in the Swiss HIV and Swiss Transplant Cohort studies. The second sub-protocol (observational study) is to collect a blood sample before the third vaccination and 8 weeks after vaccination to analyze an additional benefit of a third SARS-CoV-2 vaccine in these immunocompromised patients. In the third sub-protocol (substudy-3; observational) we will recruit patients who have received m-RNA-1273.214 by Moderna in the frame of clinical routine. We will start a second arm of our observational study as soon as another bivalent mRNA vaccine (from Pfizer-BioNTech) has been approved by Swissmedic. We aim to compare the immunologic response and safety of the bivalent mRNA-1273.214 vaccine from Moderna among immunocompromised persons (persons living with HIV or kidney or lung transplant recipients) to the immunologic response of immunocompromised persons who received the bivalent mRNA vaccine from Pfizer-BioNTech.

Timeline

Start

2021-04-19

Primary completion

2023-09-23

Completion

2023-09-23

Publications

• Results Speich B, Chammartin F, Abela IA, Amico P, Stoeckle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Audige A, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Trkola A, Briel M, Kusejko K, Bucher HC; Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Antibody Response in Immunocompromised Patients After the Administration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine BNT162b2 or mRNA-1273: A Randomized Controlled Trial. Clin Infect Dis. 2022 Aug 24;75(1):e585-e593. doi: 10.1093/cid/ciac169.
• Results Kusejko K, Chammartin F, Smith D, Odermatt M, Schuhmacher J, Koller M, Gunthard HF, Briel M, Bucher HC, Speich B; Swiss HIV Cohort Study; Swiss Transplant Cohort Study. Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients. BMC Infect Dis. 2022 Jul 28;22(1):654. doi: 10.1186/s12879-022-07621-x.
• Amstutz A, Chammartin F, Audige A, Eichenberger AL, Braun DL, Amico P, Stoeckle MP, Hasse B, Papadimitriou-Olivgeris M, Manuel O, Bongard C, Schuurmans MM, Hage R, Damm D, Tamm M, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Schonenberger CM, Griessbach A, Labhardt ND, Kouyos RD, Trkola A, Kusejko K, Bucher HC, Abela IA, Briel M, Speich B; Swiss HIV Cohort Study; Swiss Transplant Cohort. Antibody and T-Cell Response to Bivalent Booster SARS-CoV-2 Vaccines in People With Compromised Immune Function: COVERALL-3 Study. J Infect Dis. 2024 Oct 16;230(4):e847-e859. doi: 10.1093/infdis/jiae291.
• Griessbach A, Chammartin F, Abela IA, Amico P, Stoeckle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Audige A, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Trkola A, Epp S, Amstutz A, Schonenberger CM, Taji Heravi A, Papadimitriou-Olivgeris M, Casutt A, Manuel O, Kusejko K, Bucher HC, Briel M, Speich B; Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Antibody Response After the Third SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients and People Living With HIV (COVERALL-2). Open Forum Infect Dis. 2023 Nov 3;10(11):ofad536. doi: 10.1093/ofid/ofad536. eCollection 2023 Nov.
• Chammartin F, Griessbach A, Kusejko K, Audige A, Epp S, Stoeckle MP, Eichenberger AL, Amstutz A, Schoenenberger CM, Hasse B, Braun DL, Rauch A, Trkola A, Briel M, Bucher HC, Gunthard HF, Speich B, Abela IA; Swiss HIV Cohort Study. Bridging the gap: identifying factors impacting mRNA severe acute respiratory syndrome coronavirus 2 vaccine booster response in people with HIV-1. AIDS. 2024 Feb 1;38(2):217-222. doi: 10.1097/QAD.0000000000003751. Epub 2023 Oct 11.
• Chammartin F, Kusejko K, Pasin C, Trkola A, Briel M, Amico P, Stoekle MP, Eichenberger AL, Hasse B, Braun DL, Schuurmans MM, Muller TF, Tamm M, Mueller NJ, Rauch A, Koller MT, Gunthard HF, Bucher HC, Speich B, Abela IA; and the Swiss HIV Cohort Study. Determinants of antibody response to severe acute respiratory syndrome coronavirus 2 mRNA vaccines in people with HIV. AIDS. 2022 Aug 1;36(10):1465-1468. doi: 10.1097/QAD.0000000000003246. Epub 2022 Jul 9.
• Speich B, Chammartin F, Smith D, Stoeckle MP, Amico P, Eichenberger AL, Hasse B, Schuurmans MM, Muller T, Tamm M, Dickenmann M, Abela IA, Trkola A, Hirsch HH, Manuel O, Cavassini M, Hemkens LG, Briel M, Mueller NJ, Rauch A, Gunthard HF, Koller MT, Bucher HC, Kusejko K; study groups from the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty(R) and COVID-19 mRNA Vaccine Moderna(R). Trials. 2021 Oct 21;22(1):724. doi: 10.1186/s13063-021-05664-0.

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