Lessons from an international trial evaluating vaccination strategies for recovered inpatients with COVID-19 (VATICO)

Eleftherios Mylonakis¹, Joseph Lutaakome², Mamta K Jain³, Angela J Rogers⁴, José Moltó⁵, Susana Benet⁶, Ahmad Mourad⁷, D Clark Files⁸, Henry Mugerwa⁹, Cissy Kityo¹⁰, Francis Kiweewa¹¹, Mary Grace Nalubega¹², Jonathan Kitonsa¹³, Evelyn Nabenkema¹⁴, Daniel D Murray¹⁵, Dominique Braun¹⁶, Dena Kamel¹⁷, Elizabeth S Higgs¹⁸, Timothy J Hatlen¹⁹, Virginia L Kan²⁰, Adriana Sanchez²¹, John Tierney²², Eileen Denner²³, Deborah Wentworth²³, Abdel G Babiker²⁴, Victoria J Davey²⁵, Annetine C Gelijns²⁶, Gail V Matthews²⁷, B Taylor Thompson²⁸, H Clifford Lane²⁹, James D Neaton³⁰, Jens D Lundgren³¹

Affiliations

¹ Division of Infectious Diseases, Rhode Island Hospital & The Miriam Hospital, Alpert Medical School of Brown University, Providence, RI, USA. Electronic address: eleftherios_mylonakis@brown.edu.
² MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.
³ U.T. Southwestern Medical Center and Parkland Health and Hospital Systems, Dallas, TX, USA.
⁴ Pulmonary, Allergy and Critical Care Medicine, Stanford University School of Medicine, Stanford, CA, USA.
⁵ Lluita contra la Sida Foundation & Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Carlos III Health Institute, Madrid, Spain.
⁶ Lluita contra la Sida Foundation & Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
⁷ Division of Infectious Diseases, Duke University School of Medicine, Durham, NC, USA.
⁸ Division of Pulmonary, Critical Care, Allergy and Immunology, Department of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC.
⁹ Joint Clinical Research Centre, Lubowa and Gulu Regional Referral Hospital, Gulu, Uganda.
¹⁰ Joint Clinical Research Centre, Lubowa, Uganda.
¹¹ Makerere University Lung Institute (MLI), Kampala, Uganda; Lira Regional Referral Hospital, Lira, Uganda.
¹² Lira Regional Referral Hospital, Lira, Uganda.
¹³ Masaka Regional Referral Hospital, Masaka, Uganda.
¹⁴ St Francis Hospital, Nsambya, Uganda.
¹⁵ CHIP Center of Excellence for Health, Immunity, and Infections and Department of Infectious Diseases, Rigshospitalet; Copenhagen, Denmark.
¹⁶ Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich and Institute of Medical Virology, University of Zurich, Zurich Switzerland University Hospital Zurich, Zurich, Switzerland.
¹⁷ UT Southwestern Medical Center, Internal Medicine, Infectious Diseases, Dallas, TX, USA.
¹⁸ National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
¹⁹ Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
²⁰ Infectious Diseases Section, VA Medical Center, Washington, DC, USA.
²¹ Washington DC VA Medical Center Washington, DC, USA.
²² Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
²³ University of Minnesota, MN, USA.
²⁴ The Medical Research Council Clinical Trials Unit at UCL, University College London, London, UK.
²⁵ United States Department of Veterans Affairs; Washington, DC, USA.
²⁶ Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
²⁷ The Kirby Institute, University of New South Wales, Sydney, Australia.
²⁸ Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital and Harvard Medical School; Boston, Massachusetts, USA.
²⁹ National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
³⁰ Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
³¹ CHIP Center of Excellence for Health, Immunity, and Infections and Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.

PMID: 35963234
PMCID: PMC9373164
DOI: 10.1016/j.medj.2022.07.003

Lessons from an international trial evaluating vaccination strategies for recovered inpatients with COVID-19 (VATICO)

Eleftherios Mylonakis et al. Med. 2022.

. 2022 Aug 12;3(8):531-537.

doi: 10.1016/j.medj.2022.07.003.

Authors

Affiliations

¹ Division of Infectious Diseases, Rhode Island Hospital & The Miriam Hospital, Alpert Medical School of Brown University, Providence, RI, USA. Electronic address: eleftherios_mylonakis@brown.edu.
² MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.
³ U.T. Southwestern Medical Center and Parkland Health and Hospital Systems, Dallas, TX, USA.
⁴ Pulmonary, Allergy and Critical Care Medicine, Stanford University School of Medicine, Stanford, CA, USA.
⁵ Lluita contra la Sida Foundation & Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Carlos III Health Institute, Madrid, Spain.
⁶ Lluita contra la Sida Foundation & Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
⁷ Division of Infectious Diseases, Duke University School of Medicine, Durham, NC, USA.
⁸ Division of Pulmonary, Critical Care, Allergy and Immunology, Department of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC.
⁹ Joint Clinical Research Centre, Lubowa and Gulu Regional Referral Hospital, Gulu, Uganda.
¹⁰ Joint Clinical Research Centre, Lubowa, Uganda.
¹¹ Makerere University Lung Institute (MLI), Kampala, Uganda; Lira Regional Referral Hospital, Lira, Uganda.
¹² Lira Regional Referral Hospital, Lira, Uganda.
¹³ Masaka Regional Referral Hospital, Masaka, Uganda.
¹⁴ St Francis Hospital, Nsambya, Uganda.
¹⁵ CHIP Center of Excellence for Health, Immunity, and Infections and Department of Infectious Diseases, Rigshospitalet; Copenhagen, Denmark.
¹⁶ Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich and Institute of Medical Virology, University of Zurich, Zurich Switzerland University Hospital Zurich, Zurich, Switzerland.
¹⁷ UT Southwestern Medical Center, Internal Medicine, Infectious Diseases, Dallas, TX, USA.
¹⁸ National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
¹⁹ Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
²⁰ Infectious Diseases Section, VA Medical Center, Washington, DC, USA.
²¹ Washington DC VA Medical Center Washington, DC, USA.
²² Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
²³ University of Minnesota, MN, USA.
²⁴ The Medical Research Council Clinical Trials Unit at UCL, University College London, London, UK.
²⁵ United States Department of Veterans Affairs; Washington, DC, USA.
²⁶ Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
²⁷ The Kirby Institute, University of New South Wales, Sydney, Australia.
²⁸ Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital and Harvard Medical School; Boston, Massachusetts, USA.
²⁹ National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
³⁰ Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
³¹ CHIP Center of Excellence for Health, Immunity, and Infections and Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.

PMID: 35963234
PMCID: PMC9373164
DOI: 10.1016/j.medj.2022.07.003

Abstract

The protection provided by natural versus hybrid immunity from COVID-19 is unclear. We reflect on the challenges from trying to conduct a randomized post-SARS-CoV-2 infection vaccination trial study with rapidly evolving scientific data, vaccination guidelines, varying international policies, difficulties with vaccine availability, vaccine hesitancy, and a constantly evolving virus.

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Conflict of interest statement

Declaration of interests D.L.B is on the advisory boards of Gilead, MerckSharpe & Dohme, Pfizer, and ViiV, and receives travel grants from ViiV Healthcare. G.M. receives research grants from Gilead, AbbvieInc., ViiV Healthcare, and Janssen, and is on the advisory boards of Gileadand AstraZeneca. The other authors declare no competing interests.

References

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Lessons from an international trial evaluating vaccination strategies for recovered inpatients with COVID-19 (VATICO)

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Lessons from an international trial evaluating vaccination strategies for recovered inpatients with COVID-19 (VATICO)

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