Vaccination for Recovered Inpatients With COVID-19 (VATICO)

Completed · Phase 4

Conditions studied: Covid19

In brief

In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, and who are still \[TICO assignment\] blinded and who are still within 28 to 90 days after initial TICO randomization, will be randomized in this 2x2 factorial design to one of four groups: (i) immediate versus 12 week deferral of first dose administration and also (ii) one dose only, versus two doses to be given 4 weeks apart of the Moderna mRNA-1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines). Choice of Moderna or Pfizer vaccine is determined based on availability at the site. The choice is individual, although participants vaccinated twice should receive the same type of vaccine for both injections. The primary objectives of this 2x2 factorial design are (i) to estimate the difference in neutralizing antibody (NAb) response to the mRNA vaccine from baseline to Week 48 among participants vaccinated early versus deferred, and (ii) to estimate the difference in NAb response to this vaccine among participants vaccinated once versus twice. The primary analyses will be carried out in participants randomized to placebo in TICO. Analyses will also be carried out for those who receive the investigational agent(s) studied in TICO. A key secondary objective is to ascertain the effect, if any, of SARS-CoV-2 monoclonal antibodies, and other interventions that have been studied in hospitalized COVID-19 subjects, on natural and vaccine-induced immunity. Participants will remain blinded to the interventions received in the ACTIV-3/TICO study, however allocation to the timing of vaccination and to one or two vaccinations in this (VATICO) study is not blinded.

Key facts

Study ID

NCT04969250

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

66

Starts

2021-08-25

Expected to finish

2022-12-21

Last updated by the study team

2024-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participating in the ACTIV-3/TICO trial and received a selected blinded investigational agent, or placebo for that agent, at selected sites.
• Willingness to strictly adhere to the randomly allocated dosage number and schedule for vaccine administration.
• Participant is between Day 28 and Day 90 TICO visits inclusive at time of randomization.
• At time of screening for this study, has experienced sustained recovery (i.e., the primary endpoint in TICO) for at least two consecutive weeks, i.e. having returned uninterrupted to the person's premorbid living facility (or equivalent) for at least 2 consecutive weeks.
• Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.

You may not qualify if…

• Receipt of a SARS-CoV-2 (COVID-19) vaccine after enrollment into TICO. Participants who received a SARS-CoV-2 vaccine prior to enrollment in TICO may be enrolled in this study.
• Known allergy to any component of the study eligible vaccine(s).

Where it is running

• Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd — Los Angeles, California, United States
• San Francisco VAMC (Site 074-002), 4150 Clement Street — San Francisco, California, United States
• Stanford University Hospitals & Clinics (Site 203-003), Stanford University, School of Medicine, 300 Pasteur Dr., Grant Bldg, Room S011 — Stanford, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson St., CDCRC — Torrance, California, United States
• Public Health Institute at Denver Health (Site 017-004), 660 Bannock Street — Denver, Colorado, United States
• Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW. — Washington D.C., District of Columbia, United States
• Hillsborough County Health Department, University of South Florida (Site 032-001), 1105 E. Kennedy Blvd. — Tampa, Florida, United States
• Minneapolis VA Medical Center (Site 105-001), 1 Veterans Drive — Minneapolis, Minnesota, United States
• Duke University Hospital (Site 301-006), 2301 Erwin Road — Durham, North Carolina, United States
• Wake Forest Baptist Health (Site 210-001), Medical Center Boulevard — Winston-Salem, North Carolina, United States
• Rhode Island Hospital (Site 080-036), 593 Eddy St. — Providence, Rhode Island, United States
• The Miriam Hospital (Site 080-039), 164 Summit Ave. — Providence, Rhode Island, United States
• CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street — Corpus Christi, Texas, United States
• UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor — Dallas, Texas, United States
• Parkland Health and Hospital Systems (Site 084-002), James Aston Ambulatory Care Center - Clinical Research Unit, 5303 Harry Hines Blvd., Ste U-9.300 — Dallas, Texas, United States
• Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd. — Salem, Virginia, United States
• Institute of Human Virology-Nigeria (Site 612-601), International Research Center of Excellence, Cadastral Zone COO Plot 62, after BAZE University, off CITEC Road — Abuja, Nigeria
• Tan Tock Seng Hospital (Site 612-201), National Center for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng — Singapore, Singapore
• Hospital Universitari Vall d'Hebron (Site 626-033), Passeig Vall Hebron, 119-129 — Barcelona, Spain
• Hospital Clinic de Barcelona (Site 626-004), Carrer de Villaroel 170 — Barcelona, Spain
• Hospital Universitari Germans Trias i Pujol (Site 626-003) Carretera de Canyet, s/n — Barcelona, Spain
• Hospital Universitari Arnau de Vilanova (Site 026-035), Institut de Recerca Biomèdica de Lleida, Av. Rovira Roure, 80 — Lleida, Spain
• Hospital General Universitario Gregorio Marañón (Site 626-001), Servicio de Inmunología Clínica, Departamento de Medicina Interna, Dr. Esquerdo, 46 — Madrid, Spain
• University Hospital Zurich (Site 621-201), Raemistrasse 100 — Zurich, Switzerland
• MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601), Plot 51-59 Nakiwogo Road, P.O. Box 49 — Entebbe, Uganda

Full record on ClinicalTrials.gov

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