Vaccination for Recovered Inpatients With COVID-19 (VATICO)
Public ClinicalTrials.gov record NCT04969250. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04969250
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Interventions
- Moderna mRNA-1273 COVID-19 vaccine Biological
- Pfizer BNT162b2 COVID-19 vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2021
- Primary completion
- Dec 20, 2022
- Completion
- Dec 20, 2022
- Last update posted
- Mar 26, 2024
2021 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd | Los Angeles | California | 90048 | — |
| San Francisco VAMC (Site 074-002), 4150 Clement Street | San Francisco | California | 94121 | — |
| Stanford University Hospitals & Clinics (Site 203-003), Stanford University, School of Medicine, 300 Pasteur Dr., Grant Bldg, Room S011 | Stanford | California | 94305 | — |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson St., CDCRC | Torrance | California | 90502 | — |
| Public Health Institute at Denver Health (Site 017-004), 660 Bannock Street | Denver | Colorado | 80204 | — |
| Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW. | Washington D.C. | District of Columbia | 20422 | — |
| Hillsborough County Health Department, University of South Florida (Site 032-001), 1105 E. Kennedy Blvd. | Tampa | Florida | 33602 | — |
| Minneapolis VA Medical Center (Site 105-001), 1 Veterans Drive | Minneapolis | Minnesota | 55417 | — |
| Duke University Hospital (Site 301-006), 2301 Erwin Road | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health (Site 210-001), Medical Center Boulevard | Winston-Salem | North Carolina | 27157 | — |
| Rhode Island Hospital (Site 080-036), 593 Eddy St. | Providence | Rhode Island | 02903 | — |
| The Miriam Hospital (Site 080-039), 164 Summit Ave. | Providence | Rhode Island | 02906 | — |
| CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street | Corpus Christi | Texas | 78404 | — |
| UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor | Dallas | Texas | 75235 | — |
| 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 | 75390 | — |
| Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd. | Salem | Virginia | 24153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04969250, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2024 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04969250 live on ClinicalTrials.gov.