Vaccination for Recovered Inpatients With COVID-19 (VATICO)
NCT ID: NCT04969250
Last Updated: 2024-03-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
66 participants
INTERVENTIONAL
2021-08-25
2022-12-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine
NCT04811664
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
NCT04762680
Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention
NCT04686773
COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities
NCT04860258
Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults
NCT04866069
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This will address the objective of evaluating if the vaccine is best administered early or deferred after recovery, and whether one injection provides comparable immune response to a two-injection course of vaccination. Participants (as well as the protocol team) will remain blinded to the interventions studied in TICO. Allocation to timing of vaccination and to one or two vaccinations is not blinded. Participants will be offered enrollment in this protocol at the Day 28 or Day 90 visits in TICO, or anytime between these visits.
Participants will have blood collected for research purposes at the time of enrollment and at Weeks 12, 24, and 48.
The study vaccine and regimen will not be blinded; there will be be no 'dummy/placebo' vaccine administered. Vaccines are expected to be made available either through the study directly, or through a reliable public vaccination program using vaccine available per the local regulatory mechanism (e.g., currently under Emergency Use Authorization (EUA) for the United States) or via other routes in case such local mechanisms are not available.
Participants will be equally allocated to 4 groups to inform each of two vaccine strategies:
* One injection versus two (for the immediate and deferred groups)
* Immediate versus deferred (for one and two vaccinations)
Hence, the outcome of the randomization will lead to one of the four following vaccination strategies for each study participant:
I1 - Immediate, one dose: vaccination at study entry only I2 - Immediate, two doses: vaccination at study entry and Week 4 D1 - Deferred, one dose: vaccination at Week 12 only D2 - Deferred, two doses: vaccination at Week 12 and Week 16
Randomization will be stratified by study site and by randomization assignment in TICO for certain pre-specified investigational agents or their matching placebo.
When addressing the two co-primary objectives, the following groups are combined:
* Immediate vs deferred vaccine: groups I1 and I2 versus D1 and D2
* One versus two vaccinations: groups I1 and D1 versus I2 and D2
Similar comparisons will be made separately for each of the two principal TICO arms, i.e., for those assigned to one of the investigational agents and for those assigned to the matching placebo. Both of these comparisons are protected by the randomization in the present study.
Given the factorial design, whether there is an interaction of one factor (timing of vaccination) with the other factor (number of doses) will need to be assessed although the study is not fully powered for this evaluation.
A key secondary objective is to address whether the investigational agent studied in TICO (versus matching placebo) is affecting the primary outcome in this protocol. Of note, this comparison may not always be protected by randomization, as there may be differential inclusion in this protocol between those receiving the investigational agent in TICO and those receiving its matching placebo. This is more likely to be the case if the investigational agent is demonstrated to affect the chance of achieving sustained recovery.
The primary endpoint, immune response specific to the vaccination received, will be assessed at Week 48. Participants will have blood collected at time of enrollment, and at Weeks 12, 24 and 48 after study entry. Approximately 640 participants will be recruited. The total sample size will depend on how many investigational agents/placebo are evaluated in ACTIV-3/TICO.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I1
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection
Group I2
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection
Group D1
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection
Group D2
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Known allergy to any component of the study eligible vaccine(s).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Minnesota
OTHER
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
NETWORK
University of Copenhagen
OTHER
Kirby Institute
OTHER_GOV
Washington D.C. Veterans Affairs Medical Center
FED
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Heart, Lung, and Blood Institute (NHLBI)
NIH
US Department of Veterans Affairs
FED
Prevention and Early Treatment of Acute Lung Injury
OTHER
Cardiothoracic Surgical Trials Network
OTHER
Medical Research Council
OTHER_GOV
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Jens Lundgren
Role: PRINCIPAL_INVESTIGATOR
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Gulu Regional Referral Hospital (Site 634-603), P.O. Box 160
Gulu, , Uganda
St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146
Kampala, , Uganda
Makerere University Lung Institute (634-604), Mulago National Referral Hospital
Kampala, , Uganda
Lira Regional Referral Hospital (Site 634-605), Plot 9/19, 21-41 Ngetta Road Police Road
Lira, , Uganda
Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556
Masaka, , Uganda
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Letter of Amendment
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
FDA Safety Alerts and Recalls
CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website
A Participant's Guide to Clinical Trials (NIAID)
Find a Clinical Trial
Clinical Trials at NIAID
National Institute for Allergy and Infectious Diseases (NIAID)
WHO COVID-19 treatment guidelines
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
016 / VATICO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.