search
Back to results

Vaccination for Recovered Inpatients With COVID-19 (VATICO)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Moderna mRNA-1273 COVID-19 vaccine
Pfizer BNT162b2 COVID-19 vaccine
Sponsored by
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, VATICO, ACTIV-3, ACTIV3, TICO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participating in (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 for at least two consecutive weeks, i.e. having return 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:

  • 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).

Sites / Locations

  • Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd
  • San Francisco VAMC (Site 074-002), 4150 Clement Street
  • Stanford University Hospitals & Clinics (Site 203-003), Stanford University, School of Medicine, 300 Pasteur Dr., Grant Bldg, Room S011
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson St., CDCRC
  • Public Health Institute at Denver Health (Site 017-004), 660 Bannock Street
  • Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.
  • Hillsborough County Health Department, University of South Florida (Site 032-001), 1105 E. Kennedy Blvd.
  • Minneapolis VA Medical Center (Site 105-001), 1 Veterans Drive
  • Duke University Hospital (Site 301-006), 2301 Erwin Road
  • Wake Forest Baptist Health (Site 210-001), Medical Center Boulevard
  • Rhode Island Hospital (Site 080-036), 593 Eddy St.
  • The Miriam Hospital (Site 080-039), 164 Summit Ave.
  • CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street
  • UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
  • Parkland Health and Hospital Systems (Site 084-002), James Aston Ambulatory Care Center - Clinical Research Unit, 5303 Harry Hines Blvd., Ste U-9.300
  • Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.
  • Institute of Human Virology-Nigeria (Site 612-601), International Research Center of Excellence, Cadastral Zone COO Plot 62, after BAZE University, off CITEC Road
  • Tan Tock Seng Hospital (Site 612-201), National Center for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
  • Hospital Universitari Vall d'Hebron (Site 626-033), Passeig Vall Hebron, 119-129
  • Hospital Clinic de Barcelona (Site 626-004), Carrer de Villaroel 170
  • Hospital Universitari Germans Trias i Pujol (Site 626-003) Carretera de Canyet, s/n
  • Hospital Universitari Arnau de Vilanova (Site 026-035), Institut de Recerca Biomèdica de Lleida, Av. Rovira Roure, 80
  • Hospital General Universitario Gregorio Marañón (Site 626-001), Servicio de Inmunología Clínica, Departamento de Medicina Interna, Dr. Esquerdo, 46
  • University Hospital Zurich (Site 621-201), Raemistrasse 100
  • MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601), Plot 51-59 Nakiwogo Road, P.O. Box 49
  • Gulu Regional Referral Hospital (Site 634-603), P.O. Box 160
  • St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146
  • Makerere University Lung Institute (634-604), Mulago National Referral Hospital
  • Lira Regional Referral Hospital (Site 634-605), Plot 9/19, 21-41 Ngetta Road Police Road
  • Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group I1

Group I2

Group D1

Group D2

Arm Description

Immediate, one dose. Vaccination at study entry

Immediate, two doses. Vaccination at study entry and Week 4

Deferred, one dose. Vaccination at Week 12 only

Deferred, two doses. Vaccination at Week 12 and Week 16

Outcomes

Primary Outcome Measures

Neutralizing antibody (NAb) levels following vaccination
Evaluated using the ratio of geometric mean responses

Secondary Outcome Measures

Antibody levels 12 weeks after first vaccination
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with > 16-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with > 16-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with 8-16-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with 8-16-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with 4-8-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with 4-8-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with 2-4-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with 2-4-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with < 2-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Estimated percentage of participants with < 2-fold differences in NAbs
Evaluated using the ratio of geometric mean responses
Ratio of post-vaccine level/pre-vaccine level
Measured by change in NAb response
Composite number of death, serious adverse event (SAE), grade 3 AEs and grade 4 AEs
Number of Deaths
Number of SAEs
Percentage of participants assigned 2nd vaccine dose who do not receive it for any reason
Percentage of participants assigned 2nd vaccine dose who do not receive it due to an AE following first dose
Incidence of non-adherence to assigned treatment strategy

Full Information

First Posted
July 16, 2021
Last Updated
January 18, 2023
Sponsor
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Collaborators
University of Minnesota, National Institute of Allergy and Infectious Diseases (NIAID), University of Copenhagen, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Medical Research Council
search

1. Study Identification

Unique Protocol Identification Number
NCT04969250
Brief Title
Vaccination for Recovered Inpatients With COVID-19 (VATICO)
Official Title
SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Collaborators
University of Minnesota, National Institute of Allergy and Infectious Diseases (NIAID), University of Copenhagen, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Medical Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial (NCT04501978) at selected study sites who receive certain pre-specified, blinded investigational agents or placebo as part of that trial and who have since achieved sustained recovery from COVID-19 and meet certain criteria, including not having received a COVID-19 vaccination since enrollment, will be randomized to one of four groups to receive the Moderna mRNA-1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines). No "dummy/placebo" vaccine will be used. 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 when receiving two injections. The study's objective is to evaluate 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 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.
Detailed Description
Participants from the ACTIV-3/TICO clinical trial must still be blinded and be within 28 to 90 days after their initial TICO randomization. They will be randomized as part of a 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. The primary objectives of this study 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. 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 be offered enrollment between 28 and 90 days after receiving select ACTIV-3/TICO investigational agents or placebo. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, VATICO, ACTIV-3, ACTIV3, TICO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I1
Arm Type
Experimental
Arm Description
Immediate, one dose. Vaccination at study entry
Arm Title
Group I2
Arm Type
Experimental
Arm Description
Immediate, two doses. Vaccination at study entry and Week 4
Arm Title
Group D1
Arm Type
Experimental
Arm Description
Deferred, one dose. Vaccination at Week 12 only
Arm Title
Group D2
Arm Type
Experimental
Arm Description
Deferred, two doses. Vaccination at Week 12 and Week 16
Intervention Type
Biological
Intervention Name(s)
Moderna mRNA-1273 COVID-19 vaccine
Intervention Description
100 µg intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Pfizer BNT162b2 COVID-19 vaccine
Intervention Description
30 µg intramuscular injection
Primary Outcome Measure Information:
Title
Neutralizing antibody (NAb) levels following vaccination
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Thru Week 48
Secondary Outcome Measure Information:
Title
Antibody levels 12 weeks after first vaccination
Description
Evaluated using the ratio of geometric mean responses
Time Frame
12 weeks after first vaccination
Title
Estimated percentage of participants with > 16-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Baseline and Week 48
Title
Estimated percentage of participants with > 16-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Just before vaccination to 12 weeks post-vaccination
Title
Estimated percentage of participants with 8-16-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Baseline and Week 48
Title
Estimated percentage of participants with 8-16-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Just before vaccination to 12 weeks post-vaccination
Title
Estimated percentage of participants with 4-8-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Baseline and Week 48
Title
Estimated percentage of participants with 4-8-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Just before vaccination to 12 weeks post-vaccination
Title
Estimated percentage of participants with 2-4-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Baseline and Week 48
Title
Estimated percentage of participants with 2-4-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Just before vaccination to 12 weeks post-vaccination
Title
Estimated percentage of participants with < 2-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Baseline and Week 48
Title
Estimated percentage of participants with < 2-fold differences in NAbs
Description
Evaluated using the ratio of geometric mean responses
Time Frame
Just before vaccination to 12 weeks post-vaccination
Title
Ratio of post-vaccine level/pre-vaccine level
Description
Measured by change in NAb response
Time Frame
Up to Week 24
Title
Composite number of death, serious adverse event (SAE), grade 3 AEs and grade 4 AEs
Time Frame
12 weeks following first dose
Title
Number of Deaths
Time Frame
Thru Week 24
Title
Number of SAEs
Time Frame
Thru Week 24
Title
Percentage of participants assigned 2nd vaccine dose who do not receive it for any reason
Time Frame
Thru Week 48
Title
Percentage of participants assigned 2nd vaccine dose who do not receive it due to an AE following first dose
Time Frame
Thru Week 48
Title
Incidence of non-adherence to assigned treatment strategy
Time Frame
Thru Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participating in (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 for at least two consecutive weeks, i.e. having return 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: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Jens Lundgren
Organizational Affiliation
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
San Francisco VAMC (Site 074-002), 4150 Clement Street
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Stanford University Hospitals & Clinics (Site 203-003), Stanford University, School of Medicine, 300 Pasteur Dr., Grant Bldg, Room S011
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson St., CDCRC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Public Health Institute at Denver Health (Site 017-004), 660 Bannock Street
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Hillsborough County Health Department, University of South Florida (Site 032-001), 1105 E. Kennedy Blvd.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Minneapolis VA Medical Center (Site 105-001), 1 Veterans Drive
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Duke University Hospital (Site 301-006), 2301 Erwin Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Health (Site 210-001), Medical Center Boulevard
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Rhode Island Hospital (Site 080-036), 593 Eddy St.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital (Site 080-039), 164 Summit Ave.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Parkland Health and Hospital Systems (Site 084-002), James Aston Ambulatory Care Center - Clinical Research Unit, 5303 Harry Hines Blvd., Ste U-9.300
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Institute of Human Virology-Nigeria (Site 612-601), International Research Center of Excellence, Cadastral Zone COO Plot 62, after BAZE University, off CITEC Road
City
Abuja
Country
Nigeria
Facility Name
Tan Tock Seng Hospital (Site 612-201), National Center for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Universitari Vall d'Hebron (Site 626-033), Passeig Vall Hebron, 119-129
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona (Site 626-004), Carrer de Villaroel 170
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol (Site 626-003) Carretera de Canyet, s/n
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova (Site 026-035), Institut de Recerca Biomèdica de Lleida, Av. Rovira Roure, 80
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón (Site 626-001), Servicio de Inmunología Clínica, Departamento de Medicina Interna, Dr. Esquerdo, 46
City
Madrid
ZIP/Postal Code
28017
Country
Spain
Facility Name
University Hospital Zurich (Site 621-201), Raemistrasse 100
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601), Plot 51-59 Nakiwogo Road, P.O. Box 49
City
Entebbe
ZIP/Postal Code
256
Country
Uganda
Facility Name
Gulu Regional Referral Hospital (Site 634-603), P.O. Box 160
City
Gulu
Country
Uganda
Facility Name
St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146
City
Kampala
ZIP/Postal Code
256
Country
Uganda
Facility Name
Makerere University Lung Institute (634-604), Mulago National Referral Hospital
City
Kampala
Country
Uganda
Facility Name
Lira Regional Referral Hospital (Site 634-605), Plot 9/19, 21-41 Ngetta Road Police Road
City
Lira
Country
Uganda
Facility Name
Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556
City
Masaka
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.cdc.gov/coronavirus/2019-nCoV/index.html
Description
CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website
URL
https://www.niaid.nih.gov/clinical-trials/participant-guide
Description
A Participant's Guide to Clinical Trials (NIAID)
URL
https://www.niaid.nih.gov/clinical-trials/find-a-clinical-trial
Description
Find a Clinical Trial
URL
https://www.niaid.nih.gov/clinical-trials
Description
Clinical Trials at NIAID
URL
https://www.niaid.nih.gov/
Description
National Institute for Allergy and Infectious Diseases (NIAID)
URL
https://www.covid19treatmentguidelines.nih.gov/
Description
NIH COVID-19 treatment guidelines
URL
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/
Description
WHO COVID-19 treatment guidelines

Learn more about this trial

Vaccination for Recovered Inpatients With COVID-19 (VATICO)

We'll reach out to this number within 24 hrs