Vaccination for Recovered Inpatients With COVID-19 (VATICO)

Sponsor
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04969250
Collaborator
University of Minnesota (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH), University of Copenhagen (Other), Kirby Institute (Other), Washington D.C. Veterans Affairs Medical Center (U.S. Fed), AIDS Clinical Trials Group (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH), US Department of Veterans Affairs (U.S. Fed), Prevention and Early Treatment of Acute Lung Injury (PETAL) (Other), Cardiothoracic Surgical Trials Network (CTSN) (Other), Medical Research Council (Other)
640
Enrollment
30
Locations
4
Arms
17.2
Anticipated Duration (Months)
21.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Moderna mRNA-1273 COVID-19 vaccine
  • Biological: Pfizer BNT162b2 COVID-19 vaccine
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients
Actual Study Start Date :
Aug 25, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group I1

Immediate, one dose. Vaccination at study entry

Biological: Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection

Biological: Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection

Experimental: Group I2

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

Biological: Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection

Biological: Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection

Experimental: Group D1

Deferred, one dose. Vaccination at Week 12 only

Biological: Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection

Biological: Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection

Experimental: Group D2

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

Biological: Moderna mRNA-1273 COVID-19 vaccine
100 µg intramuscular injection

Biological: Pfizer BNT162b2 COVID-19 vaccine
30 µg intramuscular injection

Outcome Measures

Primary Outcome Measures

  1. Neutralizing antibody (NAb) levels following vaccination [Thru Week 48]

    Evaluated using the ratio of geometric mean responses

Secondary Outcome Measures

  1. Antibody levels 12 weeks after first vaccination [12 weeks after first vaccination]

    Evaluated using the ratio of geometric mean responses

  2. Estimated percentage of participants with > 16-fold differences in NAbs [Baseline and Week 48]

    Evaluated using the ratio of geometric mean responses

  3. Estimated percentage of participants with > 16-fold differences in NAbs [Just before vaccination to 12 weeks post-vaccination]

    Evaluated using the ratio of geometric mean responses

  4. Estimated percentage of participants with 8-16-fold differences in NAbs [Baseline and Week 48]

    Evaluated using the ratio of geometric mean responses

  5. Estimated percentage of participants with 8-16-fold differences in NAbs [Just before vaccination to 12 weeks post-vaccination]

    Evaluated using the ratio of geometric mean responses

  6. Estimated percentage of participants with 4-8-fold differences in NAbs [Baseline and Week 48]

    Evaluated using the ratio of geometric mean responses

  7. Estimated percentage of participants with 4-8-fold differences in NAbs [Just before vaccination to 12 weeks post-vaccination]

    Evaluated using the ratio of geometric mean responses

  8. Estimated percentage of participants with 2-4-fold differences in NAbs [Baseline and Week 48]

    Evaluated using the ratio of geometric mean responses

  9. Estimated percentage of participants with 2-4-fold differences in NAbs [Just before vaccination to 12 weeks post-vaccination]

    Evaluated using the ratio of geometric mean responses

  10. Estimated percentage of participants with < 2-fold differences in NAbs [Baseline and Week 48]

    Evaluated using the ratio of geometric mean responses

  11. Estimated percentage of participants with < 2-fold differences in NAbs [Just before vaccination to 12 weeks post-vaccination]

    Evaluated using the ratio of geometric mean responses

  12. Ratio of post-vaccine level/pre-vaccine level [Up to Week 24]

    Measured by change in NAb response

  13. Composite number of death, serious adverse event (SAE), grade 3 AEs and grade 4 AEs [12 weeks following first dose]

  14. Number of Deaths [Thru Week 24]

  15. Number of SAEs [Thru Week 24]

  16. Percentage of participants assigned 2nd vaccine dose who do not receive it for any reason [Thru Week 48]

  17. Percentage of participants assigned 2nd vaccine dose who do not receive it due to an AE following first dose [Thru Week 48]

  18. Incidence of non-adherence to assigned treatment strategy [Thru Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly BlvdLos AngelesCaliforniaUnited States90048
2San Francisco VAMC (Site 074-002), 4150 Clement StreetSan FranciscoCaliforniaUnited States94121
3Stanford University Hospitals & Clinics (Site 203-003), Stanford University, School of Medicine, 300 Pasteur Dr., Grant Bldg, Room S011StanfordCaliforniaUnited States94305
4Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson St., CDCRCTorranceCaliforniaUnited States90502
5Public Health Institute at Denver Health (Site 017-004), 660 Bannock StreetDenverColoradoUnited States80204
6Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.WashingtonDistrict of ColumbiaUnited States20422
7Hillsborough County Health Department, University of South Florida (Site 032-001), 1105 E. Kennedy Blvd.TampaFloridaUnited States33602
8Minneapolis VA Medical Center (Site 105-001), 1 Veterans DriveMinneapolisMinnesotaUnited States55417
9Duke University Hospital (Site 301-006), 2301 Erwin RoadDurhamNorth CarolinaUnited States27710
10Wake Forest Baptist Health (Site 210-001), Medical Center BoulevardWinston-SalemNorth CarolinaUnited States27157
11Rhode Island Hospital (Site 080-036), 593 Eddy St.ProvidenceRhode IslandUnited States02903
12The Miriam Hospital (Site 080-039), 164 Summit Ave.ProvidenceRhode IslandUnited States02906
13CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth StreetCorpus ChristiTexasUnited States78404
14UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd FloorDallasTexasUnited States75235
15Parkland Health and Hospital Systems (Site 084-002), James Aston Ambulatory Care Center - Clinical Research Unit, 5303 Harry Hines Blvd., Ste U-9.300DallasTexasUnited States75390
16Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.SalemVirginiaUnited States24153
17Institute of Human Virology-Nigeria (Site 612-601), International Research Center of Excellence, Cadastral Zone COO Plot 62, after BAZE University, off CITEC RoadAbujaNigeria
18Tan Tock Seng Hospital (Site 612-201), National Center for Infectious Diseases (NCID), 11 Jalan Tan Tock SengSingaporeSingapore308433
19Hospital Universitari Vall d'Hebron (Site 626-033), Passeig Vall Hebron, 119-129BarcelonaSpain08035
20Hospital Clinic de Barcelona (Site 626-004), Carrer de Villaroel 170BarcelonaSpain08036
21Hospital Universitari Germans Trias i Pujol (Site 626-003) Carretera de Canyet, s/nBarcelonaSpain08916
22Hospital Universitari Arnau de Vilanova (Site 026-035), Institut de Recerca Biomèdica de Lleida, Av. Rovira Roure, 80LleidaSpain25198
23Hospital General Universitario Gregorio Marañón (Site 626-001), Servicio de Inmunología Clínica, Departamento de Medicina Interna, Dr. Esquerdo, 46MadridSpain28017
24University Hospital Zurich (Site 621-201), Raemistrasse 100ZürichSwitzerland8091
25MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601), Plot 51-59 Nakiwogo Road, P.O. Box 49EntebbeUganda256
26Gulu Regional Referral Hospital (Site 634-603), P.O. Box 160GuluUganda
27St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146KampalaUganda256
28Makerere University Lung Institute (634-604), Mulago National Referral HospitalKampalaUganda
29Lira Regional Referral Hospital (Site 634-605), Plot 9/19, 21-41 Ngetta Road Police RoadLiraUganda
30Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556MasakaUganda

Sponsors and Collaborators

  • International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
  • 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 (PETAL)
  • Cardiothoracic Surgical Trials Network (CTSN)
  • Medical Research Council

Investigators

  • Principal Investigator: Prof. Jens Lundgren, INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
ClinicalTrials.gov Identifier:
NCT04969250
Other Study ID Numbers:
  • 016 / VATICO
First Posted:
Jul 20, 2021
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022