Vaccination for Recovered Inpatients With COVID-19 (VATICO)

NCT04969250 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 016 / VATICO
• Study Type: interventional
• Target: 66
• Locations: 6 countries
• Sites: 30

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Ratio of 48-Week to Baseline Neutralizing Antibody (NAb) Levels

  Change in antibody level as measured by ratio of follow-up to baseline level

  Pre-vaccination baseline and 48 weeks post-vaccination

Secondary Outcomes (7)

• Ratio of 12-Week to Baseline Neutralizing Antibody (NAb) Levels

  Pre-vaccination baseline and 12 weeks post-vaccination

• Ratio of 24-Week to Baseline Neutralizing Antibody (NAb) Levels

  Pre-vaccination baseline and 24 weeks post-vaccination

• Number of Deaths

  Through Week 24 after enrollment

• Number of Serious Adverse Events (SAEs)

  Through Week 24

• Number of Patients Non-adherent to 2nd Dose

  Second vaccine doses were due at 4 and 16 weeks after randomization in Arm 2 and 4, respectively

Study Arms (4)

Group I1

EXPERIMENTAL

Immediate, one dose. Vaccination at study entry

Biological: Moderna mRNA-1273 COVID-19 vaccine; Biological: Pfizer BNT162b2 COVID-19 vaccine

Group I2

EXPERIMENTAL

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

Biological: Moderna mRNA-1273 COVID-19 vaccine; Biological: Pfizer BNT162b2 COVID-19 vaccine

Group D1

EXPERIMENTAL

Deferred, one dose. Vaccination at Week 12 only

Biological: Moderna mRNA-1273 COVID-19 vaccine; Biological: Pfizer BNT162b2 COVID-19 vaccine

Group D2

EXPERIMENTAL

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

Biological: Moderna mRNA-1273 COVID-19 vaccine; Biological: Pfizer BNT162b2 COVID-19 vaccine

Interventions

Moderna mRNA-1273 COVID-19 vaccine BIOLOGICAL

100 µg intramuscular injection

Group D1; Group D2; Group I1; Group I2

Pfizer BNT162b2 COVID-19 vaccine BIOLOGICAL

30 µg intramuscular injection

Group D1; Group D2; Group I1; Group I2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• University of Minnesota: collaborator
• International Network for Strategic Initiatives in Global HIV Trials (INSIGHT): collaborator
• University of Copenhagen: collaborator
• Kirby Institute: collaborator
• Washington D.C. Veterans Affairs Medical Center: collaborator
• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• US Department of Veterans Affairs: collaborator
• Prevention and Early Treatment of Acute Lung Injury: collaborator
• Cardiothoracic Surgical Trials Network: collaborator
• Medical Research Council: collaborator

Study Sites (30)

Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd

Los Angeles, California, 90048, United States

Location

San Francisco VAMC (Site 074-002), 4150 Clement Street

San Francisco, California, 94121, United States

Location

Stanford University Hospitals & Clinics (Site 203-003), Stanford University, School of Medicine, 300 Pasteur Dr., Grant Bldg, Room S011

Stanford, California, 94305, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson St., CDCRC

Torrance, California, 90502, United States

Location

Public Health Institute at Denver Health (Site 017-004), 660 Bannock Street

Denver, Colorado, 80204, United States

Location

Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.

Washington D.C., District of Columbia, 20422, United States

Location

Hillsborough County Health Department, University of South Florida (Site 032-001), 1105 E. Kennedy Blvd.

Tampa, Florida, 33602, United States

Location

Minneapolis VA Medical Center (Site 105-001), 1 Veterans Drive

Minneapolis, Minnesota, 55417, United States

Location

Duke University Hospital (Site 301-006), 2301 Erwin Road

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health (Site 210-001), Medical Center Boulevard

Winston-Salem, North Carolina, 27157, United States

Location

Rhode Island Hospital (Site 080-036), 593 Eddy St.

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital (Site 080-039), 164 Summit Ave.

Providence, Rhode Island, 02906, United States

Location

CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street

Corpus Christi, Texas, 78404, United States

Location

UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor

Dallas, Texas, 75235, United States

Location

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, United States

Location

Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.

Salem, Virginia, 24153, United States

Location

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

Location

Tan Tock Seng Hospital (Site 612-201), National Center for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng

Singapore, 308433, Singapore

Location

Hospital Universitari Vall d'Hebron (Site 626-033), Passeig Vall Hebron, 119-129

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona (Site 626-004), Carrer de Villaroel 170

Barcelona, 08036, Spain

Location

Hospital Universitari Germans Trias i Pujol (Site 626-003) Carretera de Canyet, s/n

Barcelona, 08916, Spain

Location

Hospital Universitari Arnau de Vilanova (Site 026-035), Institut de Recerca Biomèdica de Lleida, Av. Rovira Roure, 80

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañón (Site 626-001), Servicio de Inmunología Clínica, Departamento de Medicina Interna, Dr. Esquerdo, 46

Madrid, 28017, Spain

Location

University Hospital Zurich (Site 621-201), Raemistrasse 100

Zurich, 8091, Switzerland

Location

MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601), Plot 51-59 Nakiwogo Road, P.O. Box 49

Entebbe, 256, Uganda

Location

Gulu Regional Referral Hospital (Site 634-603), P.O. Box 160

Gulu, Uganda

Location

St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146

Kampala, 256, Uganda

Location

Makerere University Lung Institute (634-604), Mulago National Referral Hospital

Kampala, Uganda

Location

Lira Regional Referral Hospital (Site 634-605), Plot 9/19, 21-41 Ngetta Road Police Road

Lira, Uganda

Location

Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556

Masaka, Uganda

Location

Related Links

• 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

MeSH Terms

Conditions

COVID-19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; Severe Acute Respiratory Syndrome

Interventions

2019-nCoV Vaccine mRNA-1273; BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Limitations and Caveats

This trial anticipated enrolling 640 participants, but enrolled just 66.

Results Point of Contact

• Title: Melissa Skeans, Statistician/Protocol Manager
• Organization: University of Minnesota

tico@insight-trials.org

612-626-9011

Study Officials

• Prof. Jens Lundgren

  INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 20, 2021
• Study Start: August 25, 2021
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Locations

NG (1); US (16); SG (1); ES (5); CH (1); UG (6)