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Vaccination for Recovered Inpatients With COVID-19 (VATICO)

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ClinicalTrials.gov Identifier: NCT04969250
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : November 26, 2021
Sponsor:
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 (PETAL)
Cardiothoracic Surgical Trials Network (CTSN)
Medical Research Council
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID) ( International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) )

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 disease Intervention/treatment Phase
Covid19 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 25, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/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




Primary Outcome Measures :
  1. Neutralizing antibody (NAb) levels following vaccination [ Time Frame: Thru Week 48 ]
    Evaluated using the ratio of geometric mean responses


Secondary Outcome Measures :
  1. Antibody levels 12 weeks after first vaccination [ Time Frame: 12 weeks after first vaccination ]
    Evaluated using the ratio of geometric mean responses

  2. Estimated percentage of participants with > 16-fold differences in NAbs [ Time Frame: Baseline and Week 48 ]
    Evaluated using the ratio of geometric mean responses

  3. Estimated percentage of participants with > 16-fold differences in NAbs [ Time Frame: 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 [ Time Frame: Baseline and Week 48 ]
    Evaluated using the ratio of geometric mean responses

  5. Estimated percentage of participants with 8-16-fold differences in NAbs [ Time Frame: 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 [ Time Frame: Baseline and Week 48 ]
    Evaluated using the ratio of geometric mean responses

  7. Estimated percentage of participants with 4-8-fold differences in NAbs [ Time Frame: 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 [ Time Frame: Baseline and Week 48 ]
    Evaluated using the ratio of geometric mean responses

  9. Estimated percentage of participants with 2-4-fold differences in NAbs [ Time Frame: 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 [ Time Frame: Baseline and Week 48 ]
    Evaluated using the ratio of geometric mean responses

  11. Estimated percentage of participants with < 2-fold differences in NAbs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks following first dose ]
  14. Number of Deaths [ Time Frame: Thru Week 24 ]
  15. Number of SAEs [ Time Frame: Thru Week 24 ]
  16. Percentage of participants assigned 2nd vaccine dose who do not receive it for any reason [ Time Frame: Thru Week 48 ]
  17. Percentage of participants assigned 2nd vaccine dose who do not receive it due to an AE following first dose [ Time Frame: Thru Week 48 ]
  18. Incidence of non-adherence to assigned treatment strategy [ Time Frame: Thru Week 48 ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969250


Contacts
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Contact: If interested in participating in this study, please contact the appropriate site or send email to tico@insight-trials.org
Contact: Do not include personal information in email. Type VATICO in subject line

Locations
Show Show 27 study locations
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
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Principal Investigator: Prof. Jens Lundgren INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
Additional Information:
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Responsible Party: International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
ClinicalTrials.gov Identifier: NCT04969250    
Other Study ID Numbers: 016 / VATICO
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID) ( International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) ):
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs