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Vaccination for Recovered Inpatients With COVID-19 (VATICO)
Not Recruiting
Trial ID: NCT04969250
Purpose
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.
Official Title
SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients
Stanford Investigator(s)
Angela Rogers
Associate Professor of Medicine (Pulmonary and Critical Care)
Eligibility
Inclusion Criteria:
- 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.
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).
Intervention(s):
biological: Moderna mRNA-1273 COVID-19 vaccine
biological: Pfizer BNT162b2 COVID-19 vaccine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305