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Vaccination for Recovered Inpatients With COVID-19 (VATICO)
Trial ID: NCT04969250
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.
SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients
- 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
- 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.
- 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
- Known allergy to any component of the study eligible vaccine(s).
biological: Moderna mRNA-1273 COVID-19 vaccine
biological: Pfizer BNT162b2 COVID-19 vaccine
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