Phase 4
N=66
Vaccination for Recovered Inpatients With COVID-19 (VATICO)
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04969250 ↗Enrolled (actual)
66
Serious AEs
3.1%
Results posted
Mar 2024
Primary outcome: Primary: Ratio of 48-Week to Baseline Neutralizing Antibody (NAb) Levels — 0.3722; 0.5883; 0.2088; 0.3073 ratio of geometric mean responses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Moderna mRNA-1273 COVID-19 vaccine (Biological); Pfizer BNT162b2 COVID-19 vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of 48-Week to Baseline Neutralizing Antibody (NAb) Levels |
0.3722; 0.5883; 0.2088; 0.3073 | — |
| SECONDARY Ratio of 12-Week to Baseline Neutralizing Antibody (NAb) Levels |
0.4827; 0.9206; 0.2418; 0.6533 | — |
| SECONDARY Ratio of 24-Week to Baseline Neutralizing Antibody (NAb) Levels |
0.3002; 0.7747; 0.2032; 0.3397 | — |
| SECONDARY Number of Deaths |
1; 0; 0; 0 | 0.73 |
| SECONDARY Number of Serious Adverse Events (SAEs) |
2; 0; 0; 1 | 0.40 |
| SECONDARY Number of Patients Non-adherent to 2nd Dose |
1; 5 | 0.078 |
| SECONDARY Number of Patients Non-adherent to Assigned Treatment Strategy |
1; 3; 5; 8 | 0.033 sig |
| SECONDARY Percent of Patients With >=4-fold Difference in NAb |
41.70; 53.30; 30.80; 27.30 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04969250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.