Onco-hematological patients
Conditions
Interventions
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with oncological or hematological malignancy • Vaccinated with priming and boosting ChAd-0x1-S vaccine • Ability to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Women who are pregnant or breastfeeding • Immune deficiency not related to cancer or cancer treatment • Allergy (multiple)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the Tri-VOICE plus project, we want to offer a BNT161b2 vaccine booster shot as third and fourth dose with priority in a cohort of cancer patients being fully vaccinated with the ChAd-Ox1-S vaccine. In this way, we provide an answer to the high probability that these patients are left unprotected. On top of that, collecting knowledge about mixing vaccines and administering a booster shot is in line with the current clinical trials.;Secondary Objective: •To investigate the safety of the third and fourth dose of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) •To investigate the kinetics and longevity of the antibody response after third and fourth dose •To investigate the proportion of high-responders per current treatment cohort from the day of receiving an additional shot of BNT162b2 vaccine and 28 days thereafter. •To analyze the IgG titer of neutralizing antibodies, only in cases lower limit of quantification for the detection of binding antibodies is exceeded, at all the different timepoints •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the immune response day 28 after each additional dose and the primary endpoints of the Tri-VOICE plus study ;Primary end point(s): The first co-primary endpoint is the difference in SARS-CoV-2 IgG levels, before and 28 days after third dose of COVID-19 mRNA vaccine BNT162b2 after 2 doses of ChAd-Ox1-S vaccine. The second co-primary endpoint is the difference in SARS-CoV-2 IgG before and 28 days after the administration of fourth dose of the COVID-19 mRNA BNT162b2 vaccine after third dose of BNT162b2 and previous 2 doses of ChAd-Ox1-S vaccine;Timepoint(s) of evaluation of this end point: day 28 after booster shot BNT162b2 vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To investigate the safety of the third and fourth dose of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) •To investigate the kinetics and longevity of the antibody response after third and fourth dose •To investigate the proportion of high-responders per current treatment cohort from the day of receiving an additional shot of BNT162b2 vaccine and 28 days thereafter. •To analyze the IgG titer of neutralizing antibodies, only in cases lower limit of quantification for the detection of binding antibodies is exceeded, at all the different timepoints •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the immune response day 28 after each additional dose and the primary endpoints of the Tri-VOICE plus study ;Timepoint(s) of evaluation of this end point: end of the study | — |
Countries
Belgium
Contacts
Public Contactdata manager
Antwerp University Hospital
Outcome results
None listed