Vaccination against cOvid-19 In CancER patients under active treatment in Belgium

Vaccination against cOvid-19 In CancER patients under active treatment (Belgium, B-VOICE) - B-VOICE

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000300-38-BE

Enrollment

200

Registered

2021-01-25

Start date

2021-02-05

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onco-hematological patients

Interventions

Trade Name: Comirnaty Product Name: COMIRNATY Pharmaceutical Form: Dispersion for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age of 18 years or older • Patients should meet one of the cohort criteria • Life expectancy > 12 months • Ability to provide informed consent ADDENDUM extra booster shot • Former participant of the B-VOICE study • Vaccinated with priming and boosting BNT162b2 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 • Systemic treatment with immune suppressive medication, including chronic steroid use of >10 mg prednisone or equivalent

Design outcomes

Primary

Measure	Time frame
Main Objective: The central question is whether patients under active treatment, can develop protective immunity against COVID-19 upon vaccination. This question needs to be answered urgently and would help the medical oncology community to decide whether optimal cancer care can be delivered safely to vaccinated patients with cancer. The primary objective is to assess the immune response and adverse events after administration of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in an oncology population of 200 patients under active treatment. In a meanwhile the results of the B-VOICE study revealed that the amount of binding antibodies produced by day 28 after full BNT161b2 vaccination is lower than expected for the vast majority of the cohort cancer patients. We absolutely do not want to lag behind the facts and will therefore administer a 3th and 4th dose of BNT161b2. ;Secondary Objective: •To study the duration of the immune response •To identify the most optimal timing of vaccination in patients under chemotherapy. •To investigate the efficacy of the immune response •Assessment of the cellular immune response •To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). ADDENDUM extra booster shot •To investigate the safety of the 3th and 4th COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) dose. •To investigate the kinetics and longevity of the antibody response after both 3th and 4th dose. •To investigate the proportion of high-responders per current treatment cohort after both 3th and 4th dose. •To measure neutralizing antibody titers, only in seroconverters, after 28 days after both 3th and 4th dose. •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the primary endpoints of the original B-VOICE study and of the Tri-VOICE study ;Primary end point(s): neutralizing antibody titers against the SARS-CoV-2 spike protein and nucleocapsid protein on day	—

Measure

Time frame

Main Objective: The central question is whether patients under active treatment, can develop protective immunity against COVID-19 upon vaccination. This question needs to be answered urgently and would help the medical oncology community to decide whether optimal cancer care can be delivered safely to vaccinated patients with cancer. The primary objective is to assess the immune response and adverse events after administration of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in an oncology population of 200 patients under active treatment. In a meanwhile the results of the B-VOICE study revealed that the amount of binding antibodies produced by day 28 after full BNT161b2 vaccination is lower than expected for the vast majority of the cohort cancer patients. We absolutely do not want to lag behind the facts and will therefore administer a 3th and 4th dose of BNT161b2. ;Secondary Objective: •To study the duration of the immune response •To identify the most optimal timing of vaccination in patients under chemotherapy. •To investigate the efficacy of the immune response •Assessment of the cellular immune response •To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). ADDENDUM extra booster shot •To investigate the safety of the 3th and 4th COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) dose. •To investigate the kinetics and longevity of the antibody response after both 3th and 4th dose. •To investigate the proportion of high-responders per current treatment cohort after both 3th and 4th dose. •To measure neutralizing antibody titers, only in seroconverters, after 28 days after both 3th and 4th dose. •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the primary endpoints of the original B-VOICE study and of the Tri-VOICE study ;Primary end point(s): neutralizing antibody titers against the SARS-CoV-2 spike protein and nucleocapsid protein on day

—

Secondary

Measure	Time frame
Secondary end point(s): •To study the duration of the immune response •To identify the most optimal timing of vaccination in patients under chemotherapy. •To investigate the efficacy of the immune response •Assessment of the cellular immune response •To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). ADDENDUM extra booster shot •To investigate the safety of the 3th and 4th COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) dose. •To investigate the kinetics and longevity of the antibody response after both 3th and 4th dose. •To investigate the proportion of high-responders per current treatment cohort after both 3th and 4th dose. •To measure neutralizing antibody titers, only in seroconverters, after 28 days after both 3th and 4th dose. •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the primary endpoints of the original B-VOICE study and of the Tri-VOICE studyy ;Timepoint(s) of evaluation of this end point: end of the study	—

Measure

Time frame

Secondary end point(s): •To study the duration of the immune response •To identify the most optimal timing of vaccination in patients under chemotherapy. •To investigate the efficacy of the immune response •Assessment of the cellular immune response •To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). ADDENDUM extra booster shot •To investigate the safety of the 3th and 4th COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) dose. •To investigate the kinetics and longevity of the antibody response after both 3th and 4th dose. •To investigate the proportion of high-responders per current treatment cohort after both 3th and 4th dose. •To measure neutralizing antibody titers, only in seroconverters, after 28 days after both 3th and 4th dose. •Assessment of the cellular immune response •Assessment of the SARS-Cov2 breakthrough infection rate •Head-to-head comparison of the primary endpoints of the original B-VOICE study and of the Tri-VOICE studyy ;Timepoint(s) of evaluation of this end point: end of the study

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Countries

Belgium

Contacts

Public Contactdata manager

Antwerp University Hospital

lise.verbruggen@uza.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026