Booster Doses of COVID-19 Vaccines for the Prevention of COVID-19 in Cancer Patients

Status: closed to accrual

This clinical trial evaluates the safety and effectiveness of booster doses of COVID-19 vaccines in preventing COVID-19 in patients with cancer whose immune system did not make antibodies against the virus that causes COVID after receiving the recommended Pfizer/BioNTech or Moderna vaccine series, currently meet the Centers for Disease Control and Prevention (CDC) definition for immunocompromised status, or received the Johnson & Johnson COVID vaccine. This trial may help doctors understand how the bodies of cancer patients react to an extra booster dose of the COVID vaccine. This trial may also help doctors learn which cancer patients benefit from an extra booster dose of the COVID vaccine, as well as which cancer treatments place an individual at higher risk of not achieving an adequate immune response to this vaccine.

Inclusion Criteria

COHORT 1: Above the age of 18
COHORT 1: Meet one of the sub-criteria below: * Meet the Centers for Disease Control and Prevention (CDC) definition for immunocompromised status for cancer patients, i.e patients receiving active treatment for solid tumor or hematologic malignancy OR * Be a recipient of stem cell transplant or chimeric antigen receptor (CAR)-T cell therapy in the last 2 years OR * Have a negative SARS-CoV-2 spike IgG despite standard vaccination series, irrespective of active/inactive cancer status, on observation, or active therapy
COHORT 1: Underwent an in-person encounter at a study facility during the study period
COHORT 1: Have received the second of the mRNA vaccines (BNT162b2 or mRNA 1273) or the adenoviral Ad26CoV2.S vaccine at least 28 days before the booster dose
COHORT 2: Above the age of 18
COHORT 2: Have a diagnosis of prior or active malignancy- either hematological or solid tumor
COHORT 2: Have a negative or low-level SARS-CoV-2 spike IgG after at least 14 days of booster vaccination series irrespective of active/inactive cancer status, on observation, or active therapy
COHORT 2: Have received a Food and Drug Administration (FDA) authorized booster dose of mRNA (BNT162b2 or mRNA 1273) vaccine at least 28 days before study enrollment

Exclusion Criteria

COHORT 1: Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines
COHORT 1: Patients who have had a documented COVID-19 infection in the 90 days prior to starting the study
COHORT 2: Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines
COHORT 2: Patients who have had a documented COVID-19 infection in the 90 days prior to study enrollment

PRIMARY OBJECTIVES:

I. To study the seroconversion for SARS-CoV-2 spike IgG in patients with cancer after administering a booster dose of the tozinameran (BNT162b2) or lipid nanoparticle-encapsulated messenger ribonucleic acid (mRNA)-based SARS-CoV-2 Vaccine mRNA-1273 (mRNA 1273 vaccine). (Cohort 1)

II. To study the spike antibody titers as well as T cell activation after a booster dose and compare them with the prior titer/baseline T cell activity. (Cohort 1)

III. To study safety and side effects from a booster dose of the BNT162b2 or mRNA 1273 COVID vaccine. (Cohort 1)

IV. To study the seroconversion for SARS-CoV-2 spike IgG in patients with cancer after administering an additional booster dose of the BNT162b2 or COVID-19 vaccine Ad26.COV2.S (AdCoV2.S) vaccine determined in a randomized fashion. (Cohort 2)

V. To study safety and side effects from an additional booster dose of the BNT162b2 or AdCoV2.S vaccine. (Cohort 2)

OUTLINE:

COHORT 1: Patients receive a booster dose of BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

COHORT 2: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive an additional booster dose of BNT162b2 (Pfizer/BioNTech).

ARM II: Patients receive a booster dose of Ad26.COV2.S (Johnson & Johnson).

After completion of study intervention, patients are followed for 28 days and then at 3, 6, 12, and 24 months.

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Booster Doses of COVID-19 Vaccines for the Prevention of COVID-19 in Cancer Patients

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