Document text
Principal Investigator: EDWARD CHU
Organization: ALBERT EINSTEIN COLLEGE OF MEDICINE
Fiscal Year: 2022
Award: $431,130
Funding agency: National Cancer Institute
Abstract
It is now well-established that COVID-19 in patients with cancer carries a higher morbidity and mortality,
especially in amongst patients with hematologic malignancies1, 2. Effective vaccines have been developed and
authorized by the FDA to combat this pandemic3-5. However, emerging data suggests that despite these
vaccines inducing high levels of immunity in the general population, patients with hematologic malignancies have
lower rates of seroconversion for the SARS-CoV-2 Spike antibody6-9. Indeed, our prior data had suggested
excellent immunogenicity of the currently FDA authorized Covid-19 vaccines for most patients with a malignant
diagnosis with exception of unique cohorts- patients with hematological malignancies and following highly
immune suppressive therapies (SCT, CAR-T, anti-CD20). Our current study plans to address the efficacy of
Covid-19 booster vaccinations amongst patients with a cancer diagnosis with a special focus on patients with
undetectable or low anti-Spike IgG antibody levels. 250 patients with a diverse range of ethnicities, cancer
diagnosis and prior cancer therapies will be enrolled in this study and the response to booster vaccinations will
be assessed using standard anti-Spike IgG as well as investigational T cell and Virus Neutralization assays. In
addition, in a second cohort we will define if a “mix and match” vaccination strategy might be more successful at
achieving detectable immunity in patients with persistently negative/low antibody levels despite booster
vaccinations. In this cohort, 100 patients will be accrued who by anti-spike IgG assays have not developed
detectable or have low levels of humoral immunity. These patients will be randomized to receive an additional
dose of an mRNA based vaccine (BNT162b2) versus an adenoviral vaccine (AdCov2.S).Both studies will assess
safety and efficacy of these vaccination schemes and will provide long-term data with 24 months of follow up
planned. These studies should provide critical information to best address proper protective strategies for
uniquely vulnerable patient populations with a cancer diagnosis.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV vaccine><7S Gamma Globulin><Active Follow-up><Address><Administrative Supplement><Anti-CD20 Antibody><Antibodies><Antibody titer measurement><Assay><BNT 162b2><BNT162b2><Bioassay><Biologic Assays><Biological Assay><Booster Immunization><CAR T cell therapy><CAR T therapy><CDC><COVID><COVID-19><COVID-19 booster><COVID-19 negative><COVID-19 positive><COVID-19 positivity><COVID-19 vaccination><COVID-19 vaccine><COVID-19 vaccine booster><COVID-19 virus><COVID19><COVID19 negative><COVID19 positive><COVID19 positivity><COVID19 vaccination><COVID19 vaccine><COVID19 virus><CV-19><CV19><Cancer Patient><Cancer Treatment><Cancers><Case Study><Cellular Assay><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Clinical Trials><CoV disease><CoV-2><CoV2><Cohort Studies><Concurrent Studies><Cooperative Agreements><Data><Diagnosis><Dose><Enrollment><Ethnic Origin><Ethnicity><General Population><General Public><Grafting Procedure><Grant><Hematologic Cancer><Hematologic Malignancies><Hematologic Neoplasms><Hematological Malignancies><Hematological Neoplasms><Hematological Tumor><Hematology><Hematopoietic Cancer><Humoral Immunities><IgG><Immune><Immune memory><Immune response><Immunes><Immunity><Immunocompromised><Immunocompromised Host><Immunocompromised Patient><Immunoglobulin G><Immunologic Memory><Immunological Memory><Immunological response><Immunosuppressed Host><Investigation><Laboratories><Malignant><Malignant - descriptor><Malignant Hematologic Neoplasm><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Medical center><MoAb Anti-B1><Moderna COVID-19 vaccine><Moderna coronavirus disease 2019 vaccine><Monoclonal Antibody Anti-B1><Morbidity><Morbidity - disease rate><NIH><National Institutes of Health><Organ Transplantation><Organ Transplants><Paper><Parents><Patients><Pfizer-BioNTech COVID-19 vaccine><Pfizer-BioNTech coronavirus disease 2019 vaccine><Progenitor Cell Transplantation><RNA immunization><RNA vaccination><RNA vaccine><RNA-based vaccine><Randomized><Recommendation><Research Design><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 booster><SARS-CoV-2 negative><SARS-CoV-2 positive><SARS-CoV-2 positivity><SARS-CoV-2 vaccination><SARS-CoV-2 vaccine><SARS-CoV-2 vaccine booster><SARS-CoV2><SARS-CoV2 vaccine><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 vaccine><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Safety><Scheme><Secondary Immunization><Series><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 positive><Severe acute respiratory syndrome coronavirus 2 positivity><Severe acute respiratory syndrome coronavirus 2 vaccination><Severe acute respiratory syndrome coronavirus 2 vaccine><Severe acute respiratory syndrome related corona virus 2><Solid><Solid Neoplasm><Solid Tumor><Stem Cell Transplantation><Stem cell transplant><Study Type><T-Cell Activation><T-Cells><T-Lymphocyte><Testing><U-Series Cooperative Agreements><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><United States National Institutes of Health><Update><Vaccination><Vaccines><Viral><Virus><Wuhan coronavirus><active followup><anamnestic reaction><anti-B1><anti-CD20><anti-cancer therapy><antibody assay><antibody based test><antibody test><antibody titering><antibody-based immunity><anticancer therapy><arm><base><booster against COVID-19><booster against SARS-CoV-2><booster dose><booster shot><booster vaccination><booster vaccine><cancer diagnosis><cancer therapy><cancer-directed therapy><case report><cell assay><chimeric antigen receptor (CAR) T cell therapy><chimeric antigen receptor T cell therapy><cohort><combat><corona virus disease><corona virus disease 2019><corona virus disease 2019 vaccine><coronavirus disease><coronavirus disease 2019><coronavirus disease 2019 negative><coronavirus disease 2019 positive><coronavirus disease 2019 positivity><coronavirus disease 2019 vaccination><coronavirus disease 2019 vaccine><coronavirus disease 2019 virus><coronavirus disease-19><coronavirus disease-19 vaccine><coronavirus disease-19 virus><coronavirus infectious disease-19><enroll><follow up><follow-up><followed up><followup><hCoV19><high risk><host response><immune system response><immunization strategy><immunogenicity><immunoresponse><immunosuppressed patient><inhibitor><mRNA immunization><mRNA vaccination><mRNA vaccine><mRNA-1273><mRNA-based vaccine><mRNA1273><malignancy><mortality><nCoV2><neoplasm/cancer><neutralizing antibody><novel><organ allograft><organ graft><organ xenograft><patient population><primary end point><primary endpoint><prospective><randomisation><randomization><randomly assigned><response><safety study><secondary end point><secondary endpoint><secondary immune response><seroconversion><severe acute respiratory syndrome coronavirus 2 negative><side effect><study design><thymus derived lymphocyte><tositumomab><vaccinate against COVID-19><vaccinate against COVID19><vaccinate against SARS-CoV-2><vaccinate against coronavirus disease 2019><vaccinate against severe acute respiratory syndrome coronavirus 2><vaccination against COVID-19><vaccination against COVID19><vaccination against SARS-CoV-2><vaccination against Severe acute respiratory syndrome coronavirus 2><vaccination against coronavirus disease 2019><vaccination strategy><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine for novel coronavirus>