# Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

> **NIH NIH P30** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2022 · $431,130

## Abstract

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.

## Key facts

- **NIH application ID:** 10494563
- **Project number:** 3P30CA013330-49S3
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** EDWARD CHU
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $431,130
- **Award type:** 3
- **Project period:** 2021-11-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10494563

## Citation

> US National Institutes of Health, RePORTER application 10494563, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) (3P30CA013330-49S3). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10494563. Licensed CC0.

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