# MACS/WIHS Combined Cohort Study: Brooklyn Clinical Research Site (Bklyn CRS): COVID-19 Vaccine Acceptance and Hesitancy (CVHB) Study in People with HIV Supplement

> **NIH NIH U01** · SUNY DOWNSTATE MEDICAL CENTER · 2021 · $39,400

## Abstract

ABSTRACT
MWCCS participants are a high-risk group for severe COVID-19 disease in terms of being HIV-infected,
predominately of elderly age, and having numerous underlying comorbidities. Therefore, it is imperative for
their health that they be vaccinated with the new COVID-19 vaccines. To date, however, there are only
anecdotal data on COVID-19 vaccine acceptance and efficacy in people with HIV (PWH). The MWCCS is ideal
for analyzing (a) the acceptancy and effects of COVID-19 vaccine(s) in male and female PWH and matched
HIV uninfected controls (HUC), (b) the impact of age and co-morbidities on vaccine immune response and
protection against COVID-19, and (c) the social, economic, and behavioral changes after COVID-19
immunization as compared to the individuals who opted to not take the vaccine. To address this issue, we will
have 2 groups of MWCCS participants in this study: Group A: Male and female PWH and HUC who choose to
receive a COVID-19 vaccine, Group B: Male and female PWH and HUC who choose NOT to receive a COVID-
19 vaccine. The aims of our proposed longitudinal observational study for this OAR Innovation application are:
Aim 1: To conduct an MWCCS-wide, mixed-methods investigation of the prevalence, correlates, and nuances
of COVID-19 vaccine hesitancy among MWCCS participants. Results will help better understand the concerns
of PWH and HUC populations regarding COVID-19 vaccines based on age, sex, race/ethnicity, and underlying
comorbidity burden. Aim 2: To determine the incidence of natural SARS-CoV-2 infections post-COVID-19
immunization in PWH as compared to HUC of the same age, sex, and ethnicity/race and also compare with the
incidence of infections in non-vaccinated individuals. Because of budgetary limitations in the OAR Innovation
Fund supplement, we will restrict Aim 2 to obtaining one specimen at baseline, just prior vaccination in Group
A, and within comparable time periods for Group B. Subsequent samples collected during the core MWCCS
visits will be used in the serological analyzes. These samples will allow us to determine the serological COVID-
19 status pre-immunization, and post-immunization seroconversions for S and N proteins. The titration of anti-
S responses post immunization will indicate vaccine immune response, while anti-N antibody titers will indicate
natural SARS-CoV-2 infection. This will allow the identification of asymptomatic and symptomatic individuals
infected with SARS-CoV-2 post-vaccination and in non-vaccinated group. The if these infections in the
MWCCS will allow a targeted use of core samples in depth investigation of the immune mechanisms of
vaccine-mediated protection, the immunologic responses and virologic characteristics of breakthrough
SARSCoV-2 infections, and the impact of the vaccination on underlying HIV infection. Importantly, timely
funding from this OAR Innovation opportunity is critical to our addressing these aims prior to the broad rollout
of the COVID-19 vaccines to our PWH parti...

## Key facts

- **NIH application ID:** 10396763
- **Project number:** 3U01HL146202-03S1
- **Recipient organization:** SUNY DOWNSTATE MEDICAL CENTER
- **Principal Investigator:** DEBORAH R. GUSTAFSON
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $39,400
- **Award type:** 3
- **Project period:** 2019-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10396763

## Citation

> US National Institutes of Health, RePORTER application 10396763, MACS/WIHS Combined Cohort Study: Brooklyn Clinical Research Site (Bklyn CRS): COVID-19 Vaccine Acceptance and Hesitancy (CVHB) Study in People with HIV Supplement (3U01HL146202-03S1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10396763. Licensed CC0.

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