# MACS/WIHS Combined Cohort Study: Cook County Clinical Research Site (CC_CRS)

> **NIH NIH U01** · HEKTOEN INSTITUTE FOR MEDICAL RESEARCH · 2021 · $31,348

## 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 comormidity 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 information 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 SARS-CoV-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 ou...

## Key facts

- **NIH application ID:** 10401710
- **Project number:** 3U01HL146245-03S1
- **Recipient organization:** HEKTOEN INSTITUTE FOR MEDICAL RESEARCH
- **Principal Investigator:** Mardge H Cohen
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $31,348
- **Award type:** 3
- **Project period:** 2019-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10401710

## Citation

> US National Institutes of Health, RePORTER application 10401710, MACS/WIHS Combined Cohort Study: Cook County Clinical Research Site (CC_CRS) (3U01HL146245-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10401710. Licensed CC0.

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