# Data Analysis and Coordination Center for the MACS-WIHS Combined Cohort Study

> **NIH NIH U01** · JOHNS HOPKINS UNIVERSITY · 2021 · $16,344

## Abstract

Contact PD/PI: Rinaldo, Charles R
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 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 ...

## Key facts

- **NIH application ID:** 10392680
- **Project number:** 3U01HL146193-03S1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Gypsyamber D'Souza
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $16,344
- **Award type:** 3
- **Project period:** 2019-04-09 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10392680

## Citation

> US National Institutes of Health, RePORTER application 10392680, Data Analysis and Coordination Center for the MACS-WIHS Combined Cohort Study (3U01HL146193-03S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10392680. Licensed CC0.

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