# Innovation Fund Application to the Multicenter AIDS Cohort Study (MACS)/Womens Interagency HIV Study (WIHS) Combined Cohort Study (MWCCS): COVID-19 Vaccine Acceptance and Hesitancy (CVHB)

> **NIH NIH U01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2021 · $33,764

## Abstract

COVID Vaccine Study Supplement to MWCCS Principal Investigators: C. Rinaldo and J. Martinson
Innovation Fund Application to the Multicenter AIDS Cohort Study (MACS)/Women’s
Interagency HIV Study (WIHS) Combined Cohort Study (MWCCS): COVID-19 Vaccine Acceptance
and Hesitancy (CVHB) Study in People with HIV
Abstract and Specific Aims
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
protecti...

## Key facts

- **NIH application ID:** 10397893
- **Project number:** 3U01HL146203-03S1
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** MARIA LUISA ALCAIDE
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $33,764
- **Award type:** 3
- **Project period:** 2019-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10397893

## Citation

> US National Institutes of Health, RePORTER application 10397893, Innovation Fund Application to the Multicenter AIDS Cohort Study (MACS)/Womens Interagency HIV Study (WIHS) Combined Cohort Study (MWCCS): COVID-19 Vaccine Acceptance and Hesitancy (CVHB) (3U01HL146203-03S1). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10397893. Licensed CC0.

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