# Clinical Research Sites for the MACS/WIHS Combined Cohort Study  (MACS/WIHS-CCS)

> **NIH NIH U01** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2021 · $40,374

## 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
Scientific Justification
A safe, highly immunogenic vaccine to prevent primary SARS-CoV-2 infection is needed to control the
COVID-19 pandemic. As of January, 2021, the United States is racing to vaccinate a significant
percentage of our 330 million population to control the COVID-19 pandemic. This extraordinary rapid
development resulted from FDA emergency use authorization (EUA) of two COVID-19 vaccines in
December, 2020, i.e., the Moderna mRNA-1273 vaccine that codes for the stabilized pre-fusion SARS-
CoV-2 spike protein 1, and the Pfizer/BioNTech vaccine BNT162b1 that is a lipid-nanoparticle-formulated,
nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain of the spike
glycoprotein of SARS-CoV-2 2.
Despite this enormous public health issue of stopping the COVID-19 pandemic, there are essentially no
data on COVID-9 vaccine acceptance or efficacy in people with HIV (PWH). This is critically important
for public health, in that an estimated 1.2 million people aged 13 and older have HIV in the United States,
including an estimated 161,800 (14%) people whose infections had not been diagnosed 3. Although
several COVID-19 vaccine clinical efficacy trials enrolled PWH without specific selectivity, there are
insufficient data exist to determine the efficacy of COVID-19 vaccines in PWH. Indeed, prior to the
COVID-19 pandemic, the CDC recommended that PWH with CD4 T cell counts of ≥200 or percentages
≥15% receive all licensed vaccines. Further, the CDC stated in a release December 12, 2020
(https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-12/COVID-03-
Mbaeyi.pdf): “The recently FDA-authorized Pfizer-BioNTech COVID-19 vaccine is not contraindicated for
people living with HIV or others with immunocompromised conditions, though vaccine efficacy data
does not currently exist for potentially immunocompromised individuals”. According to the CDC
Advisory Committee on Immunization Practices (ACIP), “people living with HIV may still receive the
vaccine, but should be counseled on unknown vaccine safety and efficacy profiles in
immunocompromised persons.” The ACIP also recently recommended that health care personnel and
residents of long-term care facilities (LTCFs) be offered vaccination in the initial phase of the COVID-19
vaccination program (Phase 1a) 4. In sum, PWH are looking to us for advice as their scientific and
clinical HIV experts, with our response being that the COVID-19 vaccines “should be” safe and
effective in them based on no specific data. Our proposed study aims to supply such data through
a well-designed protocol nested in the most well-established and trusted MACS-WIHS Combined
Co...

## Key facts

- **NIH application ID:** 10401178
- **Project number:** 3U01HL146204-03S1
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** Kathryn M. Anastos
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $40,374
- **Award type:** 3
- **Project period:** 2019-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10401178

## Citation

> US National Institutes of Health, RePORTER application 10401178, Clinical Research Sites for the MACS/WIHS Combined Cohort Study  (MACS/WIHS-CCS) (3U01HL146204-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10401178. Licensed CC0.

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