# Longitudinal SARS-CoV-2 mRNA vaccine-induced mucosal, serological, and cellular immunity in children and human milk

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $789,208

## Abstract

PROJECT SUMMARY
COVID-19 cases and hospitalizations in children have increased dramatically worldwide. Although most COVID-
19 is mild in children, severe illness and post-infectious complications can occur. We and others have found that
children are an important source of household and community transmission. Vaccination is the most effective
way to prevent severe infection and decrease transmission. Infants under 6 months of age are at high risk for
life-threatening complications, but a vaccine for this age group is not yet in clinical trials; thus, maternal
vaccination and breastfeeding may be an important strategy to protect infects. SARS-CoV-2 infection and
vaccine immunity studies have focused predominantly on adults, but children have developing immune
systems and may respond to the new mRNA vaccination platform differently from adults. This proposal
addresses the critical need to study the short- and long-term immune responses to COVID-19 mRNA vaccination
in children, human milk, and breastfeeding infants. We have a successful ongoing longitudinal COVID-19
vaccination cohort that began in December 2020, in which we have collected biologic specimens from 368
individuals including adults, children, and lactating mother-infant pairs. We will enroll a total of 560 individuals
down to 6 months of age after the mRNA vaccine receives Emergency Use Authorization (EUA) for the younger
age group. Participants are followed every 3 months for nasal, saliva, milk (if lactating), and blood samples. We
will test all COVID-19 symptomatic or exposed participants for breakthrough infection throughout the study
period. Our central hypothesis is that the repertoire, magnitude, and longevity of COVID-19 vaccine-
induced immune responses will be dependent on age and previous experience with SARS-CoV-2
infection. Importantly, our study will also move beyond the systemic immune responses to examine
mucosal immunity in the respiratory tract and in human milk. To test the hypothesis, we will characterize
vaccine induced serum, nasal, and saliva SARS-CoV-2-specific antibody response (Aim 1) and cellular
(CD4+/CD8+) response (Aim 2) in children compared with adults and identify key immunologic correlates of
protection against breakthrough infection. We will also determine humoral and cellular responses in human milk
and secretory IgA in the breastfed infants’ upper respiratory tract and evaluate vaccine-induced differential gene
expression in milk that direct the immune response (Aim 3). Our collaborative team with expertise in vaccinology,
immunology, virology, epidemiology, and bioinformatics will ensure successful integrative analyses and
interpretation of these immunologic and transcriptomic data. Completion of the study will provide a
comprehensive characterization of longitudinal COVID-19 mRNA vaccination-induced immunity across age
groups and in human milk to inform vaccination strategies to optimize the protection of children and infants.

## Key facts

- **NIH application ID:** 10892183
- **Project number:** 5R01AI173194-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Pia S Pannaraj
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $789,208
- **Award type:** 5
- **Project period:** 2022-09-21 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10892183

## Citation

> US National Institutes of Health, RePORTER application 10892183, Longitudinal SARS-CoV-2 mRNA vaccine-induced mucosal, serological, and cellular immunity in children and human milk (5R01AI173194-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10892183. Licensed CC0.

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