# Core D: Early and IND-Enabling Translational Research for Vaccines and MAbs

> **NIH NIH U19** · UNIVERSITY OF TEXAS MED BR GALVESTON · 2024 · $4,640,499

## Abstract

ABSTRACT/PROJECT SUMMARY – Core D (Early and IND-Enabling Translational Research for Vaccines
and mAbs)
Core D will leverage the relationship between vaccines and antibodies to optimize the translational activities
performed by the PABVAX Center. Vaccines and antibodies are inextricably linked:
 1. mAbs can help define protective epitopes for a vaccine
 2. mAbs can help establish correlates of protection for vaccines
 3. Vaccine antigens can be used to discover mAbs
 4. mAbs can provide an alternative to a vaccine in immunocompromised populations and in emergency
 situations where immediate protection is required (i.e. there isn’t sufficient time to allow natural host
 immunity to develop from vaccination)
Developing mAb countermeasures and vaccines simultaneously will allow us to take advantage of natural
synergies between the two types of interventions and more efficiently advance superior prototypes.
To meet the goals of the PABVAX Center, Core D has the following Specific Aims:
Aim 1: Manufacture vaccine antigens and mAbs in support of the RPs and Cores
Manufacturing will be performed by Mapp Biopharmaceutical and Genovac to support the efforts of the other
Scientific Cores and the Research Projects. The largest scale manufacturing runs will be sufficient to support
stability testing and NHP dosing. This will also include production of a mAb prototype for an intramuscular (IM)
long-acting alternative to a vaccine to be evaluated in Core E (Animal Models).
Aim 2: Stability, manufacturability testing, and early process development of subunit vaccines.
Small scale manufacturing, stability testing and early-stage process development will be performed. As vaccines
are regulated by CBER, all activities will be performed consistent with regulatory expectations for this branch of
the FDA. Input from the Core’s vaccine industrial partners (Emergent Biosolutions and Moderna) will be
integrated into the translational development efforts.
Aim 3: Identification of correlates of protection, lead optimization, stability and manufacturability testing of mAbs.
Together with Dr. Gunn, engineered mAbs (altered N-glycans, Fc mutations for effector functions and extended
half-life, multimeric formats and nanobodies from RP5) will be evaluated to correlate mechanisms of action with
maximal efficacy. This work, in conjunction with stability and manufacturability assessment, will identify a lead
prototype format to transition to early process development. The goal will be to identify a single prototype for
long-term intramuscular prophylaxis as well as for intravenous post-exposure prophylaxis and therapy. As mAbs
are regulated by CDER, performance of all activities will be as per regulatory expectations.

## Key facts

- **NIH application ID:** 10862500
- **Project number:** 1U19AI181930-01
- **Recipient organization:** UNIVERSITY OF TEXAS MED BR GALVESTON
- **Principal Investigator:** Larry Zeitlin
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $4,640,499
- **Award type:** 1
- **Project period:** 2024-07-30 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10862500

## Citation

> US National Institutes of Health, RePORTER application 10862500, Core D: Early and IND-Enabling Translational Research for Vaccines and MAbs (1U19AI181930-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10862500. Licensed CC0.

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