# Live nasal recombinant B. pertussis vaccine against tuberculosis

> **NIH NIH R61** · ILIAD BIOTECHNOLOGIES, LLC · 2022 · $329,260

## Abstract

ABSTRACT: Live nasal recombinant B. pertussis vaccine against tuberculosis
An effective TB vaccine that blocks infection and interrupts transmission of TB from infected adolescents
and adults is urgently needed as a complement to the worldwide use of BCG in infants. Although BCG is
moderately effective in preventing disseminated forms of TB, new vaccine strategies are necessary for
improved control and prevention of TB which infects over 10 million people annually. True correlates of
protective immunity have not been identified. However, local, lung-resident memory T cells have been
implicated in protection against pulmonary forms of TB in many prior animal model studies. Furthermore,
recent evidence shows that IL-17 secreting T cells that are enriched in the lung tissue of infected humans
are likely involved with immunological control of pulmonary infections. New vaccine strategies are needed
that can induce mucosal response and better induce protective T cells in the lungs. Our vaccine strategy
will advance a live vaccine platform based on B-Tech, an attenuated strain of Bordetella pertussis, which
has already completed Phase 2 clinical trials and has demonstrated ability to induce durable and specific
mucosal and systemic immune responses. We propose to develop the platform bacterial vector (called
B-Tech-Mtb) for intranasal vaccination. B-Tech strains transiently colonize the nasopharyngeal mucosa in
animal models and humans and induce mucosal (including secretory IgA and resident memory T cells)
and systemic (including serum antibodies and circulating T cells) responses against pertussis antigens.
In addition, B-Tech vaccines are lyophilized, have >2-year stability at 25°C, and can be produced by most
if not all developing countries at low cost. In murine studies, transient colonization induces a resident
memory T cell response that is associated with protection against B. pertussis infection. Indeed, transient
colonization of the nasopharyngeal mucosa by B. pertussis results in targeting of mucosal dendritic cells,
the induction of Th17 T cell responses, and high expression of IL-17 that is associated with the
development of robust secretory IgA and resident T cell memory in the lungs. We propose to engineer
genetically modified bacterial systems developed in our labs for expression and secretion of several Mtb
hybrid antigens that have been tested clinically as parenteral vaccines. We will construct and test B-Tech-
Mtb vaccine candidates after intranasal administration in mice and non-human primate models, secreting
selected M. tuberculosis antigens continuously in the vicinity of mucosal inductive sites. By developing B.
pertussis strains secreting one or more Mtb antigens, we anticipate that Th1/Th17 skewed T cell
responses will be more robust than observed in prior vaccine studies with other mucosally or parenterally
administered TB vaccine candidates. With success, this program will enable production of enhanced Mtb-
specific mucosal ...

## Key facts

- **NIH application ID:** 10442002
- **Project number:** 1R61AI169201-01
- **Recipient organization:** ILIAD BIOTECHNOLOGIES, LLC
- **Principal Investigator:** Peter Goldstein
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $329,260
- **Award type:** 1
- **Project period:** 2022-05-04 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10442002

## Citation

> US National Institutes of Health, RePORTER application 10442002, Live nasal recombinant B. pertussis vaccine against tuberculosis (1R61AI169201-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10442002. Licensed CC0.

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