# Phase II STTR development of an intranasal/oral Spirulina-based PfCSP malaria vaccine.

> **NIH NIH R42** · LUMEN BIOSCIENCE, INC. · 2021 · $1,000,000

## Abstract

ABSTRACT
Vaccination represents the single most effective and cost‐effective medical intervention devised to date, saving lives and
reducing morbidity and disability for billions of humans. Despite the early success of the oral polio vaccine, most
vaccines are delivered parenterally, and as such are associated with pain, non‐compliance, biohazardous medical waste
and the need for trained medical personnel. Moreover, strict requirements for production, transport and storage
logistics (the “cold chain”) are costly and present substantial logistical challenges. Mucosal (oral, intranasal, etc.) vaccine
strategies eliminate or significantly reduce these drawbacks. The potential use of Arthrospira platensis (commonly called
spirulina) as an oral vaccine delivery platform is highly attractive, given its safety profile, rich nutritional content and
wide acceptance as a human food source. Lumen Bioscience has developed unique, patented technology to genetically
engineer spirulina to express heterologous proteins. Lumen Bioscience's spirulina vaccine platform consists of
recombinant strains designed to express viral capsid proteins that assemble and form durable high‐order complexes
commonly called virus‐like particles (VLPs). Parenterally‐administered VLP‐based vaccines have been used in humans for
prevention of infections with human papilloma virus, hepatitis B virus, and malaria parasites. Intranasally and orally‐
administered spirulina‐expressed VLPs have been engineered to efficiently express pathogen‐derived antigens inserted
into the exterior‐facing VLP domains. Here, VLPs bearing epitopes derived from Plasmodium falciparum
circumsporozoite protein (CSP) in spirulina will be administered intranasally and orally to mice and non‐human primates.
This approach has been shown to induce systemic anti‐CSP IgG, which confers protection against sporozoite challenge in
mouse models. This project aims to optimize and develop the intranasal/oral spirulina vaccine model as a safe and
effective malaria vaccine using mice and non‐human primate models to enable a future transition to the clinic.

## Key facts

- **NIH application ID:** 10325170
- **Project number:** 2R42AI138623-03A1
- **Recipient organization:** LUMEN BIOSCIENCE, INC.
- **Principal Investigator:** Nhi Khuong
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,000,000
- **Award type:** 2
- **Project period:** 2018-05-17 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325170

## Citation

> US National Institutes of Health, RePORTER application 10325170, Phase II STTR development of an intranasal/oral Spirulina-based PfCSP malaria vaccine. (2R42AI138623-03A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10325170. Licensed CC0.

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