# The development of a recombinant vaccine against human onchocerciasis

> **NIH NIH R01** · NEW YORK BLOOD CENTER · 2021 · $775,846

## Abstract

ABSTRACT
Human onchocerciasis (ONCHO) is a major cause of infectious blindness, skin disease, and chronic disability,
infecting many millions worldwide99% in Sub-Saharan Africaand resulting in widespread vision impairment
and blindness. Caused by the filarial nematode Onchocerca volvulus (Ov), attempts to eliminate this neglected
tropical disease via annual mass drug administration (MDA) with donated ivermectin (IVM) have proved largely
ineffective, decreasing its incidence only 31% in the last 20 years. Optimists call for an additional 1.15 billion
treatments to achieve elimination by 2045. Mathematical modelling and expert opinions are more pessimistic,
indicating that ONCHO in Africa cannot be eliminated solely through MDA with IVM. Supporting their viewpoint
is that IVM cannot be administered safely in Central Africa where the disease is co-endemic with Loa loa
infections, and early evidence points to the possible emergence of IVM drug resistance. New tools are needed,
such as a preventive vaccine to accelerate ONCHO elimination. Our goal is to develop a safe and effective
prophylactic vaccine to protect vulnerable populations of children <5 living in endemic areas against Ov
infections. Reducing the adult worm burden and possibly also fecundity will inexorably reduce microfilaridermia
and pathology. The vaccine could also contribute to lower transmission rates and protect areas where local
elimination may have been achieved, thus lowering the number of annual MDA with IVM, forestalling drug
resistance, and ensuring the success of the existing MDA. We have already identified 2 Ov protective vaccine
antigens (Ov-103 and Ov-RAL-2) with a proven production pathway and with efficacy in 2 small-animal models;
they were protective as monovalent vaccines, and their efficacy was enhanced when the two monovalent
vaccines were co-administered in separate locations (i.e. ONCHO vaccine). We seek now to leverage these
achievements by advancing to the next stage on the critical path to Ov vaccine development. Our hypothesis is
that an optimal ONCHO vaccine formulation can be identified by further employing the mouse model before
testing it in naïve calves against a natural infection with O. ochengi, an infection system with a closely related
parasite known to mimic immunologically the status of humans living in regions endemic for Ov. Notably, both
vaccine antigens pose minimal risk of generating atopic responses in children <5 years of age who are
naturally exposed to ONCHO; neither elicits significant functional IgE responses. We have 2 specific aims for
meeting our goal: (1) Test in naïve calves under field conditions the efficacy of two ONCHO vaccine
formulations against O. ochengi infection. (2) Establish immune correlates and mechanisms associated in mice
with protective immunity induced by two ONCHO vaccine formulations. Ascertaining which of the 2 adjuvanted
ONCHO vaccines (formulated with alum or with Advax-2 with or without alum) is more effica...

## Key facts

- **NIH application ID:** 10114187
- **Project number:** 5R01AI078314-10
- **Recipient organization:** NEW YORK BLOOD CENTER
- **Principal Investigator:** Sara Lustigman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $775,846
- **Award type:** 5
- **Project period:** 2009-08-25 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10114187

## Citation

> US National Institutes of Health, RePORTER application 10114187, The development of a recombinant vaccine against human onchocerciasis (5R01AI078314-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10114187. Licensed CC0.

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