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Trial Set for Covid-19 Nasal Spray Vaccine

Nasal spray

(Pixy.org)

5 Jan. 2022. A clinical trial testing a vaccine to protect against Covid-19 disease, given as a nasal spray, is scheduled to begin later this year in the Netherlands. The nasal spray called Nanovac will be produced by vaccine developer Intravacc in Bilthoven, the Netherlands, in partnership with Leiden University Medical Center, also in the Netherlands.

Intravacc says the vaccine targets the SARS-CoV-2 spike protein, like other vaccines, but also proteins from other parts of the virus to increase its potency against current and future variants. The company says Nanovac is made of nanoscale protein particles formulated into soluble spheres for delivery as a nasal spray, where the particles can act quickly in mucous membranes in the nose and throat. Nanovac does not use messenger RNA or inactivated cold viruses for delivery.

The vaccine, says Intravacc, is designed to produce both neutralizing antibodies and T-cells for both rapid and durable protection. In addition, Nanovac uses an hepatitis B core antigen as an adjuvant to strengthen immune responses that the company says is shown to be safe for nasal spray administration in a vaccine developed for liver inflammation. Nanovac was designed and tested in lab animals at Leiden University Medical Center, with a team led by radiology professor Luis Cruz who studies nanoscale materials and drug delivery systems.

First of two Covid-19 nasal spray vaccines

The early- and mid-stage clinical trial plans to enroll healthy volunteers looking primarily for Nanovac’s safety and tolerability. The study, led by Leiden University infectious disease professor Leo Visser, is not expected to begin until late in 2022, with first results released in 2023. (The trial is not yet listed in ClinicalTrials.gov or the EU’s clinical trial registry.) The company says Nanovac has more preclinical work scheduled and vaccine manufacturing issues still need to be resolved.

Intravacc says it’s working on its own nasal spray vaccine for Covid-19 code-named AVACC-10 using a technology that produces spherical containers resembling outer membranes of bacteria. The company generates these outer membrane vesicles, as they’re called, from meningococcal bacteria, engineered for vaccine delivery and rendered non-toxic to humans. Intravacc says its outer membrane vesicles act as a delivery vehicle for vaccines, as well as an adjuvant. Intravacc says both vaccines do not need refrigeration and can be stored at room temperature.

In a company statement, Intravacc CEO Jan Groen calls Nanovac and AVACC-10 vaccines “potential game-changers in the fight against Covid.” Groen cites immunologist Ed Lavelle of Trinity College Dublin that “transmission of the virus is best blocked where it enters the body. It is therefore preferable to administer the vaccine via a spray in the nose for direct immunization of the throat and nasal mucosa.”

Nasal spray vaccines against Covid-19 are showing mixed results so far. As reported in Science & Enterprise in September 2021, a clinical trial testing a Covid-19 vaccine nasal spray made by CyanVac LLC in Athens, Georgia enrolled its first participant. But earlier in the year, Altimmune Inc. in Gaithersburg, Maryland discontinued its work on a Covid-19 nasal spray vaccine after clinical trial results showed it produces little immune response.

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