Codagenix, in partnership with the Serum Institute of India, has announced the dosing of the first patient in a Phase I clinical trial of a new intranasal vaccine, CoviLiv, for use as a Covid-19 booster.
The UK-based trial will evaluate the use of Codagenix’s live-attenuated virus vaccine as a booster in healthy adult subjects.
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Actively recruiting subjects, the trial is assessing the immunogenicity and safety of CoviLiv as a heterologous booster in nearly 30 healthy adults.
Earlier, these subjects were vaccinated against Covid-19 with an authorised mRNA or adenovirus-vectored vaccine.
Humoral immunogenicity, as determined by immunoglobulin G and neutralising antibody concentrations at days one, 29, and 181 after administration, include the primary outcome measures for the study.
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Additionally, the trial will measure viral shedding on days four and eight as an early gauge of booster efficacy.
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By GlobalDataCodagenix expects initial data from the trial in August this year.
Codagenix co-founder and CEO Robert Coleman said: “As we enter the endemic phase of Covid-19, there’s a need for boosters that can both reduce nasal transmission and protect against multiple and future strains without the need for variant-specific reformulation.
“An intranasal, live-attenuated vaccine, CoviLiv has an advantageous safety and product profile, with previous clinical data showing its potential to be an effective solution as either a primary vaccine or booster.”
In previous trials, CoviLiv was studied as a primary vaccine and showed to stimulate strong cellular immune responses and blocked nasal replication after a single dose that was administered intranasally.
Furthermore, as part of a World Health Organization placebo-controlled, international Phase II/III efficacy trial for Covid-19, dosing with CoviLiv is expected in the first half of this year.
