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.
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.
Additionally, the trial will measure viral shedding on days four and eight as an early gauge of booster efficacy.
Codagenix 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.