Bavarian Nordic has launched a Phase II clinical trial to evaluate its Covid-19 vaccine candidate, ABNCoV2, as a booster for people with prior SARS-CoV-2 infection or vaccination.
Initially developed by AdaptVac using its capsid virus-like particle (cVLP) technology, ABNCoV2 was licensed by Bavarian Nordic for worldwide commercialisation and clinical development.
Sponsored by Bavarian Nordic, the new Phase II trial is designed to enrol up to 210 healthy adults.
A group of 150 seropositive, which includes existing immunity from previous illness or a complete vaccination with approved Covid-19 vaccines, participants will be given one 100μg dose of ABNCoV2.
In these subjects, the aim is to bolster existing SARS-CoV-2 neutralising antibody levels.
Two 100μg doses of the vaccine will be administered 28 days apart in the second group of up to 60 seronegative volunteers without previous infection or inoculation.
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This group is intended to assess neutralising antibody levels from when the vaccine is given as a prime booster.
The trial’s primary endpoint is SARS-CoV-2 neutralising antibody titres at two weeks following the last vaccination, which is following the second inoculation in initially seronegative participants and after the single booster dose in seropositive participants.
Additional study goals are the vaccine’s safety and neutralising antibody titres against variant strains that are circulating during analysis at two weeks from the last inoculation, among others.
Preliminary data from the trial are anticipated in the fourth quarter of this year.
Participants in the first group will continue the trial for up to two years to analyse the immune response durability from the booster vaccine dose.
Bavarian Nordic president and CEO Paul Chaplin said: “There is a growing expectation that booster vaccinations will be required to manage the pandemic and to broaden the protection against emerging variants and we remain committed to the development of ABNCoV2, as we believe it has the potential to fulfil these requirements.”
Earlier this month, the company announced positive preliminary data from the first-in-human Phase I/II dose-escalation trial of ABNCoV2.
The company is currently also working to conduct a Phase III trial of the vaccine next year.