Inovio has extended the Phase III portion of its Phase II/III INNOVATE clinical trial of its Covid-19 vaccine candidate, INO-4800, to Colombia.
The move comes after Colombia’s National Food and Drug Surveillance Institute (INVIMA) granted authorisation to carry out the trial in the country.
INO-4800 contains an accurately designed DNA plasmid and is administered intradermally with subsequent electroporation using a smart device.
The device can carry the DNA plasmid directly into body cells, potentially inducing a well-tolerated immune response.
In collaboration with Advaccine Biopharmaceuticals Suzhou, Inovio is conducting the Phase III trial in various nations, mainly focusing on Asia, Latin America and Africa.
In August this year, Inovio received authorisation in Brazil to commence the Phase III trial of the vaccine.
The company also secured authorisation to carry out the trial in the Philippines and Mexico.
The international Phase III trial will assess the efficacy of the two-dose regimen of the vaccine given at a gap of one month in adult subjects aged 18 years and above.
Virologically confirmed Covid-19 will be the primary goal of the trial.
The Phase III segment builds upon positive data from the Phase II part of the trial in the US.
Findings from the Phase II trial showed that the vaccine was well-tolerated and immunogenic in adults aged 18 and above.
The vaccine offered wide-ranging cross-reactive immune responses against SARS-CoV-2 variants of concern, including Alpha, Beta, Gamma and Delta in a study.
Inovio president and CEO Dr J Joseph Kim said: “INO-4800 is well-positioned to support vaccination efforts in Colombia and beyond, if approved, with the prospects of potentially serving both as a primary series and as a booster vaccine, with a strong thermostability profile and ability to generate neutralising antibodies and robust T cell responses.”
The company also obtained authorisation in China to conduct two Advaccine-funded trials analysing heterologous boost combinations with the INO-4800 vaccine candidate.