Germany-based biopharmaceutical company Curevac has announced positive interim data from the Phase II study evaluating its Covid-19 mRNA vaccine candidates.
The monovalent vaccine CV0601 showed a 5.0-fold increase in neutralising antibodies against the Omicron BA/4-5 variant on day 29 post-booster when administered at a medium dose, surpassing the comparator vaccine’s 3.6-fold ratio.
For the bivalent vaccine CV0701, which was tested at low, medium, and high doses, the post-booster neutralising antibody titres were 2.7-fold, 3.7-fold, and 4.6-fold higher than pre-booster levels on day 29, respectively. The comparator vaccine showed a 3.6-fold ratio of post-booster to pre-booster titers.
The randomised, active-controlled, observer-blind study (NCT05960097) enrolled 427 participants and evaluated monovalent CV0601 against Omicron BA.4-5 and bivalent CV0701 vaccines against Omicron BA.4-5 variant and original SARS-CoV-2.
Both vaccines, which are developed in partnership with GSK, were compared to a licensed bivalent mRNA-based Covid-19 vaccine.
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The head-to-head study demonstrated well-tolerated reactogenicity for both candidates. All three tested dose levels were lower than the ones used in mRNA-based Covid-19 vaccines licensed in the US and Europe.
CureVac is now discussing the next steps with regulatory authorities, including a Phase III study.
In the announcement accompanying the results, CureVac chief development officer Myriam Mendila said: “We are greatly encouraged by the strong immunogenicity results achieved for our Covid-19 mRNA vaccine candidates and are in advanced discussions with regulatory authorities to determine the best path forward for a pivotal Phase III study.”
CureVac and pharma-giant GSK dosed the first subject in the study in August 2023.
CureVac and GSK are also continuing to advance their joint flu vaccine programme, as highlighted in the announcement. In May 2023, GSK and CureVac dosed the first subject in the Phase II part of the combined Phase I/II study of multivalent mRNA vaccine against WHO-recommended flu strains. Data from the influenza trial is expected in 2024.
CureVac hit a setback in June 2021 when its Covid-19 vaccine failed to meet Phase IIb/III prespecified efficacy criteria. The trial enrolled 40,000 subjects across ten countries, with Bayer added as a partner to help with manufacturing, distribution, regulatory affairs, pharmacovigilance, medical information and supply chain performance in preparation for potential launch.