Confirmation on CVnCoV a vaccine based on mRNA’s ability to induce a neutralizing antibody response which is similar to that observed in COVID-19 patients with two 12µg vaccine doses has been made in interim Phase I trials.
CVnCoV is an mRNA-based COVID-19 vaccine candidate which integrates a prefusion stabilized full-length SARS-CoV-2 Spike protein. Formulation of this vaccine is based on lipid nanoparticle (LNP) technology licensed from Acuitas Therapeutics.
The Phase I interim study conducted by CureVac N.V. includes dose-escalation to evaluate the safety, reactogenecity and immunogenicity of CVnCoV an investigational SARS-CoV-2 vaccine candidate, the results obtained from this has been positive.
250 healthy individuals ranging from 18 to 60 years grouped as 10 participants per group based on dose levels partook in the study. Intramuscular immunization at increasing doses of two, four, six, eight and 12µg were administered on days 1 and 29. Each of these participants had previously tested positive for COVID-19 infection.
Comments include high toleration of all tested doses, it was also observed that the vaccine induced strong binding and neutralizing antibody responses in addition to indications of T cell activation. Phase II trials for CVnCoV is being undertaken in older adults in Panama and Peru. This is a brilliant indicator of success and Phase IIb/III trial are on under way
Peak serum titers of symptomatic covalescent COVID-19 patients were compared with geometric Mean Titers (GMTs) of binding and neutralizing antibodies in study participants. This was used to validate CVnCoV potency. At 12µg GMTs of binding antibodies increased to the level measured in the HCS panel. Analysis of mediated T cell mediated immunity is ongoing, however early data indicate functional T cells.
This initial study is indicative of a highly efficient immune response to the vaccine in addition to antibody and initial T cell responses at the level of a relevant panel of symptomatic convalescent patients. The reactogenicity of this vaccine was monitored further by a Data and Safety Monitoring bored. No adverse reactions were recorded for all doses administered, however, at 12µg grade three adverse events fatigue, chills, headache and muscle pain occurred after second dose was given. All of these reactions were transient and resolved and within 36 hours