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CureVac Covid vaccine induces immune response in early trial - Berlin News

Berlin, Nov 2 (IANS) German vaccine maker CureVac on Monday said that interim results from early trials showed that its investigational Covid-19 vaccine candidate, CvnCoV, appeared safe and triggered immune response among volunteers.

Updated Nov 02, 2020 13:45 PM

CureVac Covid vaccine induces immune response in early trial - Berlin News

The vaccine candidate was generally well tolerated across all tested doses and induced strong binding and neutralising antibody responses in addition to first indication of T cell activation, the company said.

The Phase 1 study has enrolled to date more than 250 healthy individuals aged 18 to 60 years.

Individuals were vaccinated intramuscularly with CVnCoV at escalating dose levels of 2, 4, 6, 8 and 12 microgram on days 1 and 29.

Per dose level, the trial included up to 10 participants who had previously tested positive for a Covid-19 infection (seropositives) to further evaluate the safety and immunogenicity of CVnCoV in this sub-population.

The data support the decision to advance the 12 microgram dose in the upcoming pivotal Phase 2b/3 study, the company said.

"We are very encouraged by the interim Phase 1 data. It represents a critical milestone in our Covid-19 vaccine programme and strongly supports the advancement of our vaccine candidate," Franz-Werner Haas, Chief Executive Officer of CureVac, said in a statement.

"Following further data readouts and discussion with regulatory authorities, we remain fully committed and on track to initiate a pivotal Phase 2b/3 trial before the end of 2020."

While saying that no related serious adverse events were observed during the early trials, at 12 microgram, grade 3 adverse events occurred mostly after administration of the second dose and included fatigue, headache, chills, muscle pain, and to a lesser extent, fever.

All reported events were transient and resolved rapidly, usually within 24 to 48 hours, the company said.

CureVac said it intends to provide a detailed Phase 1 data overview and publication in a scientific journal in the coming weeks.

"These initial data show a robust and highly efficient immune response to our natural mRNA (messenger ribonucleic acid)-based CVnCoV vaccine candidate, including antibody and initial T cell responses at the level of a relevant panel of symptomatic convalescent patients," said Mariola Fotin-Mleczek, Chief Technology Officer of CureVac.

The company said that CVnCoV's mode of action mimics the natural immune response to the infection observed in recovered Covid-19 patients.

CVnCoV is currently also being investigated in a Phase 2a clinical trial in older adults in Peru and Panama.

Disclaimer: This story is auto-aggregated by a computer program and has not been created or edited by FreshersLIVE.Publisher : IANS-Media