Clinical Trial for mRNA Vaccine Safety and Efficacy

Example 8

To demonstrate safety and efficiency of the mRNA vaccine composition(s), a clinical trial (phase I) is initiated. In the clinical trial, a cohort of human volunteers is intradermally or intramuscularly injected for at least two times. In order to assess the safety profile of the vaccine compositions according to the invention, subjects are monitored after administration (vital signs, vaccination site tolerability assessments, hematologic analysis). The efficacy of the immunization is analyzed by determination of virus neutralizing titers (VNT) in sera from vaccinated subjects. Blood samples are collected on day 0 as baseline and after completed vaccination. Sera are analyzed for virus neutralizing antibodies.

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US11865084B2. MERS coronavirus vaccine (2024-01-09). CureVac SE [DE]. Inventors: Susanne Rauch [DE].

Patent 2024

Blood Hendra virus Human volunteers Immunization Mrna vaccine Neutralizing antibodies Nipah virus Safety Sera Vaccination Vaccine Virus Vital signs

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Variable analysis

independent variables

Route of administration (intradermal or intramuscular)

dependent variables

Safety profile (vital signs, vaccination site tolerability assessments, hematologic analysis)
Virus neutralizing titers (VNT) in sera from vaccinated subjects

control variables

Number of vaccine administrations (at least two times)

controls

Positive control: Not specified
Negative control: Not specified

Annotations

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