Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult
      volunteer participants consisting of two phases, an unblinded dose escalation and a double
      blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel
      measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083/V-591).
    

Detailed description: 
      This is a prospective, interventional, randomized, Phase I trial comparing two different dose
      levels and immunization regimen of a novel COVID-19 vaccine candidate (TMV-083/V-591) against
      SARS-CoV-2 infection, consisting of two phases, an unblinded dose escalation and a
      double-blind treatment phase, to assess the safety, tolerability and immunogenicity.

      90 subjects will be enrolled, 30 per cohort in three cohorts, each cohort comprising 24
      vaccinees and 6 placebo recipients. Subjects will either receive two immunizations with a low
      dosage vaccine (Cohort A), two immunization with a high dosage vaccine (Cohort B), a single
      immunization with the high dosage vaccine (Cohort C) or placebo (randomized to all three
      cohorts).

      As safety precaution, the study will begin with the enrolment of a small group of 6 sentinel
      subjects (2 Sentinel Groups, three subjects each of cohorts A and B) each of whom will
      receive the vaccine on days 0 and 28 in an unblinded and non-randomized manner.

      Thereafter, 84 remaining participants will be enrolled in a double-blinded, randomized manner
      into one of the three cohorts (A, B or C). Placebo will be applied to blind the different
      regimen.

      After the screening visit, participants will be expected to return to the investigational
      clinical site for 8 visits (9 for the sentinel groups) up to day 91 for immunogenicity sample
      collection and up to day 210 for safety assessments.

      Samples for measles shedding will be collected from subjects of the Sentinel Groups
      (unblinded regiment in cohort A and B). Body fluids including saliva, nasal swab, urine and
      whole blood will be collected from day 0 up to day 42.

      The investigator and site personnel assessing Adverse Events (AEs), all participants, as well
      as the sponsor's representatives involved in the monitoring and conduct of the study will be
      unblinded to which vaccine was administered within the unblinded treatment phase. Only the
      site personnel performing randomization, preparation and administration of Investigational
      Medicinal Product (IMP) will be unblinded within the randomized double-blinded treatment
      phase.
    

Intervention name(s): Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose; Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose; One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2); Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2); Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2) and placebo; Physiological saline solution (0.9% NaCl)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SARS-CoV-2; Vaccine; Prevention