Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

      

Healthy male and female individuals will be stratified to the
following groups:

  
 

°e Group I: Healthy adults (aged 18-65)
e Group Il: Healthy elderly age group >65-85y
and randomized to one of the dose cohorts

        
 

e 1x 107 +0.5 log pfu MVA-SARS-2-S

e 1x 10° +0.5 log pfu MVA-SARS-2-S

e  Heterologous prime-boost (HL): study subjects will be
boosted with 1 x 108 + 0.5 log pfu MVA-SARS-2-S 28d
after priming with TBD vaccine candidate

e Placebo

e 25 Covid-19 seropositive per group: 1x 107 + 0.5 log

fu MVA-SARS-2-S

  
    
      
    
   

    

Number of participants: | 700

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Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
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11.5. Synopsis of MVA-SARS-2-S Phase Ilb clinical trial

 

   
   
  
  
   
   
   
   
  
  
  

Title of Study: An open, single-center Phase Ilb trial to assess the safety,
tolerability and immunogenicity ofthe candidate vaccine MVA-
SARS-2-S in children and adolescents

 
     
 

Principal Investigator

 

Study center:

 

UKE-DZIF1-SARS -2 CHILD

 

Protocol-No,

 

|

EudraCT-No. To be requested

 

Study Period Study Timelines:
Total study duration (FSFV to LSLV) approx. 7 months
Planned screening Start JAN 2020
FSFV FEB 2020
LSFV MAR 2021
LSLV AUG 2021

Phase of development: | Phase Ilb

Objectives: e To evaluate safety, tolerability and reactogenicity of two-dose
Primary Obiective intramuscular administrations and two ascending dose levels

En of the candidate MVA-SARS-2-S vaccine in healthy children
and adolescents

 

 

  
    
  
 

   

® To evaluate SARS-CoV-2-S-specific antibody responses in
healthy children and adolescents after two administrations of
MVA-SARS-2-S

   

Secondary Objectives

  
  
  

 
   

 

« Toevaluate SARS-CoV-2-specific cellular immune responses
after administration of MVA-SARS-2-S

e To evaluate SARS-CoV-2-induced B and T cell memory
responses

» To evaluate innate cell subset phenotypes and function
induced by MVA-SARS-2-S

e Toevaluate early innate immunity gene expression signatures
induced by MVA-SARS-2-S

e To investigate vaccine-induced humoral immune responses
and antibody functions, including vector-immunity and
neutralizing and non-neutralizing antibody functions

e To evaluate pre-existing humoral and cellular immunity to
coronaviruses

s Toidentify potential biomarkers and gene signatures of innate

immune responses to MVA-SARS-2-S and their correlation to

dose, reactogenicity, immune response and age.

Exploratory Objectives

    
   
   
   
   
   
   
 
       
 
     
   
 
    

  

Study Design Single-center, open-label, phase IIb study

 

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Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
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Methodology: |

| This will be a Phase Ilb, single-center trial in a total of 120
participants.

 

 

 

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Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
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Note:

 
 
 

* tentative groups, may be not included

Forthe decision on dose escalation, the Local Safety Board (LSB)
will review safety data (AEs, vital signs, and laboratory safety
data) obtained until day 7 after the 1°! immunization of all
participants ofthe low-dose cohort.

 
       
 
 

Number of participants:

   

|

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Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

Il.6. Synopsis of MVA-SARS-2-S Phase Ill clinical trial

 

 

Title of Study: A multi-center, randomized placebo-controlled Phase Il-Ill trial to
assess the efficacy of the candidate vaccine MVA-SARS-2-S

 

Principal Investigator /
Sponsor

Study centers:

 

 

 

 

Protocol-No. KUM-DZIF-SARS-COV-2-2/3
EudraCT-No. To be requested
Study Period | Study Timelines:

 

Total study duration (FSFV to LSLV) approx. 15 months
FSFV JUN 2021
LSFV OCT 2021
LSLV JAN 2023

Note: Duration of this study is not finally defined and at this stage
too late. Further adjustments are required

Phase of development: Phase Ill

 

Objectives: e Assess the efficacy of the candidate MVA-SARS-2-S against
i Inu SARS-CoV-2 infection in adults aged 18 and older;
Primary Objective incidence is measured by antibody response against

 

nucleocapsid N-protein.

e Assess the safety of the candidate vaccine MVA-SARS-2-S |
Secondary Objectives e Assess the efficacy of the candidate MVA-SARS-2-S against
COVID-19; measured by the number of virologically
confirmed (PCR positive) symptomatic cases of COVID-19

e Assess efficacy ofthe candidate MVA-SARS-2-S against |

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Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

 

 

 

severe and non-severe COVID-19: hospital admissions
associated with COVID-19

e  Assess efficacy of the candidate MVA-SARS-2-S against
severe and non-severe COVID-19; measured by the number
of intensive care unit (ICU) admissions associated with
COVID-19

e  Assess efficacy ofthe candidate MVA-SARS-2-S against
severe and non-severe COVID-19: number of associated
with COVID-19

e  Assess efficacy ofthe candidate MVA-SARS-2-S by
comparing the magnitude and durability of antibodies against
the N-Protein, as a marker of severity of infection

e  Assess humoral immunogenicity of MVA-SARS-2-S:

seroconversion and titre; proportion of seroconversion and

magnitude to antibodies against SARS-CoV-2 spike protein

at Day 28 post-vaccination

Study Design Double blinded, multi-center, randomized-controlled phase Ill
study

The dose ofthe MVA-SARS-2 vaccine (107PFU or 108 PFU)
will be defined through interims analysis at phase Il.

 
  
 
 
 
   

 

Methodology: Phase Ill will take place in at least 40 study centers in in
Germany. However, the final decision will be based on the
epidemiology at the time of the start of phase Ill. Current
planning uses a moderate incidence rate of 1,2 % over the first 6
months, assuming that the vaccine provides a 75% protection
from infection with measurable seroconversion. Highly exposed

individuals, such as health care workers, workers at logistic

centers (DHL or Amazon), will be preferentially enrolled.

   
  
 
 
     
   

14.000

  
  

Number of participants:

  

7.000 individuals receiving Vaccine and 7.000 placebo

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