Human Challenge Modelling SGS conducts human challenge studies to rapidly evaluate the efficacy of vaccines and antivirals in safely breaking the cycle of infection and disease caused by problem pathogens including RSV, influenza and hRV. New approaches outside of largescale field trials must be considered to provide early evidence of proof of principle in humans if the industry is to avoid costly failures in late phase. Our human challenge testing facility provides the means for clients to explore these new options.
Controlled Human Infection Process Map
Challenge And Containment
Prescreening
Screening
V accination
Follo w- up
Immune St ate B Immune State 1 [only applicable for vaccines]
Immune St ate A Immune State 0
Immune State 2
Mnt / Hai (>20) MNT
Volunteer Data base
Fail
Fail
Np Swabs / Ssc / Monitoring PCR swab / symptoms / monitoring
Clinical Testing And Medical History ; Ic/e c Clinical Testing and Medical History
V accine Inoculation Vaccine Inoculation
Challenge Agent Inoculation
• Adapted
• Nasal / Serum •
• CMI •
Safety Vist
Immune St ate 0
Immunity
Pass
V accine Vaccine/Antiviral
Intervention
• Dose Response • Safety
• Other
MNT / HAI ( 20) MNT
• Adapted
• CMI •
• Nasal / Serum •
Immune St ate 1 Immune State 1 [only applicable for vaccines]
Volunteer Data base
Immunity
Fail
Virus Virus
Borderlin e
Challenge
•Infection •
Illness
• Shedding
Pass
Fail
• Adapted
• C MI •
• Nasal / Serum •
Immune St ate 2
Discharge
Immunity
Re-test
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