Articles & Research
from hVIVO

Advantages of Human Challenge Studies (Part 1)

Human challenge studies or controlled human infection model (CHIM) studies are Phase Ib or Phase IIa clinical trials, in which study participants, i.e. healthy volunteers, are deliberately exposed to infectious...

Accelerated regulatory pathways: Vaccines for tropical diseases

Human Clinical Trials: A Tool in the Fight Against Infectious Diseases

In the wake of the COVID-19 pandemic, research into infectious diseases remains an integral and growing avenue of clinical research. What benefits can Human Challenge Trials have for clinicians exploring...

RSV Vaccines/Prophylactics: Key learnings from the RSV challenge model and efficacy of vaccines

Challenge studies can be a powerful tool in the development of both therapeutic agents and vaccines. However, key decisions made in the study design process can have a profound impact...

Initial characteristics of respiratory viruses in symptomatic subjects during the pandemic, a cohort study

During the most intense waves of the recent pandemic, we have witnessed a clear and almost complete wipe-out of many respiratory viruses routinely circulating in the community over the north-hemisphere...

Immunomodulators and treatment of disease in the influenza human challenge model

Human challenge studies using wild-type viruses replicate what is seen in the field in the same populations, and as such they have been used to aid vaccine and drug development...

Human Challenge Studies: Their Conduct and Safety Aspects

If there would be a survey of 100 clinical research professionals either from CRO or from Pharma/Biotech industry to explain what a human challenge study is, the most common answer...

Scientific Paper

Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial

RSV Human Challenge Study as a tool for a break-through designation

An international biotech company, headquartered in the EU approached hVIVO to explore the possibility of performing a RSV Phase IIa challenge study. The investigational product was a novel recombinant modified...

Infectious Diseases Blog – ‘The Pathogenda’ Part 5

In one of the most important discoveries in medicine this year, Epstein-Barr virus (EBV) has been collared as the link/early causal role in multiple sclerosis. Finding the virus underpinning multiple...