Open Orphan plc changed its name to hVIVO plc on 26 October 2022, learn more here.

Articles & Research
from hVIVO

Utilising Human Challenge Trials as a tool in expedited review programs for infectious diseases

Featured on pages 18-19

Advantages to Centralising Laboratory Services at hVIVO

Clinical field studies are a critical part of the drug development and approval process. They are conducted to evaluate the safety, immunogenicity, and efficacy of a new drug. These studies...

EMA’s updated guideline to include broader coverage on Human Challenge Trials

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...