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Articles & Research
from hVIVO

Pharma Focus Asia, Issue 52, 2023 – Human Challenge Trials: Establishing early risk-benefit in development of vaccines and therapies for infectious diseases

Featured on pages 54-56

Scientific Paper

Viral emissions into the air and environment after SARS-CoV-2 human challenge: a phase 1, open label, first-in-human study

Effectively implementing strategies to curb SARS-CoV-2 transmission requires understanding who is contagious and when. Although viral load on upper respiratory swabs has commonly been used to infer contagiousness, measuring viral...

Why are Biotech’s & Pharma Using Human Challenge Studies for Drug Development?

What is a human challenge study? In a human challenge study, healthy volunteers are intentionally infected with a virus/bacteria or parasite in a quarantine facility. The volunteers are monitored under...

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...