# Open Orphan’s hVIVO awarded new study with existing Big Pharma client

- Link: https://www.directorstalkinterviews.com/open-orphans-hvivo-awarded-new-study-with-existing-big-pharma-client/4121063114
- Published: 2022-05-05T07:09:30+01:00
- Author: Amilia Stone

**Open Orphan plc** ([LON:ORPH](https://www.directorstalkinterviews.com/company/open-orphan-plc/orph.l)),
a rapidly growing specialist contract research organisation (CRO) and world leader
in testing infectious and respiratory disease products using human challenge clinical
trials, has announced that hVIVO, a subsidiary of Open Orphan, has been awarded 
a new study with an existing Big Pharma client to act as a vaccination site for 
a Phase II field study of the client’s respiratory syncytial virus (RSV) vaccine
candidate.

As part of the study, hVIVO will recruit 60 healthy volunteers to the Company’s 
new site clinic at Plumbers Row, where they will then be inoculated with either 
the RSV vaccine candidate or a placebo. As opposed to a human challenge study, where
volunteers would then be challenged and quarantined within hVIVO’s FluCamp facilities,
these participants will then be free to leave the facilities. Participants will 
then be monitored for RSV symptoms over the following months, with regular clinical
check-ups at Plumbers Row, to assess the efficacy of the vaccine candidate and its
ability to prevent illness through RSV. The study is expected to begin in Q3 2022
with the majority of revenue from the contract recognised in 2023.

This is the first vaccine field study the Company has been awarded since it announced
the expansion of its facilities on 8 March 2022. In addition to the core human challenge
studies the expansion has enabled Open Orphan to provide a larger service offering
including non-first in human Phase I trials such as PK (pharmacokinetics) studies,
bridging studies and Phase II trials in patients and healthy volunteers.  

The volunteers for the study will be recruited through the Company’s specialist 
volunteer recruitment arm, FluCamp. FluCamp has decades of experience attracting
suitable healthy subjects to meet recruitment requirements, primarily sourcing subjects
for hVIVO trials to date. FluCamp’s large database, tech-enabled platform and recently
improved screening capabilities will mean that hVIVO is able to efficiently recruit
and assess potential volunteers for its client’s field studies in a timely and cost-
effective manner.

> **Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said:** “This is a 
> significant award for Open Orphan as it is our first study as a site. To date 
> we have mainly acted as a Contract Research Organisation to provide either challenge
> studies, laboratory or consulting services. Although we have acted as a site as
> part of the challenge studies, we have not provided stand-alone site services.
> We expanded our facilities at Plumbers Row in March of this year with the aim 
> to provide site services. It is a great testament to the team that they have been
> able to fulfil site activity work in such a short timeframe. There are a great
> number of synergies between our core challenge study activities and new the site
> services, this will help us to conduct the new work in an efficient manner.”

Share on: