hVIVO, Inc.
hVIVO is a world leader in challenge trials and laboratory services, specializing in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. With over 25 years of experience, they provide end-to-end early clinical development services for a global client base, including a portfolio of 11+ challenge study models and highly specialized virology and immunology lab services. Their mission is to deliver today's healthcare by empowering tomorrow's innovation, aiming to transform global healthcare through scientific ingenuity.
Industries
Nr. of Employees
large (251-1000)
Products
GMP-manufactured P. falciparum sporozoite challenge agent
Validated, GMP-manufactured Plasmodium falciparum sporozoite material used as a controlled challenge agent for malaria human infection studies.
Centralised virology and immunology testing platform (hLAB)
A centralised laboratory service offering virology and immunology assays to support pre-clinical and clinical respiratory drug and vaccine development with submission-ready outputs.
Volunteer recruitment and cohort platform (FluCamp)
A recruitment and volunteer engagement service that maintains an active cohort for screening and enrolment into human challenge and other clinical studies.
GMP-manufactured P. falciparum sporozoite challenge agent
Validated, GMP-manufactured Plasmodium falciparum sporozoite material used as a controlled challenge agent for malaria human infection studies.
Centralised virology and immunology testing platform (hLAB)
A centralised laboratory service offering virology and immunology assays to support pre-clinical and clinical respiratory drug and vaccine development with submission-ready outputs.
Volunteer recruitment and cohort platform (FluCamp)
A recruitment and volunteer engagement service that maintains an active cohort for screening and enrolment into human challenge and other clinical studies.
Services
Human challenge trials (controlled human infection studies)
End-to-end CHIM services including protocol design, volunteer screening, quarantine admission, controlled pathogen administration, continuous monitoring and clinical data collection.
Centralised virology and immunology laboratory services (hLAB)
Specialist virology and immunology testing to support pre-clinical and clinical respiratory drug and vaccine development, delivering submission‑ready data.
Clinical trial recruitment and volunteer screening (FluCamp)
Participant recruitment and screening services using an active volunteer database and screening sites to identify healthy participants and specific phenotypes.
Clinical trial site services for Phase II–III vaccine and respiratory trials
Provision of site services for later-stage vaccine and respiratory clinical trials, including outpatient execution and specialised trial conduct.
Specialised renal and hepatic impairment study services
Clinical services to design and execute trials evaluating pharmacokinetics and safety in participants with renal or hepatic impairment.
GxP ultra-low temperature biological storage (Cryostore)
Offsite, GxP-compliant ultra-low temperature storage for biological and clinical materials in temperature-controlled conditions.
Human challenge trials (controlled human infection studies)
End-to-end CHIM services including protocol design, volunteer screening, quarantine admission, controlled pathogen administration, continuous monitoring and clinical data collection.
Centralised virology and immunology laboratory services (hLAB)
Specialist virology and immunology testing to support pre-clinical and clinical respiratory drug and vaccine development, delivering submission‑ready data.
Clinical trial recruitment and volunteer screening (FluCamp)
Participant recruitment and screening services using an active volunteer database and screening sites to identify healthy participants and specific phenotypes.
Clinical trial site services for Phase II–III vaccine and respiratory trials
Provision of site services for later-stage vaccine and respiratory clinical trials, including outpatient execution and specialised trial conduct.
Specialised renal and hepatic impairment study services
Clinical services to design and execute trials evaluating pharmacokinetics and safety in participants with renal or hepatic impairment.
GxP ultra-low temperature biological storage (Cryostore)
Offsite, GxP-compliant ultra-low temperature storage for biological and clinical materials in temperature-controlled conditions.
Expertise Areas
- Human challenge trial management and execution
- Respiratory and infectious disease clinical trials
- Vaccine clinical development and proof-of-concept studies
- Centralised virology and immunology laboratory services
Key Technologies
- Controlled human infection models (CHIM)
- GMP challenge agent production
- Containment laboratory capability up to CL3
- Quarantine inpatient monitoring systems