A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

July 23, 2015

Primary Completion Date

June 10, 2022

Study Completion Date

June 10, 2022

Conditions
HIVCommunicable DiseasesHepatitis BHBVInfectious Diseases
Interventions
DRUG

Engerix B

"Engerix B 20 micrograms/1ml Licensee: GlaxoSmithKline UK Intra-muscular~Prescription and administration:~The vaccine will be stored in the Investigators pharmacy as clinical trial stock and dispensed on a subject by subject basis.~Shelf life and storage The product must be kept refrigerated (2°C - 8°C). Prescriptions will be written and dispensed from pharmacy on the day of consent, screening and vaccination. The shelf life is 3 years."

DRUG

Fendrix

"Fendrix suspension for injection GlaxoSmithKline UK~Route of Administration, dose regimen:~Intra-muscular Dose: 0.5ml (20mcg of Hepatitis B Surface Antigen) per vaccination at baseline and weeks 4, 8 and 24.~Prescription and administration:~The vaccine will be stored in the Investigators pharmacy as clinical trial stock and dispensed on a subject by subject basis.~Packaging and labeling The vaccine will have clinical trial labeling. Shelf-life and storage The product must be kept refrigerated (2°C - 8°C).~The shelf life is 3 years."

Trial Locations (1)

S10 2JF

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

All Listed Sponsors
lead

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

NCT02434848 - A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses | Biotech Hunter | Biotech Hunter