Vaccine responses to hepatitis B vaccinations in HIV-infected individuals who do not respond to standard vaccination courses
Conditions
Interventions
Trade Name: Fendrix suspension for injection
Product Name: Fendrix
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Hepatitis B surface antigen
Concentration un
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age =18 HIV-1 infected On antiretroviral therapy Viral load undetectable (for at least 6 months, last available measurement within 9 months) or viral load under 200 (includes blips) after 6 months on antiretrovial therapy. History of having received at least one complete course of non-Fendrix-based hepatitis B vaccination in the past. Patients who have already received a double-dose Engerix B course in the past will still be eligible. HBsAb levels persistently =65 years) no F.1.3.1 Number of subjects for this age range 0 ;Inclusion criteria: Age =18 HIV-1 infected On antiretroviral therapy Viral load undetectable (for at least 6 months, last available measurement within 9 months) or viral load under 200 (includes blips) after 6 months on antiretrovial therapy. History of having received at least one complete course of non-Fendrix-based hepatitis B vaccination in the past. Patients who have already received a double-dose Engerix B course in the past will still be eligible. HBsAb levels persistently =65 years) no F.1.3.1 Number of subjects for this age range 0 ;Inclusion criteria: Age =18 HIV-1 infected On antiretroviral therapy Viral load undetectable (for at least 6 months, last available measurement within 9 months) or viral load under 200 (includes blips) after 6 months on antiretrovial therapy. History of having received at least one complete course of non-Fendrix-based hepatitis B vaccination in the past. Patients who have already received a double-dose Engerix B course in the past will still be eligible. HBsAb levels persistently =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: A history of hypersensitivity to any previous hepatitis B vaccination A history of hypersensitivity to any components of either Engerix B or Fendrix (see Summary of Product Characteristics). Currently undergoing an incomplete course of any hepatitis B vaccination Having received at least one vaccination with Fendrix in the past Recipient of any other vaccination within the last 2 weeks Any previously detectable HBsAb level (=10) Pregnant or breastfeeding Individuals who have a current severe febrile illness Individuals with a known and current history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range on a full blood count taken within the last 3 months. Current (active) participation in any clinical trial Inability to communicate in English or convey willingness to participate End Stage Renal Disease undergoing renal replacement therapy ;Exclusion criteria: A history of hypersensitivity to any previous hepatitis B vaccination A history of hypersensitivity to any components of either Engerix B or Fendrix (see Summary of Product Characteristics). Currently undergoing an incomplete course of any hepatitis B vaccination Having received at least one vaccination with Fendrix in the past Recipient of any other vaccination within the last 2 weeks Any previously detectable HBsAb level (=10) Pregnant or breastfeeding Individuals who have a current severe febrile illness Individuals with a known and current history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range on a full blood count taken within the last 3 months. Current (active) participation in any clinical trial Inability to communicate in English or convey willingness to participate End Stage Renal Disease undergoing renal replacement therapy ;Exclusion criteria: A history of hypersensitivity to any previous hepatitis B vaccination A history of hypersensitivity to any components of either Engerix B or Fendrix (see Summary of Product Characteristics). Currently undergoing an incomplete course of any hepatitis B vaccination Having received at least one vaccination with Fendrix in the past Recipient of any other vaccination within the last 2 weeks Any previously detectable HBsAb level (=10) Pregnant or breastfeeding Individuals who have a current severe febrile illness Individuals with a known and current history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range on a full blood count taken within the last 3 months. Current (active) participation in any clinical trial Inability to communicate in English or convey willingness to participate End Stage Renal Disease undergoing renal replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does a course of Fendrix (GSK) as compared to double-dose Engerix B (GSK) hepatitis B (HBV) vaccine result in a higher proportion of individuals serocoverting with Hepatitis B surface antibody (HBsAb) levels >100, in HIV-infected previous non-responders to standard HBV vaccine courses?;Secondary Objective: Are HBV-specific CD4+ T-cell responses of greater magnitude present following vaccination with Fendrix as compared to double-dose Engerix B vaccine, thus potentially providing greater T-cell help to the B-cell mediated antibody response?;Primary end point(s): HBsAb titre at 8 weeks following the completion of the vaccination course (week 16 for double-dose Engerix B and week 32 for Fendrix). ;Timepoint(s) of evaluation of this end point: 8 weeks following completion of the vaccination course;Main Objective: Does a course of Fendrix (GSK) as compared to double-dose Engerix B (GSK) hepatitis B (HBV) vaccine result in a higher proportion of individuals serocoverting with Hepatitis B surface antibody (HBsAb) levels >100, in HIV-infected previous non-responders to standard HBV vaccine courses?;Secondary Objective: Are HBV-specific CD4+ T-cell responses of greater magnitude present following vaccination with Fendrix as compared to double-dose Engerix B vaccine, thus potentially providing greater T-cell help to the B-cell mediated antibody response?;Primary end point(s): HBsAb titre at 8 weeks following the completion of the vaccination course (week 16 for double-dose Engerix B and week 32 for Fendrix). ;Timepoint(s) of evaluation of this end point: 8 weeks following completion of the vaccination course;Main Objective: Does a course of Fendrix (GSK) as compared to double-dose Engerix B (GSK) hepatitis B (HBV) vaccine result in a higher proportion of individuals serocoverting with Hepatitis B surface antibody (HBsAb) levels >100, in HIV-infected previous non-responders to standard HBV vaccine courses?;Secondary Objective: Are HBV-specific CD4+ T-cell respo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hepatitis B-specific CD4+ T-cell response at 2 weeks following the first vaccination and 2 weeks following the 3rd vaccination. HBsAb titre at 1 year following the completion of the vaccination course. ;Timepoint(s) of evaluation of this end point: as above;Secondary end point(s): Hepatitis B-specific CD4+ T-cell response at 2 weeks following the first vaccination and 2 weeks following the 3rd vaccination. HBsAb titre at 1 year following the completion of the vaccination course. ;Timepoint(s) of evaluation of this end point: as above;Secondary end point(s): Hepatitis B-specific CD4+ T-cell response at 2 weeks following the first vaccination and 2 weeks following the 3rd vaccination. HBsAb titre at 1 year following the completion of the vaccination course. ;Timepoint(s) of evaluation of this end point: as above | — |
Countries
United Kingdom
Contacts
Public ContactCard;Card;Card ;;
Sheffield Teaching Hospitals NHS Foundation Trust;Sheffield Teaching Hospitals NHS Foundation Trust;Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed