Abstract
Approximately 5% of the healthy adult population respond inadequately to the commercial recombinant hepatitis B vaccines. As the recombinant vaccines all have an aluminium-based adjuvant, we tried to enhance the immune response by adding a cytokine-based adjuvant. This new adjuvant AI20, containing 20g recombinant human IL-2 attached to 20g aluminium hydroxide, was added to HBVaxPro (c)-10g (HBAI20). In a double-blind randomized controlled trial (RCT), 24 naive subjects were randomized to receive either HBAI20 or commercial HBVaxPro (c)-10g vaccine. In an open-label study, 10 nonresponders received HBAI20 vaccine. All participants received 3 vaccinations (0, 1 and 6months). In the RCT, the occurrence of any adverse events or severe events was similar between the trial arms. At month 7, all naive participants were seroprotected; moreover, 92% in the HBAI20 group had protective antibodies 10days after the second vaccination vs 58% in the HBVaxPro (c)-10g group, P=.16. In the open-label study, no serious adverse events were noted. The HBAI20 vaccine was able to elicit protective anti-HBs titres in 90% of nonresponders, 1month after the third vaccination. According to these results, the new HBAI20 vaccine seems safe, well-tolerated and may promote more rapid protection against hepatitis B infection.
Original language | English |
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Pages (from-to) | 1048-1056 |
Number of pages | 9 |
Journal | Journal of Viral Hepatitis |
Volume | 25 |
Issue number | 9 |
DOIs | |
Publication status | Published - Sept 2018 |
Keywords
- adjuvant
- HBAI20
- Hepatitis B
- immunogenicity
- nonresponder
- safety
- vaccine
- CONTROLLED CLINICAL-TRIAL
- CHRONIC UREMIC PATIENTS
- LOW-DOSE INTERLEUKIN-2
- T-CELL-ACTIVATION
- RECOMBINANT INTERLEUKIN-2
- DENDRITIC CELLS
- SURFACE-ANTIGEN
- INFLUSOME-VAC
- DIFFERENTIATION
- EFFICACY