Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naïve and nonresponding adults

Autor: A. M. L. Oude Lashof, Özgür M Koc, Paul H. M. Savelkoul, Anna Peeters, I. H. M. van Loo
Přispěvatelé: AII - Infectious diseases, Medical Microbiology and Infection Prevention, AGEM - Digestive immunity, Amsterdam Reproduction & Development (AR&D), Promovendi NTM, Med Microbiol, Infect Dis & Infect Prev, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: DA Medische Microbiologie en Infectieziekten (5), MUMC+: DA MMI AIOS (9), MUMC+: DA MMI Infectieserologie (9), MUMC+: DA MMI Staf (9)
Rok vydání: 2018
Předmět:
Male
0301 basic medicine
SURFACE-ANTIGEN
medicine.medical_treatment
Aluminum Hydroxide
immunogenicity
law.invention
T-CELL-ACTIVATION
0302 clinical medicine
Randomized controlled trial
nonresponder
law
vaccine
030212 general & internal medicine
Young adult
HBAI20
INFLUSOME-VAC
Immunogenicity
Middle Aged
Hepatitis B
Vaccination
DIFFERENTIATION
Infectious Diseases
Female
Adjuvant
Adult
safety
medicine.medical_specialty
Hepatitis B vaccine
Adolescent
Drug-Related Side Effects and Adverse Reactions
CONTROLLED CLINICAL-TRIAL
DENDRITIC CELLS
Young Adult
03 medical and health sciences
Adjuvants
Immunologic
Double-Blind Method
adjuvant
Virology
Internal medicine
medicine
Humans
Hepatitis B Vaccines
Adverse effect
Immunization Schedule
Hepatology
business.industry
LOW-DOSE INTERLEUKIN-2
EFFICACY
medicine.disease
RECOMBINANT INTERLEUKIN-2
030104 developmental biology
Interleukin-2
business
CHRONIC UREMIC PATIENTS
Zdroj: Koc, M, Savelkoul, P H M, van Loo, I H M, Peeters, A & Oude Lashof, A M L 2018, ' Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naïve and nonresponding adults ', Journal of Viral Hepatitis, vol. 25, no. 9, pp. 1048-1056 . https://doi.org/10.1111/jvh.12909
Journal of Viral Hepatitis, 25(9), 1048-1056
Journal of Viral Hepatitis, 25(9), 1048-1056. Wiley
ISSN: 1352-0504
Popis: 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.
Databáze: OpenAIRE
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