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Safety, immunogenicity and antibody persistence following an investigational Streptococcus pneumoniae and Haemophilus influenzae tri-protein vaccine: a phase 1 randomized controlled study in healthy adults.
Blekinge Tekniska Högskola, Sektionen för hälsa.
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2014 (engelsk)Inngår i: Clinical and Vaccine Immunology, ISSN 1556-6811, E-ISSN 1556-679X, Vol. 21, nr 1, s. 56-65Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

We investigated a protein-based nontypeable Haemophilus influenzae (NTHi) and pneumococcal (HiP) vaccine containing pneumococcal histidine triad D (PhtD), detoxified pneumolysin (dPly), and NTHi protein D (PD) in adults. In a phase I study, 40 healthy 18- to 40-year-old subjects were randomized (2:2:1) to receive two HiP doses administered 60 days apart, with or without AS03 adjuvant (HiP-AS and HiP groups, respectively), or Engerix B (GlaxoSmithKline, Belgium) as a control. Safety, antibodies, and antigen-specific CD4+ T-cell immune responses were assessed before and until 480 days after vaccination. No serious adverse events were reported, and no subject withdrew due to an adverse event. Local and systemic symptoms were reported more frequently in the HiP-AS group than in the other two groups. The frequency and intensity of local and systemic symptoms appeared to increase after the second dose of HiP-AS or HiP but not Engerix B. Antibody geometric mean concentrations (GMCs) for PhtD, dPly, and PD increased after each dose of HiP-AS or HiP, with higher GMCs being observed in the HiP-AS group (statistically significant for anti-PD after dose 1 and anti-Ply after dose 2). GMCs remained higher at day 420 than prior to vaccination in both the HiP-AS and HiP groups. Antigen-specific CD4+ T cells increased after each dose but were unmeasurable by day 480. Two doses of an investigational PhtD-dPly-PD protein vaccine induced humoral immunity and antigen-specific CD4+ T-cell responses after each dose, with generally higher responses when the vaccine was administered with AS03. HiP combined with AS03 appeared to be more reactogenic than the antigens alone. (This study has been registered at ClinicalTrials.gov under registration no. NCT00814489.)

sted, utgiver, år, opplag, sider
American Society for Microbiology , 2014. Vol. 21, nr 1, s. 56-65
HSV kategori
Identifikatorer
URN: urn:nbn:se:bth-6709DOI: 10.1128/CVI.00430-13ISI: 000329169700008Lokal ID: oai:bth.se:forskinfo9F1D47DA358DE56FC1257C38004F1948OAI: oai:DiVA.org:bth-6709DiVA, id: diva2:834241
Tilgjengelig fra: 2014-04-23 Laget: 2013-12-05 Sist oppdatert: 2018-05-23bibliografisk kontrollert

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