The immunological effects of oral polio vaccine provided with BCG vaccine at birth: A randomised trial |
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Authors: | Kristoffer Jarlov Jensen Hanne Sophie Karkov Najaaraq Lund Andreas Andersen Helle Brander Eriksen Amarildo Gomes Barbosa Bjørn Kantsø Peter Aaby Christine Stabell Benn |
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Institution: | 1. Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen S, Denmark;2. Department of Cardiovascular and Renal Research, Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 25, 3, DK-5000 Odense C, Denmark;3. Bandim Health Project, INDEPTH Network, Apartado 861, 1004 Bissau codex, Guinea-Bissau;4. Biopharmaceutical Research Unit, Novo Nordisk A/S, Novo Nordisk Park 1, DK-2760 Måløv, Denmark;5. Microbiological Diagnostics & Virology, Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen S, Denmark;6. Odense Patient data Explorative Network, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, J.B. Winsløws Vej 25, 3, DK-5000 Odense C, Denmark |
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Abstract: | BackgroundVaccines may have non-specific effects. An observational study from Guinea-Bissau suggested that oral polio vaccine at birth (OPV0) provided with Bacillus Calmette–Guérin (BCG) vaccine was associated with down-regulation of the immune response to BCG vaccine 6 weeks later. Based on the previous finding, we wanted to test our a priori hypothesis that OPV would dampen the immune response to BCG, and secondarily to test immune responses to other antigens.MethodsThe study was conducted at the Bandim Health Project in Guinea-Bissau in 2009–2010. Infants were randomised to OPV0 + BCG versus BCG alone at birth, and subsequently randomised to have a blood sample taken at 2, 4 or 6 weeks post-randomisation. Excreted levels of cytokines (IL-2, IL-5, IL-10, TNF-α and IFN-γ) were measured from whole blood in vitro stimulations with a panel of recall vaccine antigens (BCG, PPD, OPV), mitogen (PHA) or innate agonists (LPS, Pam3cys, PolyI:C). Additionally, we measured the local reaction to BCG, white blood cell distribution, C-reactive protein (CRP) and retinol-binding protein (RBP). Cytokine production was analysed as the prevalence ratios of responders above the median.ResultsBlood samples from 430 infants (209 OPV0 + BCG; 221 BCG alone) were analysed. There were no strong differences in effects 2, 4 and 6 weeks post-randomisation and subsequent analyses were performed on the pooled data. As hypothesised, receiving OPV0 + BCG versus BCG alone was associated with significantly lower prevalence of IFN-γ responses to PPD (prevalence ratio (PR): 0.84 (0.72–0.98)) and reduced IL-5 to PPD (PR: 0.78 (0.64–0.96)). No effects were observed for CPR, RBP, white blood cell distribution, or BCG scar prevalence.ConclusionThe results corroborate that OPV attenuates the immune response to co-administered BCG at birth. |
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Keywords: | NCT00710983 |
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