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Contradictory mortality results in early 2-dose measles vaccine trials: interactions with oral polio vaccine may explain differences

Objectives - Between 2003 and 2019, three trials (randomised controlled trials [RCTs]) in Guinea-Bissau randomised infants to an early 2-dose measles vaccine (MV) schedule at 4 and 9 months vs standard MV at 9 months. The RCTs produced contradictory mortality results; the effect being beneficial in...

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Main Authors: Nielsen, Sebastian (Author) , Fisker, Ane B. (Author) , Sie, Ali (Author) , Müller, Olaf (Author) , Nebie, Eric (Author) , Becher, Heiko (Author) , van der Klis, Fiona (Author) , Biering-Sørensen, Sofie (Author) , Byberg, Stine (Author) , Thysen, Sanne M. (Author) , da Silva, Isaquel (Author) , Rodrigues, Amabelia (Author) , Martins, Cesario (Author) , Whittle, Hilton C. (Author) , Aaby, Peter (Author) , Benn, Christine S. (Author)
Format: Article (Journal)
Language:English
Published: November 2024
In: International journal of infectious diseases
Year: 2024, Volume: 148, Pages: [1]-9
ISSN:1878-3511
DOI:10.1016/j.ijid.2024.107224
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.ijid.2024.107224
Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S1201971224002959
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Author Notes:Sebastian Nielsen, Ane B. Fisker, Ali Sie, Olaf Müller, Eric Nebie, Heiko Becher, Fiona van der Klis, Sofie Biering-Sørensen, Stine Byberg, Sanne M. Thysen, Isaquel da Silva, Amabelia Rodrigues, Cesario Martins, Hilton C. Whittle, Peter Aaby, Christine S. Benn
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Summary:Objectives - Between 2003 and 2019, three trials (randomised controlled trials [RCTs]) in Guinea-Bissau randomised infants to an early 2-dose measles vaccine (MV) schedule at 4 and 9 months vs standard MV at 9 months. The RCTs produced contradictory mortality results; the effect being beneficial in the 2-dose group in the first but tending to have higher mortality in the last two RCTs. We hypothesised that increased frequency of campaigns with oral polio vaccine (C-OPV) explained the pattern. - Methods - We performed per-protocol analysis of individual-level survival data from the three RCTs in Cox proportional hazards models yielding hazard ratios (HR) for the 2-dose vs the 1-dose MV group. We examined whether timing of C-OPVs and early administration of OPV0 (birth to day 14) affected the HRs for 2-dose/1-dose MV. - Results - The combined HR(2-dose/1-dose) was 0.79 (95% confidence interval: 0.62-1.00) for children receiving no C-OPV-before-enrolment, but 1.39 (0.97-1.99) for those receiving C-OPV-before-enrolment (homogeneity, P = 0.01). C-OPV-before-enrolment had a beneficial effect in the 1-dose group but tended to have a negative effect in the 2-dose group, especially in females. These effects were amplified further by early administration of OPV0. - Conclusion - In the absence of C-OPVs, an early 2-dose MV strategy had beneficial effects on mortality, but frequent C-OPVs may have benefitted the 1-dose group more than the 2-dose MV group, leading to varying results depending on the intensity of C-OPVs.
Item Description:Gesehen am 26.03.2025
Physical Description:Online Resource
ISSN:1878-3511
DOI:10.1016/j.ijid.2024.107224

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