Indirect effectiveness of a novel SARS-COV-2 vaccine (SCB-2019) in unvaccinated household contacts in the Philippines: a cluster randomised analysis
Background - Though observational evidence supports indirect effects of SARS-CoV-2 vaccines, randomised experiments are lacking. To address this gap, the double-blinded, prospective follow-up of the household contacts (HHCs) of Philippine participants of the individually-randomised, placebo-controll...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
October 2024
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| In: |
Journal of infection
Year: 2024, Jahrgang: 89, Heft: 4, Pages: [1]-12 |
| ISSN: | 1532-2742 |
| DOI: | 10.1016/j.jinf.2024.106260 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.jinf.2024.106260 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0163445324001944 
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| Verfasserangaben: | Asma Binte Aziz, Jonathan Dewing Sugimoto, Sye Lim Hong, Young Ae You, Lulu Bravo, Camilo Roa, Charissa Borja-Tabora, May Emmeline B. Montellano, Josefina Carlos, Mari Rose A. de Los Reyes, Edison R. Alberto, Milagros Salvani-Bautista, Hwa Young Kim, Irene Njau, Ralf Clemens, Florian Marks, Birkneh Tilahun Tadesse |
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| 245 | 1 | 0 | |a Indirect effectiveness of a novel SARS-COV-2 vaccine (SCB-2019) in unvaccinated household contacts in the Philippines |b a cluster randomised analysis |c Asma Binte Aziz, Jonathan Dewing Sugimoto, Sye Lim Hong, Young Ae You, Lulu Bravo, Camilo Roa, Charissa Borja-Tabora, May Emmeline B. Montellano, Josefina Carlos, Mari Rose A. de Los Reyes, Edison R. Alberto, Milagros Salvani-Bautista, Hwa Young Kim, Irene Njau, Ralf Clemens, Florian Marks, Birkneh Tilahun Tadesse |
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| 520 | |a Background - Though observational evidence supports indirect effects of SARS-CoV-2 vaccines, randomised experiments are lacking. To address this gap, the double-blinded, prospective follow-up of the household contacts (HHCs) of Philippine participants of the individually-randomised, placebo-controlled trial of the adjuvanted-subunit protein COVID-19 vaccine, SCB-2019, (EudraCT, 2020-004272-17; ClinicalTrials.gov, NCT04672395) was analyzed in a cluster-randomised fashion. - Methods - Over an eight-week period, HHCs were followed by rRT-PCR and paired rapid antibody tests (RATs) to detect symptomatic (SCI, primary) and all (ACI, secondary) SARS-CoV-2 infection. A standard analysis estimated the indirect effectiveness of SCB-2019 for each endpoint, excluding HHC RAT-positive at enrollment. A secondary analysis employed enzyme-linked immunosorbent assay (ELISA) results to correct for suspected bias. - Findings - SCB-2019 (N = 3470) and placebo (N = 3225) exposed HHCs contributed to at least one analysis. The standard analysis estimated that SCB-2019 reduced the risk of SCI by 83% (95% confidence/credible interval [CI: 32% to 96%), with no effect against ACI. The bias-corrected relative risk reduction was 97% (95% CI: 74% to 100%) for SCI and 79% (95% CI: 14% to 96%) for ACI, with an estimated one SARS-CoV-2 infection prevented per 4.8 households where one member received SCB-2019. - Interpretation - SCB-2019 demonstrated bias-corrected indirect effectiveness against SARS-CoV-2 infection among HHC, even at a modest coverage level in the household (approximately 25%). Further research into the indirect effects of SARS-CoV-2 vaccines is needed to optimize the impact of limited doses in low and middle-income settings. | ||
| 650 | 4 | |a Household contacts | |
| 650 | 4 | |a Indirect effectiveness | |
| 650 | 4 | |a SCB-2019, SARS-CoV-2 vaccine | |
| 700 | 1 | |a Sugimoto, Jonathan Dewing |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hong, Sye Lim |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Los Reyes, Mari Rose A. de |e VerfasserIn |4 aut | |
| 700 | 1 | |a Alberto, Edison R. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Salvani-Bautista, Milagros |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Tadesse, Birkneh Tilahun |e VerfasserIn |0 (DE-588)1328708160 |0 (DE-627)1888121114 |4 aut | |
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