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      Developing Global Norms for Sharing Data and Results during Public Health Emergencies

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          Abstract

          Vasee Moorthy and colleagues describe the outcomes of a recent, WHO-led meeting on sharing research data and results during public health emergencies.

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          Chimpanzee Adenovirus Vector Ebola Vaccine - Preliminary Report.

          Background The unprecedented 2014 epidemic of Ebola virus disease (EVD) has prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3-vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation. Methods We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×10(10) particle units or 2×10(11) particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 4 weeks after vaccination. Results In this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccination in two participants who had received the 2×10(11) particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 participants; the titers were of greater magnitude in the group that received the 2×10(11) particle-unit dose than in the group that received the 2×10(10) particle-unit dose (geometric mean titer against the Zaire antigen, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2x10(11) particle-unit dose than among those who received the 2×10(10) particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07). Conclusions Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2×10(11) particle-unit dose, glycoprotein Zaire-specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates. Clinical trials assessing cAd3-EBO are ongoing. (Funded by the Intramural Research Program of the National Institutes of Health; VRC 207 ClinicalTrials.gov number, NCT02231866 .).
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            Data sharing: Make outbreak research open access.

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              Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results

              Vasee Moorthy and colleagues explain why the WHO is calling for public disclosure of clinical trial results.
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                Author and article information

                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                5 January 2016
                January 2016
                : 13
                : 1
                : e1001935
                Affiliations
                [001]World Health Organization, Geneva, Switzerland
                Author notes

                The authors have declared that no competing interests exist.

                Wrote the first draft of the manuscript: KM VSM CR MPK. Contributed to the writing of the manuscript: KM VSM PSG PM CR MPK. Agree with the manuscript’s results and conclusions: KM VSM PSG PM CR MPK. All authors have read, and confirm that they meet, ICMJE criteria for authorship.

                Article
                PMEDICINE-D-15-02911
                10.1371/journal.pmed.1001935
                4701443
                26731342
                d6f2c66e-3615-4772-a2c6-0277806cca5d
                © 2016 Modjarrad et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

                History
                Page count
                Figures: 0, Tables: 1, Pages: 5
                Funding
                The Wellcome Trust contributed towards the cost of the consultation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Policy Forum

                Medicine
                Medicine

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