Rapid Establishment of a Cold Chain Capacity of –60°C or Colder for the STRIVE Ebola Vaccine Trial During the Ebola Outbreak in Sierra Leone
Open accessAbstract
In response to the 2014‒2015 Ebola virus disease (Ebola) epidemic in West Africa, researchers accelerated the development of Ebola vaccines. The Centers for Disease Control and Prevention, in collaboration with local partners, sponsored a phase 2/3 trial in Sierra Leone of a single dose (2 × 107 plaque-forming units/mL) of a candidate replication-competent recombinant vesicular stomatitis virus–Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Because of its early development status and limited, critical stability data, the vaccine had to be stored at –60°C or colder. Planning for the trial began in late 2014 on an accelerated timeline with significant challenges, including the lack of –60°C or colder vaccine storage, handling, and transport capability in a country with high year-round ambient temperatures. The supply chain needs for vaccine handling from storage through transport, up to the time of administration, were carefully evaluated, and then the supply chain was designed. Critical equipment that was procured, shipped, installed, and qualified to meet an aggressive timeline for launching the trial included ultracold freezers, custom-developed Arktek DF containers for storage at –60°C or colder, insulated containers for storage at 2°C–8°C, and multiple backup power sources at vaccine storage sites. Local personnel were trained in good clinical practices and trial documentation. During 9 April–12 December 2015, the trial staff vaccinated approximately 8000 participants. Five temperature excursions occurred, but the vaccine manufacturer assessed that vaccine quality was not impaired because of improper storage or transport temperatures. Both the infrastructure and the human capacity developed for the cold chain during the trial will continue to be useful as the country maintains preparedness for ring vaccination responses and future clinical research. Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Each pathogen poses a unique set of challenges, including high lethality, rapid mutations, immune evasion, new strains and variants.
“Each pathogen poses a unique set of challenges, including high lethality, rapid mutations, immune evasion, new strains and variants252–258.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [254]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Restrepo, A. M. H., Camacho, A., Longini, I. M., Watson, C., Edmunds, W. J., Egger, M., Carroll, M. W., Dean, N. E., Diatta, I. D., Doumbia, M. M., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)32621-6 · Cited by 1,112 · see citing works
Restrepo, A. M. H., Longini, I. M., Egger, M., Dean, N. E., Edmunds, W. J., Camacho, A., Carroll, M. W., Doumbia, M. M., Draguez, B., Duraffour, S., et al. (2015) · The Lancet · doi:10.1016/s0140-6736(15)61117-5 · Cited by 794 · see citing works
Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe
Agnandji, S. T., Huttner, A. C., Zinser, M. E., Njuguna, P., Dahlke, C., Fernandes, J. F., Yerly, S., Dayer, J.-A., Krähling, V., Kasonta, R., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1502924 · Cited by 415 · see citing works
A Recombinant Vesicular Stomatitis Virus Ebola Vaccine
Regules, J. A., Beigel, J. H., Paolino, K. M., Voell, J., Castellano, A. R., Hu, Z., Muñoz, P., Moon, J. E., Ruck, R. C., Bennett, J. W., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1414216 · Cited by 388 · see citing works
Turner, N. (2009) · ResearchSpace (University of Auckland) · Cited by 254 · see citing works
Gostin, L. O., Lucey, D. R., & Phelan, A. (2014) · JAMA · doi:10.1001/jama.2014.11176 · Cited by 149 · see citing works
Who, 。. (2010) · Biologicals · doi:10.1016/j.biologicals.2009.12.007 · Cited by 139 · see citing works
Ebola ça suffit ring vaccination trial consortium (2015) · BMJ · doi:10.1136/bmj.h3740 · Cited by 127 · see citing works
Kennedy, S. B., Neaton, J. D., Lane, H. C., et al. (2016) · Clinical Trials · doi:10.1177/1740774515621037 · Cited by 92 · see citing works
Implementing an Ebola Vaccine Study — Sierra Leone
Widdowson, M., Schrag, S. J., Carter, R. J., Carr, W., Legardy-Williams, J. K., Gibson, L. L., Lisk, D. R., Jalloh, M. I., Bash-Taqi, D. A., Kargbo, S. A., et al. (2016) · MMWR Supplements · doi:10.15585/mmwr.su6503a14 · Cited by 62 · see citing works
Self-citationFriend, M., & Stone, S. (2015) · IEEE Global Humanitarian Technology Conference (GHTC) · doi:10.1109/ghtc.2015.7343999 · Cited by 11 · see citing works
Self-citationEbola vaccine will be made available for emergency use
Gulland, A. (2016) · BMJ · doi:10.1136/bmj.i386 · Cited by 7 · see citing works
Is the world ready for an Ebola vaccine?
Lee, B. Y., Moss, W. J., Privor-Dumm, L. A., et al. (2015) · The Lancet · doi:10.1016/s0140-6736(14)62398-9 · Cited by 5 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- Lyon DJ, Cheng AFB, Norrby SR. Mechanisms of cefotaxime resistance in blood culture isolates of Enterobacter high prevalence of extended-spectrum β-lactamases [abstract C43]. In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, California, 17-20 September, 1995. Washington, DC: American Society for Microbiology, 1995:47.
Cited by
Sorted by citations
mRNA vaccines for infectious diseases: principles, delivery and clinical translation
Chaudhary, N., Weissman, D., & Whitehead, K. A. (2021) · Nature Reviews Drug Discovery · doi:10.1038/s41573-021-00283-5 · Cited by 1,555 · see citing works
- Authors
- Jusu, M. O., Glauser, G., Seward, J. F., Bawoh, M., Tempel, J., Friend, M., Littlefield, D., Lahai, M., Jalloh, H. M., Sesay, A. B., Caulker, A. F., Samai, M., Thomas, V., Farrell, N., & Widdowson, M.-A.
- Affiliations
- University of Sierra Leone (SL)
- Conceptual Mindworks (United States) (US)
- Centers for Disease Control and Prevention (US)
- Modality Solutions, League City, Texas
- Intellectual Ventures (United States) (US)
- Corresponding author
- Glauser, Geoffrey
- Venue
- The Journal of Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2018-05-18
- Volume
- 217
- Issue
- suppl_1
- Pages
- S48-S55
- ISSN
- 0022-1899 (ISSN-L)
- 1537-6613
- PMC
- PMC6927859
- OpenAlex
- W2804691102
- Cited by
- 42
- References
- 14
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 4 · 2023: 10 · 2022: 6 · 2021: 10 · 2020: 2 · 2019: 1 · 2017: 1
- FWCI
- 0.84
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- public-domain
- Locations
- The Journal of Infectious Diseases (publishedVersion, public-domain)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- NIH
- Topics
- Health Sciences › Medicine › Infectious Diseases › Viral Infections and Outbreaks Research
- Health Sciences › Health Professions › Medical Laboratory Technology › Quality and Safety in Healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Keywords
- Ebola vaccine, cold chain, vaccine storage and transport, 2014-2015 Ebola outbreak, Sierra Leone, STRIVE trial, vaccine stability, temperature excursions, ring vaccination, clinical trial capacity building, vesicular stomatitis virus vector
- MeSH terms
- Disease Outbreaks, Freezing, Humans, Refrigeration, Sierra Leone, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Hemorrhagic Fever, Ebola, Ebola Vaccines
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
