| 词条 | Dengue vaccine |
| 释义 |
| Verifiedfields = | verifiedrevid = | image = | caption = | type = vaccine | target = Dengue fever | vaccine_type = various | tradename = | MedlinePlus = | pregnancy_AU = | pregnancy_US = | pregnancy_category = | legal_AU = | legal_CA = | legal_UK = | legal_US = | legal_status = | routes_of_administration = | ChemSpiderID = none | CAS_number_Ref = | CAS_number = | ATC_prefix = | ATC_suffix = | PubChem = | DrugBank_Ref = | DrugBank = }}Dengue vaccine is a vaccine to prevent dengue fever in humans. The World Health Organization recommends that countries should consider vaccination with the dengue vaccine CYD-TDV only if the risk of severe dengue in seronegative individuals can be minimized either through pre-vaccination screening or recent documentation of high seroprevalence rates in the area (at least 80% by age 9 years).[1] In 2017 the manufacturer recommended that the vaccine only be used in people who have previously had a dengue infection, as outcomes may be worsened in those who have not been previously infected.[2] This has caused a scandal in the Philippines where more than 733,000 children and more than 50,000 adult volunteers were vaccinated regardless of serostatus.[2] The development of vaccine for dengue fever began as early as 1929, but has been hindered first by incomplete knowledge of the disease pathogenesis, and later by the need to simultaneously create a stable immunity against all four dengue serotypes. Several vaccine candidates are in development including live attenuated, inactivated, DNA and subunit vaccines. Live attenuated vaccine candidates are the furthest along in development.[3] In 2016 a partially effective vaccine for dengue fever (Dengvaxia) became commercially available in 11 countries: Mexico, the Philippines, Indonesia, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Thailand, and Singapore.[4][5][7] In Indonesia it costs about US$207 for the recommended three doses.[6] WHO updated its recommendations regarding the use of Dengvaxia in September 2018 based on the evidence that seronegative vaccine recipients have an excess risk of severe dengue compared to unvaccinated seronegative individuals . It is not clear why the vaccinated sereonegative population have more serious adverse outcomes. A plausible hypothesis is the phenomenon of antibody-dependent enhancement.[7] CYD-TDVCYD-TDV, sold under the brand name Dengvaxia and made by Sanofi Pasteur, is a live attenuated tetravalent chimeric vaccine made using recombinant DNA technology by replacing the PrM (pre-membrane) and E (envelope) structural genes of the yellow fever attenuated 17D strain vaccine with those from the four dengue serotypes.[8][9] In 2017 the manufacturer recommended that the vaccine only be used in people who have previously had a dengue infection as otherwise there was evidence it may worsen subsequent infections.[10] The initial protocol did not require baseline blood samples prior to vaccination in order to establish an understanding of increased risk of severe dengue in participants who had not been previously exposed. In November 2017 Sanofi acknowledged that some participants were put at risk of severe dengue if they had no prior exposure to the infection; subsequently the Philippines government suspended the mass immunization program with the backing of the WHO which began a review of the safety data.[11] Ongoing phase III trials in Latin America and Asia involve over 31,000 children between the ages of 2 and 14 years. In the first reports from the trials, vaccine efficacy was 56.5% in the Asian study and 64.7% in the Latin American study in patients who received at least one injection of the vaccine.[12][13] Efficacy varied by serotype. In both trials vaccine reduced by about 80% the number of severe dengue cases.[14] An analysis of both the Latin American and Asian studies at the 3rd year of follow-up showed that the efficacy of the vaccine was 65.6% in preventing hospitalization in children older than 9 years of age, but considerably greater (81.9%) for children who were seropositive (indicating previous dengue infection) at baseline.[15] The vaccination series consists of three injections at 0, 6 and 12 months.[9] The vaccine was approved in Mexico, Philippines, and Brazil in December 2015, and in El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore in 2016.[4] Tradenamed Dengvaxia, it is approved for use for those aged nine and older and can prevent all four serotypes.[16] In developmentDENVax or TAK-003DENVax or TAK-003 is a recombinant chimeric vaccine with DENV1, DENV3, and DENV4 components on a dengue virus type 2 (DENV2) backbone originally developed at Mahidol University in Bangkok and now funded by Inviragen (DENVax) and Takeda (TAK-003).[17][18] Phase I and II trials are ongoing in the United States, Colombia, Puerto Rico, Singapore and Thailand.[19] Based on the latest 18-month data published in the journal Lancet Infectious Diseases, indicated that TAK-003 produced sustained antibody responses against all four virus strains, regardless of previous dengue exposure and dosing schedule.[20] TetraVax-DVTetraVax-DV is a tetravalent admixture of monovalent vaccines that were tested separately for safety and immunogenicity. The vaccine passed phase I trials and is being tested in phase II studies in Thailand and Brazil.[21] In Brazil, the studies are being done in collaboration with the Instituto Butantan. TDENV PIVTDEN PIV is inactivated tetravalent vaccine undergoing phase I trials as part of a collaboration between GSK and the Walter Reed Army Institute of Research. A synergistic formulation with another live attenuated candidate vaccine (prime-boost strategy) is also being evaluated in a phase II study. In prime-boosting, one type of vaccine is followed by a boost with another type in an attempt to improve immunogenicity.[22] V180Merck is studying recombinant subunit vaccines expressed in Drosophila cells. Studies are in phase I stage as of 2015.[22] DNA vaccinesThe Naval Medical Research Center attempted to develop a monovalent DNA plasmid vaccine, but early results showed it to be only moderately immunogenic.[19] Manufacturer in India and VietnamPanacea Biotec and Biological E. Limited have vaccine candidates in the earliest stages of development. A company in Vietnam (VABIOTECH) is conducting safety tests and developing a clinical trial plan.[23] All three companies are involved in studies of a TetraVax-DV vaccine in conjunction with the National Institutes of Health.[24]Society and culturePhilippines controversyThe 2017 dengue vaccine controversy in the Philippines involved a vaccination program run by the Philippines Department of Health.[5] It vaccinated schoolchildren with Sanofi Pasteur's CYD-TDV (Dengvaxia) dengue vaccine. Some of the children who received the vaccine had never been infected by the dengue virus before. The program was stopped when Sanofi Pasteur advised the government that the vaccine could put previously uninfected people at a somewhat higher risk of a severe case of dengue fever.[10] A political controversy erupted over whether the program was run with sufficient care and who should be held responsible for the alleged harm to the vaccinated children.[11] References1. ^{{cite journal|last=|first=|date=September 7, 2018|title=Dengue vaccine: WHO position paper – September 2018|url=http://apps.who.int/iris/bitstream/handle/10665/274315/WER9336.pdf?ua=1|journal=Weekly Epidemiological Record|volume=93|issue=36|pages=457–476|pmid=|via=}} 2. ^{{cite web|title=DOJ orders NBI to investigate P3.5-B dengue vaccine scandal|url=http://www.gmanetwork.com/news/news/nation/635301/doj-orders-nbi-to-investigate-p3-5-b-dengue-vaccine-scandal/story/|website=STAT|accessdate=14 December 2017|date=4 December 2017}} 3. ^{{citejournal|last1=McArthur|first1=MA|last2=Sztein|first2=MB|last3=Edelman|first3=R|title=Dengue vaccines: recent developments, ongoing challenges and current candidates. |journal=Expert Review of Vaccines |date=August 2013|volume=12|issue=8|pages=933–53|pmid=23984962|doi=10.1586/14760584.2013.815412}} 4. ^1 {{cite web|title=Sanofi's dengue vaccine approved in 11 countries|url=https://www.reuters.com/article/us-sanofi-vacccine-idUSKCN1240C5|website=Reuters|accessdate=13 August 2017|date=2016}} 5. ^1 {{cite news|last1=East|first1=Susie|title=World's first dengue fever vaccine launched in the Philippines|url=http://edition.cnn.com/2016/04/06/health/dengue-fever-vaccine-philippines/|accessdate=17 October 2016|publisher=CNN|date=6 April 2016}} 6. ^1 {{cite web |url=http://en.tempo.co/read/news/2016/10/17/310812742/Dengue-Fever-Vaccine-Available-in-Indonesia |title=Dengue Fever Vaccine Available in Indonesia |date=October 17, 2016}} 7. ^{{cite web|title=Caution on new dengue vaccine: In some countries, harm outweighs benefit|url=https://www.statnews.com/2016/09/01/dengue-vaccine-can-harm/|website=STAT|accessdate=13 August 2017|date=1 September 2016}} 8. ^{{cite journal | doi = 10.1177/2051013613507862 | pmid=24757522 | title=Latest developments and future directions in dengue vaccines | journal=Therapeutic Advances in Vaccines | date=2014 | volume=2 | issue=1 | pages=3–9 | first=U. | last=Thisyakorn| pmc=3991153 }} 9. ^1 {{cite journal | doi = 10.1016/B978-0-12-800098-4.00007-6 | pmid=24373316 | title=Dengue Virus Vaccine Development | journal=Advances in Virus Research | volume=88 | date=2014 | pages=315–372 | first=Lauren E. | last=Yauch| isbn=9780128000984 }} 10. ^1 2 {{cite web|title=Sanofi restricts dengue vaccine but downplays antibody enhancement|url=http://www.cidrap.umn.edu/news-perspective/2017/12/sanofi-restricts-dengue-vaccine-downplays-antibody-enhancement|website=CIDRAP|accessdate=2 December 2017|language=en}} 11. ^1 Steenhuysen, Julie and Hirschler, Ben. (12 December 2017). "Did Sanofi, WHO ignore warning signals on dengue vaccine?". [https://www.reuters.com/article/us-sanofi-dengue-science-insight/did-sanofi-who-ignore-warning-signals-on-dengue-vaccine-idUSKBN1E7072 Reuters website] Retrieved 13 December 2017. 12. ^{{cite journal|last1=Capeding|first1=MR|last2=Tran|first2=NH|last3=Hadinegoro|first3=SR|last4=Ismail|first4=HI|last5=Chotpitayasunondh|first5=T|last6=Chua|first6=MN|last7=Luong|first7=CQ|last8=Rusmil|first8=K|last9=Wirawan|first9=DN|last10=Nallusamy|first10=R|last11=Pitisuttithum|first11=P|last12=Thisyakorn|first12=U|last13=Yoon|first13=IK|last14=van der Vliet|first14=D|last15=Langevin|first15=E|last16=Laot|first16=T|last17=Hutagalung|first17=Y|last18=Frago|first18=C|last19=Boaz|first19=M|last20=Wartel|first20=TA|last21=Tornieporth|first21=NG|last22=Saville|first22=M|last23=Bouckenooghe|first23=A|last24=CYD14 Study|first24=Group|title=Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.|journal=Lancet|date=11 October 2014|volume=384|issue=9951|pages=1358–65|pmid=25018116|doi=10.1016/s0140-6736(14)61060-6}} 13. ^{{cite journal|last1=Villar|first1=L|last2=Dayan|first2=GH|last3=Arredondo-García|first3=JL|last4=Rivera|first4=DM|last5=Cunha|first5=R|last6=Deseda|first6=C|last7=Reynales|first7=H|last8=Costa|first8=MS|last9=Morales-Ramírez|first9=JO|last10=Carrasquilla|first10=G|last11=Rey|first11=LC|last12=Dietze|first12=R|last13=Luz|first13=K|last14=Rivas|first14=E|last15=Miranda Montoya|first15=MC|last16=Cortés Supelano|first16=M|last17=Zambrano|first17=B|last18=Langevin|first18=E|last19=Boaz|first19=M|last20=Tornieporth|first20=N|last21=Saville|first21=M|last22=Noriega|first22=F|last23=CYD15 Study|first23=Group|title=Efficacy of a tetravalent dengue vaccine in children in Latin America.|journal=The New England Journal of Medicine|date=8 January 2015|volume=372|issue=2|pages=113–23|pmid=25365753|doi=10.1056/nejmoa1411037}} 14. ^{{cite news|url=http://www.sciencenewsline.com/articles/2014071023270026.html#footer|title=The Lancet: World's Most Advanced Dengue Vaccine Candidate Shows Promise in Phase 3 Trial|accessdate=13 July 2014|date=10 July 2014|work=Science Newsline medicine}} 15. ^{{cite journal|last1=Hadinegoro|first1=SR|last2=Arredondo-García|first2=JL|last3=Capeding|first3=MR|last4=Deseda|first4=C|last5=Chotpitayasunondh|first5=T|last6=Dietze|first6=R|last7=Ismail|first7=HI|last8=Reynales|first8=H|last9=Limkittikul|first9=K|last10=Rivera-Medina|first10=DM|last11=Tran|first11=HN|last12=Bouckenooghe|first12=A|last13=Chansinghakul|first13=D|last14=Cortés|first14=M|last15=Fanouillere|first15=K|last16=Forrat|first16=R|last17=Frago|first17=C|last18=Gailhardou|first18=S|last19=Jackson|first19=N|last20=Noriega|first20=F|last21=Plennevaux|first21=E|last22=Wartel|first22=TA|last23=Zambrano|first23=B|last24=Saville|first24=M|last25=CYD-TDV Dengue Vaccine Working|first25=Group|title=Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease.|journal=The New England Journal of Medicine|date=27 July 2015|pmid=26214039|doi=10.1056/NEJMoa1506223|volume=373|issue=13|pages=1195–206}} 16. ^{{cite web|url= http://www.fiercepharma.com/story/sanofi-gets-first-approval-long-anticipated-vaccine-against-dengue-fever/2015-12-09|title=Sanofi gets first approval for long-anticipated vaccine against dengue fever|author=Palmer, Eric|publisher=fiercepharma.com|date=9 December 2015|accessdate=10 December 2015}} 17. ^{{cite journal|last1=Osorio|first1=JE|last2=Huang|first2=CY|last3=Kinney|first3=RM|last4=Stinchcomb|first4=DT|title=Development of DENVax: a chimeric dengue-2 PDK-53-based tetravalent vaccine for protection against dengue fever.|journal=Vaccine|date=23 September 2011|volume=29|issue=42|pages=7251–60|pmid=21777638|doi=10.1016/j.vaccine.2011.07.020|pmc=4592106}} 18. ^{{cite journal|last1=Schwartz|first1=Lauren M.|last2=Halloran|first2=M. Elizabeth|last3=Durbin|first3=Anna P.|last4=Longini|first4=Ira M.|title=The dengue vaccine pipeline: Implications for the future of dengue control|journal=Vaccine|date=June 2015|volume=33|issue=29|pages=3293–3298|doi=10.1016/j.vaccine.2015.05.010|pmid=25989449|pmc=4470297}} 19. ^1 {{cite journal|last1=Schwartz|first1=LM|last2=Halloran|first2=ME|last3=Durbin|first3=AP|last4=Longini IM|first4=Jr|title=The dengue vaccine pipeline: Implications for the future of dengue control.|journal=Vaccine|date=26 June 2015|volume=33|issue=29|pages=3293–3298|pmid=25989449|doi=10.1016/j.vaccine.2015.05.010|pmc=4470297}} 20. ^{{cite web|url= https://www.reuters.com/article/us-takeda-pharma-dengue/takeda-takes-on-sanofi-with-new-global-dengue-vaccine-data-idUSKBN1D62Y5|title=With interim phase 2 data, Takeda's dengue vaccine casts shadow on Sanofi|author=Liu, Angus|publisher=reuters.com|date=7 November 2017|accessdate=18 February 2018}} 21. ^{{cite web|title=NIH-Developed Candidate Dengue Vaccine Shows Promise in Early-Stage Trial|url=http://www.niaid.nih.gov/news/newsreleases/2013/Pages/DengueVax.aspx|publisher=National Institute of Allergy and Infectious Diseases|accessdate=30 July 2015}} 22. ^1 {{cite journal|last1=McArthur|first1=MA|last2=Sztein|first2=MB|last3=Edelman|first3=R|title=Dengue vaccines: recent developments, ongoing challenges and current candidates.|journal=Expert Review of Vaccines|date=August 2013|volume=12|issue=8|pages=933–53|pmid=23984962|doi=10.1586/14760584.2013.815412|pmc=3773977}} 23. ^{{cite web|title=Vaccine Development. Dengue Vaccine Initiative|url=http://www.denguevaccines.org/vaccine-development|accessdate=31 July 2015}} 24. ^{{cite web|last1=Roehrig|first1=John T|title=Current Status of Dengue Vaccine Development|url=http://www.who.int/immunization/sage/meetings/2013/april/2_Roehrig_Dengue_SAGE_April2013.pdf|accessdate=31 July 2015}} External links
2 : Vaccines|Dengue fever |
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