Dengue vaccine

Dengue vaccine
Dengvaxia being given as part of an immunization program in Paraná state, Brazil
Vaccine description
Target diseaseDengue fever
TypeAttenuated virus
Names
Trade namesDengvaxia
Other namesCYD-TDV
Clinical data
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Subcutaneous injection
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
  • US: ℞-only
  • In general: ℞ (Prescription only)

Dengue vaccine is a vaccine used to prevent dengue fever in humans.[1] As of 2019, one version is commercially available, known as CYD-TDV, and sold under the brand name Dengvaxia.[2] The vaccine is only recommended in those who have previously had dengue fever or populations in which most people have been previously infected.[2] The value of the vaccine is limited by the fact that it may increase the risk of severe dengue in those who have not previously been infected.[2][3] It is given as three injections over a year.[1]

Common side effects include headache, pain at the site of injection, and general muscle pains.[1] Severe side effects may include anaphylaxis.[1] Use is not recommended in people with poor immune function.[1] Safety of use during pregnancy is unclear.[1] Dengvaxia is a weakened but live vaccine and works by triggering an immune response against four types of dengue virus.[4][1]

As of 2021, the dengue vaccine had been approved for medical use in 19 countries, including the United States in 2019.[4][5][6] It is on the World Health Organization's List of Essential Medicines.[7] In Indonesia it costs about US$207 for the recommended three doses as of 2016.[8] Development of dengue vaccines began in the 1920s, but was hindered by the need to create immunity against all four dengue serotypes.[9] Several other vaccine candidates in development including live attenuated, inactivated, DNA and subunit vaccines.[9]

Medical uses

Dosage

The defined daily dose is not established.[10]

CYD-TDV

CYD-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.[11][12] Evidence indicates that CYD-TDV is partially effective in preventing infection, but may lead to a higher risk of severe disease in those who have not been previously infected and then do go on to contract the disease. It is not clear why the vaccinated sereonegative population have more serious adverse outcomes. A plausible hypothesis is the phenomenon of antibody-dependent enhancement.[13]

Dengvaxia became commercially available in 2016, in 11 countries: Mexico, the Philippines, Indonesia, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Thailand, and Singapore.[14][15][8]

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.[16] This led to the 2017–18 Philippine dengue vaccination controversy where more than 733,000 children and more than 50,000 adult volunteers were vaccinated regardless of serostatus.[17]

The World Health Organization (WHO) 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 nine years).[2]

The 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.[13]

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.[16] 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 Philippine government suspended the mass immunization program with the backing of the WHO which began a review of the safety data.[18]

Phase III trials in Latin America and Asia involved over 31,000 children between the ages of two 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.[19][20] Efficacy varied by serotype. In both trials vaccine reduced by about 80% the number of severe dengue cases.[21] 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 nine years of age, but considerably greater (81.9%) for children who were seropositive (indicating previous dengue infection) at baseline.[22] The vaccination series consists of three injections at 0, 6 and 12 months.[12] 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.[14] Tradenamed Dengvaxia, it is approved for use for those aged nine and older and can prevent all four serotypes.[23]

Society and culture

Cost

In Indonesia it costs about US$207 for the recommended three doses as of 2016.[8]

Philippines controversy

The 2017 dengue vaccine controversy in the Philippines involved a vaccination program run by the Philippines Department of Health.[15] 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.[16] 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.[18]

In development

DENVax or TAK-003

DENVax 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).[24][25] Phase I and II trials were conducted in the United States, Colombia, Puerto Rico, Singapore and Thailand.[26] Based on the 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.[27]

Data from the ongoing phase III trial show that TAK-003 was efficacious against symptomatic dengue.[28] TAK-003 appears to not lack efficacy in seronegative people or potentially cause them harm, unlike CYD-TDV. The data appear to show only moderate efficacy in other dengue serotypes than DENV2. These results will be investigated in another part of the phase III trial, scheduled to last six months.[29]

TetraVax-DV

TetraVax-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.[30] In Brazil, the studies are being done in collaboration with the Instituto Butantan. Panacea 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.[31] All four companies are involved in studies of a TetraVax-DV vaccine in conjunction with the National Institutes of Health.[32]

TDENV PIV

TDENV PIV (tetravalent dengue virus purified inactivated vaccine) is undergoing phase I trials as part of a collaboration between GlaxoSmithKline (GSK) and the Walter Reed Army Institute of Research (WRAIR). 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.[33]

V180

Merck is studying recombinant subunit vaccines expressed in Drosophila cells. As of 2019, it has completed phase I stage and V180 formulations found to be generally well tolerated.[34]

DNA vaccines

In 2011, the Naval Medical Research Center attempted to develop a monovalent DNA plasmid vaccine, but early results showed it to be only moderately immunogenic.[26]

History

In December 2018, Dengvaxia was approved in the European Union.[35]

In May 2019, Dengvaxia was approved in the United States as the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages nine through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.[4] Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.[4]

The safety and effectiveness of the vaccine was determined in three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacific region.[4] The vaccine was determined to be approximately 76 percent effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease.[4] Dengvaxia has already been approved in 19 countries and the European Union.[4]

Dengvaxia is not approved in the U.S. for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown.[4][36]

Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and twelve months later.[4]

The U.S. Food and Drug Administration (FDA) granted the application for Dengvaxia priority review designation and a tropical disease priority review voucher.[4] The approval of Dengvaxia was granted to Sanofi Pasteur.[4]

References

  1. 1 2 3 4 5 6 7 "Dengue Vaccine Live Monograph for Professionals". Drugs.com. Archived from the original on 14 October 2019. Retrieved 14 November 2019.
  2. 1 2 3 4 World Health Organization (September 2018). "Dengue vaccine: WHO position paper – September 2018". Weekly Epidemiological Record. 93 (36): 457–76. hdl:10665/274316.
  3. ↑ Redoni M, Yacoub S, Rivino L, Giacobbe DR, Luzzati R, Di Bella S. (February 2020). "Dengue: Status of current and under-development vaccines". Reviews in Medical Virology: e2101. doi:10.1002/rmv.2101. PMID 32101634.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  4. 1 2 3 4 5 6 7 8 9 10 11 "First FDA-approved vaccine for the prevention of dengue disease in endemic regions". U.S. Food and Drug Administration (FDA) (Press release). 1 May 2019. Archived from the original on 6 December 2019. Retrieved 14 November 2019.Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ Prevatt, Natalie; Behrens, Ron H. (2021). "23. Paediatric vaccines for travel outside Europe". In Vesikari, Timo; Damme, Pierre Van (eds.). Pediatric Vaccines and Vaccinations: A European Textbook (Second ed.). Switzerland: Springer. pp. 275–276. ISBN 978-3-030-77172-0. Archived from the original on 11 January 2022. Retrieved 8 January 2022.
  6. ↑ "Dengvaxia". U.S. Food and Drug Administration (FDA). 21 May 2019. STN 125682. Archived from the original on 6 December 2019. Retrieved 6 December 2019.Public Domain This article incorporates text from this source, which is in the public domain.
  7. ↑ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  8. 1 2 3 "Dengue Fever Vaccine Available in Indonesia". 17 October 2016. Archived from the original on 18 October 2016. Retrieved 17 October 2016.
  9. 1 2 McArthur, MA; Sztein, MB; Edelman, R (August 2013). "Dengue vaccines: recent developments, ongoing challenges and current candidates". Expert Review of Vaccines. 12 (8): 933–53. doi:10.1586/14760584.2013.815412. PMC 3773977. PMID 23984962.
  10. ↑ "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 1 July 2021. Retrieved 10 September 2020.
  11. ↑ Thisyakorn, U. (2014). "Latest developments and future directions in dengue vaccines". Therapeutic Advances in Vaccines. 2 (1): 3–9. doi:10.1177/2051013613507862. PMC 3991153. PMID 24757522.
  12. 1 2 Yauch, Lauren E. (2014). "Dengue Virus Vaccine Development". Advances in Virus Research. 88: 315–372. doi:10.1016/B978-0-12-800098-4.00007-6. ISBN 9780128000984. PMID 24373316.
  13. 1 2 "Caution on new dengue vaccine: In some countries, harm outweighs benefit". STAT. 1 September 2016. Archived from the original on 20 January 2021. Retrieved 13 August 2017.
  14. 1 2 "Sanofi's dengue vaccine approved in 11 countries". Reuters. 2016. Archived from the original on 30 November 2020. Retrieved 13 August 2017.
  15. 1 2 East, Susie (6 April 2016). "World's first dengue fever vaccine launched in the Philippines". CNN. Archived from the original on 18 October 2016. Retrieved 17 October 2016.
  16. 1 2 3 "Sanofi restricts dengue vaccine but downplays antibody enhancement". CIDRAP. Archived from the original on 14 March 2021. Retrieved 2 December 2017.
  17. ↑ "DOJ orders NBI to investigate P3.5-B dengue vaccine scandal". STAT. 4 December 2017. Archived from the original on 9 November 2020. Retrieved 14 December 2017.
  18. 1 2 Steenhuysen, Julie and Hirschler, Ben. (12 December 2017). "Did Sanofi, WHO ignore warning signals on dengue vaccine?". Reuters website Did Sanofi, WHO ignore warning signals on dengue vaccine? at the Wayback Machine (archived 14 December 2017)(Positional parameters ignored) Retrieved 13 December 2017.
  19. ↑ Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, et al. (11 October 2014). "Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial". Lancet. 384 (9951): 1358–65. doi:10.1016/s0140-6736(14)61060-6. PMID 25018116.
  20. ↑ Villar L, Dayan GH, Arredondo-García JL, Rivera DM, Cunha R, Deseda C, et al. (8 January 2015). "Efficacy of a tetravalent dengue vaccine in children in Latin America". The New England Journal of Medicine. 372 (2): 113–23. doi:10.1056/nejmoa1411037. PMID 25365753.
  21. ↑ "The Lancet: World's Most Advanced Dengue Vaccine Candidate Shows Promise in Phase 3 Trial". Science Newsline medicine. 10 July 2014. Archived from the original on 15 July 2014. Retrieved 13 July 2014.
  22. ↑ Hadinegoro SR, Arredondo-García JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, et al. (27 July 2015). "Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease". The New England Journal of Medicine. 373 (13): 1195–206. doi:10.1056/NEJMoa1506223. PMID 26214039.
  23. ↑ Palmer, Eric (9 December 2015). "Sanofi gets first approval for long-anticipated vaccine against dengue fever". FiercePharma. Archived from the original on 16 March 2016. Retrieved 10 December 2015.
  24. ↑ Osorio, JE; Huang, CY; Kinney, RM; Stinchcomb, DT (23 September 2011). "Development of DENVax: a chimeric dengue-2 PDK-53-based tetravalent vaccine for protection against dengue fever". Vaccine. 29 (42): 7251–60. doi:10.1016/j.vaccine.2011.07.020. PMC 4592106. PMID 21777638.
  25. ↑ Schwartz, Lauren M.; Halloran, M. Elizabeth; Durbin, Anna P.; Longini, Ira M. (June 2015). "The dengue vaccine pipeline: Implications for the future of dengue control". Vaccine. 33 (29): 3293–3298. doi:10.1016/j.vaccine.2015.05.010. PMC 4470297. PMID 25989449.
  26. 1 2 Schwartz, LM; Halloran, ME; Durbin, AP; Longini IM, Jr (26 June 2015). "The dengue vaccine pipeline: Implications for the future of dengue control". Vaccine. 33 (29): 3293–3298. doi:10.1016/j.vaccine.2015.05.010. PMC 4470297. PMID 25989449.
  27. ↑ Liu, Angus (7 November 2017). "With interim phase 2 data, Takeda's dengue vaccine casts shadow on Sanofi". Reuters. Archived from the original on 18 February 2018. Retrieved 18 February 2018.
  28. ↑ Biswal, Shibadas, et al. (6 November 2019). "Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents". The New England Journal of Medicine. 381 (21): 2009–2019. doi:10.1056/NEJMoa1903869. PMID 31693803. Retrieved 4 January 2020.{{cite journal}}: CS1 maint: url-status (link)
  29. ↑ Armstrong, Madeleine (7 November 2019). "Takeda's dengue data spell more bad news for Sanofi". Evaluate Ltd. Archived from the original on 11 November 2019. Retrieved 11 November 2019.
  30. ↑ "NIH-Developed Candidate Dengue Vaccine Shows Promise in Early-Stage Trial". National Institute of Allergy and Infectious Diseases. Archived from the original on 9 July 2015. Retrieved 30 July 2015.
  31. ↑ "Vaccine Development. Dengue Vaccine Initiative". Archived from the original on 21 August 2019. Retrieved 31 July 2015.
  32. ↑ Roehrig, John T. "Current Status of Dengue Vaccine Development" (PDF). Archived (PDF) from the original on 29 August 2017. Retrieved 31 July 2015.
  33. ↑ McArthur, MA; Sztein, MB; Edelman, R (August 2013). "Dengue vaccines: recent developments, ongoing challenges and current candidates". Expert Review of Vaccines. 12 (8): 933–53. doi:10.1586/14760584.2013.815412. PMC 3773977. PMID 23984962.
  34. ↑ Manoff, Susan B; Sausser, Michelle; Russel, Amy Flak; Martin, Jason; Radley, David; Hyatt, Donna (3 June 2019). "Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naïve adults". Human Vaccines & Immunotherapeutics. 15 (2019): 2195–2204. doi:10.1080/21645515.2018.1546523. PMC 6773383. PMID 30427741.
  35. ↑ "Dengvaxia EPAR". European Medicines Agency (EMA). 23 October 2019. Archived from the original on 6 December 2019. Retrieved 6 December 2019.
  36. ↑ "Dengvaxia- dengue tetravalent vaccine, live kit". DailyMed. 9 August 2019. Archived from the original on 28 August 2021. Retrieved 17 May 2020.
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