Chikungunya vaccine explained

Type:vaccine
Target:Chikungunya virus
Vaccine Type:attenuated
Tradename:Ixchiq
Dailymedid:Ixchiq
Routes Of Administration:Intramuscular
Atc Prefix:None
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[1] [2]
Legal Us:Rx-only
Legal Eu:Rx-only

A Chikungunya vaccine is a vaccine intended to provide acquired immunity against the chikungunya virus.[3]

The most commonly reported side effects include headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.

The first chikungunya vaccine was approved for medical use in the United States in November 2023.[4]

Medical uses

The chikungunya vaccine is indicated for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at high risk of exposure to the chikungunya virus.

History

The safety of the chikungunya vaccine was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo. The effectiveness of the chikungunya vaccine is based on immune response data from a clinical study conducted in the United States in individuals 18 years of age and older. In this study, the immune response of 266 participants who received the vaccine was compared to the immune response of 96 participants who received placebo. The level of antibody evaluated in study participants was based on a level shown to be protective in non-human primates that had received blood from people who had been vaccinated. Almost all vaccine study participants achieved this antibody level.

The US Food and Drug Administration (FDA) granted the application for the chikungunya vaccine fast track, breakthrough therapy, and priority review designations. The FDA granted approval of Ixchiq to Valneva Austria GmbH.[5]

Society and culture

Legal status

In May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ixchiq, intended for the prevention of chikungunya disease in adults. The applicant for this medicinal product is Valneva Austria GmbH.[6] Ixchiq was reviewed under EMA's accelerated assessment program.[7] [8] It contains the live attenuated chikungunya virus (CHIKV) Δ5nsP3 strain of the ECSA/IOL genotype. Ixchiq was approved for medical use in the European Union in June 2024.[9]

Research

A phase-II vaccine trial used a live, attenuated virus, to develop viral resistance in 98% of those tested after 28 days and 85% still showed resistance after one year.[10] However, 8% of people reported transient joint pain, and attenuation was found to be due to only two mutations in the E2 glycoprotein.[11] Alternative vaccine strategies have been developed, and show efficacy in mouse models.[12] [13]

In August 2014, researchers at the National Institute of Allergy and Infectious Diseases in the USA tested an experimental vaccine using virus-like particles (VLPs) instead of attenuated virus. All of the 25 people participating in this phase I trial developed strong immune responses.[14]

As of 2015, a phase II trial was planned, using 400 adults aged 18 to 60 and to take place at six locations in the Caribbean.[15] In 2021, two vaccine manufacturers, one in France, the other in the United States, reported successful completion of phase II clinical trials.[16] [17]

Notes and References

  1. Web site: Register Of Innovative Drugs [Updated: 2024-07-04] ]. . 4 July 2024 . 15 July 2024.
  2. Web site: Ixchiq Product information . . 20 June 2024 . 15 July 2024.
  3. Web site: Ixchiq . U.S. Food and Drug Administration . 9 November 2023 . 10 November 2023 . 9 November 2023 . https://web.archive.org/web/20231109224929/https://www.fda.gov/vaccines-blood-biologics/ixchiq . live .
  4. FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus . U.S. Food and Drug Administration . 9 November 2023 . 10 November 2023 . 9 November 2023 . https://web.archive.org/web/20231109234738/https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-prevent-disease-caused-chikungunya-virus . live .
  5. News: Malhi . Sabrina . 10 November 2023 . FDA approves first vaccine against mosquito-borne virus chikungunya . 13 November 2023 . . 11 November 2023 . https://web.archive.org/web/20231111001243/https://www.washingtonpost.com/health/2023/11/10/chikungunya-vaccine-approved-mosquito-bites/ . live .
  6. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024 . European Medicines Agency . 31 May 2024 . 13 June 2024 . 13 June 2024 . https://web.archive.org/web/20240613053159/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2024 . live .
  7. Web site: Ixchiq EPAR . European Medicines Agency . 30 May 2024 . 1 June 2024 . 1 June 2024 . https://web.archive.org/web/20240601040318/https://www.ema.europa.eu/en/medicines/human/EPAR/ixchiq . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. First vaccine to protect adults from Chikungunya . European Medicines Agency (EMA) . 31 May 2024 . 1 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. Web site: Ixchiq PI . European Medicines Agency . 30 May 2024 . 2 July 2024 . 1 June 2024 . https://web.archive.org/web/20240601045534/https://www.ema.europa.eu/en/medicines/human/EPAR/ixchiq . live .
  10. Edelman R, Tacket CO, Wasserman SS, Bodison SA, Perry JG, Mangiafico JA . Phase II safety and immunogenicity study of live chikungunya virus vaccine TSI-GSD-218 . The American Journal of Tropical Medicine and Hygiene . 62 . 6 . 681–5 . June 2000 . 11304054 . 10.4269/ajtmh.2000.62.681 . free .
  11. Gorchakov R, Wang E, Leal G, Forrester NL, Plante K, Rossi SL, Partidos CD, Adams AP, Seymour RL, Weger J, Borland EM, Sherman MB, Powers AM, Osorio JE, Weaver SC . Attenuation of Chikungunya virus vaccine strain 181/clone 25 is determined by two amino acid substitutions in the E2 envelope glycoprotein . Journal of Virology . 86 . 11 . 6084–96 . June 2012 . 22457519 . 3372191 . 10.1128/JVI.06449-11 .
  12. Plante K, Wang E, Partidos CD, Weger J, Gorchakov R, Tsetsarkin K, Borland EM, Powers AM, Seymour R, Stinchcomb DT, Osorio JE, Frolov I, Weaver SC . Novel chikungunya vaccine candidate with an IRES-based attenuation and host range alteration mechanism . PLOS Pathogens . 7 . 7 . e1002142 . July 2011 . 21829348 . 3145802 . 10.1371/journal.ppat.1002142 . free .
  13. Hallengärd D, Kakoulidou M, Lulla A, Kümmerer BM, Johansson DX, Mutso M, Lulla V, Fazakerley JK, Roques P, Le Grand R, Merits A, Liljeström P . Novel attenuated Chikungunya vaccine candidates elicit protective immunity in C57BL/6 mice . Journal of Virology . 88 . 5 . 2858–66 . March 2014 . 24371047 . 3958085 . 10.1128/JVI.03453-13 .
  14. News: Experimental chikungunya vaccine passes first test. 15 August 2014. 15 August 2014. NPR. live. https://web.archive.org/web/20140819075049/http://www.npr.org/blogs/goatsandsoda/2014/08/18/341360645/experimental-vaccine-for-chikungunya-passes-first-test. 19 August 2014.
  15. Web site: NIAID to bring Chikungunya vaccine into Phase II. Al Idrus, Amirah. fiercevaccines.com. 2 December 2015. 24 March 2016. live. https://web.archive.org/web/20160410115003/http://www.fiercevaccines.com/story/niaid-bring-chikungunya-vaccine-phase-ii/2015-12-02. 10 April 2016.
  16. Web site: Hackett . Karen McClory . Chikungunya Vaccine Candidate Approaches Authorization . www.precisionvaccinations.com . 10 June 2021 . 10 November 2023 . 4 September 2023 . https://web.archive.org/web/20230904005848/https://www.precisionvaccinations.com/2021/06/10/chikungunya-vaccine-candidate-approaches-authorization . live .
  17. Web site: Keown . Alex . Emergent Enjoys Some Good News, Posting Positive Results for Chikungunya Vaccine . BioSpace . Urbandale IA . 26 May 2021 . 10 November 2023 . 4 September 2023 . https://web.archive.org/web/20230904005845/https://www.biospace.com/article/halting-mosquito-borne-illnesses-emergent-biosolutions-posts-positive-chikungunya-vaccine-data-/ . live .

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