Medicine:Chikungunya vaccine
| Vaccine description | |
|---|---|
| Target disease | Chikungunya virus |
| Type | Attenuated virus |
| Clinical data | |
| Trade names | Ixchiq |
| AHFS/Drugs.com | Ixchiq |
| License data | |
| Routes of administration | Intramuscular |
| ATC code |
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| Legal status | |
| Legal status | |
A Chikungunya vaccine is a vaccine intended to provide acquired immunity against the chikungunya virus.[1]
The most commonly reported side effects include headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.[2]
The first chikungunya vaccine was approved for medical use in the United States in November 2023.[2]
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.[1]
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.[2] 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.[2] 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.[2] 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.[2] Almost all vaccine study participants achieved this antibody level.[2]
The US Food and Drug Administration (FDA) granted the application for the chikungunya vaccine fast track, breakthrough therapy, and priority review designations.[2] The FDA granted approval of Ixchiq to Valneva Austria GmbH.[2][3]
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.[4] However, 8% of people reported transient joint pain, and attenuation was found to be due to only two mutations in the E2 glycoprotein.[5] Alternative vaccine strategies have been developed, and show efficacy in mouse models.[6][7]
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.[8]
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.[9] In 2021, two vaccine manufacturers, one in France, the other in the United States, reported successful completion of phase II clinical trials.[10][11]
References
- ↑ 1.0 1.1 1.2 "Ixchiq". 9 November 2023. https://www.fda.gov/vaccines-blood-biologics/ixchiq.
This article incorporates text from this source, which is in the public domain.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus". U.S. Food and Drug Administration (Press release). 9 November 2023. Archived from the original on 9 November 2023. Retrieved 10 November 2023. This article incorporates text from this source, which is in the public domain.
- ↑ Malhi, Sabrina (10 November 2023). "FDA approves first vaccine against mosquito-borne virus chikungunya". The Washington Post. https://www.washingtonpost.com/health/2023/11/10/chikungunya-vaccine-approved-mosquito-bites/.
- ↑ "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. doi:10.4269/ajtmh.2000.62.681. PMID 11304054. http://www.ajtmh.org/cgi/pmidlookup?view=long&pmid=11304054.
- ↑ "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. doi:10.1128/JVI.06449-11. PMID 22457519.
- ↑ "Novel chikungunya vaccine candidate with an IRES-based attenuation and host range alteration mechanism". PLOS Pathogens 7 (7): e1002142. July 2011. doi:10.1371/journal.ppat.1002142. PMID 21829348.
- ↑ "Novel attenuated Chikungunya vaccine candidates elicit protective immunity in C57BL/6 mice". Journal of Virology 88 (5): 2858–66. March 2014. doi:10.1128/JVI.03453-13. PMID 24371047.
- ↑ "Experimental chikungunya vaccine passes first test". NPR. 15 August 2014. https://www.npr.org/blogs/goatsandsoda/2014/08/18/341360645/experimental-vaccine-for-chikungunya-passes-first-test.
- ↑ Al Idrus, Amirah (2 December 2015). "NIAID to bring Chikungunya vaccine into Phase II". fiercevaccines.com. http://www.fiercevaccines.com/story/niaid-bring-chikungunya-vaccine-phase-ii/2015-12-02.
- ↑ Hackett, Karen McClory (10 June 2021). "Chikungunya Vaccine Candidate Approaches Authorization". https://www.precisionvaccinations.com/2021/06/10/chikungunya-vaccine-candidate-approaches-authorization.
- ↑ Keown, Alex (26 May 2021). "Emergent Enjoys Some Good News, Posting Positive Results for Chikungunya Vaccine". Urbandale IA. https://www.biospace.com/article/halting-mosquito-borne-illnesses-emergent-biosolutions-posts-positive-chikungunya-vaccine-data-/.
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