Chikungunya vaccine

Last updated

Chikungunya vaccine
Vaccine description
Target Chikungunya virus
Vaccine type Attenuated
Clinical data
Trade names Ixchiq
AHFS/Drugs.com Ixchiq
License data
Routes of
administration 		Intramuscular
ATC code
  • None
Legal status
Legal status

A Chikungunya vaccine is a vaccine intended to provide acquired immunity against the chikungunya virus. [5]

Contents

The most commonly reported side effects include headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site. [8]

The first chikungunya vaccine was approved for medical use in the United States in November 2023. [8]

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. [5]

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. [8] 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. [8] 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. [8] 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. [8] Almost all vaccine study participants achieved this antibody level. [8]

The US Food and Drug Administration (FDA) granted the application for the chikungunya vaccine fast track, breakthrough therapy, and priority review designations. [8] The FDA granted approval of Ixchiq to Valneva Austria GmbH. [8] [9]

Society and culture

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. [6] The applicant for this medicinal product is Valneva Austria GmbH. [6] [10] Ixchiq was reviewed under EMA's accelerated assessment program. [6] [11] It contains the live attenuated chikungunya virus (CHIKV) Δ5nsP3 strain of the ECSA/IOL genotype. [6] Ixchiq was approved for medical use in the European Union in June 2024. [7]

In January 2025, European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorization for Vimkunya (chikungunya vaccine (recombinant, adsorbed)), a vaccine to protect young people from 12 years of age and adults against disease caused by the Chikungunya virus. [12]

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. [13] However, 8% of people reported transient joint pain, and attenuation was found to be due to only two mutations in the E2 glycoprotein. [14] Alternative vaccine strategies have been developed, and show efficacy in mouse models. [15] [16]

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. [17]

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. [18] In 2021, two vaccine manufacturers, one in France, the other in the United States, reported successful completion of phase II clinical trials. [19] [20]

Related Research Articles

<span class="mw-page-title-main">Live attenuated influenza vaccine</span> Nasal influenza vaccine

Live attenuated influenza vaccine (LAIV) is a type of influenza vaccine in the form of a nasal spray that is recommended for the prevention of influenza.

<span class="mw-page-title-main">European Medicines Agency</span> Agency of the European Union

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

<span class="mw-page-title-main">Pneumococcal conjugate vaccine</span> Vaccine against Strep pneumoniae

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children.

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23. It is administered either by intravenous infusion or subcutaneous injection. The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells. By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease. Ustekinumab was developed by Centocor Ortho Biotech.

<span class="mw-page-title-main">Denosumab</span> Human monoclonal antibody

Denosumab, sold under the brand names Prolia among others, is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.

<span class="mw-page-title-main">Hepatitis B vaccine</span> Vaccine against hepatitis B

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected.

Aflibercept, sold under the brand names Eylea and Zaltrap among others, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals.

<span class="mw-page-title-main">Fostemsavir</span> Chemical compound

Fostemsavir, sold under the brand name Rukobia, is an antiretroviral medication for adults living with HIV/AIDS who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.

Dengue vaccine is a vaccine used to prevent dengue fever in humans. Development of dengue vaccines began in the 1920s but was hindered by the need to create immunity against all four dengue serotypes. As of 2023, there are two commercially available vaccines, sold under the brand names Dengvaxia and Qdenga.

<span class="mw-page-title-main">Ebola vaccine</span> Vaccine against Ebola

Ebola vaccines are vaccines either approved or in development to prevent Ebola. As of 2022, there are only vaccines against the Zaire ebolavirus. The first vaccine to be approved in the United States was rVSV-ZEBOV in December 2019. It had been used extensively in the Kivu Ebola epidemic under a compassionate use protocol. During the early 21st century, several vaccine candidates displayed efficacy to protect nonhuman primates against lethal infection.

Inebilizumab, sold under the brand name Uplizna, is a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults. Inebilizumab is a humanized mAb that binds to and depletes CD19+ B cells including plasmablasts and plasma cells.

Valneva SE is a French biotech company headquartered in Saint-Herblain, France, developing and commercializing vaccines for infectious diseases. It has manufacturing sites in Livingston, Scotland; Solna, Sweden, and Vienna, Austria; with other offices in France, Canada and the United States.

A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year.

<span class="mw-page-title-main">Valneva COVID-19 vaccine</span> Vaccine candidate against COVID-19

Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.

<span class="mw-page-title-main">Novavax COVID-19 vaccine</span> Vaccine against COVID-19

The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations.

<span class="mw-page-title-main">History of COVID-19 vaccine development</span> Scientific work to develop a vaccine for COVID-19

SARS-CoV-2, the virus that causes COVID-19, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten the development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.

<span class="mw-page-title-main">Sanofi–GSK COVID-19 vaccine</span> Protein subunit vaccine against COVID-19

The Sanofi–GSK COVID-19 vaccine, sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.

Valoctocogene roxaparvovec, sold under the brand name Roctavian, is a gene therapy used for the treatment of hemophilia A. It was developed by BioMarin Pharmaceutical. Valoctocogene roxaparvovec is made of a virus (AAV5) that has been modified to contain the gene for factor VIII, which is lacking in people with hemophilia A. It is an adeno-associated virus vector-based gene therapy. It is given by intravenous infusion.

Penbraya is a pentavalent conjugate vaccine developed by Pfizer for the prevention of invasive meningococcal disease in people 10 through 25 years of age. Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis, can lead to serious conditions such as meningitis and sepsis. Penbraya is approved for use by the US Food and Drug Administration (FDA). Penbraya is the first pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease.

References

  1. ↑ "Register Of Innovative Drugs [Updated: 2024-07-04]". Health Canada . 4 July 2024. Retrieved 15 July 2024.
  2. ↑ "Ixchiq Product information". Health Canada . 20 June 2024. Retrieved 15 July 2024.
  3. ↑ "Summary Basis of Decision for Ixchiq". Drug and Health Products Portal. 1 September 2012. Retrieved 17 December 2024.
  4. ↑ "Regulatory Decision Summary for Ixchiq". Drug and Health Products Portal. 20 June 2024. Retrieved 27 December 2024.
  5. 1 2 3 "Ixchiq". U.S. Food and Drug Administration. 9 November 2023. Archived from the original on 9 November 2023. Retrieved 10 November 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  6. 1 2 3 4 5 "Ixchiq EPAR". European Medicines Agency. 30 May 2024. Archived from the original on 1 June 2024. Retrieved 1 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. 1 2 "Ixchiq PI". European Medicines Agency. 30 May 2024. Archived from the original on 1 June 2024. Retrieved 2 July 2024.
  8. 1 2 3 4 5 6 7 8 9 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  9. ↑ Malhi S (10 November 2023). "FDA approves first vaccine against mosquito-borne virus chikungunya". The Washington Post . Archived from the original on 11 November 2023. Retrieved 13 November 2023.
  10. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024". European Medicines Agency (Press release). 31 May 2024. Archived from the original on 13 June 2024. Retrieved 13 June 2024.
  11. ↑ "First vaccine to protect adults from Chikungunya". European Medicines Agency (EMA) (Press release). 31 May 2024. Retrieved 1 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025 | European Medicines Agency (EMA)". www.ema.europa.eu. 31 January 2025. Retrieved 3 February 2025.
  13. ↑ Edelman R, Tacket CO, Wasserman SS, Bodison SA, Perry JG, Mangiafico JA (June 2000). "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. doi: 10.4269/ajtmh.2000.62.681 . PMID   11304054.
  14. ↑ Gorchakov R, Wang E, Leal G, Forrester NL, Plante K, Rossi SL, et al. (June 2012). "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. doi:10.1128/JVI.06449-11. PMC   3372191 . PMID   22457519.
  15. ↑ Plante K, Wang E, Partidos CD, Weger J, Gorchakov R, Tsetsarkin K, et al. (July 2011). "Novel chikungunya vaccine candidate with an IRES-based attenuation and host range alteration mechanism". PLOS Pathogens. 7 (7): e1002142. doi: 10.1371/journal.ppat.1002142 . PMC   3145802 . PMID   21829348. Open Access logo PLoS transparent.svg
  16. ↑ Hallengärd D, Kakoulidou M, Lulla A, Kümmerer BM, Johansson DX, Mutso M, et al. (March 2014). "Novel attenuated Chikungunya vaccine candidates elicit protective immunity in C57BL/6 mice". Journal of Virology. 88 (5): 2858–66. doi:10.1128/JVI.03453-13. PMC   3958085 . PMID   24371047.
  17. ↑ "Experimental chikungunya vaccine passes first test". NPR. 15 August 2014. Archived from the original on 19 August 2014. Retrieved 15 August 2014.
  18. ↑ Al Idrus, Amirah (2 December 2015). "NIAID to bring Chikungunya vaccine into Phase II". fiercevaccines.com. Archived from the original on 10 April 2016. Retrieved 24 March 2016.
  19. ↑ Hackett KM (10 June 2021). "Chikungunya Vaccine Candidate Approaches Authorization". www.precisionvaccinations.com. Archived from the original on 4 September 2023. Retrieved 10 November 2023.
  20. ↑ Keown A (26 May 2021). "Emergent Enjoys Some Good News, Posting Positive Results for Chikungunya Vaccine". BioSpace. Urbandale IA. Archived from the original on 4 September 2023. Retrieved 10 November 2023.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.