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NDV-HXP-S

From Wikipedia, the free encyclopedia
Vaccine candidate against COVID-19

Pharmaceutical compound
NDV-HXP-S
Packaging for the Brazilian version of NDV-HXP-S, ButanVac
Vaccine description
TargetSARS-CoV-2
Vaccine typeviral vector or inactivated
Clinical data
Trade namesButanVac (Brazil)
COVIVAC (Vietnam)
HXP-GPOVac (Thailand)
Patria (Mexico)
Other namesADAPTCOV
Routes of
administration
Intramuscular,[1]Intranasal
Part ofa series on the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
virus iconCOVID-19 portal

NDV-HXP-S (known asButanVac[2][3] orADAPTCOV[4] in Brazil,COVIVAC[5] in Vietnam,HXP-GPOVac[6] in Thailand,Patria[7] in Mexico) is aCOVID-19 vaccine candidate developed under the leadership ofPeter Palese, Adolfo García-Sastre, and Florian Krammer at theIcahn School of Medicine at Mount Sinai, in New York, United States.[8][9]

The name NDV-HXP-S comes from the termsNewcastle disease virus,HexaPro, andspike protein.[8] The stabilization of the S protein ofSARS-CoV-2 (HexaPro) was achieved byJason McLellan from theUniversity of Texas at Austin.[10]

Pharmacology

[edit]

NDV-HXP-S uses theNewcastle disease virus as itsviral vector. The platform can be live orinactivated.[9]

Manufacturing

[edit]

Unlike vaccines such as Moderna'smRNA-1273, theJanssen vaccine, and Pfizer–BioNTech'sTozinameran, which all require both specialized manufacturing facilities and also rare or expensive ingredients, NDV-HXP-S can be produced usingchicken eggs in a fashion similar to influenza vaccine production, making it especially important to and for middle- and low-income countries.[8] Those existing vaccines are based on the 2P spike, while NDV-HXP-S is further refined via the same process, resulting in a new spike called HexaPro;[10] the 2P spike contained twoprolines compared with HexaPro's six. It is also more resistant to heat and chemicals than the original 2P spike; the vaccine can be stored at 2–8 °C.[11]

History

[edit]

Development

[edit]

Its development was coordinated by thePATH Center for Vaccine Innovation and Access, and UT Austin and ISMMS have arranged royalty-free licensing agreements with labs and corporations in 80 countries. McLellan has noted that "the share of vaccines ['low- and middle-income countries' have] received so far is terrible".[8]

Clinical trials

[edit]
São Paulo governorJoão Doria displaying Butanvac at a press conference on March 26, 2021.

As of December 2021, NDV-HXP-S is undergoing clinical trials in humans in at least four countries. In Brazil, on March 26, 2021, theButantan Institute announced it would seek to begin clinical trials. Mexico-based Avimex plans to create anintranasal spray version of the vaccine. In Thailand theGovernment Pharmaceutical Organization is conducting a trial in coordination withMahidol University.[12][13] Reflecting the freedom offered by the ease of the manufacturing process, Thai health ministerAnutin Charnvirakul referred to the vaccine as "produced by Thai people for Thai people".[8] A phase II study has been completed in Vietnam, but the phase III study has been discontinued due to shortage of unvaccinated volunteers.[14]

The Butantan trials were discontinued at phase II in late 2023 due to lack of efficacy.[15]

References

[edit]
  1. ^"Study of a Live rNDV Based Vaccine Against COVID-19".ClinicalTrials.gov. United States National Library of Medicine. 4 May 2021. NCT04871737. Retrieved4 May 2021.
  2. ^"Butantan vai desenvolver e produzir nova vacina contra a Covid-19; testes clínicos da ButanVac devem começar em abril".butantan.gov.br (in Portuguese). Retrieved16 December 2021.
  3. ^Simões E, Fonseca P (26 March 2021)."Brazil posts record 3,650 new COVID-19 deaths, unveils two homegrown vaccines".Reuters. Retrieved7 April 2021.Earlier, Sao Paulo's Butantan biomedical institute said it will seek approval ... Butantan aims to produce 40 million doses of the Butanvac vaccine ... The vaccine was developed using a modified virus, which causes the Newcastle disease in birds ...
  4. ^"Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil (ADAPTCOV)".clinicaltrials.gov. United States National Library of Medicine. 6 August 2021. Retrieved6 August 2021.
  5. ^"A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC".clinicaltrials.gov. United States National Library of Medicine. April 2021. Retrieved9 April 2021.
  6. ^"Mahidol-GPO's human trials of its COVID-19 vaccine show promising results". Thai PBS World. 1 July 2021. Retrieved19 July 2021.
  7. ^Juarez C (22 April 2021)."Vacuna Patria: esto es lo que se sabe de su avance y eventual producción". The Logistics World. Retrieved24 June 2021.
  8. ^abcdeZimmer C (5 April 2021)."Researchers Are Hatching a Low-Cost Coronavirus Vaccine".The New York Times. Retrieved7 April 2021.
  9. ^abSun W, Leist SR, McCroskery S, Liu Y, Slamanig S, Oliva J, et al. (December 2020)."Newcastle disease virus (NDV) expressing the spike protein of SARS-CoV-2 as a live virus vaccine candidate".eBioMedicine.62 103132.doi:10.1016/j.ebiom.2020.103132.PMC 7679520.PMID 33232870.
  10. ^abHsieh CL, Goldsmith JA, Schaub JM, DiVenere AM, Kuo HC, Javanmardi K, et al. (September 2020)."Structure-based design of prefusion-stabilized SARS-CoV-2 spikes".Science.369 (6510):1501–1505.Bibcode:2020Sci...369.1501H.doi:10.1126/science.abd0826.PMC 7402631.PMID 32703906.
  11. ^Airhart M (5 April 2021)."Human Trials Begin for a Low-Cost COVID-19 Vaccine to Extend Global Access".University of Texas. Retrieved7 April 2021.
  12. ^Clinical trial numberNCT04764422 for "Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand" atClinicalTrials.gov
  13. ^Wipatayotin A (11 February 2021)."Thai-made vaccine ready 'by next year'".Bangkok Post. Bangkok Post Public Company Limited. Retrieved9 April 2021.
  14. ^"Việt Nam's COVID vaccine developer stops third phase trial due to volunteers shortage".vietnamnews.vn. Retrieved12 February 2023.
  15. ^"Desenvolvimento da Butanvac é suspenso após vacina não atingir resultados nos estudos de fase 2".G1 (in Brazilian Portuguese). 23 August 2024. Retrieved26 August 2024.
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