Medicine:NDV-HXP-S

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Short description: Vaccine candidate against COVID-19
NDV-HXP-S
Butanvac embalagem.jpg
Packaging for the Brazilian version of NDV-HXP-S, ButanVac
Vaccine description
Target diseaseSARS-CoV-2
Typeviral vector or inactivated
Clinical data
Trade namesButanVac (Brazil)
COVIVAC (Vietnam)
HXP-GPOVac (Thailand)
Patria (Mexico)
Other namesADAPTCOV
Routes of
administration		Intramuscular,[1] Intranasal

NDV-HXP-S (known as ButanVac[2][3] or ADAPTCOV[4] in Brazil, COVIVAC[5] in Vietnam, HXP-GPOVac[6] in Thailand, Patria[7] in Mexico) is a COVID-19 vaccine candidate developed under the leadership of Peter Palese, Adolfo García-Sastre, and Florian Krammer at the Icahn School of Medicine at Mount Sinai.[8][9]

The name NDV-HXP-S comes from the terms Newcastle disease virus, HexaPro, and spike protein.[8] The stabilization of the S protein of SARS-CoV-2 (HexaPro) was achieved by Jason McLellan from the University of Texas at Austin.[10]

Pharmacology

NDV-HXP-S uses the Newcastle disease virus as its viral vector. The platform can be live or inactivated.[9][11][12][13][14][15][16][excessive citations]

Manufacturing

Unlike vaccines such as Moderna's mRNA-1273, the Janssen vaccine, and Pfizer–BioNTech's Tozinameran, which all require both specialized manufacturing facilities and also rare or expensive ingredients, NDV-HXP-S can be produced using chicken 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 two prolines 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.[17]

History

Development

Its development was coordinated by the PATH 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

São Paulo governor João 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, the Butantan Institute announced it would seek to begin clinical trials. Mexico-based Avimex plans to create an intranasal spray version of the vaccine. In Thailand the Government Pharmaceutical Organization is conducting a trial in coordination with Mahidol University.[18][19] Reflecting the freedom offered by the ease of the manufacturing process, Thai health minister Anutin 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.[20]

References

  1. ↑ "Study of a Live rNDV Based Vaccine Against COVID-19". ClinicalTrials.gov. United States National Library of Medicine. 4 May 2021. NCT04871737. Retrieved 4 May 2021.
  2. ↑ "Butantan vai desenvolver e produzir nova vacina contra a Covid-19; testes clínicos da ButanVac devem começar em abril" (in PT). https://butantan.gov.br/noticias/butantan-vai-desenvolver-e-produzir-nova-vacina-contra-a-covid-19--testes-clinicos-da-butanvac-devem-comecar-em-abril. 
  3. ↑ "Brazil posts record 3,650 new COVID-19 deaths, unveils two homegrown vaccines". Reuters. March 26, 2021. https://www.reuters.com/article/us-health-coronavirus-brazil-vaccine/brazil-posts-record-3650-new-covid-19-deaths-unveils-two-homegrown-vaccines-idUSKBN2BI1KF. "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). United States National Library of Medicine. 6 August 2021. https://clinicaltrials.gov/ct2/show/NCT04993209. Retrieved 6 August 2021. 
  5. ↑ A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC. United States National Library of Medicine. April 2021. https://clinicaltrials.gov/ct2/show/NCT04830800. Retrieved 9 April 2021. 
  6. ↑ "Mahidol-GPO's human trials of its COVID-19 vaccine show promising results". Thai PBS World. 1 July 2021. https://www.thaipbsworld.com/mahidol-gpos-human-trials-of-its-covid-19-vaccine-show-promising-results/. 
  7. ↑ Juarez, Carlos (22 April 2021). "Vacuna Patria: esto es lo que se sabe de su avance y eventual producción". The Logistics World. https://thelogisticsworld.com/manufactura/vacuna-patria-esto-es-lo-que-se-sabe-de-su-avance-y-eventual-produccion/. 
  8. ↑ 8.0 8.1 8.2 8.3 8.4 "Researchers Are Hatching a Low-Cost Coronavirus Vaccine". The New York Times. April 5, 2021. https://www.nytimes.com/2021/04/05/health/hexapro-mclellan-vaccine.html. 
  9. ↑ 9.0 9.1 "Newcastle disease virus (NDV) expressing the spike protein of SARS-CoV-2 as a live virus vaccine candidate". EBioMedicine 62: 103132. December 2020. doi:10.1016/j.ebiom.2020.103132. PMID 33232870. 
  10. ↑ 10.0 10.1 "Structure-based design of prefusion-stabilized SARS-CoV-2 spikes". Science 369 (6510): 1501–1505. September 2020. doi:10.1126/science.abd0826. PMID 32703906. Bibcode: 2020Sci...369.1501H. 
  11. ↑ "Newcastle disease virus (NDV) expressing the spike protein of SARS-CoV-2 as a live virus vaccine candidate". EBioMedicine 62: 103132. December 2020. doi:10.1016/j.ebiom.2020.103132. PMID 33232870. 
  12. ↑ "A Newcastle Disease Virus (NDV) Expressing a Membrane-Anchored Spike as a Cost-Effective Inactivated SARS-CoV-2 Vaccine". Vaccines 8 (4): E771. December 2020. doi:10.3390/vaccines8040771. PMID 33348607. 
  13. ↑ "Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs". mBio 12 (5): e0190821. October 2021. doi:10.1128/mBio.01908-21. PMID 34544278. 
  14. ↑ "Safety and Immunogenicity of an Inactivated Recombinant Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomised, Placebo-Controlled, Phase 1/2 Trial". medRxiv: 2021.09.17.21263758. September 2021. doi:10.1101/2021.09.17.21263758. PMID 34580673. 
  15. ↑ "Mosaic Hemagglutinin-Based Whole Inactivated Virus Vaccines Induce Broad Protection Against Influenza B Virus Challenge in Mice". Frontiers in Immunology 12: 746447. 2021. doi:10.3389/fimmu.2021.746447. PMID 34603333. 
  16. ↑ "Safety and Immunogenicity Analysis of a Newcastle Disease Virus (NDV-HXP-S) Expressing the Spike Protein of SARS-CoV-2 in Sprague Dawley Rats". Frontiers in Immunology 12: 791764. 2021. doi:10.3389/fimmu.2021.791764. PMID 34868082. 
  17. ↑ "Human Trials Begin for a Low-Cost COVID-19 Vaccine to Extend Global Access". April 5, 2021. https://news.utexas.edu/2021/04/05/human-trials-begin-for-a-low-cost-covid-19-vaccine-to-extend-global-access/. 
  18. ↑ Clinical trial number NCT04764422 for "Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand" at ClinicalTrials.gov
  19. ↑ "Thai-made vaccine ready 'by next year'". Bangkok Post (Bangkok Post Public Company Limited). 11 February 2021. https://www.bangkokpost.com/thailand/general/2066063/thai-made-vaccine-ready-by-next-year. 
  20. ↑ "Việt Nam's COVID vaccine developer stops third phase trial due to volunteers shortage" (in en). https://vietnamnews.vn/society/1090227/viet-nam-s-covid-vaccine-developer-stops-third-phase-trial-due-to-volunteers-shortage.html. 





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