NDV-HXP-S explained

Type:vaccine
Target:SARS-CoV-2
Vaccine Type:viral vector or inactivated
Tradename:ButanVac (Brazil)
COVIVAC (Vietnam)
HXP-GPOVac (Thailand)
Patria (Mexico)
Routes Of Administration:Intramuscular, Intranasal
Synonyms:ADAPTCOV

NDV-HXP-S (known as ButanVac[1] [2] or ADAPTCOV[3] in Brazil, COVIVAC[4] in Vietnam, HXP-GPOVac[5] in Thailand, Patria[6] 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.[7]

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

Pharmacology

NDV-HXP-S uses the Newcastle disease virus as its viral vector. The platform can be live or inactivated.[8]

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.[7] 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;[9] 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.[10]

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".[7]

Clinical trials

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.[11] 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".[7] A phase II study has been completed in Vietnam, but the phase III study has been discontinued due to shortage of unvaccinated volunteers.[12]

The Butantan trials were discontinued at phase II in late 2023 due to lack of efficacy.[13]

Notes and References

  1. Web site: Butantan vai desenvolver e produzir nova vacina contra a Covid-19; testes clínicos da ButanVac devem começar em abril. 2021-12-16. butantan.gov.br. PT.
  2. News: Simões E, Fonseca P . Brazil posts record 3,650 new COVID-19 deaths, unveils two homegrown vaccines . 7 April 2021 . Reuters . March 26, 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....
  3. Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil (ADAPTCOV) . clinicaltrials.gov . 6 August 2021 . United States National Library of Medicine . 6 August 2021 .
  4. A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC . clinicaltrials.gov . April 2021 . United States National Library of Medicine . 9 April 2021 .
  5. News: Mahidol-GPO's human trials of its COVID-19 vaccine show promising results . 19 July 2021 . Thai PBS World . 1 July 2021.
  6. News: Juarez C . Vacuna Patria: esto es lo que se sabe de su avance y eventual producción . 24 June 2021 . The Logistics World . 22 April 2021.
  7. News: April 5, 2021. Researchers Are Hatching a Low-Cost Coronavirus Vaccine. The New York Times. 7 April 2021. Zimmer C.
  8. Sun W, Leist SR, McCroskery S, Liu Y, Slamanig S, Oliva J, Amanat F, Schäfer A, Dinnon KH, García-Sastre A, Krammer F, Baric RS, Palese P . 6 . Newcastle disease virus (NDV) expressing the spike protein of SARS-CoV-2 as a live virus vaccine candidate . eBioMedicine . 62 . 103132 . December 2020 . 33232870 . 7679520 . 10.1016/j.ebiom.2020.103132.
  9. Hsieh CL, Goldsmith JA, Schaub JM, DiVenere AM, Kuo HC, Javanmardi K, Le KC, Wrapp D, Lee AG, Liu Y, Chou CW, Byrne PO, Hjorth CK, Johnson NV, Ludes-Meyers J, Nguyen AW, Park J, Wang N, Amengor D, Lavinder JJ, Ippolito GC, Maynard JA, Finkelstein IJ, McLellan JS . 6 . Structure-based design of prefusion-stabilized SARS-CoV-2 spikes . Science . 369 . 6510 . 1501–1505 . September 2020 . 32703906 . 7402631 . 10.1126/science.abd0826 . 2020Sci...369.1501H .
  10. Web site: April 5, 2021. Human Trials Begin for a Low-Cost COVID-19 Vaccine to Extend Global Access. 7 April 2021. University of Texas. Airhart M.
  11. News: Wipatayotin A . 11 February 2021 . Bangkok Post Public Company Limited . Thai-made vaccine ready 'by next year'. Bangkok Post . 2021-04-09 .
  12. Web site: Việt Nam's COVID vaccine developer stops third phase trial due to volunteers shortage . 2023-02-12 . vietnamnews.vn . en.
  13. Web site: Desenvolvimento da Butanvac é suspenso após vacina não atingir resultados nos estudos de fase 2 . 2024-08-23 . Brazilian Portuguese . G1 . 26 August 2024.

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