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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, in New York, United States.[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]

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.[11]

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.[12][13] 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.[14]

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

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”. butantan.gov.br (in Portuguese). Retrieved 16 December 2021.
  3. ^ Simões E, Fonseca P (26 March 2021). “Brazil posts record 3,650 new COVID-19 deaths, unveils two homegrown vaccines”. Reuters. Retrieved 7 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. Retrieved 6 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. Retrieved 9 April 2021.
  6. ^ “Mahidol-GPO’s human trials of its COVID-19 vaccine show promising results”. Thai PBS World. 1 July 2021. Retrieved 19 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. Retrieved 24 June 2021.
  8. ^ a b c d e Zimmer C (5 April 2021). “Researchers Are Hatching a Low-Cost Coronavirus Vaccine”. The New York Times. Retrieved 7 April 2021.
  9. ^ a b Sun 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. ^ a b Hsieh 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. Retrieved 7 April 2021.
  12. ^ Clinical trial number NCT04764422 for “Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand” at ClinicalTrials.gov
  13. ^ Wipatayotin A (11 February 2021). “Thai-made vaccine ready ‘by next year’“. Bangkok Post. Bangkok Post Public Company Limited. Retrieved 9 April 2021.
  14. ^ “Việt Nam’s COVID vaccine developer stops third phase trial due to volunteers shortage”. vietnamnews.vn. Retrieved 12 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. Retrieved 26 August 2024.
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