NDV-HXP-S

NDV-HXP-S

Packaging for the Brazilian version of NDV-HXP-S, ButanVac
Vaccine description
Target	SARS-CoV-2
Vaccine type	viral vector or inactivated
Clinical data
Trade names	ButanVac (Brazil) COVIVAC (Vietnam) HXP-GPOVac (Thailand) Patria (Mexico)
Other names	ADAPTCOV
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]

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. Zimmer C (5 April 2021). "Researchers Are Hatching a Low-Cost Coronavirus Vaccine". The New York Times . Retrieved 7 April 2021.
9. 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. 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.