A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.

Summary

This study will be a phase-1, open-label, placebo-controlled, evaluation of two-dosages of a live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2 (NDV-HXP-S), an investigational product for IN, IM, or a combined IN+IM vaccination in healthy adults previously immunized against COVID-19. The IN and IM live virus vaccinations will be identical in composition and only differ in route of administration.

Timeline

Start

2022-02-09

Primary completion

2023-05-03

Completion

2024-04-19

Publications

• Background Sun W, McCroskery S, Liu WC, Leist SR, Liu Y, Albrecht RA, Slamanig S, Oliva J, Amanat F, Schafer A, Dinnon KH 3rd, Innis BL, Garcia-Sastre A, Krammer F, Baric RS, Palese P. A Newcastle Disease Virus (NDV) Expressing a Membrane-Anchored Spike as a Cost-Effective Inactivated SARS-CoV-2 Vaccine. Vaccines (Basel). 2020 Dec 17;8(4):771. doi: 10.3390/vaccines8040771.
• Background Punnee Pitisuttithum, Viravarn Luvira, Saranath Lawpoolsri, Sant Muangnoicharoen, Supitcha Kamolratanakul, Chaisith Sivakorn, Piengthong Narakorn, Somchaiya Surichan, Sumalee Prangpratanporn, Suttida Puksuriwong, Steven Lamola, Laina D Mercer, Rama Raghunandan, Weina Sun, Yonghong Liu, Juan Manuel Carreño, Rami Scharf, Weerapong Phumratanaprapin, Fatima Amanat, Luc Gagnon, Ching-Lin Hsieh, Ruangchai Kaweepornpoj, Sarwat Khan, Manjari Lal, Stephen McCroskery, Jason McLellan, Ignacio Mena, Marcia Meseck, Benjaluck Phonrat, Yupa Sabmee, Ratsamikorn Singchareon, Stefan Slamanig, Nava Suthepakul, Johnstone Tcheou, Narumon Thantamnu, Sompone Theerasurakarn, Steven Tran, Thanakrit Vilasmongkolchai, Jessica A White, Adolfo Garcia-Sastre, Peter Palese, Florian Krammer, Kittisak Poopipatpol, Ponthip Wirachwong, Richard Hjorth, Bruce L Innis. 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; doi: https://doi.org/10.1101/2021.09.17.21263758
• Liu STH, Gonzalez-Dominguez I, Martinez-Perez A, Bozkus CC, Bladh O, Broomes-Pennicott T, Jen A, Egan E, Leiva-Ortiz E, Abid A, Aguilera K, Aberg M, Bhavsar D, Yellin T, Abbad A, Singh G, Carreno JM, Adams J, Quigley C, Saxena M, Meseck M, Ceglia I, Thalin C, Weiskopf D, Garcia-Sastre A, Palese P, Sun W, Krammer F, Aberg JA. Phase 1 trial of intranasal NDV-HXP-S in previously vaccinated adults. Vaccine. 2026 Jun 30;89:128870. doi: 10.1016/j.vaccine.2026.128870. Online ahead of print.
• Slamanig S, Lemus N, Lai TY, Singh G, Mishra M, Abdeljawad A, Boza M, Dolange V, Singh G, Lee B, Gonzalez-Dominguez I, Schotsaert M, Krammer F, Palese P, Sun W. A single immunization with intranasal Newcastle disease virus (NDV)-based XBB.1.5 variant vaccine reduces disease and transmission in animals against matched-variant challenge. Vaccine. 2025 Jan 25;45:126586. doi: 10.1016/j.vaccine.2024.126586. Epub 2024 Dec 12.

Drugs

Indications