Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil

Summary

NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing S protein from SARS-CoV-2 stabilized in pre-fusion form with Hexapro technology. This vaccine was successfully tested in non-clinical study with a good safety profile and eliciting neutralizing antibodies against SARS-CoV-2. Clinical testing is conducted by an international consortium including three different manufacturers. Butantan, in Brazil, is one of them.

Timeline

Start

2021-07-09

Primary completion

2021-12-10

Completion

2022-11-04

Publications

• Peixoto de Miranda EJF, Calado RT, Boulos FC, de Sousa Moreira JA, Machado FF, Almeida MAALDS, Da Rocha MCO, Infante V, Mercer LD, Hjorth R, Scharf R, White J, Polyak C, Raghunandan R, Garcia-Sastre A, Sun W, Palese P, Krammer F, Innis B, Pereira CG, Kallas EG. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Results of a randomized vaccine-controlled phase I ADAPTCOV trial in Brazil. Vaccine. 2025 Apr 11;52:126680. doi: 10.1016/j.vaccine.2024.126680. Epub 2025 Mar 3.

Drugs

Indications