NDV-HXP-S Vaccine Clinical Trial (COVIVAC)

Phase 2 Completed 374 enrolled Institute of Vaccines and Medical Biologicals, Vietnam Center for Disease Control of Thai Binh Province, Vietnam · collab National Institute of Hygiene and Epidemiology, Vietnam · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts. After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2. In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to AZD1222, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results.

Timeline

Start: 2021-08-11
Primary completion: 2021-10-18
Completion: 2022-03-11

Publications

Thiem VD, Anh DD, Ha VH, Van Thom N, Thang TC, Mateus J, Carreno JM, Raghunandan R, Huong NM, Mercer LD, Flores J, Escarrega EA, Raskin A, Thai DH, Van Be L, Sette A, Innis BL, Krammer F, Weiskopf D. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial. Vaccine. 2025 Jan 12;44:126542. doi: 10.1016/j.vaccine.2024.126542. Epub 2024 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CoviVac	Vaccine	3 ug	Intramuscular
Subject	CoviVac	Vaccine	6 ug	Intramuscular

NDV-HXP-S Vaccine Clinical Trial (COVIVAC)

Summary

Timeline

Publications

Drugs

Indications