One year follow up of phase 1/2 randomized, placebo controlled trial of NDV-HXP-S vaccine in Thailand
Issued Date
2025-12-01
Resource Type
eISSN
20590105
Scopus ID
2-s2.0-105025399220
Journal Title
Npj Vaccines
Volume
10
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Npj Vaccines Vol.10 No.1 (2025)
Suggested Citation
Phumratanaprapin W., Luvira V., Lawpoolsri S., Cowan J., Muangnoicharoen S., Kamolratanakul S., Sabmee Y., Narakorn P., Surichan S., Mercer L.D., Raghunandan R., Polyak C.S., Wirachwong P., Flores J., Innis B.L., Pitisuttithum P. One year follow up of phase 1/2 randomized, placebo controlled trial of NDV-HXP-S vaccine in Thailand. Npj Vaccines Vol.10 No.1 (2025). doi:10.1038/s41541-025-01321-8 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/113701
Title
One year follow up of phase 1/2 randomized, placebo controlled trial of NDV-HXP-S vaccine in Thailand
Corresponding Author(s)
Other Contributor(s)
Abstract
To promote self-reliance in vaccine production, a chimeric Newcastle Disease Virus (NDV) based vaccine (NDV-HXP-S) was developed in Bangkok, Thailand, with the support of PATH. The interim results of phase 1 on initial safety and immune responses of five formulations: 1 µg, 3 µg, 10 µg, 1 µg+ CpG, and 3 µg+CpG adjuvant were reported. The 3 µg and 3 µg+CpG formulations were selected to advance into phase 2. The full one-year follow-up of safety and immune responses of the NDV-HXP-S vaccine from a pooled phase 1/2 randomized, double-blind, placebo-controlled trial in vaccine naïve individuals with no prior SARS-CoV-2 infection was reported here. The two-dose NDV-HPX-S primary series was safe and elicited a strong immune response over one year, especially in the 3 µg+CpG and 10 µg groups. The 3 µg+CpG group had a significantly higher geometric mean fold rise (GMFR) than the 3 µg group (57.1 vs 40.0, p = 0.028) 14 days after the second dose.