One year follow up of phase 1/2 randomized, placebo controlled trial of NDV-HXP-S vaccine in Thailand
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.
Authors
- Yupa Sabmee
- Viravarn Luvira (ORCID: https://orcid.org/0000-0001-9270-3720)
- Christina S. Polyak (ORCID: https://orcid.org/0000-0002-9801-2012)
- Ponthip Wirachwong
- Laina D. Mercer (ORCID: https://orcid.org/0000-0002-2517-8900)
- Piengthong Narakorn
- Jorge Flores (ORCID: https://orcid.org/0000-0001-5069-1186)
- Saranath Lawpoolsri (ORCID: https://orcid.org/0000-0003-4841-7924)
- Punnee Pitisuttithum (ORCID: https://orcid.org/0000-0003-3215-2183)
- Somchaiya Surichan (ORCID: https://orcid.org/0000-0002-1058-5247)
- Sant Muangnoicharoen (ORCID: https://orcid.org/0000-0002-8236-8954)
- Rama Raghunandan (ORCID: https://orcid.org/0000-0001-8254-0809)
- Bruce L. Innis (ORCID: https://orcid.org/0000-0002-1753-7248)
- Weerapong Phumratanaprapin (ORCID: https://orcid.org/0000-0001-5896-1961)
- Juthaporn Cowan (ORCID: https://orcid.org/0000-0001-6648-5109)
Institutions
- Program for Appropriate Technology in Health (US)
- Mahidol University (TH)
- Government of Thailand (TH)
- Mahidol Oxford Tropical Medicine Research Unit (TH)
Publication Details
- Journal
- npj Vaccines
- Published
- 2025-11-25
- DOI
- https://doi.org/10.1038/s41541-025-01321-8
- Citations
- 1
- Primary Topic
- Virology and Viral Diseases
- Type
- article
- Field-Weighted Citation Impact
- 1.35
Funders
- Bill and Melinda Gates Foundation