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.

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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

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article

One year follow up of phase 1/2 randomized, placebo controlled trial of NDV-HXP-S vaccine in Thailand

Yupa Sabmee, Viravarn Luvira, Christina S. Polyak, Ponthip Wirachwong et al.
1 citations
npj Vaccines
Virology and Viral Diseases
1.35
article

One year follow up of phase 1/2 randomized, placebo controlled trial of NDV-HXP-S vaccine in Thailand

Yupa Sabmee, Viravarn Luvira, Christina S. Polyak, Ponthip Wirachwong, Laina D. Mercer, Piengthong Narakorn, Jorge Flores, Saranath Lawpoolsri, Punnee Pitisuttithum, Somchaiya Surichan, Sant Muangnoicharoen, Rama Raghunandan, Bruce L. Innis, Weerapong Phumratanaprapin, Juthaporn Cowan
article en
1 citations

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.

npj VaccinesVol. 10(1)
Program for Appropriate Technology in Health (US), Mahidol University (TH), Government of Thailand (TH), Mahidol Oxford Tropical Medicine Research Unit (TH)
Bill and Melinda Gates Foundation
Openalex Percentile: Top 14%
Virology and Viral Diseases
1.35
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