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<p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月25日

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

摘要

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.