Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand
Condition: Covid-19; SARS Pneumonia; Pneumonia, Viral; Covid-19 Vaccine
MeSH terms: COVID-19; Pneumonia; Pneumonia, Viral
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will be conducted in 2 phases. Phase 1 designed to evaluate safety, tolerability
      and immunogenicity COVID-19 vaccine (NDV-HXP-S) administered at different doses levels (1, 3,
      and 10 µg) without adjuvant, and at two different dose levels (1 and 3 µg) with the adjuvant
      CpG 1018 among healthy adults, (age 18-59 years) (210 subjects). Subjects will receive 2
      doses of assigned investigational product (IP) on D1 and D29 (V1 and V3), and be assessed in
      clinic for safety and reactogenicity at 7 days after each vaccination (day 1 as day
      vaccination). An interim analysis of Phase 1 data will be conducted as the basis for
      decisions about advancement to Phase 2 of the study and about treatment group down selection.
      Phase 2 (250 subjects) will include approximately one-third subjects with age 60-75 years.
    

Detailed description: 
      This study (GPO NDV-HXP-S) will be conducted in 2 phases. Phase 1 will evaluate the safety,
      tolerability and immunogenicity COVID-19 vaccine (NDV-HXP-S) administered at different doses
      levels (1, 3, and 10 µg) without adjuvant, and at two different dose levels (1 and 3 µg) with
      the adjuvant CpG 1018 among healthy adults, (age 18-59 years, 210 subjects). NDV-HXP-S or
      placebo (0.9% normal saline for injection) will administer IM according to a repeat
      vaccination schedule (given 28 days apart). In addition, as exploratory objectives, a total
      of 36 subjects will be randomly selected (1:1:1 ratio) from placebo and two high-dose groups
      i.e., NDV-HXP-S 10 µg and NDV-HXP-S 3 µg + CpG 1018, to provide additional blood at V1, V5
      and V7 for assessment of T-cell-mediated immunity (CMI). An interim analysis of Phase 1 data
      will be conducted as the basis for decisions about advancement to Phase 2 of the study and
      about treatment group down selection.

      In the Phase 2 study, 250 subjects aged 18-75 years will be randomized (1:2:2) to placebo
      (0.9% normal saline for injection), or one of two selected formulations of NDV HXP S being
      evaluated in Phase 1 will be enrolled to Phase 2 study. Twelve subjects in each of the three
      Phase 2 groups (distributed among the two age strata) will be randomized to provide
      additional blood at V1, V5 and V7 for assessment of T-cell-mediated immunity (CMI).

      Unblinding will be done as per specific SOP provided by Sponsor. The PI will be expected to
      provide a rationale for the necessity of unblinding, based on the expectation that knowledge
      of the subject's treatment assignment will have a meaningful impact on the subject's medical
      care in the short term. If a subject's treatment assignment is unblinded, the subject will
      remain in the study and continue with protocol-defined study visits and procedures, unless
      there is another reason for subject discontinuation.

      Scheduled unblinding regarding safety concern during severe COVID-19 situation:

      The elderly subjects (60-75 years) who received placebo will be unblinded and discontinued as
      soon as COVID-19 vaccine (AstraZeneca) become available from Sponsor. If unblinding is
      occurred before complete enrollment of 75 elderly subjects, the randomization assignment will
      be skipped in placebo arm. Therefore, no further subjects will be randomly assigned to
      receive placebo after unblinding.
    

Intervention name(s): Normal Saline; NDV-HXP-S vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.9% normal saline for injection; Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; COVID-19 VACCINE; ADULT; THAILAND; GPO; The Government Pharmaceutical Organization; SAFETY; TOLERABILITY; IMMUNOGENICITY; NDV-HXP-S Vaccine; CpG1018; SARS-CoV-2