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Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand

NCT04764422 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2022-11-15

No results posted yet for this study

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.

Conditions

  • Covid-19
  • SARS Pneumonia
  • Pneumonia, Viral
  • Covid-19 Vaccine

Interventions

BIOLOGICAL

Normal Saline

0.9% normal saline for injection

BIOLOGICAL

NDV-HXP-S vaccine

Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.

Sponsors & Collaborators

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • Mahidol University

    lead OTHER

Principal Investigators

  • Punnee Pitisutthithum · Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-20
Primary Completion
2022-09-12
Completion
2022-09-12

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764422 on ClinicalTrials.gov