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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764422
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
The Government Pharmaceutical Organization
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University

Brief 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.

Condition or disease Intervention/treatment Phase
Covid-19 SARS Pneumonia Pneumonia, Viral Covid-19 Vaccine Biological: Normal Saline Biological: NDV-HXP-S vaccine Phase 1 Phase 2

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 administered 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 will be randomized to provide additional blood at V1, V5 and V7 for assessment of T-cell-mediated immunity (CMI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Unblinded study staff, including the site pharmacist, will be responsible for preparing study products (in accordance with the randomly determined assignment), administering the study vaccine, and handling all drug accountability procedures. These personnel will not participate in the other aspects of the clinical trial, to help ensure the integrity of the blind at the site. Unblinded staff will retrieve a subject's randomization assignment after being informed by the PI or designee that a subject is eligible for randomization. They will prepare the 0.5 ml dose of study product based on the subject's randomization
Primary Purpose: Prevention
Official Title: A Phase 1/2 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand
Actual Study Start Date : March 20, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
Placebo Comparator: Placebo
0.9% Normal Saline for injection
Biological: Normal Saline
0.9% normal saline for injection

Active Comparator: NDV-HXP-S 1 µg
35 subjects age 18-59 will receive NDV-HXP-S 1 µg study vacine administered 0.5 mL IM
Biological: NDV-HXP-S vaccine
Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.

Active Comparator: NDV-HXP-S 3 µg
35 subjects age 18-59 will receive NDV-HXP-S 3 µg study vacine administered 0.5 mL IM
Biological: NDV-HXP-S vaccine
Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.

Active Comparator: NDV-HXP-S 10 µg
35 subjects age 18-59 will receive NDV-HXP-S 10 µg study vacine administered 0.5 mL IM
Biological: NDV-HXP-S vaccine
Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.

Active Comparator: NDV-HXP-S 1 µg + CpG1018 1.5 mg
35 subjects age 18-59 will receive NDV-HXP-S 1 µg + CpG1018 1.5 mg study vacine administered 0.5 mL IM
Biological: NDV-HXP-S vaccine
Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.

Active Comparator: NDV-HXP-S 3 µg + CpG1018 1.5 mg
35 subjects age 18-59 will receive NDV-HXP-S 3 µg + CpG1018 1.5 mg study vacine administered 0.5 mL IM
Biological: NDV-HXP-S vaccine
Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.




Primary Outcome Measures :
  1. Frequency of solicited reportable local adverse event after first vaccination [ Time Frame: Day 1 up to Day 7 ]
    Frequency of solicited reportable local adverse events (pain or tenderness, erythema, swelling or induration) of first vaccination

  2. Frequency of solicited reportable local adverse event after second vaccination [ Time Frame: Day 1 up to Day 7 ]
    Frequency of solicited reportable local adverse events (pain or tenderness, erythema, swelling or induration) of second vaccination

  3. Frequency of solicited reportable systemic adverse event after first vaccination [ Time Frame: Day 1 up to Day 7 ]
    Frequency of solicited reportable systemic adverse events (fever, headache,fatigue or malaise, myalgia, arthralgia,nausea or vomitting) of first vaccination

  4. Frequency of solicited reportable systemic adverse event after second vaccination [ Time Frame: Day 1 up to Day 7 ]
    Frequency of solicited reportable systemic adverse events (fever, headache,fatigue or malaise, myalgia, arthralgia,nausea or vomitting) of second vaccination

  5. Measurement of hemoglobin changed from baseline at 7 days after first vaccination [ Time Frame: Day 8 ]
    Measurement of hemoglobin (g/dl) changed from baseline at 7 days after first vaccination

  6. Measurement of hemoglobin changed from baseline at 7 days after second vaccination [ Time Frame: Day 36 ]
    Measurement of hemoglobin (g/dl) changed from baseline at 7 days after the second vaccination

  7. Measurement of white blood cells changed from baseline at 7 days after first vaccination [ Time Frame: Day 8 ]
    Measurement of white blood cells (10^3 cells/ul) changed from baseline at 7 days after first vaccination

  8. Measurement of white blood cells changed from baseline at 7 days after second vaccination [ Time Frame: Day 36 ]
    Measurement of white blood cells (10^3 cells/ul) changed from baseline at 7 days after second vaccination

  9. Measurement of platelet count changed from baseline at 7 days after first vaccination [ Time Frame: Day 8 ]
    Measurement of platelet count (10^3 cells/ul) changed from baseline at 7 days after first vaccination

  10. Measurement of platelet count changed from baseline at 7 days after second vaccination [ Time Frame: Day 36 ]
    Measurement of platelet count (10^3 cells/ul) changed from baseline at 7 days after second vaccination

  11. Measurement of creatinine changed from baseline at 7 days after first vaccination [ Time Frame: Day 8 ]
    Measurement of creatinine (mg/dl) changed from baseline at 7 days after first vaccination

  12. Measurement of creatinine changed from baseline at 7 days after second vaccination [ Time Frame: Day 36 ]
    Measurement of creatinine (mg/dl) changed from baseline at 7 days after second vaccination

  13. Measurement of AST changed from baseline at 7 days after first vaccination [ Time Frame: Day 8 ]
    Measurement of AST (U/L) changed from baseline at 7 days after first vaccination

  14. Measurement of AST changed from baseline at 7 days after second vaccination [ Time Frame: Day 36 ]
    Measurement of AST (U/L) changed from baseline at 7 days after second vaccination

  15. Measurement of ALT change from baseline at 7 days after first vaccination [ Time Frame: Day 8 ]
    Measurement of ALT (U/L) change from baseline at 7 days after first vaccination

  16. Measurement of ALT change from baseline at 7 days after second vaccination [ Time Frame: Day 36 ]
    Measurement of ALT (U/L) change from baseline at 7 days after second vaccination

  17. Measurement of total bilirubin changed from baseline at 7 days after first vaccination [ Time Frame: Day 8 ]
    Measurement of total bilirubin (mg/dl) change from baseline at 7 days after first vaccination

  18. Measurement of total bilirubin changed from baseline at 7 days after second vaccination [ Time Frame: Day 36 ]
    Measurement of total bilirubin (mg/dl) change from baseline at 7 days after second vaccination

  19. Frequency of all unsolicited AEs [ Time Frame: Day 56 ]
    Frequency of all unsolicited AEs

  20. Frequency of SAEs [ Time Frame: Day 365 ]
    Frequency of SAEs throughout the entire study period

  21. Frequency of medically-attended adverse event (MAAEs) [ Time Frame: Day 365 ]
    Frequency of medically-attended adverse event (MAAEs) throughout the entire study period

  22. Frequency of AESI [ Time Frame: Day 365 ]
    Frequency of AESI throughout the entire study period, including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC) presented as number and percentage


Secondary Outcome Measures :
  1. GMT Neutralizing antibody titer 50 changed from baseline at 28 days after the first vaccination [ Time Frame: Day 29 ]
    GMT Neutralizing antibody titer 50 changed from baseline at 28 days after the first vaccination

  2. GMT Neutralizing antibody titer 50 changed from baseline at 14 days after the second vaccination [ Time Frame: Day 43 ]
    GMT Neutralizing antibody titer 50 changed from baseline at 14 days after the second vaccination

  3. GMT Neutralizing antibody titer 50 changed from baseline at 6 months after the second vaccination [ Time Frame: Day 197 ]
    GMT Neutralizing antibody titer 50 changed from baseline at 6 months after the second vaccination

  4. GMT Neutralizing antibody titer 50 changed from baseline at 12 months after the second vaccination [ Time Frame: Day 365 ]
    GMT Neutralizing antibody titer 50 changed from baseline at 12 months after the second vaccination

  5. GMT Neutralizing antibody titer 80 changed from baseline at 28 days after the first vaccination [ Time Frame: Day 29 ]
    GMT Neutralizing antibody titer 80 changed from baseline at 28 days after the first vaccination

  6. GMT Neutralizing antibody titer 80 changed from baseline at 14 days after the second vaccination [ Time Frame: Day 43 ]
    GMT Neutralizing antibody titer 80 changed from baseline at 14 days after the second vaccination

  7. GMT Neutralizing antibody titer 80 changed from baseline at 6 months after the second vaccination [ Time Frame: Day 197 ]
    GMT Neutralizing antibody titer 80 changed from baseline at 6 months after the second vaccination

  8. GMT Neutralizing antibody titer 80 changed from baseline at 12 months after the second vaccination [ Time Frame: Day 365 ]
    GMT Neutralizing antibody titer 80 changed from baseline at 12 months after the second vaccination

  9. NT50 seroresponses changed from baseline at 28 days after the first vacccination [ Time Frame: Day 29 ]
    Frequency of subjects with NT50 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at 28 days after the first vacccination compare to baseline

  10. NT50 seroresponses changed from baseline at 14 days after the second vaccination [ Time Frame: Day 43 ]
    Frequency of subjects with NT50 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at 14 days after the second vaccination compare to baseline

  11. NT50 seroresponses changed from baseline at 6 months after the second vaccination [ Time Frame: Day 197 ]
    Frequency of subjects with NT50 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at 6 months after the second vaccination compare to baseline

  12. NT50 seroresponses changed from baseline at 12 months after the second vaccination [ Time Frame: Day 365 ]
    Frequency of subjects with NT50 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at12 months after the second vaccination compare to baseline

  13. NT80 seroresponses changed from baseline at 28 days after the first vaccination [ Time Frame: Day 29 ]
    Frequency of subjects with NT80 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at 28 days after first vaccination compare to baseline

  14. NT80 seroresponses changed from baseline at 14 days after the second vaccination [ Time Frame: Day 43 ]
    Frequency of subjects with NT80 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at 14 after the second vaccination compare to baseline

  15. NT80 seroresponses changed from baseline at 6 months after the second vaccination [ Time Frame: Day 197 ]
    Frequency of subjects with NT80 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at 6 months after the second vaccination compare to baseline

  16. NT80 seroresponses changed from baseline at 12 months after the second vaccination [ Time Frame: Day 365 ]
    Frequency of subjects with NT80 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline at 12 months after the second vaccination compare to baseline

  17. GMT Anti-S IgG at 28 days after the first vaccination [ Time Frame: Day 29 ]
    GMT Anti-S IgG at 28 days after the first vaccination in subjects who are anti-S IgG seronegative at baseline

  18. GMT Anti-S IgG at 14 days after the second vaccination [ Time Frame: Day 43 ]
    GMT Anti-S IgG at 14 days after the second vaccination in subjects who are anti-S IgG seronegative at baseline

  19. GMT Anti-S IgG at 6 months after the second vaccination [ Time Frame: Day 197 ]
    GMT Anti-S IgG at 6 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline

  20. GMT Anti-S IgG at 12 months after the second vaccination [ Time Frame: Day 365 ]
    GMT Anti-S IgG at 12 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline

  21. GMFR changed from baseline in anti-S IgG GMT at 28 days after the first vaccination [ Time Frame: Day 29 ]
    GMFR changed from baseline in anti-S IgG GMT at 28 days after the first vaccination

  22. GMFR changed from baseline in anti-S IgG GMT at 14 days after the second vaccination [ Time Frame: Day 43 ]
    GMFR changed from baseline in anti-S IgG GMT 14 days after second vaccination

  23. GMFR changed from baseline in anti-S IgG GMT at 6 months after the second vaccination [ Time Frame: Day 197 ]
    GMFR changed from baseline in anti-S IgG GMT at 6 months after the second vaccination

  24. GMFR changed from baseline in anti-S IgG GMT at 12 months after the second vaccination [ Time Frame: Day 365 ]
    GMFR changed from baseline in anti-S IgG GMT at 12 months after the second vaccination

  25. Anti-S IgG Seroresponses changed from baseline at 28 days after the first vaccination [ Time Frame: Day 29 ]
    Frequency of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline, at 28 days after the first vaccination

  26. Anti-S IgG Seroresponses changed from baseline at 14 days after the second vaccination [ Time Frame: Day 43 ]
    Frequency of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline, at 14 days after the second vaccination

  27. Anti-S IgG Seroresponses changed from baseline at 6 months after the second vaccination [ Time Frame: Day 197 ]
    Frequency of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline, at 6 months after the second vaccination

  28. Anti-S IgG Seroresponses changed from baseline at 12 months after the second vaccination [ Time Frame: Day 365 ]
    Frequency of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline, at 12 months after the second vaccination


Other Outcome Measures:
  1. S protein-specific T cells response changed from baseline at 14 days after the second vaccination [ Time Frame: Day 43 ]
    Frequency of S protein-specific T cells relative to baseline at 14 days after the second vaccination

  2. S protein-specific T cells response changed from baseline at 6 months after the second vaccination [ Time Frame: Day 197 ]
    Frequency of S protein-specific T cells relative to baseline at 6 months after the second vaccination

  3. Anti-NDV HN GMT changed from baseline at 28 days after the first vaccination [ Time Frame: Day 29 ]
    Anti-NDV HN GMT changed from baseline at 28 days after the first vaccination

  4. Anti-NDV HN IgG GMT changed from baseline at 14 days after the second vaccination [ Time Frame: Day 43 ]
    Anti-NDV HN IgG GMT changed from baseline at 14 days after the second vaccination

  5. Anti-NDV HN IgG GMT changed from baseline at 6 months after the second vaccination [ Time Frame: Day 197 ]
    Anti-NDV HN IgG GMT changed from baseline at 6 months after the second vaccination

  6. Anti-NDV HN IgG GMT changed from baseline at 12 months after the second vaccination [ Time Frame: Day 365 ]
    Anti-NDV HN IgG GMT changed from baseline at 12 months after the second vaccination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Phase 1 Only:

  1. Adult 18 through 59 years of age, inclusive, at screening
  2. Healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.

Phase 2 Only:

  1. Adult 18 through 75 years of age, inclusive, at screening.
  2. Having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.

Both Phase 1 and Phase 2:

  1. Has provided written informed consent prior to performance of any study-specific procedure.
  2. Has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
  3. Resides in study site area and is able and willing to adhere to all protocol visits and procedures.
  4. If a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to receipt of the first dose of IP), must plan to avoid pregnancy for at least 28 days after the last dose of IP, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of IP.

Exclusion Criteria:

Phase 1 Only:

1. A positive serologic test for SARS-CoV-2 IgG test.

Both Phase 1 and Phase 2:

  1. Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
  2. History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination during the course of study participation Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Thailand during the course of study participation is not exclusionary if administered after Visit 5
  3. Previous receipt of investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results
  4. History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine
  5. History of egg or chicken allergy
  6. History of angioedema
  7. History of anaphylaxis
  8. Acute illness (moderate or severe) and/or fever (body temperature measured orally ≥38°C)
  9. Any abnormal vital sign deemed clinically relevant by the PI.
  10. Abnormality in screening laboratory test deemed exclusionary by the PI.
  11. A positive serologic test for SARS-CoV-2 IgM test, human immunodeficiency virus (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab)
  12. History of laboratory-confirmed COVID-19 (RT-PCR positive to SAR-CoV-2)
  13. History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ
  14. Any confirmed or suspected immunosuppressive or immunodeficient state
  15. Administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period.
  16. Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; the use of topical steroids including inhaled and intranasal steroids is permitted).
  17. History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. (e.g, thalassemia, coagulation factor deficiencies).
  18. Recent history (within the past year) or signs of alcohol or substance abuse.
  19. Any medical, psychiatric or behavior condition that in the opinion of the PI may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
  20. Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764422


Contacts
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Contact: Punnee Pitisuttithum, M.D 081- 829 4906 punnee.pit@mahidol.ac.th
Contact: Weerapong Phumrataprapin, M.D 081-646 6326 weerapong.phu@mahidol.ac.th

Locations
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Thailand
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University Recruiting
Bangkok, Thailand, 10400
Contact: Punnee Pitisuttithum, MD    662-643-5599    punnee.pit@mahidol.ac.th   
Contact: Weerapong Phumratanaprapin, MD    662-643-5599    weerapong.phu@mahidol.ac.th   
Principal Investigator: Punnee Pitisuttithum, MD         
Sub-Investigator: Weerapong Phumratanaprapin, MD         
Sub-Investigator: Viravarn Luvira, MD         
Sub-Investigator: Sant Muangnoicharoen, MD         
Sub-Investigator: Chaisith Sivakorn, MD         
Sub-Investigator: Arom Pitisuthitham, MD         
Sub-Investigator: Supitcha Kamolratanakul, MD         
Sub-Investigator: Benjaluck Phonrat, M.Sc.         
Sponsors and Collaborators
Mahidol University
The Government Pharmaceutical Organization
Investigators
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Principal Investigator: Punnee Pitisutthithum Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
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Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT04764422    
Other Study ID Numbers: GPO NDV-HXP-S
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data or left over specimen will be shared for future study ONLY subject who consent allow using their data/specimens. Sharing will be done without personnel identification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 2 years after vaccine marketing
Access Criteria: as document attach when completed study in NCT clinicaltrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Punnee Pitisuttithum, Mahidol University:
COVID-19
COVID-19 VACCINE
ADULT
THAILAND
GPO
The Government Pharmaceutical Organization
SAFETY
TOLERABILITY
IMMUNOGENICITY
NDV-HXP-S Vaccine
CpG1018
SARS-CoV-2
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases