We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ChulaCov19 Vaccine in Healthy Adults

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04566276
Recruitment Status : Active, not recruiting
First Posted : September 28, 2020
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
Chula Vaccine Research Center (ChulaVRC), Bangkok, Thailand
Center of Excellence in Vaccine Research and Development, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Chula Clinical Research Center (Chula CRC), King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
King Chulalongkorn Memorial Hospital (KCMH), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Center of Excellence for Vaccine Trial (Vaccine Trial Centre), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
National Vaccine Institute, Thailand
Information provided by (Responsible Party):
Chulalongkorn University

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 28, 2020
Last Update Posted Date February 8, 2022
Actual Study Start Date  ICMJE May 3, 2021
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • Phase 1 and 2: Frequency of Adverse Events [ Time Frame: up to Day 50 ]
    Frequency of Adverse Events
  • Phase 1 and 2: Grade of Adverse Events [ Time Frame: up to Day 50 ]
    Grade of Adverse Events
  • Phase 1 and 2: Frequency of solicited reportable local Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Frequency of solicited reportable local Adverse Events (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
  • Phase 1 and 2: Grade of solicited reportable local Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Grade of solicited reportable local Adverse Events: (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
  • Phase 1 and 2: Frequency of solicited reportable systemic reactogenicity Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Frequency of solicited reportable systemic Adverse Events: (i.e., headache, fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea/vomiting, diarrhea, light headedness, dizziness, or any other symptoms)
  • Phase 1 and 2: Grade of of solicited reportable systemic Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Grade of solicited reportable systemic Adverse Events: (i.e., headache, fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea/vomiting, diarrhea, light headedness, dizziness, or any other symptoms)
  • Phase 1 and 2: Frequency of Serious Adverse Events [ Time Frame: up to Day 387 ]
    Frequency of Serious Adverse Events
  • Phase 1 and 2: Frequency of Medically-Attended Adverse Events [ Time Frame: up to Day 387 ]
    Frequency of Medically-Attended Adverse Events
  • Phase 1 and 2: Frequency of New-Onset Chronic Medical Conditions [ Time Frame: up to Day 387 ]
    Frequency of New-Onset Chronic Medical Conditions
  • Phase 1 and 2: Changes in vital signs [ Time Frame: up to Day 50 ]
    Changes in vital signs: (i.e., body temperature, respiratory rate, pulse rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP))
  • Phase 1 and 2: Changes in physical examinations [ Time Frame: up to Day 50 ]
    Changes in physical examinations: (i.e., head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin)
  • Phase 1 and 2: Changes in laboratory measurements [ Time Frame: up to Day 50 ]
    Changes in laboratory measurements: (i.e., haemoglobin (Hb), haematocrit (HCT), white blood cells (WBC), neutrophil, lymphocytes, eosinophil, basophil, monocytes, platelet, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, total protein, albumin, lipase, phosphorus, gamma-glutamyl transferase (GGT), glucose, creatinine phosphokinase (CPK), calcium, uric acid, C-reactive protein (CRP), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin, estimated glomerular filtration rate (eGFR), prothrombin time (PR), partial thromboplastin time (PTT) and international normalized ratio (INR))
  • Phase 1 and 2: Presence of injection site reactions [ Time Frame: up to Day 50 ]
    Presence of injection site reactions
  • Phase 2: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels [ Time Frame: at Day 29 (7 days after the second dose) ]
    Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
  • Frequency of Adverse Events [ Time Frame: up to Day 50 ]
    Frequency of Adverse Events
  • Grade of Adverse Events [ Time Frame: up to Day 50 ]
    Grade of Adverse Events
  • Frequency of solicited reportable local Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Frequency of solicited reportable local Adverse Events: pain at the injection site, redness, swelling, erythema
  • Grade of solicited reportable local Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Grade of solicited reportable local Adverse Events: pain at the injection site, redness, swelling, erythema
  • Frequency of solicited reportable systemic Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Frequency of solicited reportable systemic Adverse Events: fever, fatigue, chills, headache, myalgias, arthralgias, vomiting, diarrhoea, new or worsened muscle pain (myalgias), and new or worsened joint pain (arthralgias).
  • Grade of of solicited reportable systemic Adverse Events [ Time Frame: during a 7-day follow-up period post each vaccination ]
    Grade of of solicited reportable systemic Adverse Events: fever, fatigue, chills, headache, myalgias, arthralgias, vomiting, diarrhoea, new or worsened muscle pain (myalgias), and new or worsened joint pain (arthralgias).
  • Frequency of Serious Adverse Events [ Time Frame: up to Day 387 ]
    Frequency of Serious Adverse Events
  • Frequency of Medically-Attended Adverse Events [ Time Frame: up to Day 387 ]
    Frequency of Medically-Attended Adverse Events
  • Frequency of New-Onset Chronic Medical Conditions [ Time Frame: up to Day 387 ]
    Frequency of New-Onset Chronic Medical Conditions
  • Measurement of body temperature [ Time Frame: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    degrees Celsius
  • measurement of respiratory rate [ Time Frame: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    per minute
  • measurement of pulse rate [ Time Frame: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    beats per minute (BPM)
  • measurement of systolic blood pressure (SBP) [ Time Frame: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    millimeter of mercury (mmHg)
  • measurement of diastolic blood pressure (DBP) [ Time Frame: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    millimeter of mercury (mmHg)
  • assess if there are any symptoms at the head [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the head
  • assess if there are any symptoms at the ears [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the ears
  • assess if there are any symptoms at the nose [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the nose
  • assess if there are any symptoms at the throat [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the throat
  • assess if there are any symptoms at the lungs [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the lungs
  • assess if there are any symptoms at the lymph nodes [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the lymph nodes
  • assess if there are any symptoms at the heart [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the heart
  • assess if there are any symptoms at the abdomen [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the abdomen
  • assess if there are any symptoms at the skin [ Time Frame: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387 ]
    assess if there are any symptoms at the skin
  • Measurement of haemoglobin (Hb) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    g/dl
  • Measurement of haematocrit (HCT) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
  • Measurement of red blood cell (RBC) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^6 cells/ul
  • Measurement of white blood cells (WBC) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^3 cells/ul
  • Assess the percentage of neutrophil [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    percentage
  • Assess the number of neutrophil [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^3 cells/ul
  • Assess the percentage of lymphocytes [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    percentage
  • Assess the number of lymphocytes [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^3 cells/ul
  • Assess the percentage of eosinophil [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    percentage
  • Assess the number of eosinophil [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^3 cells/ul
  • Assess the percentage of basophil [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    Percentage
  • Assess the number of basophil [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^3 cells/ul
  • Assess the percentage of monocytes [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    percentage
  • Assess the number of monocytes [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^3 cells/ul
  • Measurement of platelet [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    10^3 cells/ul
  • Measurement of sodium [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mmol/l
  • Measurement of potassium [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mmol/l
  • Measurement of chloride [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mmol/l
  • Measurement of bicarbonate [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mmol/l
  • Measurement of blood urea nitrogen (BUN) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mg/dL
  • Measurement of creatinine [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mg/dl
  • Assess total protein [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    g/dL
  • Measurement of albumin [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    g/dL
  • Measurement of lipase [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    unit/Liter (U/L)
  • Measurement of phosphorus [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mmol/L
  • Measurement of gamma-glutamyl transferase (GGT) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    U/L
  • Measurement of glucose [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mg/dL
  • Measurement of creatinine phosphokinase (CPK) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    U/L
  • Measurement of calcium [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mmol/L
  • Measurement of uric acid [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mg/dL
  • Measurement of C-reactive protein (CRP) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mg/dL
  • Measurement of alanine transaminase (ALT) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    U/L
  • Measurement of aspartate transaminase (AST) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    U/L
  • Measurement of alkaline phosphatase (ALP) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    U/L
  • Assess total bilirubin [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    mg/dL
  • Assess estimated glomerular filtration rate (eGFR) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    ml/min/1-73m^2
  • Measurement of prothrombin time (PT) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    second
  • Measurement of partial thromboplastin time (PTT) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    second
  • Measurement of international normalized ratio (INR) [ Time Frame: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50 ]
    ratio
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • Phase 1: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels [ Time Frame: at Day 29 (7 days after the second dose) ]
    Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
  • Phase 1 and Phase 2: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels [ Time Frame: At Day 29 ]
    Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels
  • Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers [ Time Frame: from baseline to Day 29 ]
    Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers
  • Phase 1 and Phase 2: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels [ Time Frame: at Day 29 ]
    Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
  • Phase 1 and Phase 2: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels [ Time Frame: at Day 29 ]
    Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels
  • Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers [ Time Frame: from baseline to Day 29 ]
    Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers
  • Phase 1 and Phase 2: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody [ Time Frame: at Day 29 ]
    Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
  • Phase 1 and Phase 2: Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody [ Time Frame: from baseline to Day 29 ]
    Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody
  • Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody [ Time Frame: from baseline to Day 29 ]
    Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody
  • Phase 1 and Phase 2: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses [ Time Frame: Day 29 ]
    Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
  • Phase 1 and Phase 2: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses [ Time Frame: Day 29 ]
    Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
  • Phase 1 and Phase 2: Median number of spot-forming cells (SFC) per 1 million PBMCs [ Time Frame: Day 29 ]
    Median number of spot-forming cells (SFC) per 1 million PBMCs
  • Phase 1 and Phase 2: Percentage of participants who shows positive specific Th1 responses [ Time Frame: Day 29 ]
    Percentage of participants who shows positive specific Th1 responses
  • Phase 1 and Phase 2: Percentage of participants who shows positive specific Th2 responses [ Time Frame: Day 29 ]
    Percentage of participants who shows positive specific Th2 responses
  • Phase 1 and Phase 2: Median percentage specific Th1 responses [ Time Frame: Day 29 ]
    Median percentage specific Th1 responses
  • Phase 1 and Phase 2: Median percentage specific Th2 responses [ Time Frame: Day 29 ]
    Median percentage specific Th2 responses
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
  • Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels [ Time Frame: at Day 29 (7 days after the second dose) ]
    Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
  • Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels [ Time Frame: At Day 29 ]
    Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels
  • Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers [ Time Frame: from baseline to Day 29 ]
    Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers
  • Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels [ Time Frame: at Day 29 ]
    Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
  • Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels [ Time Frame: at Day 29 ]
    Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels
  • Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers [ Time Frame: from baseline to Day 29 ]
    Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers
  • Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody [ Time Frame: at Day 29 ]
    Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
  • Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody [ Time Frame: from baseline to Day 29 ]
    Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody
  • Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody [ Time Frame: from baseline to Day 29 ]
    Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody
  • Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses [ Time Frame: Day 29 ]
    Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
  • Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses [ Time Frame: Day 29 ]
    Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
  • Median number of spot-forming cells (SFC) per 1 million PBMCs [ Time Frame: Day 29 ]
    Median number of spot-forming cells (SFC) per 1 million PBMCs
  • Percentage of participants who shows positive specific Th1 responses [ Time Frame: Day 29 ]
    Percentage of participants who shows positive specific Th1 responses
  • Percentage of participants who shows positive specific Th2 responses [ Time Frame: Day 29 ]
    Percentage of participants who shows positive specific Th2 responses
  • Median percentage specific Th1 responses [ Time Frame: Day 29 ]
    Median percentage specific Th1 responses
  • Median percentage specific Th2 responses [ Time Frame: Day 29 ]
    Median percentage specific Th2 responses
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ChulaCov19 Vaccine in Healthy Adults
Official Title  ICMJE A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 Vaccine in Healthy Adults
Brief Summary

This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive).

Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).

Detailed Description

This study will be conducted as a combined phase 1/2 study in healthy participants.

The first phase of the study will evaluate the safety, tolerability, and reactogenicity of escalating doses (10 µg, 25 µg, and 50 µg) of the ChulaCov19 vaccine, administered intramuscularly (IM) according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-55 years and in elderly adults aged 56-75 years, up to Visit 10 (Day 50 ±3).

The second phase of the study will evaluate the safety, tolerability, and reactogenicity of escalating doses of the ChulaCov19 vaccine, administered intramuscularly (IM) according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18--75 years, up to Visit 10 (Day 50 ±3). The study will also evaluate the immunogenicity measured as neutralising antibody titre (measured by Micro-viral neutralising test [MicroVNT]) following repeat vaccination of escalating doses of the ChulaCov19 vaccine, administered IM according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-75 years, at Visit 9 (Day 29 +3).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Phase 1: Group 1 (healthy adults aged 18 to 55 years) and Group 2 (elderlies aged 56 to 75 years) will be enrolled sequentially in an ascending dose fashion (10 µg, 25 µg, 50 µg). Up to 36 eligible healthy volunteers for each of the 2 age groups will be enrolled into 1 of 3 treatment cohorts (12 participants/ cohort). For each cohort, if only 1 participant withdraws prior to the second vaccination, no replacement is deemed necessary. For each cohort, if more than 1 participant withdraws prior to the second vaccination all withdrawn participants will be replaced.

Phase 2: The Phase 2 adult cohorts will include adults between 18 and 59 years of age (inclusive). Participants in the Phase 2 will be enrolled into at least 1 dose level cohort with a vaccination dose of 50 ug which was determined by DSMB and SRPT review and approval of the applicable Phase 1 data. Phase 2 treatment group will consist of participants randomly assigned to active treatment versus placebo in a ratio of 4:1.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • COVID-19 Vaccine
  • Safety Issues
Intervention  ICMJE
  • Biological: ChulaCov19 vaccine
    SARS-Cov2 Wild-type S-spike mRNA/ lipid nanoparticle (LNP) vaccine
  • Other: Placebo
    Saline
Study Arms  ICMJE
  • Experimental: Adult Cohort 1: 10 µg
    12 healthy adults aged 18-55 years will receive 10 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 vaccine
  • Experimental: Adult Cohort 2: 25 µg
    12 healthy adults aged 18-55 years will receive 25 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 vaccine
  • Experimental: Adult Cohort 3: 50 µg
    12 healthy adults aged 18-55 years will receive 50 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 vaccine
  • Experimental: Elderly Cohort 1 :10 µg
    12 elderlies aged 56-75 years will receive 10 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 vaccine
  • Experimental: Elderly Cohort 2: 25 µg
    12 elderlies aged 56-75 years will receive 25 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 vaccine
  • Experimental: Elderly Cohort 3: 50 µg
    12 elderlies aged 56-75 years will receive 50 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 vaccine
  • Experimental: Phase 2: ChulaCov19 vaccine Dose 50 ug
    adults between 18 and 59 years of age will receive 2 IM ChulaCov19 vaccine Dose 50 ug vaccinations; administered 21days apart (on Day 1 and Day 22 ±3)
    Intervention: Biological: ChulaCov19 vaccine
  • Phase 2: Placebo
    adults between 18 and 59 years of age will receive 2 IM saline vaccinations; administered 21days apart (on Day 1 and Day 22 ±3)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2021)
222
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2020)
96
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Participants who meet all the following criteria at Screening are eligible to participate in the study:

Inclusion criteria:

  1. Participants must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
  2. Participants must sign the written informed consent form prior to undertaking any protocol related procedures.
  3. Participants must have a body mass index (BMI) at Screening, calculated as the body mass divided (in kilograms [kg]) by the square of the body height (in metres [m]) of 18.0-30.0 kg/m2, inclusive.
  4. Participants must have haematology, clinical chemistry, coagulation (for all participants in Phase 1, and, only if applicable, for participants in Phase 2), and urinalysis test results that are not deviating from the normal reference range by age and gender to a clinically relevant extent at Screening.
  5. Males must be surgically sterile (>30 days since vasectomy with no viable sperm), practice true abstinence or, if engaged in sexual relations with a female of child-bearing potential, the participants and their partner must use an acceptable, highly effective, double-barrier contraceptive method* from Screening and for a period of at least 60 days after the last dose of investigational vaccine.
  6. Women of child-bearing potential must practice true abstinence or, if engaged in sexual relations with a male, they must agree to use highly effective (failure rate of < 1% per year when used consistently and correctly), double-barrier contraceptive measures* throughout the study and intend to continue use of contraception for at least 60 days following the last vaccination.

    * The PI is to assess the adequacy of methods of contraception on a case-by-case basis. These criteria do not apply if the participants are in a same-sex relationship.

  7. Women of child-bearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [β-HCG]) at Screening and a negative urine-based test within 24 hours prior to each investigational vaccine administration.
  8. Women of non-child-bearing potential must:

    1. be classified as being postmenopausal (defined as having a history of amenorrhea of at least one year), or
    2. where history of amenorrhea is less than one year, female participants must have a follicle stimulating hormone (FSH) level > 40 milli-international units per milliliter (mIU/mL), or
    3. have a documented status of being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy).
  9. Participants must be in general good health based on medical history and physical examination, as determined by the PI, at Screening.
  10. Body temperature must be less than 37.8ºC, at Screening.
  11. Pulse must be no greater than 100 beats per minute, at Screening.
  12. Systolic blood pressure (SBP) must be between 85 to 150 millimetres of mercury (mm Hg), inclusive, at Screening.
  13. Participants must agree to refrain from donating blood, plasma, ovules, sperm, or organs during the whole study.

    Adult Participants (Group 1 of Phase 1) only

  14. Must be a male or female aged 18-55 years (inclusive) at the time of enrolment.

    Elderly Participants (Group 2 of Phase 1) only

  15. Must be a male or female aged 56-75 years (inclusive) at the time of enrolment.

    Participants for Phase 2 only

  16. Must be a male or female aged 18 -59 years (inclusive) at the time of enrolment.

Exclusion Criteria

The presence of any of the following criteria will constitute cause for the exclusion of the participant:

  1. Presence of clinically significant medical history, unstable chronic or acute disease, or physical, or laboratory findings that, in the opinion of the PI may potentially increase the expected risk of exposure to the investigational vaccine, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results. This will include asthma and any thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  2. Presence of self-reported or medically documented significant medical or psychiatric condition(s).
  3. Presence of an acute illness, as determined by the participating site PI or appropriate sub-PI, with or without fever (temperature ≥ 38.0 ºC) within 72 hours prior to each vaccination.
  4. Presence of birthmarks, tattoos, wound, or other skin conditions over the deltoid region of both arms that, in the PI's opinion, could reasonably obscure and interfere with evaluation of local ISRs.
  5. Inadequate venous access to allow collection of blood samples.
  6. Breastfeeding or planning to breastfeed from the time of the first vaccination through 60 days after the last vaccination, or pregnant as confirmed by a positive serum β-HCG pregnancy test at Screening or positive urine pregnancy test at subsequent clinic visits at timepoints as delineated in the schedule of assessments.
  7. Received any prophylactic or therapeutic vaccine, or licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication, within 4 weeks of first vaccination or 5 half-lives (whichever is longer), or anticipate to do so in the follow-up period defined for this study.
  8. Participant has previously participated in an investigational study involving LNPs (a component of the investigational vaccine assessed in this trial).
  9. History of severe allergy (requiring hospital care), severe reaction to any drug or prior vaccination, or any known or suspected allergies or sensitivities to any component of the investigational vaccine or placebo.
  10. History of ever had an anaphylaxis reaction to food, medication or vaccination.
  11. Participant is immunosuppressed as caused by disease (such as HIV).
  12. Chronic use (more than 14 continuous days) of or anticipated need to use, within the next 6 months, of any medications that may be associated with impaired immune responsiveness or with immunosuppression.
  13. History of hepatitis B or hepatitis C infection.
  14. Receipt of immunoglobulins or blood products within 3 months of first vaccination.
  15. Requirement for antipyretic or analgesic medication on a daily or every other day basis from enrolment through 72 hours after vaccination.
  16. Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the PI.
  17. History of alcohol or drug abuse that in the opinion of the PI could affect the participant's safety or compliance with study.
  18. Participant unwilling to abstain from blood donation during the course of the study, and/or participation in any research study involving blood sampling (more than 450 mL /unit of blood), or blood donation to any blood bank during the 2 months prior to the Screening visit.
  19. Close contact with anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
  20. Positive for SAR-CoV-2 by antibody IgG/IgM and anti spike IgG at screening
  21. History of COVID-19 diagnosis (the criteria for COVID-19 diagnosis will follow the local guidelines).
  22. On current treatment with investigational agents for prophylaxis of COVID-19.
  23. Planning to travel outside Thailand from enrolment through 28 days after the second vaccination.
  24. Residing in a nursing home or other skilled nursing facility or having a requirement for skilled nursing care.
  25. Is a participant at high risk of SARS-CoV2 exposure in the opinion of the PI (e.g., healthcare workers, active health care workers with direct patient contact, emergency response personnel).

    Elderly Participants (Group 2 of Phase 1) only

  26. Chronically smoking (defined as ≥10 Pack years [packs/day × years smoked]) within the 12 months prior to enrolment.
  27. Presence of co-morbidities that can be associated with an increased risk of severe COVID-19 Cancer, Chronic kidney diseases, COPD, cardiovascular disease, solid organ transplantation, DM type 2, HT, cerebrovascular disease, Obesity (BMI> 30 kg/m2)

    Participants for Phase 2 only

  28. Presence of co-morbidities that can be associated with an increased risk of severe COVID-19 Cancer, Chronic kidney diseases, COPD, cardiovascular disease, solid organ transplantation, DM type 2, uncontrolled HT, cerebrovascular disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04566276
Other Study ID Numbers  ICMJE ChulaVac 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chulalongkorn University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chulalongkorn University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Chula Vaccine Research Center (ChulaVRC), Bangkok, Thailand
  • Center of Excellence in Vaccine Research and Development, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
  • Chula Clinical Research Center (Chula CRC), King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
  • King Chulalongkorn Memorial Hospital (KCMH), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
  • Center of Excellence for Vaccine Trial (Vaccine Trial Centre), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
  • National Vaccine Institute, Thailand
Investigators  ICMJE
Study Director: Kiat Ruxrungtham, MD Center of Excellence in Vaccine Research and Development, Faculty of Medicine, Chulalongkorn University
PRS Account Chulalongkorn University
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP