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ChulaCov19 mRNA 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. 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: NCT04566276
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
Center of Excellence in Vaccine Research and Development, Chulalongkorn University
Center of Excellence for Vaccine Trial (Vaccine Trial Centre), Faculty of Tropical Medicine, Mahidol University
Chula Vaccine Research Center (ChulaVRC), Faculty of Medicine, Chulalongkorn University
National Vaccine Institute (NVI), Thailand
National Research Council of Thailand
C2F Chulalongkorn University, Faculty of Medicine, Chulalongkorn University
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 October 6, 2020
Estimated Study Start Date  ICMJE January 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ChulaCov19 mRNA Vaccine in Healthy Adults
Official Title  ICMJE A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 mRNA Vaccine in Healthy Adults
Brief Summary This study is conducted in two phases. The first phase of the study will assess the safety, tolerability and reactivity to the COVID-19 vaccine (ChulaCov19 messenger ribonucleic acid) administered at various doses through the muscles among healthy adults and the elderlies (age 65-75 years) (total 96 participants). Phase 2 will proceed dependent upon the results from phase 1 of the study. The second phase of the study will assess whether the vaccine can activate the immune system or not (total 600 participants) among healthy adults and the elderlies.
Detailed Description

This study will be conducted in 2 phases.

The first phase of the study will evaluate the safety, tolerability and the reactogenicity of escalating doses (10 µg, 25 µg, 50 µg, and 100 µg) of the ChulaCov19 messenger ribonucleic acid (mRNA) vaccine, administered IM according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-55 years and in elderly adults aged 65-75 years, up to Day 50. For each dose, there will be 12 participants. There will be a total of 8 arms (4 arms for healthy adults aged 18-55 years and 4 arms for the elderlies). There will be a total of 96 participants.

The second phase of the study (if DSMB approves for the study to proceed to the next phase) will evaluate the immunogenicity measured as neutralising antibody titer (measured by MicroVNT [Micro-viral neutralising test]) following repeat vaccination of escalating doses of the ChulaCov19 mRNA vaccine, administered IM according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-55 years and in elderly adults aged 65-75 years, at Day 29 (7 days after the second vaccination). Each treatment group will consist of participants randomly assigned to active treatment versus placebo in a ratio of 4:1 per dose cohort. The participants, the care providers, the PI(s), and the outcome assessors will be blinded to the treatment assignment of the participants. Two different doses will be evaluated in the healthy adults (total 4 arms, including placebo). Two different doses will be investigated in the elderlies (total 4 arms, including placebo). There will be a total of 600 participants (120 participants per dose; 30 participants for placebo).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Healthy adults (age 18 to 55 years) and elderlies (age 65 to 75 years) will be enrolled sequentially in an ascending dose fashion (10 µg, 25 µg, 50 µg, and 100 µg).
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • COVID-19 Vaccine
  • Safety Issues
Intervention  ICMJE Biological: ChulaCov19 mRNA vaccine
novel lipid nanoparticles (LNPs)-encapsulated mRNA-based ChulaCov19 investigational vaccine
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 mRNA 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 mRNA 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 mRNA vaccine
  • Experimental: Adult Cohort 4: 100 µg
    12 healthy adults aged 18-55 years will receive 100 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 mRNA vaccine
  • Experimental: Elderly Cohort 1 :10 µg
    12 elderlies aged 65-75 years will receive 10 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 mRNA vaccine
  • Experimental: Elderly Cohort 2: 25 µg
    12 elderlies aged 65-75 years will receive 25 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 mRNA vaccine
  • Experimental: Elderly Cohort 3: 50 µg
    12 elderlies aged 65-75 years will receive 50 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 mRNA vaccine
  • Experimental: Elderly Cohort 4: 100 µg
    12 elderlies aged 65-75 years will receive 100 µg of the vaccine IM
    Intervention: Biological: ChulaCov19 mRNA vaccine
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2020)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 meters [m]) of 18.0-30.0 kg/m2, inclusive, at screening.
  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-childbearing potential must:

    • be classified as being postmenopausal (defined as having a history of amenorrhea of at least one year), or
    • if having a history of amenorrhea of less than one year they must have an FSH level > 40 milli-international units per milliliter (mIU/mL), or
    • 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.
  10. Body temperature measured orally must be less than 37.8ºC.
  11. Pulse must be no greater than 100 beats per minute.
  12. Systolic blood pressure (SBP) must be between 85 to 150 millimetres of mercury (mm Hg), inclusive.
  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 and Phase 2) 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 and Phase 2) only 15. Must be a male or female aged 65-75 years (inclusive) at the time of enrolment.

Exclusion Criteria:

  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 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 (oral temperature ≥ 38.0 ºC) within 72 hours prior to each vaccination.

    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.

  4. Inadequate venous access to allow collection of blood samples.
  5. 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 study schedule.
  6. 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.
  7. Participant has previously participated in an investigational study involving LNPs (a component of the investigational vaccine assessed in this trial).
  8. 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.
  9. Participant is immunosuppressed as caused by disease (such as HIV).
  10. 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*.

    * Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.

  11. History of hepatitis B or hepatitis C infection.
  12. Receipt of immunoglobulins or blood products within 3 months of first vaccination.
  13. Requirement for antipyretic or analgesic medication on a daily or every other day basis from enrolment through 72 hours after vaccination.
  14. Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the PI.
  15. History of alcohol or drug abuse or psychiatric disorder that in the opinion of the PI could affect the participant's safety or compliance with study.
  16. 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.
  17. Participant unwilling to abstain from donating plasma, ovules, sperm, or organs during the course of the study.
  18. Close contact with anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
  19. History of COVID-19 diagnosis.
  20. On current treatment with investigational agents for prophylaxis of COVID-19.
  21. Planning to travel outside Thailand from enrolment through 28 days after the second vaccination.
  22. Residing in a nursing home or other skilled nursing facility or having a requirement for skilled nursing care.
  23. 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 and Phase 2) only

  24. Chronically smoking (defined as ≥10 Pack years [packs/day × years smoked]) within the 12 months prior to enrolment.
  25. Presence of comorbidities that can be associated with an increased risk of severe COVID-19.
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: Sivaporn Gatechompol, MD 662 652 3040 ext 171 sivaporn.k@hivnat.org
Contact: Nitiya Chomchey, PhD nitiya.c@searchthailand.org
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
Responsible Party Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE
  • Center of Excellence in Vaccine Research and Development, Chulalongkorn University
  • Center of Excellence for Vaccine Trial (Vaccine Trial Centre), Faculty of Tropical Medicine, Mahidol University
  • Chula Vaccine Research Center (ChulaVRC), Faculty of Medicine, Chulalongkorn University
  • National Vaccine Institute (NVI), Thailand
  • National Research Council of Thailand
  • C2F Chulalongkorn University, Faculty of Medicine, Chulalongkorn University
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 September 2020

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