COVID-19 VaccinePhase 1/2NCT04566276

ChulaCov19 Vaccine in Healthy Adults

A Phase 1/2 study testing ChulaCov19 vaccine in people with COVID-19 Vaccine and Safety Issues, run by Chulalongkorn University at 2 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19 Vaccine, Safety Issues
What is being tested?: ChulaCov19 vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 192 participants
Where: 2 sitesThailand
Study dates: 3 May 2021to 6 Dec 2022
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
Participants must sign the written informed consent form prior to undertaking any protocol related procedures.
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.
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.
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.
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.

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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.
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.
Women of non-child-bearing potential must:
be classified as being postmenopausal (defined as having a history of amenorrhea of at least one year), or
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
have a documented status of being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy).
Participants must be in general good health based on medical history and physical examination, as determined by the PI, at Screening.
Body temperature must be less than 37.8ºC, at Screening.
Pulse must be no greater than 100 beats per minute, at Screening.
Systolic blood pressure (SBP) must be between 85 to 150 millimetres of mercury (mm Hg), inclusive, at Screening.
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
Must be a male or female aged 18-55 years (inclusive) at the time of enrolment.
Elderly Participants (Group 2 of Phase 1) only
Must be a male or female aged 56-75 years (inclusive) at the time of enrolment.
Participants for Phase 2 only
Must be a male or female aged 18 -59 years (inclusive) at the time of enrolment.

Who cannot join

The presence of any of the following criteria will constitute cause for the exclusion of the participant:
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.
Presence of self-reported or medically documented significant medical or psychiatric condition(s).
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.
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.
Inadequate venous access to allow collection of blood samples.

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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.
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.
Participant has previously participated in an investigational study involving LNPs (a component of the investigational vaccine assessed in this trial).
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.
History of ever had an anaphylaxis reaction to food, medication or vaccination.
Participant is immunosuppressed as caused by disease (such as HIV).
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.
History of hepatitis B or hepatitis C infection.
Receipt of immunoglobulins or blood products within 3 months of first vaccination.
Requirement for antipyretic or analgesic medication on a daily or every other day basis from enrolment through 72 hours after vaccination.
Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the PI.
History of alcohol or drug abuse that in the opinion of the PI could affect the participant's safety or compliance with study.
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.
Close contact with anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
Positive for SAR-CoV-2 by antibody IgG/IgM and anti spike IgG at screening
History of COVID-19 diagnosis (the criteria for COVID-19 diagnosis will follow the local guidelines).
On current treatment with investigational agents for prophylaxis of COVID-19.
Planning to travel outside Thailand from enrolment through 28 days after the second vaccination.
Residing in a nursing home or other skilled nursing facility or having a requirement for skilled nursing care.
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
Chronically smoking (defined as ≥10 Pack years [packs/day × years smoked]) within the 12 months prior to enrolment.
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
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

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

Chula Vaccine Research Center (ChulaCRC) Faculty of Medicine Chulalongkorn University
Bangkok, 10330
Center of Excellence for Vaccine Trial (Vaccine Trial Centre), Faculty of Tropical Medicine Mahidol University
Bangkok

Other trials in Thailand

About this study

Official title: A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 Vaccine in Healthy Adults

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).

Read the 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).

Conditions: COVID-19 Vaccine, Safety Issues
Being tested: ChulaCov19 vaccine, Placebo
Keywords: tolerability, reactivity, immunogenicity, healthy adults, healthy elderlies, coronavirus disease 2019, SARS-CoV-2-specific serum neutralising antibody titer, SARS-CoV-2-surrogate viral neutralising antibody, SARS-Cov2 spike protein-binding IgG antibody titer, SARS-Cov2 spike protein-specific CD4+ and CD8+ T-cells responses, IFNγ enzyme-linked immune absorbent spot (ELISpot), SARS-Cov2 spike protein-specific Th1/Th2 polarisation, novel lipid nanoparticles (LNPs)-encapsulated mRNA-based vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChulaCov19 vaccineBiological
SARS-Cov2 Wild-type S-spike mRNA/ lipid nanoparticle (LNP) vaccine
PlaceboOther
Saline

Study groups in NCT04566276
Study group	Role	What they receive
Adult Cohort 1: 10 µg	Experimental	12 healthy adults aged 18-55 years will receive 10 µg of the vaccine IM Receives: Biological: ChulaCov19 vaccine
Adult Cohort 2: 25 µg	Experimental	12 healthy adults aged 18-55 years will receive 25 µg of the vaccine IM Receives: Biological: ChulaCov19 vaccine
Adult Cohort 3: 50 µg	Experimental	12 healthy adults aged 18-55 years will receive 50 µg of the vaccine IM Receives: Biological: ChulaCov19 vaccine
Elderly Cohort 1 :10 µg	Experimental	12 elderlies aged 56-75 years will receive 10 µg of the vaccine IM Receives: Biological: ChulaCov19 vaccine
Elderly Cohort 2: 25 µg	Experimental	12 elderlies aged 56-75 years will receive 25 µg of the vaccine IM Receives: Biological: ChulaCov19 vaccine
Elderly Cohort 3: 50 µg	Experimental	12 elderlies aged 56-75 years will receive 50 µg of the vaccine IM Receives: Biological: ChulaCov19 vaccine
Phase 2: ChulaCov19 vaccine Dose 50 ug	Experimental	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) Receives: Biological: ChulaCov19 vaccine
Phase 2: Placebo	Other	adults between 18 and 59 years of age will receive 2 IM saline vaccinations; administered 21days apart (on Day 1 and Day 22 ±3) Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1 and 2: Frequency of Adverse Events
Frequency of Adverse Events
Measured: up to Day 50
Phase 1 and 2: Grade of Adverse Events
Grade of Adverse Events
Measured: up to Day 50
Phase 1 and 2: Frequency of solicited reportable local Adverse Events
Frequency of solicited reportable local Adverse Events (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
Measured: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Grade of solicited reportable local Adverse Events
Grade of solicited reportable local Adverse Events: (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
Measured: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Frequency of solicited reportable systemic reactogenicity Adverse Events
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)
Measured: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Grade of of solicited reportable systemic Adverse Events
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)
Measured: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Frequency of Serious Adverse Events
Frequency of Serious Adverse Events
Measured: up to Day 387
Phase 1 and 2: Frequency of Medically-Attended Adverse Events
Frequency of Medically-Attended Adverse Events
Measured: up to Day 387
Phase 1 and 2: Frequency of New-Onset Chronic Medical Conditions
Frequency of New-Onset Chronic Medical Conditions
Measured: up to Day 387
Phase 1 and 2: Changes in vital signs
Changes in vital signs: (i.e., body temperature, respiratory rate, pulse rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP))
Measured: up to Day 50
Phase 1 and 2: Changes in physical examinations
Changes in physical examinations: (i.e., head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin)
Measured: up to Day 50
Phase 1 and 2: Changes in laboratory measurements
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))
Measured: up to Day 50
Phase 1 and 2: Presence of injection site reactions
Presence of injection site reactions
Measured: up to Day 50
Phase 2: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Measured: at Day 29 (7 days after the second dose)

Secondary outcomes (16)

Phase 1: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Measured: at Day 29 (7 days after the second dose)
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
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
Measured: At Day 29
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers
Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers
Measured: from baseline to Day 29
Phase 1 and Phase 2: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
Measured: at Day 29
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
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
Measured: at Day 29
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers
Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers
Measured: from baseline to Day 29
Phase 1 and Phase 2: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
Measured: at Day 29
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
Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody
Measured: from baseline to Day 29
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody
Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody
Measured: from baseline to Day 29
Phase 1 and Phase 2: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
Measured: Day 29
Phase 1 and Phase 2: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
Measured: Day 29
Phase 1 and Phase 2: Median number of spot-forming cells (SFC) per 1 million PBMCs
Median number of spot-forming cells (SFC) per 1 million PBMCs
Measured: Day 29
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th1 responses
Percentage of participants who shows positive specific Th1 responses
Measured: Day 29
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th2 responses
Percentage of participants who shows positive specific Th2 responses
Measured: Day 29
Phase 1 and Phase 2: Median percentage specific Th1 responses
Median percentage specific Th1 responses
Measured: Day 29
Phase 1 and Phase 2: Median percentage specific Th2 responses
Median percentage specific Th2 responses
Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 20216 Dec 2022

First posted28 Sep 2020
Study start3 May 2021
Primary completion1 Oct 2022
Study completion6 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
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 blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04566276
Sponsor's protocol ID: ChulaVac 001
Status last verified: Feb 2023
First submitted: 15 Sep 2020
Last updated: 9 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Puthanakit T, Prompetchara E, Gatechompol S, Ketloy C, Thitithanyanont A, Jongkaewwattana A, Buranapraditkun S, Ubolyam S, Kerr SJ, Sophonphan J, Apornpong T, Kittanamongkolchai W, Siwamogsatham S, Sriplienchan S, Patarakul K, Theerawit T, Promsena P, Nantanee R, Manomaisantiphap S, Chokyakorn S, Hong L, Samija M, Montefiori DC, Gao H, Eaton A, Wijagkanalan W, Alameh MG, Weissman D, Ruxrungtham K; ChulaVac001-Phase 2 study team. Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study. Sci Rep. 2024 Jan 29;14(1):2373. doi: 10.1038/s41598-023-49653-6.
PubMed 38287068

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 Vaccine in Healthy Adults
ClinicalTrials.gov ID: NCT04566276
Acronym / sponsor ID: ChulaVac 001
Conditions: COVID-19 Vaccine, Safety Issues
Keywords: tolerability, reactivity, immunogenicity, healthy adults, healthy elderlies, coronavirus disease 2019, SARS-CoV-2-specific serum neutralising antibody titer, SARS-CoV-2-surrogate viral neutralising antibody
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Collaborators: Chula Vaccine Research Center (ChulaVRC), Bangkok, Thailand, King Chulalongkorn Memorial Hospital, Mahidol University, National Vaccine Institute, Thailand
Study start: 3 May 2021 (actual)
Primary completion: 1 Oct 2022 (actual)
Study completion: 6 Dec 2022 (actual)
First posted: 28 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8
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.

Arm	Type	Receives
Adult Cohort 1: 10 µg	Experimental	Biological: ChulaCov19 vaccine12 healthy adults aged 18-55 years will receive 10 µg of the vaccine IM
Adult Cohort 2: 25 µg	Experimental	Biological: ChulaCov19 vaccine12 healthy adults aged 18-55 years will receive 25 µg of the vaccine IM
Adult Cohort 3: 50 µg	Experimental	Biological: ChulaCov19 vaccine12 healthy adults aged 18-55 years will receive 50 µg of the vaccine IM
Elderly Cohort 1 :10 µg	Experimental	Biological: ChulaCov19 vaccine12 elderlies aged 56-75 years will receive 10 µg of the vaccine IM
Elderly Cohort 2: 25 µg	Experimental	Biological: ChulaCov19 vaccine12 elderlies aged 56-75 years will receive 25 µg of the vaccine IM
Elderly Cohort 3: 50 µg	Experimental	Biological: ChulaCov19 vaccine12 elderlies aged 56-75 years will receive 50 µg of the vaccine IM
Phase 2: ChulaCov19 vaccine Dose 50 ug	Experimental	Biological: ChulaCov19 vaccineadults 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)
Phase 2: Placebo	Other	Other: Placeboadults between 18 and 59 years of age will receive 2 IM saline vaccinations; administered 21days apart (on Day 1 and Day 22 ±3)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Participants must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
Participants must sign the written informed consent form prior to undertaking any protocol related procedures.
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.
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.
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.

Key exclusion criteria (31 listed)

The presence of any of the following criteria will constitute cause for the exclusion of the participant:
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.
Presence of self-reported or medically documented significant medical or psychiatric condition(s).
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChulaCov19 vaccineSARS-Cov2 Wild-type S-spike mRNA/ lipid nanoparticle (LNP) vaccine	Biological	Adult Cohort 1: 10 µg, Adult Cohort 2: 25 µg, Adult Cohort 3: 50 µg, Elderly Cohort 1 :10 µg, Elderly Cohort 2: 25 µg, Elderly Cohort 3: 50 µg, Phase 2: ChulaCov19 vaccine Dose 50 ug
PlaceboSaline	Other	Phase 2: Placebo

Primary outcome

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

16 secondary outcomes

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)
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
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
Phase 1 and Phase 2: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
Time frame: at Day 29
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
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
Phase 1 and Phase 2: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
Time frame: at Day 29
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
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
Phase 1 and Phase 2: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
Time frame: Day 29
Phase 1 and Phase 2: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
Time frame: Day 29
Phase 1 and Phase 2: Median number of spot-forming cells (SFC) per 1 million PBMCs
Time frame: Day 29
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th1 responses
Time frame: Day 29
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th2 responses
Time frame: Day 29
Phase 1 and Phase 2: Median percentage specific Th1 responses
Time frame: Day 29
Phase 1 and Phase 2: Median percentage specific Th2 responses
Time frame: Day 29

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Derived from this study: PubMed 38287068Puthanakit T, Prompetchara E, Gatechompol S, Ketloy C, Thitithanyanont A, Jongkaewwattana A, Buranapraditkun S, Ubolyam S, Kerr SJ, Sophonphan J, Apornpong T, Kittanamongkolchai W, Siwamogsatham S, Sriplienchan S, Patarakul K, Theerawit T, Promsena P, Nantanee R, Manomaisantiphap S, Chokyakorn S, Hong L, Samija M, Montefiori DC, Gao H, Eaton A, Wijagkanalan W, Alameh MG, Weissman D, Ruxrungtham K; ChulaVac001-Phase 2 study team. Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study. Sci Rep. 2024 Jan 29;14(1):2373. doi: 10.1038/s41598-023-49653-6.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kiat Ruxrungtham, MD study director

Chulalongkorn University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ChulaCov19 vaccine in people with COVID-19 Vaccine and Safety Issues, run by Chulalongkorn University at 2 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 and 2: Frequency of Adverse Events (time frame: up to Day 50). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04566276, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.