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Safety of 25 ug of ChulaCov19-BNA159 mRNA VaccinePhase 1NCT05231369

Safety and Immunogenicity of ChulaCov19 BNA159 mRNA Vaccine

A Phase 1 study testing ChulaCov19 BNA159 mRNA vaccine in people with Safety of 25 ug of ChulaCov19-BNA159 mRNA Vaccine and Tolerability of 25 ug of ChulaCov19-BNA159 mRNA Vaccine, run by Chulalongkorn University at 2 sites in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
ChulaCov19 BNA159 mRNA vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesThailand
Study dates
14 Dec 2022to 1 Jul 2023
Phase
Phase 1
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female participants between the ages of 18 and 60 years, inclusive, at enrolment
  • Women of child-bearing potential (WOCBP) may be enrolled in the study if the participant fulfils all the following criteria:
  • Has a negative urine-based pregnancy test at screening and on the day of the first dose (Day1) and second dose (Day22)
  • 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* from screening and for a period of at least 60 days after the last dose of investigational vaccine.
  • Is not currently breastfeeding.
  • Women of non-child-bearing potential may be enrolled in the study if the participant meet one of these following criteria:
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  • Postmenopausal (defined as having a history of amenorrhea of at least one year), or e. History of amenorrhea is less than one year, must have an FSH level > 40 milli-international units per milliliter (mIU/mL), or f. Have a documented status of being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy).
  • 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.
  • 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.
  • Type of Participant and Disease Characteristics:
  • Participants must be able to communicate effectively with study personnel and agree to comply with the study procedures.
  • Capable to provide written informed consent.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Participants must have haematology, clinical chemistry, coagulation and urinalysis test results that are not deviating from the normal reference range by age and gender to a clinically relevant extent at Screening.

Who cannot join

  • 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.
  • Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • Participant has previously participated in an investigational study involving LNPs (a component of the investigational vaccine assessed in this trial).
  • Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
  • Close contact with anyone known to have SARS-CoV-2 infection within 10 days prior to vaccine administration.
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  • Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
  • Uncontrolled hypertension
  • Diabetes mellitus
  • Cardiovascular disease
  • Chronic pulmonary disease
  • Asthma
  • Chronic liver disease
  • Stage 3 or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m2)
  • BMI >30 kg/m2
  • Individuals with a history of autoimmune disease
  • Prior/Concomitant Therapy:
  • Previous vaccination with any coronavirus vaccine at any time prior to the study or planned receipt of any other licensed or experimental SARS-CoV-2 vaccine within 50 days of receipt of the first study vaccination.
  • Receipt of medications intended to prevent COVID-19.
  • 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.
  • Receipt of immunoglobulins or blood products within 3 months of first vaccination.
  • Diagnostic Assessments:
  • Positive on SAR-CoV-2 -RBD and/or -N antibody IgG/IgM at screening visit
  • Positive test for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV Abs) at the screening visit.
  • Other Exclusions:
  • Is a participant at high risk of SARS-CoV-2 exposure in the opinion of the PI (e.g., healthcare workers, active health care workers with direct patient contact, emergency response personnel).
  • Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.

Trial locations and contacts

2 sites in 1 country.

Sivaporn Gatechompol, MD contact

662 652 3040 ext. 171

sivaporn.k@hivnat.org

Thailand2 sites, 2 recruiting

  • Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University

    Bangkok, 10330

    Sivaporn Gatechompol, MD, 662 652 3040 ext. 171, sivaporn.k@hivnat.org

    Sivaporn Gatechompol, MD

    Recruiting

  • Academic Clinical Research Office (ACRO) Faculty of Medicine, Khon Kaen University

    Khon Kaen

    Atibordee Meesing, MD, 089 842 2698, atibordee@kku.ac.th

    Atibordee Meesing, MD

    Recruiting

Other trials in Thailand

About this study

Official title: A Phase 1 Study to Evaluate Safety, Immunogenicity of the ChulaCov19 BNA159 mRNA Vaccine in Healthy Adults

This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults.

Read the detailed description

ChulaCov19 BNA159 mRNA vaccine is the lipid nanoparticles (LNPs)-encapsulated mRNA-based ChulaCov19 vaccine developed by Chula VRC and manufactured by BioNet Asia, Thailand for the active immunisation of healthy adults against coronavirus disease 2019 (COVID-19). This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults. This study will be conducted in 2 study centers, open-label , dose finding, first in human (FIH) study conducted in healthy participants. There are two groups. One group will receive 25 ug of ChulaCov19 BNA159 mRNA vaccine and the other group will receive 50 ug of ChulaCov19 BNA159 mRNA vaccine. Each group will have 12 participants. Intramuscular injection of the investigational vaccine at the assigned dose, will be administered 21 days apart, on Day 1 and Day 22 ( ±3) .

Being tested
ChulaCov19 BNA159 mRNA vaccine

What participants receive

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

  • ChulaCov19 BNA159 mRNA vaccineBiological

    ChulaCov19 BNA159 mRNA vaccine is the lipid nanoparticles (LNPs)-encapsulated mRNA-based ChulaCov19 vaccine

Study groups in NCT05231369
Study groupRoleWhat they receive
group 1: 25 ug of ChulaCov19 BNA159 mRNA vaccineExperimentalThe participants will receive 25 ug of the vaccine.
Receives: Biological: ChulaCov19 BNA159 mRNA vaccine
group 2: 50 ug of ChulaCov19 BNA159 mRNA vaccineExperimentalIf 25 ug is safe, then will proceed to enroll 12 more participants to receive 50 ug.
Receives: Biological: ChulaCov19 BNA159 mRNA vaccine

What is being measured

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

  1. Frequency of solicited local reactogenicity adverse events (AE)

    Frequency of solicited local reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

    Measured: during a 7-day follow-up period post each vaccination (up to Day 29+3)

  2. Grade of solicited local reactogenicity adverse events (AE)

    Grade of solicited local reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

    Measured: during a 7-day follow-up period post each vaccination (up to Day 29+3)

  3. Frequency of solicited systemic reactogenicity adverse events (AE)

    Frequency of solicited systemic reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

    Measured: during a 7-day follow-up period post each vaccination (up to Day 29+3)

  4. Grade of solicited systemic reactogenicity adverse events (AE)

    Grade of solicited systemic reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

    Measured: during a 7-day follow-up period post each vaccination (up to Day 29+3)

  5. Changes in vital signs

    Changes in vital signs

    Measured: up to Visit 9 - Day 29 +3

  6. Changes in physical examinations

    Changes in physical examinations

    Measured: up to Visit 9 - Day 29 +3

  7. Clinically relevant changes in laboratory measurement

    Clinically relevant changes in laboratory measurement

    Measured: up to Visit 9 - Day 29 +3

  8. Treatment-emergent, clinically significant changes in vital signs

    Treatment-emergent, clinically significant changes in vital signs

    Measured: up to Visit 9 - Day 29 +3

  9. Treatment-emergent, clinically significant changes in physical examinations

    Treatment-emergent, clinically significant changes in physical examinations

    Measured: up to Visit 9 - Day 29 +3

Secondary outcomes (8)

  1. Frequency of unsolicited AEs

    Frequency of unsolicited AEs

    Measured: up to Day 50 ±3

  2. Grade of unsolicited AEs

    Grade of unsolicited AEs

    Measured: up to Day 50 ±3

  3. Frequency of SAEs

    Frequency of SAEs

    Measured: up to the end of the study Day387 ±14

  4. Frequency of MAAEs

    Frequency of MAAEs

    Measured: up to the end of the study Day387 ±14

  5. Frequency of NOCMCs

    Frequency of NOCMCs

    Measured: up to the end of the study Day387 ±14

  6. Geometric mean titres (GMT)

    SARS-Cov2-RBD-binding IgG antibody measured by enzyme-linked immunosorbent assay (ELISA)

    Measured: at Day29 (+3)

  7. Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination to Day29 (+3)

    SARS-Cov2-RBD-binding IgG antibody measured by enzyme-linked immunosorbent assay (ELISA)

    Measured: before vaccination to Day29 (+3)

  8. Geometric mean ratio (GMR) defined as GMT ratio between the two doses of ChulaCov19 BNA159 mRNA vaccine

    SARS-Cov2-RBD-binding IgG antibody measured by enzyme-linked immunosorbent assay (ELISA)

    Measured: at Day29 (+3)

Timeline

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

  1. First posted9 Feb 2022
  2. Study start14 Dec 2022
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

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
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
If 25 ug dose is safe, then will proceed to enroll participants to receive 50 ug.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05231369
Sponsor's protocol ID
ChulaVac 003
Status last verified
Feb 2023
First submitted
7 Feb 2022
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ChulaCov19 BNA159 mRNA vaccine in people with Safety of 25 ug of ChulaCov19-BNA159 mRNA Vaccine and Tolerability of 25 ug of ChulaCov19-BNA159 mRNA Vaccine, 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 14 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 10 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Sivaporn Gatechompol, MD (662 652 3040 ext. 171, sivaporn.k@hivnat.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of solicited local reactogenicity adverse events (AE) (time frame: during a 7-day follow-up period post each vaccination (up to Day 29+3)). The study lists 9 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 NCT05231369.

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 10 Feb 2023.

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