This clinical trial is designed to assess the safety, tolerability and immunogenicity ofa single dose of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 vaccines as a booster dose,given at least 3 months after receipt of a previous booster dose of anyauthorized/approved COVID-19 vaccine.
This is a phase II, randomised open-label trial in which 150 healthy males and
non-pregnant females aged 18-64 years, will be recruited from multi-sites in Australia.
This is a 2-part study (Part A and Part B). In Part A, the randomisation will be a 2:1
design to receive either ChulaCov19 BNA159 vaccine or Comirnaty Pfizer/BNT vaccine. In
Part B, participants will receive only ChulaCov19 BNA159.2 (Bivalent, COMVIGEN) vaccine.
Participants in part A and B will be followed up using a combination of an-site and
telephone visits for assessment of safety and immunogenicity for 6 months
post-vaccination.
Biological: ChulaCov19 BNA159 vaccine (50 mcg)
Single dose of ChulaCov19 BNA159 vaccine 0.5 ml will be given by IM at Day 1
Biological: Pfizer/BNT vaccine (30 mcg)
Single dose of Pfizer/BNT vaccine 0.3 ml will be given by IM at Day 1
Biological: COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)
Single dose of COMVIGEN vaccine 0.5 ml will be given by IM at Day 1
Inclusion Criteria:
1. Must be a male or female aged 18 - 64 (inclusive) at the time of enrolment
2. Must have completed a primary course of 2 doses of any approved COVID-19 vaccine and
3 months or more have passed since receipt of last booster dose (1 or 2 prior
booster doses for a total of 3 or 4 doses) as described in Table 1
3. Must be able to communicate effectively with study personnel and considered
reliable, willing, and cooperative in terms of compliance with the protocol
requirements
4. Participants must sign the written informed consent form prior to undertaking any
protocol-related procedures
5. SARS-CoV-2 rapid antigen test is negative at Day 1 (the day of receiving the study
booster dose)
6. Does not intend to receive any other authorized/approved COVID-19 vaccine at the
time of enrolment and up to 3 months of the study
7. 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
childbearing potential, the participants and their partner must use an acceptable,
highly effective, dual contraceptive method* from Screening and for a period of at
least 90 days after vaccination
8. A female participant is eligible if she is not pregnant, or breastfeeding indicated
by one of the following conditions:
1. With childbearing potential: she agrees to use an effective contraceptive
method or abstinence from at least 4 weeks prior to the study intervention
administration until at least 90 days after the study intervention
administration, or
2. With non-childbearing potential. To be considered of non-childbearing
potential, a female must be post-menopausal for at least 1 year or surgically
sterile. If the participant is < 1 year post-menopausal, an FSH test may be
conducted to establish childbearing potential.
9. Participants must be in general good health* based on medical history and physical
examination, as determined by the PI at Screening.
10. Participants must agree to refrain from donating blood, plasma, ova, sperm, or
organs during the whole study.
Exclusion Criteria:
1. History of a systemic hypersensitivity or life-threatening reaction to a vaccine
containing any of the same or similar substances.
2. History of test-confirmed by PCR or rapid antigen test to SARS-CoV-2 COVID-19
infection within 3 months prior to randomisation.
3. Presence of clinically significant medical history*, unstable chronic or acute
disease that, in the opinion of the PI, may increase the risk of exposure to the
investigational vaccine
4. History of having any significant side effects after receipt of any other COVID-19
vaccine eg. endocarditis, pericarditis or myocarditis. History of any severe
reactogenic side effects or other medical illness that were thought to be associated
with vaccine.
5. Presence of an acute illness* or with fever at 38.00 C or more within 72 hours prior
to vaccination.
6. Bleeding disorders or taking an anticoagulant or anti-platelet agent that may
contraindicate for intramuscular injection based on Investigator's judgment
7. Inadequate venous access to allow the collection of blood samples.
8. Received any prophylactic or therapeutic vaccine, biologic product, device or blood
product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or
anticipate doing so in the follow-up period defined for this study. For influenza
vaccine, however, can be administered up to 14 days prior to randomization and
following Visit 3 (Day 29+3) blood sample collection.
9. History of ever had an anaphylaxis reaction to food, medication, or vaccination.
10. Participant is immunosuppressed as caused by disease or immunosuppressive therapy or
anticipated need to use of any chemotherapy or immunosuppressive agents* within the
next 6 months.
11. Participation in any of the other investigational trials of vaccines, therapeutic,
or medical devices 12 weeks before or during the 6 months of this study.
12. Received immunoglobulins and/or any blood or blood products within 3 months before
vaccination day or plans to receive any blood or blood products at any time during
the study.
Paratus research Canberra Clinic
Bruce, Australian Capital Territory, Australia
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
The Children's Hospital at Westmead Sydney
Westmead, New South Wales, Australia
Paratus Clinical Research- Brisbane Clinic
Albion, Queensland, Australia
Kiat Ruxrunghtam, MD, Study Director
Chulalongkorn University