Official Title
A Phase 2, Non-inferiority, Open-label, Randomized Controlled Study to Evaluate the Immunogenicity and Safety of Comvigen (Bivalent) Vaccine as a Booster Dose in Adults Who Have Received a Previous Booster Dose of an Approved COVID-19 Vaccine
Brief Summary

This study will assess the safety, reactogenicity and immunogenicity of a single dose ofComvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine as abooster among healthy males and non-pregnant females aged 18-64 years after receiving aprevious booster dose of any approved mRNA COVID-19 vaccine for more than 3 months. Theresults of Combiven will be compared to BIVALENT Pfizer/BNT vaccine.

Detailed Description

This is a phase II, non-inferiority, multicenter randomized open-label trial in which 450
healthy males and non-pregnant females, aged 18-64 years, will be recruited from
multi-sites in Thailand. The randomization will be a 2:1 design to receive either
Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine. This
clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a
single dose of COMVIGEN at 50 ug, as a booster dose, given at 3 months and above after
receipt of a previous booster dose of any approved mRNA COVID-19 vaccine. The estimated
sample size would also allow a comparison between a booster dose, Comvigen (Bivalent,
ChulaCov19 BNA159.2) vaccine at 50 ug to Comirnaty, BIVALENT of Pfizer/BNT Bivalent
vaccine at 30 ug dose.

Recruiting
Safety of a Single Dose of COMVIGEN Vaccine
Reactogenicity of a Single Dose of COMVIGEN Vaccine
Immunogenicity of a Single Dose of COMVIGEN Vaccine
Safety of a Single Dose of BIVALENT Pfizer/BNT Vaccine
Reactogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine
Immunogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine

Biological: Comvigen (Bivalent, ChulaCov19 BNA159.2)

single dose of COMVIGEN at 50 ug, as a booster dose, given at 3 months and above after
receipt of a previous booster dose of any approved mRNA COVID-19 vaccine

Biological: BIVALENT Pfizer/BNT vaccine

single dose of BIVALENT of Pfizer/BNT Bivalent vaccine at 30 ug, as a booster dose, given
at 3 months and above after receipt of a previous booster dose of any approved mRNA
COVID-19 vaccine

Eligibility Criteria

Inclusion Criteria:

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

1. Must be a male or female aged 18 - 64 (inclusive) at the time of enrolment

2. Must have completed at least a primary course of 2 doses of any approved COVID-19
vaccine which the last dose have to be mRNA vaccine and completed the last doser 3
months or more

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
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 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 (WOCBP): she agrees to use an effective
contraceptive method or abstinence from at least 4 weeks prior to the study
intervention administration until at least 12 weeks 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

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:

Participants who meet any of the following criteria are not eligible to participate in
the study:

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) after 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 64 Years
Countries
Thailand
Locations

Department of Pediatric, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand

HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, Thailand

Contacts

Watsamon Jantarabenjakul, MD
+66 818276255
watsamon.j@chula.ac.th

Chulalongkorn University
NCT Number
Keywords
Non-inferiority study
Open-label
randomized controlled study
Immunogenicity of the booster dose
safety of booster dose
reactogenicity of booster dose
COMVIGEN (Bivalent, ChulaCov19 BNA159.2 vaccine)
Pfizer bivalent vaccine (Comirnaty, BIVALENT)
mRNA from the ancestral (original) strain
Omicron variant (BA.4/BA.5) of SARS-CoV-2