Immunogenicity and Safety of Comvigen (Bivalent) Vaccine (NCT05930730) | Clinical Trial Compass
UnknownPhase 2
Immunogenicity and Safety of Comvigen (Bivalent) Vaccine
Thailand450 participantsStarted 2023-10-09
Plain-language summary
This study will assess the safety, reactogenicity and immunogenicity of a single dose of Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine as a booster among healthy males and non-pregnant females aged 18-64 years after receiving a previous booster dose of any approved mRNA COVID-19 vaccine for more than 3 months. The results of Combiven will be compared to BIVALENT Pfizer/BNT vaccine.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Must be a male or female aged 18 - 64 (inclusive) at the time of enrolment
✓. 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
✓. 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
✓. SARS-CoV-2 rapid antigen test is negative at Day 1 (the day of receiving the study booster dose)
✓. 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
✓. 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
✓. A female participant is eligible if she is not pregnant, or breastfeeding indicated by one of the following conditions:
Exclusion criteria
✕. History of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances.
. History of test-confirmed by PCR or rapid antigen test to SARS-CoV-2 COVID-19 infection within 3 months prior to randomisation.
✕. 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
✕. 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.
✕. Presence of an acute illness\* or with fever at 38.00 C or more within 72 hours prior to vaccination.
✕. Bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on Investigator's judgment
✕. Inadequate venous access to allow the collection of blood samples.
✕. 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.
Timeframe: 169 days
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clinical changes
Timeframe: 169 days
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Geometric mean titers of neutralizing antibody titer
Timeframe: Day 29
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Geometric mean titers of neutralizing antibody titer
Timeframe: Day 29
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Geometric mean titers of neutralizing antibody titer
Timeframe: Day 29
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Geometric mean titers of neutralizing antibody titer
Timeframe: Day 29
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Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Timeframe: Day 29
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Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Timeframe: Day 29
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Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Timeframe: Day 29
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Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Timeframe: Day 29
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Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
Timeframe: Day 29
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Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
Timeframe: Day 29
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Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
Timeframe: Day 29
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Proportion of participants with at least 4-fold-rise in neutralizing antibody titer