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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
450
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
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
Department of Pediatric, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
RECRUITINGHIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, Thailand
RECRUITINGadverse events
Presence of immediate adverse events within 30 minutes after vaccination
Time frame: 30 minutes after vaccination
solicited injection site or systemic reactions
Presence of solicited injection site or systemic reactions within 7 days after vaccination
Time frame: within 7 days after vaccination
unsolicited adverse events
Presence of unsolicited adverse events within 28 days after vaccination
Time frame: within 28 days after vaccination
serious adverse events (SAEs)
Presence of serious adverse events (SAEs) from day 1 to Day 169
Time frame: 169 days
medically attended adverse events (MAAEs)
Presence of medically attended adverse events (MAAEs) from day 1 to Day 169
Time frame: 169 days
New Onset Chronic Medical Condition (NOCMCs)
Presence of New Onset Chronic Medical Condition (NOCMCs) from day 1 to Day 169
Time frame: 169 days
vital signs
Number of participants with abnormal vital signs
Time frame: 169 days
vital signs
Percent of participants with abnormal vital signs
Time frame: 169 days
clinical changes
Number of participants with abnormal physical examinations finding
Time frame: 169 days
clinical changes
Percent of participants with abnormal physical examinations findingexaminations
Time frame: 169 days
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against Omicron BA.4/BA.5 exposed to COMVIGEN (Bivalent) vaccine
Time frame: Day 29
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against wild-type virus exposed to COMVIGEN (Bivalent) vaccine
Time frame: Day 29
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against Omicron BA.4/BA.5 exposed to BIVALENT vaccine
Time frame: Day 29
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against wild-type virus exposed to BIVALENT vaccine
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against wild-type virus exposed to COMVIGEN (Bivalent) vaccine
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against Omicron BA.4/BA.5 exposed to COMVIGEN (Bivalent) vaccine
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against wild-type virus exposed to BIVALENT vaccine
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against Omicron BA.4/BA.5 exposed to BIVALENT vaccine
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer, psVNT-50 against wild-type virus exposed to COMVIGEN (Bivalent)
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer, psVNT-50 against Omicron BA.4/BA.5 exposed to COMVIGEN (Bivalent)
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer, psVNT-50 against against wild-type virus exposed to BIVALENT vaccine
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer, psVNT-50 against against Omicron BA.4/BA.5 exposed to BIVALENT vaccine
Time frame: Day 29
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer at Day 29 measured by psVNT-50 against other relevant variants of concerns (VOCs)
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against other relevant VOCs from Day 1 to Day 29
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in neutralization antibody titer
Proportion of participants with at least 4-fold-rise in neutralization antibody titer, psVNT-50 against other relevant VOCs from Day 1 to Day 29
Time frame: Day 29
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer at Day 1 measured by live-virus microneutralization assay (micro-VNT-50) against wild-type virus
Time frame: Day 1
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer at Day 29 measured by live-virus microneutralization assay (micro-VNT-50) against wild-type virus
Time frame: Day 29
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer at Day 1 measured by live-virus microneutralization assay (micro-VNT-50) against omicron BA.4/BA.5
Time frame: Day 1
Geometric mean titers of neutralizing antibody titer
Geometric mean titers of neutralizing antibody titer at Day 29 measured by live-virus microneutralization assay (micro-VNT-50) against omicron BA.4/BA.5
Time frame: Day 29
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Geometric mean of the fold-rise post-vaccination of micro-VNT-50
Geometric mean of the fold-rise post-vaccination of micro-VNT-50 against wild-type on Day 29.
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of micro-VNT-50
Geometric mean of the fold-rise post-vaccination of micro-VNT-50 against omicron BA.4/BA.5 virus on Day 29.
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in micro-VNT-50
Proportion of participants with at least 4-fold-rise in micro-VNT-50 against wild-type virus on Day 29.
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in micro-VNT-50
Proportion of participants with at least 4-fold-rise in micro-VNT-50 against omicron BA.4/BA.5 virus on Day 29.
Time frame: Day 29
Geometric mean titers of anti-RBD antibody titer
Geometric mean titers of anti-RBD antibody titer at Day 29 against wild type.
Time frame: Day 29
Geometric mean titers of anti-Spike (S) antibody titer
Geometric mean titers of anti-Spike (S) antibody titer at Day 29 against wild type.
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of anti-RBD antibody
Geometric mean of the fold-rise post-vaccination of anti-RBD antibody against wild-type virus at Day 29.
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of anti-S antibody titer
Geometric mean of the fold-rise post-vaccination of anti-S antibody titer against wild-type virus at Day 29.
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in anti-RBD
Proportion of participants with at least 4-fold-rise in anti-RBD titer against wild-type virus at Day 29
Time frame: Day 29
Proportion of participants with at least 4-fold-rise in anti-RBD
Proportion of participants with at least 4-fold-rise in anti-S antibody titer against wild-type virus at Day 29
Time frame: Day 29
Geometric mean of SARS-CoV2-specific T-cell responses
Geometric mean of SARS-CoV2-specific T-cell responses (spot-forming cells or SFC per 1 million PBMCs) measured by IFN gamma-ELISPOT assay against wild-type peptides at day 1
Time frame: Day 1
Geometric mean of SARS-CoV2-specific T-cell responses
Geometric mean of SARS-CoV2-specific T-cell responses (spot-forming cells or SFC per 1 million PBMCs) measured by IFN gamma-ELISPOT assay against wild-type peptides at day 29
Time frame: Day 29
median number of SARS-CoV2-specific T-cell responses
median number of SARS-CoV2-specific T-cell responses (spot-forming cells or SFC per 1 million PBMCs) measured by IFN gamma-ELISPOT assay against wild-type peptides at day 1
Time frame: Day 1
median number of SARS-CoV2-specific T-cell responses
median number of SARS-CoV2-specific T-cell responses (spot-forming cells or SFC per 1 million PBMCs) measured by IFN gamma -ELISPOT assay against wild-type peptides at day 29
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses
Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses (spot-forming cells (SFC) per 1 million PBMCs) measured by IFN gamma-ELISPOT assay against wild-type peptides exposed to COMVIGEN (Bivalent) vaccine on Day 29
Time frame: Day 29
Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses
Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses (spot-forming cells (SFC) per 1 million PBMCs) measured by IFN gamma-ELISPOT assay against wild-type peptides exposed to BIVALENT vaccine on Day 29
Time frame: Day 29