Immunogenicity and Safety of Comvigen (Bivalent) Vaccine
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Comvigen (Bivalent, ChulaCov19 BNA159.2)
|
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
|
| Active Comparator: BIVALENT Pfizer/BNT 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
|
Outcome Measures
Primary Outcome Measures
- adverse events [30 minutes after vaccination]
Presence of immediate adverse events within 30 minutes after vaccination
- solicited injection site or systemic reactions [within 7 days after vaccination]
Presence of solicited injection site or systemic reactions within 7 days after vaccination
- unsolicited adverse events [within 28 days after vaccination]
Presence of unsolicited adverse events within 28 days after vaccination
- serious adverse events (SAEs) [169 days]
Presence of serious adverse events (SAEs) from day 1 to Day 169
- medically attended adverse events (MAAEs) [169 days]
Presence of medically attended adverse events (MAAEs) from day 1 to Day 169
- New Onset Chronic Medical Condition (NOCMCs) [169 days]
Presence of New Onset Chronic Medical Condition (NOCMCs) from day 1 to Day 169
- vital signs [169 days]
Number of participants with abnormal vital signs
- vital signs [169 days]
Percent of participants with abnormal vital signs
- clinical changes [169 days]
Number of participants with abnormal physical examinations finding
- clinical changes [169 days]
Percent of participants with abnormal physical examinations findingexaminations
- Geometric mean titers of neutralizing antibody titer [Day 29]
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
- Geometric mean titers of neutralizing antibody titer [Day 29]
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against wild-type virus exposed to COMVIGEN (Bivalent) vaccine
- Geometric mean titers of neutralizing antibody titer [Day 29]
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against Omicron BA.4/BA.5 exposed to BIVALENT vaccine
- Geometric mean titers of neutralizing antibody titer [Day 29]
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against wild-type virus exposed to BIVALENT vaccine
- Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [Day 29]
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against wild-type virus exposed to COMVIGEN (Bivalent) vaccine
- Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [Day 29]
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
- Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [Day 29]
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against wild-type virus exposed to BIVALENT vaccine
- Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [Day 29]
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against Omicron BA.4/BA.5 exposed to BIVALENT vaccine
- Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [Day 29]
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer, psVNT-50 against wild-type virus exposed to COMVIGEN (Bivalent)
- Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [Day 29]
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)
- Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [Day 29]
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer, psVNT-50 against against wild-type virus exposed to BIVALENT vaccine
- Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [Day 29]
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
Secondary Outcome Measures
- Geometric mean titers of neutralizing antibody titer [Day 29]
Geometric mean titers of neutralizing antibody titer at Day 29 measured by psVNT-50 against other relevant variants of concerns (VOCs)
- Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [Day 29]
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against other relevant VOCs from Day 1 to Day 29
- Proportion of participants with at least 4-fold-rise in neutralization antibody titer [Day 29]
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
- Geometric mean titers of neutralizing antibody titer [Day 1]
Geometric mean titers of neutralizing antibody titer at Day 1 measured by live-virus microneutralization assay (micro-VNT-50) against wild-type virus
- Geometric mean titers of neutralizing antibody titer [Day 29]
Geometric mean titers of neutralizing antibody titer at Day 29 measured by live-virus microneutralization assay (micro-VNT-50) against wild-type virus
- Geometric mean titers of neutralizing antibody titer [Day 1]
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
- Geometric mean titers of neutralizing antibody titer [Day 29]
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
- Geometric mean of the fold-rise post-vaccination of micro-VNT-50 [Day 29]
Geometric mean of the fold-rise post-vaccination of micro-VNT-50 against wild-type on Day 29.
- Geometric mean of the fold-rise post-vaccination of micro-VNT-50 [Day 29]
Geometric mean of the fold-rise post-vaccination of micro-VNT-50 against omicron BA.4/BA.5 virus on Day 29.
- Proportion of participants with at least 4-fold-rise in micro-VNT-50 [Day 29]
Proportion of participants with at least 4-fold-rise in micro-VNT-50 against wild-type virus on Day 29.
- Proportion of participants with at least 4-fold-rise in micro-VNT-50 [Day 29]
Proportion of participants with at least 4-fold-rise in micro-VNT-50 against omicron BA.4/BA.5 virus on Day 29.
- Geometric mean titers of anti-RBD antibody titer [Day 29]
Geometric mean titers of anti-RBD antibody titer at Day 29 against wild type.
- Geometric mean titers of anti-Spike (S) antibody titer [Day 29]
Geometric mean titers of anti-Spike (S) antibody titer at Day 29 against wild type.
- Geometric mean of the fold-rise post-vaccination of anti-RBD antibody [Day 29]
Geometric mean of the fold-rise post-vaccination of anti-RBD antibody against wild-type virus at Day 29.
- Geometric mean of the fold-rise post-vaccination of anti-S antibody titer [Day 29]
Geometric mean of the fold-rise post-vaccination of anti-S antibody titer against wild-type virus at Day 29.
- Proportion of participants with at least 4-fold-rise in anti-RBD [Day 29]
Proportion of participants with at least 4-fold-rise in anti-RBD titer against wild-type virus at Day 29
- Proportion of participants with at least 4-fold-rise in anti-RBD [Day 29]
Proportion of participants with at least 4-fold-rise in anti-S antibody titer against wild-type virus at Day 29
- Geometric mean of SARS-CoV2-specific T-cell responses [Day 1]
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
- Geometric mean of SARS-CoV2-specific T-cell responses [Day 29]
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
- median number of SARS-CoV2-specific T-cell responses [Day 1]
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
- median number of SARS-CoV2-specific T-cell responses [Day 29]
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
- Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses [Day 29]
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
- Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses [Day 29]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants who meet all the following criteria at Screening are eligible to participate in the study:
-
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:
-
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
-
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
-
Participants must be in general good health* based on medical history and physical examination, as determined by the PI at Screening.
-
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:
-
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.
-
History of ever had an anaphylaxis reaction to food, medication, or vaccination.
-
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.
-
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pediatric, Faculty of Medicine, Chulalongkorn University | Bangkok | Thailand | 10330 | |
| 2 | HIV-NAT, Thai Red Cross - AIDS Research Centre | Bangkok | Thailand | 10330 |
Sponsors and Collaborators
- Chulalongkorn University
- Chula Clinical Research Center (Chula CRC), Faculty of Medicine Chulalongkorn University, Bangkok, Thailand
- HIV-NAT, Thai Red Cross - AIDS Research Centre
Investigators
- Principal Investigator: Watsamon Jantarabenjakul, MD, Department of Pediatric, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
- Principal Investigator: Sivaporn Gatechompol, MD, HIVNAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChulaVac 006