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Immunogenicity and Safety of Comvigen (Bivalent) Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05930730
Recruitment Status : Recruiting
First Posted : July 5, 2023
Last Update Posted : October 18, 2023
Sponsor:
Collaborators:
Chula Clinical Research Center (Chula CRC), Faculty of Medicine Chulalongkorn University, Bangkok, Thailand
HIV-NAT, Thai Red Cross - AIDS Research Centre
Information provided by (Responsible Party):
Chulalongkorn University

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
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) Biological: BIVALENT Pfizer/BNT vaccine 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : October 9, 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. adverse events [ Time Frame: 30 minutes after vaccination ]
    Presence of immediate adverse events within 30 minutes after vaccination

  2. solicited injection site or systemic reactions [ Time Frame: within 7 days after vaccination ]
    Presence of solicited injection site or systemic reactions within 7 days after vaccination

  3. unsolicited adverse events [ Time Frame: within 28 days after vaccination ]
    Presence of unsolicited adverse events within 28 days after vaccination

  4. serious adverse events (SAEs) [ Time Frame: 169 days ]
    Presence of serious adverse events (SAEs) from day 1 to Day 169

  5. medically attended adverse events (MAAEs) [ Time Frame: 169 days ]
    Presence of medically attended adverse events (MAAEs) from day 1 to Day 169

  6. New Onset Chronic Medical Condition (NOCMCs) [ Time Frame: 169 days ]
    Presence of New Onset Chronic Medical Condition (NOCMCs) from day 1 to Day 169

  7. vital signs [ Time Frame: 169 days ]
    Number of participants with abnormal vital signs

  8. vital signs [ Time Frame: 169 days ]
    Percent of participants with abnormal vital signs

  9. clinical changes [ Time Frame: 169 days ]
    Number of participants with abnormal physical examinations finding

  10. clinical changes [ Time Frame: 169 days ]
    Percent of participants with abnormal physical examinations findingexaminations

  11. Geometric mean titers of neutralizing antibody titer [ Time Frame: 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

  12. Geometric mean titers of neutralizing antibody titer [ Time Frame: 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

  13. Geometric mean titers of neutralizing antibody titer [ Time Frame: 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

  14. Geometric mean titers of neutralizing antibody titer [ Time Frame: Day 29 ]
    Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against wild-type virus exposed to BIVALENT vaccine

  15. Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [ Time Frame: 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

  16. Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [ Time Frame: 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

  17. Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [ Time Frame: Day 29 ]
    Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against wild-type virus exposed to BIVALENT vaccine

  18. Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [ Time Frame: 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

  19. Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [ Time Frame: 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)

  20. Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [ Time Frame: 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)

  21. Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [ Time Frame: 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

  22. Proportion of participants with at least 4-fold-rise in neutralizing antibody titer [ Time Frame: 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 :
  1. Geometric mean titers of neutralizing antibody titer [ Time Frame: Day 29 ]
    Geometric mean titers of neutralizing antibody titer at Day 29 measured by psVNT-50 against other relevant variants of concerns (VOCs)

  2. Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer [ Time Frame: 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

  3. Proportion of participants with at least 4-fold-rise in neutralization antibody titer [ Time Frame: 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

  4. Geometric mean titers of neutralizing antibody titer [ Time Frame: 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

  5. Geometric mean titers of neutralizing antibody titer [ Time Frame: 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

  6. Geometric mean titers of neutralizing antibody titer [ Time Frame: 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

  7. Geometric mean titers of neutralizing antibody titer [ Time Frame: 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

  8. Geometric mean of the fold-rise post-vaccination of micro-VNT-50 [ Time Frame: Day 29 ]
    Geometric mean of the fold-rise post-vaccination of micro-VNT-50 against wild-type on Day 29.

  9. Geometric mean of the fold-rise post-vaccination of micro-VNT-50 [ Time Frame: Day 29 ]
    Geometric mean of the fold-rise post-vaccination of micro-VNT-50 against omicron BA.4/BA.5 virus on Day 29.

  10. Proportion of participants with at least 4-fold-rise in micro-VNT-50 [ Time Frame: Day 29 ]
    Proportion of participants with at least 4-fold-rise in micro-VNT-50 against wild-type virus on Day 29.

  11. Proportion of participants with at least 4-fold-rise in micro-VNT-50 [ Time Frame: 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.

  12. Geometric mean titers of anti-RBD antibody titer [ Time Frame: Day 29 ]
    Geometric mean titers of anti-RBD antibody titer at Day 29 against wild type.

  13. Geometric mean titers of anti-Spike (S) antibody titer [ Time Frame: Day 29 ]
    Geometric mean titers of anti-Spike (S) antibody titer at Day 29 against wild type.

  14. Geometric mean of the fold-rise post-vaccination of anti-RBD antibody [ Time Frame: Day 29 ]
    Geometric mean of the fold-rise post-vaccination of anti-RBD antibody against wild-type virus at Day 29.

  15. Geometric mean of the fold-rise post-vaccination of anti-S antibody titer [ Time Frame: Day 29 ]
    Geometric mean of the fold-rise post-vaccination of anti-S antibody titer against wild-type virus at Day 29.

  16. Proportion of participants with at least 4-fold-rise in anti-RBD [ Time Frame: Day 29 ]
    Proportion of participants with at least 4-fold-rise in anti-RBD titer against wild-type virus at Day 29

  17. Proportion of participants with at least 4-fold-rise in anti-RBD [ Time Frame: Day 29 ]
    Proportion of participants with at least 4-fold-rise in anti-S antibody titer against wild-type virus at Day 29

  18. Geometric mean of SARS-CoV2-specific T-cell responses [ Time Frame: 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

  19. Geometric mean of SARS-CoV2-specific T-cell responses [ Time Frame: 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

  20. median number of SARS-CoV2-specific T-cell responses [ Time Frame: 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

  21. median number of SARS-CoV2-specific T-cell responses [ Time Frame: 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

  22. Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses [ Time Frame: 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

  23. Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930730


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

Locations
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Thailand
Department of Pediatric, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Watsamon Jantarabenjakul, MD    +66 818276255    Watsamon.J@chula.ac.th   
Principal Investigator: Watsamon Jantarabenjakul, MD         
HIV-NAT, Thai Red Cross - AIDS Research Centre Recruiting
Bangkok, Thailand, 10330
Contact: Sivaporn Gatechompol, MD    +66 85-048-5053    sivaporn.k@hivnat.org   
Principal Investigator: Sivaporn Gatechompol, MD         
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
Layout table for investigator information
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
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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT05930730    
Other Study ID Numbers: ChulaVac 006
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: October 18, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chulalongkorn University:
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