Immunogenicity and Safety of Comvigen (Bivalent) Vaccine

NCT05930730 | Unknown Phase 2 DMC

• 1 other identifier: ChulaVac 006
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (22)

• adverse events

  Presence of immediate adverse events within 30 minutes after vaccination

  30 minutes after vaccination

• solicited injection site or systemic reactions

  Presence of solicited injection site or systemic reactions within 7 days after vaccination

  within 7 days after vaccination

• unsolicited adverse events

  Presence of unsolicited adverse events within 28 days after vaccination

  within 28 days after vaccination

• serious adverse events (SAEs)

  Presence of serious adverse events (SAEs) from day 1 to Day 169

  169 days

• medically attended adverse events (MAAEs)

  Presence of medically attended adverse events (MAAEs) from day 1 to Day 169

  169 days

• New Onset Chronic Medical Condition (NOCMCs)

  Presence of New Onset Chronic Medical Condition (NOCMCs) from day 1 to Day 169

  169 days

• vital signs

  Number of participants with abnormal vital signs

  169 days

• vital signs

  Percent of participants with abnormal vital signs

  169 days

• clinical changes

  Number of participants with abnormal physical examinations finding

  169 days

• clinical changes

  Percent of participants with abnormal physical examinations findingexaminations

  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

  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

  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

  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

  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

  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

  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

  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

  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)

  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)

  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

  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

  Day 29

Secondary Outcomes (23)

• Geometric mean titers of neutralizing antibody titer

  Day 29

• Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer

  Day 29

• Proportion of participants with at least 4-fold-rise in neutralization antibody titer

  Day 29

• Geometric mean titers of neutralizing antibody titer

  Day 1

• Geometric mean titers of neutralizing antibody titer

  Day 29

Study Arms (2)

Comvigen (Bivalent, ChulaCov19 BNA159.2)

EXPERIMENTAL

Biological: Comvigen (Bivalent, ChulaCov19 BNA159.2)

BIVALENT Pfizer/BNT vaccine

ACTIVE COMPARATOR

Biological: BIVALENT Pfizer/BNT vaccine

Interventions

Comvigen (Bivalent, ChulaCov19 BNA159.2) BIOLOGICAL

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

Comvigen (Bivalent, ChulaCov19 BNA159.2)

BIVALENT Pfizer/BNT vaccine BIOLOGICAL

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

BIVALENT Pfizer/BNT vaccine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead
• Chula Clinical Research Center (Chula CRC), Faculty of Medicine Chulalongkorn University, Bangkok, Thailand: collaborator
• HIV-NAT, Thai Red Cross - AIDS Research Centre: collaborator

Study Sites (2)

Department of Pediatric, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

HIV-NAT, Thai Red Cross - AIDS Research Centre

Bangkok, 10330, Thailand

RECRUITING

Related Publications (1)

• Jantarabenjakul W, Nantanee R, Puthanakit T, Gatechompol S, Avihingsanon A, Punrin S, Tantawichien T, Nitayaphan S, Thitithanyanont A, Buranapraditkun S, Jongkaewwattana A, Ketloy C, Prompetchara E, Lawpoolsri S, Wijagkanalan W, Alameh MG, Hong L, Samija M, Weissman D, Ruxrungtham K; ChulaVac006 Study Team. Immunogenicity and safety of 'Comvigen', a bivalent SARS-CoV-2 vaccine, in comparison to Comirnaty bivalent vaccine in Thailand: a phase 2, non-inferiority randomised trial. Lancet Reg Health Southeast Asia. 2025 Aug 15;40:100650. doi: 10.1016/j.lansea.2025.100650. eCollection 2025 Sep.

  PMID: 40895389 DERIVED

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Watsamon Jantarabenjakul, MD

CONTACT

+66 818276255; watsamon.j@chula.ac.th

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 5, 2023
• Study Start: October 9, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

TH (2)