Assessing the safety and effectiveness of the Comvigen vaccine compared to the Pfizer/BNT vaccine
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
This study is testing whether the Comvigen vaccine is safe and effective as a booster compared to the Pfizer/BNT vaccine for healthy adults who have already had a COVID-19 booster.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Bangkok and 1 other locations) |
| Trial ID | NCT05930730 on ClinicalTrials.gov |
What this trial studies
This phase II, multicenter, randomized open-label trial aims to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine compared to the BIVALENT Pfizer/BNT vaccine. A total of 450 healthy males and non-pregnant females aged 18-64 years will be recruited from multiple sites in Thailand. Participants must have received a previous booster dose of any approved mRNA COVID-19 vaccine at least three months prior to enrollment. The study will utilize a 2:1 randomization design to compare the two vaccines' effects as booster doses.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and non-pregnant females aged 18-64 who have received a prior mRNA COVID-19 vaccine booster at least three months ago.
Not a fit: Patients who have not received a prior mRNA COVID-19 vaccine or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and effectiveness of the Comvigen vaccine as a viable booster option for COVID-19.
How similar studies have performed: Other studies have shown success with similar vaccine comparisons, but the specific Comvigen vaccine's efficacy is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bangkok and 1 other locations
- Department of Pediatric, Faculty of Medicine, Chulalongkorn University — Bangkok, Thailand (Recruiting)
- HIV-NAT, Thai Red Cross - AIDS Research Centre — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Watsamon Jantarabenjakul, MD — Department of Pediatric, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
- Study coordinator: Watsamon Jantarabenjakul, MD
- Email: watsamon.j@chula.ac.th
- Phone: +66 818276255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.