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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Thailand
Department of Pediatric, Faculty of Medicine, Chulalongkorn University
RECRUITING
Bangkok
HIV-NAT, Thai Red Cross - AIDS Research Centre
RECRUITING
Bangkok
Contact Information
Primary
Watsamon Jantarabenjakul, MD
watsamon.j@chula.ac.th
+66 818276255
Time Frame
Start Date: 2023-10-09
Estimated Completion Date: 2024-02
Participants
Target number of participants: 450
Treatments
Experimental: Comvigen (Bivalent, ChulaCov19 BNA159.2)
Active_comparator: BIVALENT Pfizer/BNT vaccine
Related Therapeutic Areas
Sponsors
Collaborators: HIV-NAT, Thai Red Cross - AIDS Research Centre, Chula Clinical Research Center (Chula CRC), Faculty of Medicine Chulalongkorn University, Bangkok, Thailand
Leads: Chulalongkorn University

This content was sourced from clinicaltrials.gov