Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults

NCT05605470 | Completed Phase 2 DMC

• 1 other identifier: TVL-ChulaVac005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

This clinical trial is designed to assess the safety, tolerability and immunogenicity of a single dose of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 vaccines as a booster dose, given at least 3 months after receipt of a previous booster dose of any authorized/approved COVID-19 vaccine.

Conditions

COVID-19, SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (7)

• Part A and Part B: Numbers and percentage of participants with immediate adverse events

  Numbers and percentage of participants who have had immediate post-immunization reactions within 30 minutes post- vaccination

  within 30 minutes post vaccination

• Part A and Part B: Numbers and percentage of participants with solicited local or systemic reactions

  Numbers and percentage of participants who have had solicited local or systemic reactions within 7-day post-vaccination

  within 7-day post-vaccination

• Part A and Part B: Numbers and percentage of participants with adverse events (AEs)

  Numbers and percentage of participants who have had adverse events (AEs) within 28-day post-vaccination

  28-day post-vaccination

• Part A and Part B:Numbers and percentage of participants with serious adverse events (SAEs), medically attended adverse events (MAAEs) and New Onset Chronic Medical Condition (NOCMCs)

  Numbers and percentage of participants who have had SAEs, MAAEs, NOCMCs within 6 months post-vaccination

  6 months post-vaccination

• Geometric mean titres (GMTs) of SARS-CoV-2-specific serum neutralising antibody as measured by psVNT-50 against wild type and/or Omicron BA.4/BA.5

  GMTs and their 95%CI of SARS-CoV-2-specific serum neutralising antibody as measured by psVNT-50 against wild type (Part A and B) and/or Omicron BA.4/BA.5 (Part B) will be reported at baseline (before vaccination) and 28 days post-vaccination.

  Baseline, 28-day post-vaccination

• Geometric mean fold rises (GMFRs) of SARS-CoV-2-specific serum neutralising titres as measured by psVNT-50 against wild type and/or Omicron BA.4/BA.5

  GMFRs and their 95%CI of SARS-CoV-2-specific serum neutralising titres as measured by psVNT-50 against wild type (Part A and B) and/or Omicron BA.4/BA.5 (Part B) will be reported from baseline to 28 days post-vaccination.

  Baseline, 28-day post-vaccination

• Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by psVNT-50 against wild type and/or Omicron BA.4/BA.5

  Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by psVNT-50 against wild type (Part A and B) and/or Omicron BA.4/BA.5 (Part B) will be reported at 28 days post-vaccination.

  28 days post-vaccination.

Secondary Outcomes (14)

• GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by psVNT-50 against Omicron BA.4/BA.5 and/or other clinically relevant variants of concerns (VOCs)

  Baseline, 28-day post-vaccination

• GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by psVNT-50 against Omicron BA.4/BA.5 and/or other clinically relevant VOCs

  Baseline, 28-day post-vaccination

• Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by psVNT-50 against Omicron BA.4/BA.5 and/or other clinically relevant VOCs

  28-day post-vaccination

• GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by MicroVNT-50 against wild type

  Baseline, 28-day post-vaccination

• GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by MicroVNT-50 against wild type

  Baseline to 28 days post-vaccination.

Study Arms (3)

Part A: Arm 1 (1 dose of ChulaCov19 BNA159 vaccine)

EXPERIMENTAL

Participants will be randomized to receive ChulaCov19 BNA159 vaccine (50 mcg) given by IM (n=55)

Biological: ChulaCov19 BNA159 vaccine (50 mcg)

Part A: Arm 2 (one dose of active comparator vaccine)

ACTIVE COMPARATOR

Participants will be randomized to receive Comirnaty® (Pfizer/BNT) vaccine (30 mcg) given by IM (n=25)

Biological: Pfizer/BNT vaccine (30 mcg)

Part B: Arm 3 (one dose of COMVIGEN vaccine)

EXPERIMENTAL

Participants will be randomized to receive ChulaCov19 BNA159.2 (COMVIGEN) vaccine (50 mcg) given by IM (n=70)

Biological: COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)

Interventions

ChulaCov19 BNA159 vaccine (50 mcg) BIOLOGICAL

Single dose of ChulaCov19 BNA159 vaccine 0.5 ml will be given by IM at Day 1

Part A: Arm 1 (1 dose of ChulaCov19 BNA159 vaccine)

Pfizer/BNT vaccine (30 mcg) BIOLOGICAL

Single dose of Pfizer/BNT vaccine 0.3 ml will be given by IM at Day 1

Part A: Arm 2 (one dose of active comparator vaccine)

COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg) BIOLOGICAL

Single dose of COMVIGEN vaccine 0.5 ml will be given by IM at Day 1

Part B: Arm 3 (one dose of COMVIGEN vaccine)

Eligibility Criteria

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

You may qualify if:

• Must be a male or female aged 18 - 64 (inclusive) at the time of enrolment
• Must have completed a primary course of 2 doses of any approved COVID-19 vaccine and 3 months or more have passed since receipt of last booster dose (1 or 2 prior booster doses for a total of 3 or 4 doses) as described in Table 1
• 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 childbearing potential, the participants and their partner must use an acceptable, highly effective, dual contraceptive method\* from Screening and for a period of at least 90 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: she agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 90 days 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. If the participant is \< 1 year post-menopausal, an FSH test may be conducted to establish childbearing potential.
• 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:

• 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) 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

• Technovalia, Pty Ltd: lead
• Chulalongkorn University: collaborator
• BioNet-Asia: collaborator
• Southern Star Research: collaborator

Study Sites (5)

Paratus research Canberra Clinic

Bruce, Australian Capital Territory, 2617, Australia

Location

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

Location

The Children's Hospital at Westmead Sydney

Westmead, New South Wales, 2145, Australia

Location

Paratus Clinical Research- Brisbane Clinic

Albion, Queensland, 4010, Australia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Kiat Ruxrunghtam, MD

  Chulalongkorn University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 4, 2022
• Study Start: January 19, 2023
• Primary Completion: July 15, 2024
• Study Completion: November 18, 2024
• Last Updated: April 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)