Third Dose of mRNA Vaccination to Boost COVID-19 Immunity (mBoost Study)

NCT05057182 | Unknown Phase 4 DMC

• 1 other identifier: BJC050
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

300 adults ≥30 years of age who have previously received two doses of an inactivated COVID-19 vaccine at least 3 months earlier will receive a third dose with an mRNA vaccine (BNT162b2, BioNTech). Investigators will monitor reactogenicity and measure the immune response to the third dose.

Conditions

COVID 19 Vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titer of SARS-CoV-2 serum neutralizing antibodies

  The primary outcome measure is the vaccine (humoral) immunogenicity at 28 days after the booster dose of BNT162b2 in individuals who have previously received two doses of any inactivated COVID-19 vaccines, measured as geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing antibodies using plaque reduction neutralization test (PRNT).

  28 days after vaccination

Secondary Outcomes (4)

• Geometric Mean Titer of SARS-CoV-2 serum neutralizing antibodies

  182 and 365 days after vaccination

• The geometric mean fold rise (GMFR) of SARS-CoV-2 serum neutralizing antibody titers from baseline to each post-vaccination timepoint measured.

  Day 28, 49, 182 and 365 after vaccination

• Reactogenicity

  7 days after vaccination or until the last symptom disappears

• Hospitalizations from any cause

  365 days after vaccination

Study Arms (1)

BNT162b2

EXPERIMENTAL

BNT162b2 mRNA vaccine (Cominarty®, BioNTech/Fosun Pharma), one dose (0.3mL after dilution) contains 30 micrograms of COVID-19 mRNA Vaccine embedded in lipid nanoparticles.

Biological: BNT162b2

Interventions

BNT162b2 BIOLOGICAL

BNT162b2 mRNA vaccine (Cominarty®, BioNTech/Fosun Pharma), one dose (0.3mL after dilution) contains 30 micrograms of COVID-19 mRNA Vaccine embedded in lipid nanoparticles.

Also known as: Comirnaty

BNT162b2

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30 years or older at enrolment.
• Have received two doses of any inactivated COVID-19 vaccines (for example Sinovac- CoronaVac, Sinopharm-BIBP) with the most recent dose at least 90 days prior to enrolment.
• Currently resident and planning to remain resident in Hong Kong during the duration of the study, i.e. for 12 months after enrolment.
• Agreement to refrain from blood donation during the course of the study.
• Willing to provide blood samples for all the required time points.
• The individual or their caregiver have a home phone or cellular or mobile phone for communications purpose.
• Capable of providing informed consent.

You may not qualify if:

• A history of laboratory-confirmed or clinically confirmed COVID-19 infection. Have received (at least one dose of) any COVID-19 vaccines other than inactivated vaccines.
• Individuals who report any medical condition, or as determined by a clinician, not suitable to receive mRNA vaccines, including but not limited to allergies to the active substance or other ingredients of the vaccine.
• With diagnosed medical conditions related to their immune system.
• Use of medication that impairs immune system in the last 6 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days).
• Have used immunoglobulins and/or any blood products within 90 days prior to enrolment (administration of the study vaccine).
• Pregnancy, lactation or intention to become pregnant in the coming 3 months.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, 00000, Hong Kong

Location

Related Publications (2)

• Shiu EYC, Cheng SMS, Martin-Sanchez M, Au NYM, Chan KCK, Li JKC, Fung LWC, Luk LLH, Chaothai S, Kwan TC, Ip DKM, Leung GM, Poon LLM, Peiris JSM, Leung NHL, Cowling BJ. Durability for 12 months of antibody response to a booster dose of monovalent BNT162b2 in adults who had initially received 2 doses of inactivated vaccine. Vaccine. 2024 Dec 2;42(26):126317. doi: 10.1016/j.vaccine.2024.126317. Epub 2024 Sep 13.

  PMID: 39276621 DERIVED

• Leung NHL, Cheng SMS, Martin-Sanchez M, Au NYM, Ng YY, Luk LLH, Chan KCK, Li JKC, Leung YWY, Tsang LCH, Chaothai S, Kwan KKH, Ip DKM, Poon LLM, Leung GM, Peiris JSM, Cowling BJ. Immunogenicity of a Third Dose of BNT162b2 to Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 and the Omicron Variant in Adults Who Received 2 Doses of Inactivated Vaccine. Clin Infect Dis. 2023 Feb 8;76(3):e299-e307. doi: 10.1093/cid/ciac458.

  PMID: 35675370 DERIVED

MeSH Terms

Interventions

BNT162 Vaccine

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Benjamin J Cowling, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 27, 2021
• Study Start: October 18, 2021
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)