Randomized Trial of COVID-19 Booster Vaccinations (Cobovax Study)

NCT05057169 | Unknown Phase 4 DMC

• 1 other identifier: BJC053
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized comparison of 3rd dose with inactivated vaccine (CoronaVac) or mRNA vaccine (Comirnaty) in adults who previously received two doses of CoronaVac (Sinovac) or two doses of BNT162b2 (Comirnaty, BioNTech/Fosun Pharma) at least 6 months earlier.

Conditions

COVID-19 Vaccination

Outcome Measures

Primary Outcomes (1)

• Geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing antibodies

  The primary outcome measure is the vaccine (humoral) immunogenicity at 28 days after the booster dose, 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 (5)

• Geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing antibodies

  182 and 365 days after vaccination

• Geometric mean fold rise of SARS-CoV-2 serum neutralizing antibodies

  Day 28, 49, 182 and 365 after vaccination

• T-cell responses to vaccination

  7 and 28 days after vaccination

• Reactogenicity

  7 days after vaccination or until symptoms resolve

• Hospitalizations from any cause

  One year after vaccination

Study Arms (4)

BNT162b2 third dose after two doses of BNT162b2

EXPERIMENTAL

Biological: BNT162b2

CoronaVac third dose after two doses of BNT162b2

EXPERIMENTAL

Biological: CoronaVac

BNT162b2 third dose after two doses of CoronaVac

EXPERIMENTAL

Biological: BNT162b2

CoronaVac third dose after two doses of CoronaVac

EXPERIMENTAL

Biological: CoronaVac

Interventions

BNT162b2 BIOLOGICAL

BNT162b2 is a nucleoside-modified mRNA encoding the trimerized SARS-CoV-2 spike glycoprotein. The vaccine is formulated in lipid nanoparticles that increase the efficiency of delivery of the mRNA into cells after intramuscular injection. BNT162b2 encodes the SARS- CoV-2 full-length spike, modified by two proline mutations to lock it in the prefusion conformation and more closely recreate the intact virus with which the elicited virus- neutralizing antibodies interact. mRNA vaccines use the pathogen's genetic code as the vaccine; hence they exploit the host cells to translate the code and generate the target spike protein. The protein then acts as an intracellular antigen to stimulate the immune response of the vaccinated individual. The mRNA is then degraded within days.

Also known as: Comirnaty

BNT162b2 third dose after two doses of BNT162b2; BNT162b2 third dose after two doses of CoronaVac

CoronaVac BIOLOGICAL

CoronaVac is a Vero cell-based, aluminium hydroxide-adjuvanted, β-propiolactone- inactivated vaccine based on the CZ02 strain. This strain of SARS-CoV-2 was isolated from the bronchoalveolar lavage of a hospitalized patient and is closely related to the 2019-nCoV- BetaCoV Wuhan/WIV04/2019 strain. Each 0.5 ml dose is composed of 3 μg of inactivated SARS-CoV-2 virus. The excipients are aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and water for injection.

CoronaVac third dose after two doses of BNT162b2; CoronaVac third dose after two doses of CoronaVac

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older at enrolment.
• Have received two doses of BNT162b2 OR two doses of CoronaVac, with the most recent dose at least six months 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 prior to enrolment.
• Have previously already received one or two doses of any COVID-19 vaccines except CoronaVac or BNT162b2, for example but not limited to BBIBP-CorV (inactivated vaccine, Sinopharm), AZD1222 (adenovirus vector-based vaccine, Oxford/AstraZeneca), Sputnik V (adenovirus vector-based vaccine, Gamaleya Research Institute) and Ad26.COV2.S (adenovirus vector-based vaccine, Johnson \& Johnson).
• Individuals who report any medical condition, or as determined by a clinician, not suitable to receive mRNA or inactivated COVID-19 vaccines, including but not limited to allergies to the active substance or other ingredients of the vaccine.
• Currently 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).
• Administration of immunoglobulins and/or any blood products within 90 days preceding the planned administration of the study vaccines.
• 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 (1)

• Leung NHL, Cheng SMS, Cohen CA, Martin-Sanchez M, Au NYM, Luk LLH, Tsang LCH, Kwan KKH, Chaothai S, Fung LWC, Cheung AWL, Chan KCK, Li JKC, Ng YY, Kaewpreedee P, Jia JZ, Ip DKM, Poon LLM, Leung GM, Peiris JSM, Valkenburg SA, Cowling BJ. Comparative antibody and cell-mediated immune responses, reactogenicity, and efficacy of homologous and heterologous boosting with CoronaVac and BNT162b2 (Cobovax): an open-label, randomised trial. Lancet Microbe. 2023 Sep;4(9):e670-e682. doi: 10.1016/S2666-5247(23)00216-1. Epub 2023 Aug 4.

  PMID: 37549680 DERIVED

MeSH Terms

Interventions

BNT162 Vaccine; sinovac COVID-19 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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 27, 2021
• Study Start: November 18, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)