NCT04800133: COVAC

Covid-19 Vaccination in Adolescents and Children

Status unknown Phase 2 Last updated 16 January 2024

What this trial tests

Phase 2 trial testing Tozinameran in Covid19 in 1,018 participants. Status unknown.

Timeline

8 May 2021

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,018
Start date	8 May 2021
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across China

Drugs / interventions tested

• Tozinameran — full drug profile →
• CoronaVac — full drug profile →
• CoronaVac, intradermal — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

The University of Hong Kong

Who can join

Adults 0 to 100, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults.

Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines in children are non-inferior to those in adults.

Design and subjects A single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection)

Instruments Mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry.

Interventions BNT162b2 and CoronaVac, by intramuscular or intradermal route

Main outcome measures Types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory T cell responses for 3 years.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. mRNA vaccines for infectious diseases: principles, delivery and clinical translation.
   Chaudhary N, Weissman D, Whitehead KA. · · 2021 · cited 1014× · PMID 34433919 · DOI 10.1038/s41573-021-00283-5
2. Advances in COVID-19 mRNA vaccine development.
   Fang E, Liu X, Li M, Zhang Z, et al · · 2022 · cited 368× · PMID 35322018 · DOI 10.1038/s41392-022-00950-y
3. COVID-19 vaccinations: The unknowns, challenges, and hopes.
   Mohamed K, Rzymski P, Islam MS, Makuku R, et al · · 2022 · cited 105× · PMID 34845731 · DOI 10.1002/jmv.27487
4. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.
   Luxi N, Giovanazzi A, Capuano A, Crisafulli S, et al · · 2021 · cited 98× · PMID 34739716 · DOI 10.1007/s40264-021-01131-6
5. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
   Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
6. Immunogenicity and reactogenicity of SARS-CoV-2 vaccines BNT162b2 and CoronaVac in healthy adolescents.
   Rosa Duque JS, Wang X, Leung D, Cheng SMS, et al · · 2022 · cited 58× · PMID 35764637 · DOI 10.1038/s41467-022-31485-z
7. mRNA vaccines: the most recent clinical applications of synthetic mRNA.
   Kwon S, Kwon M, Im S, Lee K, et al · · 2022 · cited 50× · PMID 35426547 · DOI 10.1007/s12272-022-01381-7
8. Delivery Routes for COVID-19 Vaccines.
   Park JH, Lee HK. · · 2021 · cited 48× · PMID 34069359 · DOI 10.3390/vaccines9050524