Covid-19 Vaccination in Adolescents and Children

NCT04800133 | Unknown Phase 2

• 1 other identifier: COVAC01
• Study Type: interventional
• Target: 1,018
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• Adverse reactions

  Percentage of occurrence, types, duration and severity of adverse reactions occurring within 7 days

  7 days post-doses 1, 2 and 3 (and 4)

• Binding antibody response

  Geometric mean levels of SARS-CoV2 S and S-RBD-specific binding antibody and related markers as determined by Enzyme-linked Immunosorbent Assay

  1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)

• Neutralizing antibody response

  Geometric mean levels and geometric mean fold rise of SARS-CoV2 neutralizing antibodies as determined by plaque reduction neutralization assay and surrogate assays

  1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)

• T cell response

  Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 S (and N and M) protein

  1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)

Secondary Outcomes (3)

• Vaccine breakthrough

  Throughout the study period, until 36 months post-dose 3/4

• Adverse events

  Throughout the study period, until 36 months post-dose 3/4

• Binding anti-N antibody response

  1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)

Study Arms (4)

BNT162b2 (adult/adolescent)

EXPERIMENTAL

BNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (or intradermal for immunocompromised patients; or by graded challenge with history of non-severe allergy to PEG-containing drugs) 30ug/0.3ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19

Biological: Tozinameran

CoronaVac (intramuscular)

EXPERIMENTAL

CoronaVac by SinoVac Intramuscular injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19

Biological: CoronaVac

CoronaVac (intradermal)

EXPERIMENTAL

CoronaVac by SinoVac Intradermal injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19

Biological: CoronaVac, intradermal

BNT162b2 (paediatric)

EXPERIMENTAL

BNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (for immunocompromised patients only) 10ug/0.1ml per dose 4 doses for immunocompromised patients

Biological: Tozinameran

Interventions

Tozinameran BIOLOGICAL

mRNA vaccine developed by BioNTech against COVID-19

Also known as: BNT162b2

BNT162b2 (adult/adolescent); BNT162b2 (paediatric)

CoronaVac BIOLOGICAL

Inactivated virus vaccine developed by SinoVac against COVID-19, intramuscular

CoronaVac (intramuscular)

CoronaVac, intradermal BIOLOGICAL

Inactivated virus vaccine developed by SinoVac against COVID-19, intradermal

CoronaVac (intradermal)

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent from the parents or a legally acceptable representative for an underage participant
• biological parents of students enrolled in the trial or unrelated healthy adults
• ability to adhere to the follow-up schedules
• willingness to report reactogenicity daily for 7 days post dose 1, 2 and 3 (and 4) proactively
• willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable)
• good past health, including pre-existing clinically stable disease, such as paediatric or immune disorders
• prior COVID-19 (for COVID-19 survivor subgroup)

You may not qualify if:

• \. reported pregnancy or breastfeeding

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

Related Publications (1)

• Rosa Duque JS, Wang X, Leung D, Cheng SMS, Cohen CA, Mu X, Hachim A, Zhang Y, Chan SM, Chaothai S, Kwan KKH, Chan KCK, Li JKC, Luk LLH, Tsang LCH, Wong WHS, Cheang CH, Hung TK, Lam JHY, Chua GT, Tso WWY, Ip P, Mori M, Kavian N, Leung WH, Valkenburg S, Peiris M, Tu W, Lau YL. Immunogenicity and reactogenicity of SARS-CoV-2 vaccines BNT162b2 and CoronaVac in healthy adolescents. Nat Commun. 2022 Jun 28;13(1):3700. doi: 10.1038/s41467-022-31485-z.

  PMID: 35764637 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; sinovac COVID-19 vaccine; Injections, Intradermal

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)

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; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yu Lung Lau, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 16, 2021
• Study Start: May 8, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 16, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)