Safety and immunogenicity of COVID-19 vaccine in healthy children and children with chronic viral hepatitis B (12-17 years old)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100050267

Enrollment

Unknown

Registered

2021-08-25

Start date

2021-09-01

Completion date

Unknown

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B

Interventions

Healthy control group:None

Chronic viral hepatitis B group:None

Eligibility

Sex/Gender

All

Age

12 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy children: 1.Aged 12 to 17 years; 2.Plan to be received COVID-19 vaccination. Inclusion criteria for children with chronic hepatitis B: 1.Aged 12 to 17 years; 2.HBsAg(+)more than 6 months; 3.HBV-DNA (+); 4.Plan to be received COVID-19 vaccination.

Exclusion criteria

Exclusion criteria: Exclusion criteria for healthy children: 1.Combined immune system disease or other chronic underlying diseases; 2.Received immunosuppressive drugs, cytotoxic drugs, corticosteroids, systemic antiviral drugs or gamma globulin within 6 months; 3.Previous laboratory diagnosis of COVID-19, COVID-19 confirmed case contact history, vaccination contraindications; Exclusion criteria for children with chronic HBV infection: 1.Combined hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus or non-hepatotropic virus infection; 2.Liver cirrhosis or hepatocellular carcinoma; 3.Combined drug-induced hepatitis, autoimmune hepatitis, genetic metabolic liver disease or other chronic underlying diseases; 4.Have received liver transplantation in the past; 5.Received immunosuppressive drugs, cytotoxic drugs, corticosteroids, systemic antiviral drugs or gamma globulin within 6 months; 6.Previous laboratory diagnosis of COVID-19, COVID-19 confirmed case contact history, vaccination contraindications.

Design outcomes

Primary

Measure	Time frame
Coronavirus antibodies;Covid specific memory B cells;Liver function;	—

Countries

China

Contacts

Public ContactXu Hongmei

Children‘s Hospital of Chongqing Medical University

xuhongm0095@sina.com+86 13883589586

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026