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A clinical trial to study the optimal dose of Hepatitis B vaccine in Human Immunodeficiency Virus (HIV) infected children

Study of immunogenicity of Hepatitis B vaccine in Human Immunodeficiency Virus (HIV) infected children: a randomized controlled trial - HBV-HIV AIDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/01/006495
Enrollment
60
Registered
2016-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Hepatitis B vaccination in HIV infected children

Interventions

Intervention1: Double dose of Hepatitis B vaccine: Dose: 1.0 ml or 20 mcg Schedule: 0, 1 and at 6 months Intramuscular Control Intervention1: Standard dose of Hepatitis B vaccine: Dose: 0.5 ml or 10 m

Sponsors

Shahid Akhtar Siddiqui
Lead Sponsor
Dr Prof D K Singh MD
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: HIV infected children (diagnosed as per NACO guidelines) HBsAg nonreactive

Exclusion criteria

Exclusion criteria: Received >=1 dose of Hepatitis B vaccine in past Critically ill/moribund patients Consent not given

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of standard dose vs. double dose of Hepatitis B vaccination in HIV infected ChildrenTimepoint: 12 weeks after complete vaccination—

Secondary

MeasureTime frame
To correlate seroprotection after Hepatitis B vaccination in HIV infected children with age, sex of patients, CD4 counts and HAART at vaccinationTimepoint: 12 weeks after complete vaccination—

Countries

India

Contacts

Public ContactShahid Akhtar Siddiqui

Moti Lal Nehru Medical College, Allahabad

drsinghdk2@yahoo.com9559441844

Outcome results

None listed

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