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CTRI Number  CTRI/2016/01/006495 [Registered on: 07/01/2016] Trial Registered Retrospectively
Last Modified On: 04/01/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Vaccine
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the optimal dose of Hepatitis B vaccine in Human Immunodeficiency Virus (HIV) infected children 
Scientific Title of Study   Study of immunogenicity of Hepatitis B vaccine in Human Immunodeficiency Virus (HIV) infected children: a randomized controlled trial 
Trial Acronym  HBV-HIV AIDS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shahid Akhtar Siddiqui 
Designation  Junior Resident 3 
Affiliation  Moti Lal Nehru Medical College, Allahabad 
Address  Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru Medical College, Church Lane, Allahabad.

Allahabad
UTTAR PRADESH
211002
India 
Phone  9559441844  
Fax    
Email  sha.akht@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prof D K Singh MD and Shahid Akhtar Siddiqui  
Designation  Head, Deptt of Pediatrics and Junior Resident 3 
Affiliation  Moti Lal Nehru Medical College, Allahabad 
Address  Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru Medical College, Church Lane, Allahabad.

Allahabad
UTTAR PRADESH
211002
India 
Phone  9559441844  
Fax    
Email  drsinghdk2@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Shahid Akhtar Siddiqui 
Designation  Junior Resident 3 
Affiliation  Moti Lal Nehru Medical College, Allahabad 
Address  Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru Medical College, Church Lane, Allahabad.

Allahabad
UTTAR PRADESH
211002
India 
Phone  9559441844  
Fax    
Email  sha.akht@gmail.com  
 
Source of Monetary or Material Support  
NONE 
 
Primary Sponsor  
Name  Shahid Akhtar Siddiqui 
Address  Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru Medical College, Church Lane, Allahabad. 
Type of Sponsor  Other [Shahid Akhtar Siddiqui] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Prof D K Singh MD  Sarojini Naidu Children Hospital, Deptt of Pediatrics, Moti Lal Nehru Medical College, Church Lane, Allahabad. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shahid Akhtar Siddiqui  Swaroop Rani Nehru Hospital and Sarojini Naidu Childen Hospital  Room No 2/40, ART Centre (Swroop Rani Nehru Hospital), Deptt of Pediatrics, Moti Lal Nehru Medical College, Church Lane, Allahabad.
Allahabad
UTTAR PRADESH 		 9559441844

sha.akht@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Moti Lal Nehru Medical College, Allahabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hepatitis B vaccination in HIV infected children,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Double dose of Hepatitis B vaccine  Dose: 1.0 ml or 20 mcg Schedule: 0, 1 and at 6 months Intramuscular 
Comparator Agent  Standard dose of Hepatitis B vaccine  Dose: 0.5 ml or 10 mcg Schedule: 0, 1 and at 6 months Intramuscular 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  HIV infected children (diagnosed as per NACO guidelines)
HBsAg nonreactive  
 
ExclusionCriteria 
Details  Received ≥1 dose of Hepatitis B vaccine in past
Critically ill/moribund patients
Consent not given
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of standard dose vs. double dose of Hepatitis B vaccination in HIV infected Children  12 weeks after complete vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate seroprotection after Hepatitis B vaccination in HIV infected children with age, sex of patients, CD4 counts and HAART at vaccination  12 weeks after complete vaccination 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomized, single blind, parallel group, single centre trial comparing the efficacy and safety of standard dose vs. double dose of Hepatitis B vaccine given with a schedule of 0,1 and 6 months in 60 human immunodeficiency virus (HIV) infected children conducted at Antiretroviral Therapy (ART) centre and deptt of pediatrics at Moti Lal Nehru Medical College, Allahabad, Uttar Pradesh, India. The primary outcome measure is to compare the efficacy of standard dose vs. double dose of Hepatitis B vaccination in HIV infected children. The secondary outcome measures are to correlate seroprotection after Hepatitis B vaccination in HIV infected children with age, sex of patients, CD4 counts and HAART at vaccination. 
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