We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA ISSUES GUIDANCE FOR PEDIATRIC HIV VACCINE STUDIES

FDA ISSUES GUIDANCE FOR PEDIATRIC HIV VACCINE STUDIES

May 15, 2006

The FDA has issued a guidance for organizers of studies to develop a preventive pediatric HIV vaccine that could be licensed for use on children. The document includes recommendations for investigators and institutional review boards (IRBs) that are involved with these pediatric studies.

The guidance directs sponsors and investigators to examine the other regulations, statutes and guidances that outline the special considerations for conducting clinical studies on children.

More specifically, the document addresses issues about developing a preventive HIV vaccine for use in healthy U.S. pediatric populations. "Because the prevalence of HIV infection in these populations is low, the risks presented by studies on these pediatric subjects would need to be commensurately low," the guidance states. It will be hard, it says, for researchers to study vertical transmission of HIV and transmission via breastfeeding in newborn babies and infants, since HIV doesn't often spread in these ways in the United States although it does in other countries. Studies may have to be conducted in other countries, which "should be conducted according to good clinical practice."

The guidance says that a safe and effective HIV vaccine in the U.S. would likely be developed and used to prevent HIV transmission by sexual or blood exposure - for which adolescents are the pediatric age group most at risk and most likely to be the subject of any clinical studies.

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • AngioDynamics Gets Expanded Clearance for Auryon Atherectomy System

  • Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate

  • FDA Issues Update on Becton Dickinson’s Recall

  • FDA Grants Accelerated Approval to Enhertu for HER2-Mutant NSCLC

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing