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Influenza Vaccine in HIV Infected Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Groome, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:
NCT00883012
First received: April 15, 2009
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
  Purpose

Influenza associated pneumonia causes significant morbidity in young HIV-infected children. Although annual vaccination against influenza is recommended for HIV infected children, it has not been implemented as routine care, due to the lack of data on disease burden and vaccine efficacy.

This study aims at determining the effectiveness of influenza vaccination in HIV infected children in South Africa.


Condition Intervention Phase
Influenza With Pneumonia, Influenza Virus Identified
 Biological: Trivalent sub-unit influenza vaccine
Biological: Saline, 0.5ml
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Efficacy of Influenza Vaccine in HIV Infected Children

Resource links provided by NLM:

MedlinePlus related topics: Flu HIV/AIDS Pneumonia
U.S. FDA Resources

Further study details as provided by University of Witwatersrand, South Africa:

Primary Outcome Measures:
  • Determine the efficacy of a tri-valent influenza sub-unit vaccine, in HIV infected children with a CD4+ percentage >15% against vaccine-strain viral confirmed influenza illness. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Define the immunogenicity of influenza vaccination in a nested cohort of HIV infected children with CD4+ percentage >15% that are naïve to anti-retroviral or on antiretroviral therapy for more than 3 months [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the safety of influenza vaccination in relation to solicited vaccine-related adverse events in the 72 hour period post-vaccination and any other unsolicited adverse event. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Compare the effect of the influenza vaccination on viral control and CD4+ cell count in HIV infected children six months following influenza vaccination. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 412
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine
Two doses of trivalent sub-unit influenza vaccine (2009) to be administered one month apart
 Biological: Trivalent sub-unit influenza vaccine

Composition per 0.5 ml dose:

Active substance:

Split Influenza virus*, inactivated Strains for 2009 Southern hemisphere A/Brisbane/59/2007- like (H1N1) 15 micrograms**, A/Brisbane/10/2007 (H3N2) - like strain (A/Brisbane/10/2007 (IVR-147) 15 micrograms**, B/Florida/4/2006 - like strain (B/Brisbane/3/2007)15 micrograms** Two doses, one month apart
Placebo Comparator: Placebo
Two doses of saline administered one month apart
 Biological: Saline, 0.5ml
Saline IMI, 0.5ml. Two doses one month apart

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected children with CD4% ≥ 15% performed within the previous 3 months in relation to the date of randomization.
  • Age 6 month- 5 years old.
  • Willing and able to maintain weekly contact at least during period of April - August (i.e. presupposed influenza period) either through SMS or telephonic contact.
  • Willing and able to adhere to study protocol re: attendance to clinic for scheduled and illness visits.

Exclusion Criteria:

  • Any contraindication to influenza vaccination, including known allergy to egg.
  • History of chronic lung disease which required maintenance therapy either currently or in the past 6 months.
  • Any contraindication to intramuscular injections.
  • Current known grade 3 or grade 4 laboratory or clinical toxicity as per DAIDS toxicity tables.
  • Any previous history of influenza vaccination.
  • Plan to emigrate from the study area within the next year.
  • On steroid therapy for > 21 days (current or within the past 30 days).
  • In the investigators opinion unable to maintain study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883012

Locations
South Africa
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa, 2013
Sponsors and Collaborators
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Shabir A Madhi, MD, PhD VPD- RMPRU
  More Information

No publications provided

Responsible Party: Michelle Groome, Investigator, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT00883012     History of Changes
Other Study ID Numbers: Paediatric influenza vax
Study First Received: April 15, 2009
Last Updated: April 2, 2012
Health Authority: South Africa: Human Research Ethics Committee
South Africa: National Health Research Ethics Council

Keywords provided by University of Witwatersrand, South Africa:
Viral-confirmed

Additional relevant MeSH terms:
Influenza, Human
Pneumonia
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on May 16, 2013