Efficacy of Influenza Vaccine in HIV Infected Adults

This study has been completed.
Sponsor:
Information provided by:
University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:
NCT00757900
First received: September 19, 2008
Last updated: October 8, 2008
Last verified: September 2008
  Purpose

Vaccination of HIV infected individuals with the sub-unit influenza vaccine is safe; however it induces only moderate immune responses and likewise is modest in its protection compared to HIV uninfected individuals. Based upon the available data, the South African Thoracic Society has provisionally recommended the use of influenza vaccine in HIV infected individuals with CD4+ counts of > 200/ml and viral loads of < 100 000 copies/ml.(Green R et al. In press, SAMJ). This proposal is however based upon recommendations made elsewhere with minimal level of evidence regarding its benefit, and no evidence from countries with a high prevalence of HIV. Very few HIV infected adults, however, actually do receive influenza vaccine in South Africa, partly because of the absence of compelling data regarding the burden of disease in Africa as well as lack of vaccine effectiveness and issues related to physician awareness and access to influenza vaccine in the public immunization program.

The conflicting evidence, between developed countries and Africa, regarding the effectiveness of PPV highlight the drawbacks of extrapolating vaccine effectiveness data from developed countries to developing countries. Differences in the epidemiology of HIV between developed countries in which the prevalence of HIV is low to that of high-burden sub-Saharan African countries include:

  • differences in the mode of transmission of HIV and demographics of the infected population.
  • differences in standard of care, including access to prophylaxis against opportunistic infections and use of highly active anti-retroviral therapy (HAART)
  • differences in risk for disease from opportunistic pathogens, e.g. Mycobacterium tuberculosis, etc.

These differences may all contribute to differences in the risk and severity of influenza illness among HIV infected adults from these communities as well as possibly responsiveness and effectiveness of vaccination.

The investigators are conducting a double-blinded, placebo controlled randomized trial at the HIV treatment clinic at Helen Joseph Hospital to determine the effectiveness of influenza vaccination in HIV infected adults in South Africa. The significance of the findings from this study will help quantify the burden of influenza illness in African HIV infected adults, as well as assist in making more informed recommendations for the use of influenza vaccine in HIV infected adults and in guiding national policy for preparing for a future influenza virus-pandemic.


Condition Intervention Phase
HIV
Influenza
Vaccination
HIV Infections
Biological: MUTAGRIP
Phase 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • First episode of culture-confirmed influenza illness caused by community-acquired subtypes antigenically similar to the strains included in the influenza vaccine which occurred at least 14 days following study-vaccine administration. [ Time Frame: 1st May 2008 and ending 30th September 2008. ] [ Designated as safety issue: No ]
  • The antibody response for each virus strain. Seroconversion will be defined as a ≥4-fold increase in antibody titer relative to that season's baseline titer for each strain. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of solicited reactogenic events occurring within 72 hours of vaccination. [ Designated as safety issue: Yes ]
  • Changes in CD4+ cell count and HIV viral load. [ Designated as safety issue: Yes ]
  • Hospitalization or death for any physician-diagnosed respiratory illness in which influenza virus antigenically similar to vaccine strain is identified. [ Designated as safety issue: Yes ]

Enrollment: 507
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
To receive a sub-unit influenza vaccine
Biological: MUTAGRIP
Purified polyvalent vaccine for active immunisation against influenza.The vaccine is an inactivated split virus mixture of different group A and B viral strains. One 0.5 ml dose, intramuscular route.
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected adult on stable first line HAART for more than 3 months or anti-retroviral naïve HIV infected adult with a CD4+ cell count >100 cells/ml performed within the previous 3 months in relation to the date of randomization.
  • Age 18-55 years.
  • 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.
  • Currently on treatment for tuberculosis or received treatment for tuberculosis in the past 6 months.
  • 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 or pneumococcal vaccination.
  • Any plan to vaccinate against influenza or pneumococcal disease during the course of the study.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757900

Locations
South Africa
Helen Joseph Hospital
Johannesburg, Gauteng, South Africa
Sponsors and Collaborators
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Shabir A Madhi, MBBCH PhD University of the Witwatersrand
Principal Investigator: Ian Sanne, MBBCh Clinical HIV Research Unit
  More Information

No publications provided by University of Witwatersrand, South Africa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shabir A Madhi, DST/NRF Vaccine Preventable Diseases (University of the Witwatersrand)
ClinicalTrials.gov Identifier: NCT00757900     History of Changes
Other Study ID Numbers: CHRU02 (Ethics ref no 080212)
Study First Received: September 19, 2008
Last Updated: October 8, 2008
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by University of Witwatersrand, South Africa:
influenza, human

Additional relevant MeSH terms:
Influenza, Human
HIV Infections
Acquired Immunodeficiency Syndrome
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 22, 2014