Efficacy of Influenza Vaccine in HIV Infected Adults - Full Text View

Sponsored by:	University of Witwatersrand, South Africa
Information provided by:	University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:	NCT00757900

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 IV

MedlinePlus related topics: AIDS Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Influenza Vaccine in HIV Infected Adults

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
1: Active Comparator 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.
2: No Intervention

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

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

Locations

South Africa, Gauteng
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

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

Keywords provided by University of Witwatersrand, South Africa:

influenza, human

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Influenza, Human
Orthomyxoviridae Infections
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Orthomyxoviridae Infections
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Sexually Transmitted Diseases
Influenza, Human
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009