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ISRCTN
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ISRCTN54494731
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ClinicalTrials.gov identifier
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NCT00371878
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Public title
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Pneumococcal conjugate vaccine trial: PNEUVAC TRIAL
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Scientific title
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Investigation of the humoral immune response to pneumococcal polysaccharides and the role of a conjugate pneumococcal vaccine in secondary prevention of invasive pneumococcal disease in human immunodeficiency virus (HIV)-infected Africans
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Acronym
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PNEUVAC
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Serial number at source
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061230
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Study hypothesis
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Efficacy of a seven-valent pneumococcal conjugate vaccine to prevent recurrent episodes of vaccine serotype invasive pneumococcal disease (IPD) in a primarily human immunodeficiency virus (HIV)-infected adult population.
Please note that as of 14/02/2007 the anticipated end date of this trial has been extended to 31/10/2007. The initial anticipated end date was 31/03/2006.
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Lay summary
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Ethics approval
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1. University of Malawi, College of Medicine Research and Ethics Committee gave approval on the 12th January 2001 (ref: P.99/00/101)
2. Liverpool School of Tropical Medicine Research and Ethics Committee gave approval on the 20th December 2000 (ref: 00.60)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Malawi
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Disease/condition/study domain
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Invasive pneumococcal disease in HIV-infected Africans.
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Participants - inclusion criteria
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1. Confirmed case of IPD discharged from hospital
2. Resident of Blantyre and its immediately neighbouring districts
3. Willing to attend Queen Elizabeth Central Hospital (QECH) when sick
4. Aged over 15 years, either sex
5. Willing to have HIV testing performed on stored serum
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Participants - exclusion criteria
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1. Pregnancy
2. Previous pneumococcal vaccine
3. Active acute systemic illness - following recovery participant may be recruited
4. Past hypersensitivity reaction to vaccination
5. Bed-ridden or life expectancy judged to be less than three months
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Anticipated start date
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28/02/2003
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Anticipated end date
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31/10/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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320
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Interventions
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Participants are recruited from individuals who are convalescing from a known invasive pneumococcal disease event. They are randomised into two arms in a 1:1 ratio to receive two doses of vaccine one month apart. In the active arm the vaccine is Prevenar® (Wyeth pharmaceuticals seven-valent pneumococcal conjugate vaccine with a CRM carrier protein). In the control arm participants receive a matching saline placebo.
Vaccine is given as a 0.5 ml injection into the non-dominant deltoid muscle. Participants are followed up at three-monthly intervals and encouraged to attend the hospital when sick for evaluation of their illness. Individuals will be followed as long as they remain alive and within the study area until the follow-up censure date which was set at 31st October 2007. Total follow up is 798 person years with a median follow up time of 1.24 years [Range 2 days to 4.66 years].
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Primary outcome measure(s)
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Vaccine serotype invasive pneumococcal disease.
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Secondary outcome measure(s)
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1. All invasive pneumococcal disease death
2. All cause pneumonia
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 061230)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20200385
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Contact name
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Mr
Neil
French
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Address
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Malawi-Liverpool-Wellcome Trust Labs
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City/town
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Blantyre
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Zip/Postcode
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Box 3009
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Country
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Malawi
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Tel
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+265 9 207898
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Fax
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+265 1 675774
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Email
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neil.french@lshtm.ac.uk
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Sponsor
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University of Liverpool (UK)
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Address
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University of Liverpool (UK)
Senate House
Research Support
Abercromby Square
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City/town
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Liverpool
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Zip/Postcode
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L69 3BX
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Country
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United Kingdom
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Sponsor website:
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http://www.liv.ac.uk/
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Date applied
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22/07/2005
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Last edited
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15/03/2010
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Date ISRCTN assigned
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22/07/2005
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