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Community randomised controlled trial to assess the impact of vaccination with a pneumococcal conjugate vaccine on nasopharyngeal carriage of pneumococci in the Gambia
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| ISRCTN |
ISRCTN51695599
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| ClinicalTrials.gov identifier |
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| Public title |
Community randomised controlled trial to assess the impact of vaccination with a pneumococcal conjugate vaccine on nasopharyngeal carriage of pneumococci in the Gambia
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| Scientific title |
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| Acronym |
Vilage study
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| Serial number at source |
SCC 1032
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| Study hypothesis |
It is likely that Prevenar®, a seven-valent pneumococcal conjugate vaccine, will soon be introduced into childhood immunisation programme in The Gambia. Pneumococci of serotypes 1 or 5 are important causes of invasive disease in The Gambia but are found infrequently in the nasopharynx and are not contained in Prevenar®. Could introduction of Prevenar® enhance their ability to establish themselves in the nasopharynx and subsequently to cause invasive disease?
In order to study the effects of maximum immune pressure of the kind that will be seen only several years after routine use of the vaccine, we propose to study the effects of vaccination of a whole community as well as that of vaccinating just the infant population.
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| Lay summary |
Not provided at time of registration
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Ethics approval
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The Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethics Committee, approved on 27/02/2006, reference number: SCC 1032
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| Study design |
Community randomised controlled pneumococcal vaccination trial
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| Countries of recruitment |
Gambia |
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| Disease/condition/study domain |
Pneumococcal infection or colonisation
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| Participants - inclusion criteria |
Resident of one of 21 Gambian villages
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| Participants - exclusion criteria |
1. Failure of the family/subject to give consent
2. Non-residence in the villages
3. Declared intent of the family/subject to leave the study area permanently within the following three months
4. Previous exposure to a conjugate pneumococcal vaccine
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| Anticipated start date |
01/07/2006
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| Anticipated end date |
01/07/2009
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| Status of trial |
Completed |
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| Patient information material |
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| Target number of participants |
7,500
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| Interventions |
All young children who enter the trial will receive three doses of pneumococcal conjugate vaccine given at ages 2, 3 and 4 months through the Expanded Programme on Immunisation (EPI) programme. Infants under the age of three months and all children aged up to 11 months at the time that the study starts will receive three doses of vaccine at monthly intervals during the next three-month period. Children aged 12 - 30 months will receive two doses of pneumococcal conjugate vaccine given at an interval of a month. All subjects above the age of 30 months living in villages in group one will receive a single dose of pneumococcal conjugate vaccine; those living in group two villages will receive a single dose of control vaccine.
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| Primary outcome measure(s) |
1. Differences in the prevalence of nasopharyngeal carriage of pneumococci of vaccine or of non-vaccine serotype in study villages after vaccination
2. Differences in the prevalence of carriage with serotype 1 and serotype 5 pneumococci will be of particular importance
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| Secondary outcome measure(s) |
1. Acquisition rates of nasopharyngeal carriage in newborns resident in vaccinated or control villages
2. Evidence for an increased rate of capsular switching in villages where community-wide pneumococcal conjugate vaccination has been introduced
3. Measurements of Immunoglobulin G (IgG) and Immunoglobulin A (IgA) levels in serum and saliva
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| Sources of funding |
1. Medical Research Council (UK) - core funding
2. Wyeth Pharmaceutical Inc. (USA)
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| Trial website |
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| Publications |
1. 2012 antibody concentration results in http://www.ncbi.nlm.nih.gov/pubmed/22916192
2. 2012 nasopharyngeal carrieage results in http://www.ncbi.nlm.nih.gov/pubmed/22700830
3. 2012 indirect effect results in http://www.ncbi.nlm.nih.gov/pubmed/23185303
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| Contact name |
Prof
Richard
Adegbola
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| Address |
MRC Laboratories
Atlantic Boulevard
Fajara
P O Box 273
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| City/town |
Banjul
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| Zip/Postcode |
-
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| Country |
Gambia
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| Tel |
+220 449 4491
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| Fax |
+220 449 7924
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| Email |
radegbola@mrc.gm
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| Sponsor |
Medical Research Council (UK)
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| Address |
20 Park Crescent
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| City/town |
London
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| Zip/Postcode |
W1B 1AL
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| Country |
United Kingdom
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| Tel |
+44 (0)20 7636 5422
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| Fax |
+44 (0)20 7436 6179
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| Email |
tcorrah@mrc.gm
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| Sponsor website |
http://www.mrc.ac.uk
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| Date applied |
02/06/2006
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| Last edited |
28/11/2012
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| Date ISRCTN assigned |
04/08/2006
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