Contact information
Type
Scientific
Primary contact
Prof Richard Adegbola
ORCID ID
Contact details
MRC Laboratories
Atlantic Boulevard
Fajara
P O Box 273
Banjul
-
Gambia
+220 449 4491
radegbola@mrc.gm
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCC 1032
Study information
Scientific title
Acronym
Vilage study
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.
Ethics approval
The Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethics Committee, approved on 27/02/2006, reference number: SCC 1032
Study design
Community randomised controlled pneumococcal vaccination trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Pneumococcal infection or colonisation
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Prevenar®
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/07/2006
Overall trial end date
01/07/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Resident of one of 21 Gambian villages
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
7,500
Participant 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
Recruitment start date
01/07/2006
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Gambia
Trial participating centre
MRC Laboratories
Banjul
-
Gambia
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
tcorrah@mrc.gm
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) - core funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wyeth Pharmaceutical Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24086259
Publication citations
-
Antibody concentration results
Ota MO, Roca A, Bottomley C, Hill PC, Egere U, Greenwood B, Adegbola RA, Pneumococcal antibody concentrations of subjects in communities fully or partially vaccinated with a seven-valent pneumococcal conjugate vaccine., PLoS ONE, 2012, 7, 8, e42997, doi: 10.1371/journal.pone.0042997.
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Nasopharyngeal carrieage results
Roca A, Bottomley C, Hill PC, Bojang A, Egere U, Antonio M, Darboe O, Greenwood BM, Adegbola RA, Effect of age and vaccination with a pneumococcal conjugate vaccine on the density of pneumococcal nasopharyngeal carriage., Clin. Infect. Dis., 2012, 55, 6, 816-824, doi: 10.1093/cid/cis554.
-
Indirect effect results
Egere U, Townend J, Roca A, Akinsanya A, Bojang A, Nsekpong D, Greenwood B, Adegbola RA, Hill PC, Indirect effect of 7-valent pneumococcal conjugate vaccine on pneumococcal carriage in newborns in rural Gambia: a randomised controlled trial., PLoS ONE, 2012, 7, 11, e49143, doi: 10.1371/journal.pone.0049143.
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Results
Roca A, Dione MM, Bojang A, Townend J, Egere U, Darboe O, Howie SR, Hill PC, Adegbola RA, Greenwood BM, Antonio M, Nasopharyngeal carriage of pneumococci four years after community-wide vaccination with PCV-7 in The Gambia: long-term evaluation of a cluster randomized trial., PLoS ONE, 2013, 8, 9, e72198, doi: 10.1371/journal.pone.0072198.