Condition category
Infections and Infestations
Date applied
02/06/2006
Date assigned
04/08/2006
Last edited
04/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mrc.ac.uk

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes