Condition category
Infections and Infestations
Date applied
04/08/2004
Date assigned
22/09/2004
Last edited
27/09/2007
Prospective/Retrospective
Prospectively 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

Dr Richard Adegbola

ORCID ID

Contact details

Medical Research Council Laboratories
Fajara
Banjul
-
Gambia
radegbola@mrc.gm

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/RPC033

Study information

Scientific title

Acronym

Study hypothesis

Following previous encouraging findings from safety and immunogenicity studies using conjugate Pnc and Hib vaccines in the Gambia, we propose to evaluate the safety and immunogenicity of 7-valent Pnc conjugate (4, 6B, 9V 14 18C 19F 23F) manufactured by Wyeth Lederle Vaccine USA, using different vaccination schedules. The aim is to determine whether fewer doses started earlier in life with or without a booster dose of Pnc polysaccharide can induce a protective antibody response throughout infancy and early childhood. 675 young infants, residing in sites where the large efficacy (Pnc) trial is on-going, will be randomly allocated to one of 3 vaccination schedules using the 7-valent conjugate vaccine to assess the magnitude, duration and quality of the antibody- response to 1-2 doses with or without a booster dose in Upper River Division of The Gambia. The impact of this vaccination schedule on carriage of pneumococci will also be determined.

The data from this immunogenicity study and the larger on-going efficacy trial could provide important data for an informed policy decision in developing countries. We propose to use 7-valent vaccine since it is licensed and available, but would be guided by WHO as to the suitability and availability of other possible conjugate vaccines.

General objectives:
Evaluating the safety and antibody response to 1 or 2 doses of 7-valent conjugate pneumococcal (Pnc) vaccine given early in life with a booster dose of polysaccharide, compared with a standard 3-dose regimen.

Specific primary objectives:
1. To determine the immunogenicity of a 7-valent Pnc Conjugate vaccine at ages 18 weeks and 9 months, after one, two and three doses of conjugate vaccines
2. To evaluate the secondary immune response (antibody) to Pnc polysaccharide vaccine at age 10 months after one, two or three doses of 7-valent conjugate vaccine

Secondary objectives:
1. To evaluate persistence of antibody at age 15 months
2. To evaluate evidence of memory response following Conjugate vaccines using assays of antibody avidity and affinity
3. To determine naso-pharyngeal carriage of vaccine and non-vaccine serotypes at ages 6 weeks, 18 weeks, 10 and 15 months

Ethics approval

Ethics approval received from the Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethics Committee on the 5th October 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Pneumococcus/vaccines

Intervention

Group 1: Infants here will receive their only dose of a 7-valent pneumococcal conjugate vaccine at 6 weeks of life and a dose of polysaccharide vaccine at 9 months.
Group 2: A dose of conjugate vaccine will be offered at 6 and 14 weeks, and a dose of polysaccharide at 9 months.

The third group (3) will be recruited and vaccinated at 6, 10 and 14 weeks of life with the study conjugate vaccine and with the polysaccharide vaccine at 9 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Pneumococcal polysaccharide/protein conjugate vaccine

Primary outcome measures

1. Immunogenicity of 7-valent pneumococcal conjugate vaccine at ages 18 weeks and 11 months after one, two and three doses of conjugate vaccines, measuring for antibody concentrations greater than or equal to 0.35 ug/ml
2. Secondary immune response (antibody) to pnuemococcal polysaccharide vaccine at age 11 months after one, two or three doses of 7-valent conjugate vaccine (antibody concentrations greater than or equal to 0.35 ug/ml)

Secondary outcome measures

1. Persistence of antibody at age 15 months of age
2. Evidence of memory response following Conjugate vaccines using assays of antibody avidity and affinity
3. Naso-pharyngeal carriage of vaccine and non-vaccine serotypes at ages 18 weeks, 11 and 15 months of age
4. Monitoring for safety and local reaction up to 15 months of age. Two main aspects of the safety surveillance will be analysed:
4.1. Serious Adverse Events (SAE)
4.2. Local and Systemic reactions

Antibody concentrations to serotypes covered by the 7-valent conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) as well as antibody concentration to selected serotypes covered by the polysaccharide vaccine (1, 3, 5 and 12) will be measured.

Overall trial start date

01/05/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Babies will be recruited when they present for first dose of Diphtheria, Pertussis, Tetanus (DPT)-Haemophilus influenzae type b (Hib) vaccine and written informed consent obtained at that time

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

675

Participant exclusion criteria

1. Babies born to known human immunodeficiency virus (HIV) positive mothers
2. Those with neurological abnormality
3. No parental consent
4. Established pneumococcal disease

Recruitment start date

01/05/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Gambia

Trial participating centre

Medical Research Council Laboratories
Banjul
-
Gambia

Sponsor information

Organisation

Medical Research Council Laboratories (The Gambia)

Sponsor details

Fajara
Banjul
-
Gambia

Sponsor type

Research council

Website

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

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

Publication citations

Additional files

Editorial Notes