Alternative vaccination schedules with pneumococcal polysaccharide/protein conjugate vaccine: immunogenicity of the prime-booster approach among Gambian infants

ISRCTN ISRCTN50377687
DOI https://doi.org/10.1186/ISRCTN50377687
Secondary identifying numbers WHO/RPC033
Submission date
04/08/2004
Registration date
22/09/2004
Last edited
27/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Adegbola
Scientific

Medical Research Council Laboratories
Fajara
Banjul
-
Gambia

Email radegbola@mrc.gm

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesFollowing 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(s)Ethics approval received from the Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethics Committee on the 5th October 2004.
Health condition(s) or problem(s) studiedPneumococcus/vaccines
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Pneumococcal polysaccharide/protein conjugate vaccine
Primary outcome measure1. 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 measures1. 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 study start date01/05/2005
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants675
Key inclusion criteriaBabies 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
Key exclusion criteria1. Babies born to known human immunodeficiency virus (HIV) positive mothers
2. Those with neurological abnormality
3. No parental consent
4. Established pneumococcal disease
Date of first enrolment01/05/2005
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Gambia

Study participating centre

Medical Research Council Laboratories
Banjul
-
Gambia

Sponsor information

Medical Research Council Laboratories (The Gambia)
Research council

Fajara
Banjul
-
Gambia

ROR logo "ROR" https://ror.org/025wfj672

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan