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 |
| Protocol serial number | WHO/RPC033 |
| Sponsor | Medical Research Council Laboratories (The Gambia) |
| Funder | World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Medical Research Council Laboratories
Fajara
Banjul
-
Gambia
| radegbola@mrc.gm |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Pneumococcal polysaccharide/protein conjugate vaccine |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Persistence of antibody at age 15 months of age |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 675 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Gambia
Study participating centre
-
Gambia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
