Neonatal immunisation with pneumoccal conjugate vaccines: immunogenicity and the generation memory (Kenya)

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN52829313
• Date of registration: 22/09/2004
• Prospective Registration: Yes
• Primary sponsor: Kenya Medical Research Institute (Kenya)
• Public title: Neonatal immunisation with pneumoccal conjugate vaccines: immunogenicity and the generation memory (Kenya)
• Date of first enrolment: 01/11/2004
• Target sample size: 300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN52829313
• Study type: Interventional
• Study design: Randomised controlled trial (Prevention)

Countries of recruitment

Kenya

Contacts

• Name: Thomas Cherian

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy infants born to mothers tested human immunodeficiency virus (HIV) negative in the voluntary counselling and testing service
2. Not known to have congenital immune deficiency
3. Birth weight greater than 2500 g
4. Informed consent
Exclusion criteria: 1. Infants requiring ongoing hospitalisation after birth
2. Suspected immune deficiency
3. Participation in another clinical trial

Any child who suffers a serious adverse event directly attributable to pneumococcal vaccination will be excluded from continued participation.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pneumococcus/vaccines
Infections and Infestations
Vaccination

Intervention(s)

Infants will receive 7-valent conjugate pneumococcal vaccine (PCV7) at birth (up to 72 hours - see point mentioned in hypothesis above), 6 and 10 weeks (group 1) or at 6, 10 and 14 weeks (group 2) along with routine Expanded Program of Immunisation (EPI) vaccines. Infants in each group will be randomised to receive either PCV7 or 23-valent pneumococcal polysaccharide vaccine at 9 months of age. Blood will be collected for measurement of antibody response prior to vaccine, 4 weeks after the primary series and pre- and 4 weeks post-booster dose. All infants will have Nasopharyngeal (NP) swabs collected at 18 weeks and 9 months of age that will be cultured for pneumococcus.

Primary Outcome(s)

1. Clinical safety data in children vaccinated at birth compared to children vaccinated first at 6 weeks of life
2. Immunogenicity as measured by anti-capsular Immunoglobulin G (IgG) Enzyme-Linked Immuno-Sorbent Assay (ELISA) to serotypes in the vaccine, measured after a complete primary course at 18 weeks.

Secondary Outcome(s)

1. Immunogenicity as measured by anti-capsular IgG ELISA after one or two doses of vaccine, of which one was given at birth
2. Immunological memory measured as IgG response to a booster vaccine dose (either PCV or 1/5th dose pneumococcal polysaccharide vaccine with a 50% probability of each) at 36 weeks
3. Functional immune response to first vaccination at birth as measured by prevalence of nasopharyngeal colonisation with S. pneumoniae at 18 and 36 weeks
4. Interference with immune response to diphtheria and tetanus attributable to vaccination with PCV at birth as measured by diphtheria and tetanus antibody concentration at 18 weeks
5. Interference with immune response to measles vaccine given at 36 weeks measured by anti-measles antibodies at 37 weeks
6. Effect of (maternal) pre-existing pneumococcal, diphtheria and tetanus antibody levels at birth on immune response to the primary course of PCV, and Diphtheria Pertussis Tetanus (DPT) vaccine.

Secondary ID(s)

WHO/RPC028

Source(s) of Monetary Support

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