The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants

Launched by LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE · Mar 29, 2018

Keywords

ClinConnect Summary

Background:

PCV is currently the most expensive vaccine in the routine immunisation schedule in Gavi-supported countries. This study aims to provide evidence which may enable a substantial decrease in the cost of PCV programmes, therefore increasing the sustainability of PCV programmes in low and middle income countries (LMICs). We propose to assess whether fractional (20% and 40%) doses of pneumococcal conjugate vaccine (PCV10 and PCV13) in a 2p+1 schedule (2 primary doses followed by a booster dose) induce non-inferior immunogenicity and effects on vaccine-serotype carriage when compared...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy infants aged 6-8 weeks of age (HIV positive or negative but with no symptoms of current clinical immunosuppression i.e. HIV infection at WHO clinical stage 1);
• • Parents are willing to provide informed consent for their child to participate in the study
• • Parents and infant are likely to remain in the study area until the infant is 18 months of age and comply with study requirements including the requirement to return to the same health facility to obtain all other childhood vaccines.
• Exclusion Criteria:
• • Infants \>8 weeks of age at time of enrolment
• • Signs or symptoms of immunosuppression or HIV infection clinical stage 2 or above.
• • Acute illness (e.g. febrile disease) on the day of vaccination
• • Contraindications precluding vaccination (e.g. hypersensitivity to any component of the vaccine, including diphtheria toxoid)
• • Previous PCV vaccination
• • Family are planning to migrate out of the study areas before the end of the study follow-up
• • Family are planning to obtain the subsequent vaccine doses of the routine immunisation schedule elsewhere and therefore their child may receive a full dose under the routine vaccination programme.