An Evaluation of PCV13 Vaccine Schedules, Comparing Impact of 2+1 vs 3+0 on Pneumococcal Carriage in Blantyre, Malawi

Launched by UNIVERSITY OF LIVERPOOL · Sep 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different schedules for the pneumococcal conjugate vaccine (PCV), which helps protect against serious infections caused by a bacteria called Streptococcus pneumoniae. The researchers want to compare a 2+1 schedule, where children receive two doses of the vaccine followed by a booster, to the current 3+0 schedule, which consists of three doses without a booster. The goal is to see if the 2+1 schedule provides better protection by lowering the number of children carrying the bacteria, which can help prevent illness not only in vaccinated children but also in those who are unvaccinated.

Eligible participants include children aged 15 to 24 months who have received either the 2+1 or 3+0 PCV schedule, as well as 9-month-old children who have had either schedule. Children aged 5 to 10 years who received the 3+0 schedule can also take part, along with HIV-infected adults aged 18 to 40 who have not yet been vaccinated with PCV. Participants will have a simple nose swab taken to check for the bacteria, and the study will help inform vaccination policies in Malawi and beyond. If you or your child qualify and decide to participate, you will be contributing to important research that could improve health outcomes for many children.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• PCV13-vaccinated children, 15-24 months of age (schedule 2+1 or 3+1):
• • Aged between 15-24 month
• • Permanent resident in Blantyre District
• • Parent/legal guardian consent for the child to have a NP swab taken
• • Evidence of having received a full schedule of PCV13 vaccination recorded in the health passport and which schedule given
• PCV13-vaccinated children, 9 months of age (schedule 2+0 or 3+0):
• • Aged 9 months
• • Permanent resident in Blantyre District
• • Parent/legal guardian consent for the child to have a NP swab taken
• • Evidence of having received either a full 3+0 schedule or both primary doses (at approximately 6 and 14 weeks of age) of the 2+1 schedule of PCV13 vaccination recorded in the health passport
• PCV13-vaccinated children, 5-10 years of age (schedule 3+0):
• • Aged between 5-10 years
• • Parent/legal guardian consent for the child to have a NP swab taken
• • If the child is ≥8 years old, child assent to have a NP swab taken
• • Either verbal or documented evidence of having received primary immunization with PCV
• PCV13-unvaccinated HIV-infected adults on ART 18 - 40 years of age:
• • • Aged 18-40 years
• EXCLUSION CRITERIA:
• For all participants:
• • Current TB treatment
• • Pneumonia hospitalization \<14 days before study enrolment
• • Terminal illness
• For Children:
• • No parental/legal guardian consent
• • No child assent (children aged \>8 years old)
• • Having received antibiotic treatment \<14 days before study enrolment
• For Adults:
• • Unable or unwilling to provide consent
• • Prior vaccination with pneumococcal vaccine