Evaluating different schedules of the PCV13 vaccine in children in Malawi
Pneumococcal Conjugate Vaccine 13 (PCV13) Schedule Change From 3+0 to 2+1 to Accelerate Reduction in Pneumococcal Vaccine Serotype Carriage in Blantyre, Malawi: an Effectiveness Study
This study is testing whether giving the PCV13 vaccine in two different ways helps reduce the spread of pneumonia-causing bacteria among children in Malawi.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5900 (estimated) |
| Ages | 15 Months to 40 Years |
| Sex | All |
| Sponsor | University of Liverpool Academic / other |
| Locations | 1 site (Blantyre, Chichiri) |
| Trial ID | NCT04078997 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of two different schedules of the 13-valent pneumococcal conjugate vaccine (PCV13) in reducing pneumococcal carriage among children in Blantyre, Malawi. The study will involve nasopharyngeal swabs from PCV13-vaccinated children aged 9 months to 10 years to assess the impact of the 2+1 versus 3+0 dosing schedules. By understanding how these schedules affect pneumococcal carriage, the study seeks to inform vaccination strategies that could enhance herd immunity and reduce disease transmission in high-burden settings. The research is conducted in collaboration with local health authorities and aims to address the unique challenges faced in low-income countries regarding pneumococcal disease.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 9 months to 10 years who have received the PCV13 vaccine and reside in Blantyre District.
Not a fit: Patients who have not received any PCV13 vaccinations or are outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccination strategies that enhance protection against pneumococcal disease in children.
How similar studies have performed: Other studies have shown success with similar vaccine evaluation approaches, particularly in industrialized countries, but this specific evaluation in a low-income setting is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Blantyre, Chichiri
- Malawi-Liverpool-Wellcome Research Programme — Blantyre, Chichiri, Malawi (Recruiting)
Study contacts
- Principal investigator: Robert Heyderman, PhD — University College, London
- Study coordinator: Todd Swarthout, PhD
- Email: t.swarthout@ucl.ac.uk
- Phone: +31 (0)6 2788 2862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.