Prevention of pneumococcal carriage and disease Infections and Infestations
Conditions
Interventions
The researchers will conduct a prospective observer-blinded two-arm randomized controlled trial (RCT) testing a PCV13-cocooning strategy targeting children 12-59 months old. This vaccine probe approac
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 27/07/2026 All participants: 1. Adult participants (>18 years old) with written informed consent and children with parental/legal guardian’s written informed consent 2. Residence in Blantyre District Mothers: 1. >28 weeks gestation 2. Household contacts 12-59 months old (HHC) 3. 18-45 years old HHC: 1. 12-59 months old at time of entry into the study 2. Record of PCV13 infant immunisation Infants 1. Written Informed consent given by mother or legal guardian Previous key inclusion criteria as of 03/02/2026: All participants: 1. Adult participants (>18 years old) with written informed consent and children with parental/legal guardian’s written informed consent 2. Residence in Blantyre District Mothers: 1. >28 weeks gestation 2. Household contacts 12-59 months old (HHC) 3. 18-45 years old HHC: 1. 12-59 months old at time of entry into the study 2. Record of PCV13 infant immunisation 3. Lives in the same household as study mothers Infants 1. 18 years old) with written informed consent and children with parental/legal guardian’s written informed consent 2. Residence in Blantyre District Mothers: 1. <32 weeks gestation 2. Household contacts 12-59 months old (HHC) 3. 18-45 years old HHC: 1. 12-59 months old at time of entry into the study 2. Record of PCV13 infant immunisation 3. Lives in the same household as study mothers Infants 1. <14 days old at recruitment
Exclusion criteria
Exclusion criteria: Previous key exclusion criteria: Mothers and household contacts 12-59 months old (HHC): 1. Ongoing antibiotic treatment 2. Ongoing TB treatment, including isoniazid prophylaxis 3. Immunosuppressive illnesses, e.g., HIV infection not on ART 4. Immunosuppressive treatment, e.g., steroids 5. Women with prior PCV vaccination 6. Women with the following comorbidities: a hypertensive disorder (including pre-eclampsia and eclampsia), diabetes (including gestational diabetes), a previous history of preterm delivery, incompetent cervix/cervical cerclage placement, or multiple gestations (twins or more babies) 7. Residence in a PAVE 2+1 catchment area HHC: 1. Previous severe adverse reaction to PCV13 or the pentavalent vaccine 2. Known hypersensitivity to any components of the Prevnar 13 or the pentavalent combination vaccine, or a severe reaction to a previous dose of either vaccine or any of its constituents. 3. 4 doses of PCV Infants: 1. Preterm birth (4 doses of PCV Infants: 1. Preterm birth (<37 weeks) 2. Congenital abnormalities of the upper airways
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The impact of the PCV13-cocooning intervention on residual pneumococcal vaccine type (VT) carriage prevalence among unvaccinated 6-week-old infants comparing study arms, estimated by prevalence risk ratio (95% confidence interval [CI]). Pneumococcal carriage will be determined microbiologically from nasopharyngeal swabs (NPS) and vaccine serotypes will be confirmed by genomic sequencing at 6-week timepoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| The impact of the PCV13-cocooning intervention comparing study arms on: 1. Fraction of VT carriage among 6-week-old infants attributed to transmission from children 12-59 months old, measured using culture and genomic sequencing at the 6-week timepoint 2. Frequency of within-household VT transmission events at each study visit. Transmission will be confirmed by sequencing the cultured pneumococci 3. VT carriage prevalence among mothers and children 12-59 months old at each study visit measured using culture and genomic sequencing 4. VT carriage prevalence among unvaccinated 1- and 4-week-old infants and vaccinated 5- and 9-month-old infants measured using culture and genomic sequencing at the 1- and 4-week timepoints 5. VT shedding prevalence among children 12-59 months old, mothers and infants at each study visit. Shedding will be determined by culturing pneumococci shed from the upper respiratory tract | — |
Countries
Malawi
Outcome results
None listed