RECRUITING Phase 4 ClinicalTrials.gov

Opportunistic Pneumococcal Immunisation Trial in MALnutrition

Sponsor: Nick Fancourt • ClinicalTrials.gov ID: NCT06817421

Registry updated: 2026-10-08

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Description

The goal of the OPTIMAL clinical trial is to learn if a dose of a pneumococcal conjugate vaccine (PCV) generates a good immune response in young children who are in hospital with severe acute malnutrition. Researchers will compare an intervention group who get a dose of a PCV (Pneumosil) to a control group who get a dose of a Typhoid conjugate vaccine (Typbar TCV). To ensure all participants receive timely potential benefits, at 3 months participants in the intervention group with receive a dose of Typbar TCV, and those in the conrol group will receive a dose of Pneumosil. Participants will be visited 4 times at their homes over six months after vaccination, with a phone review at 12 months after vaccination.

Interventions

Pneumococcal conjugate vaccine (Biological)
10-valent pneumococcal polysaccharide conjugate vaccine at a dosage of 2μg for each serotype polysaccharide for 1, 5, 6A, 7F, 9V, 14, 19A, 19F, 23F, and 4μg for serotype 6B, conjugated to a carrier protein (CRM197), polysorbate 20 and aluminium phosphate as an adjuvant. Administered as an intramuscular injection of 0.5mL.
Typhoid conjugate vaccine (Biological)
Typhoid conjugate vaccine at a dosage of 25μg purified Vi capsular polysaccharide of Salmonella typhi Ty2 conjugated to Tetanus Toxoid with preservative (2-Phenoxyethanol). Administered as an intramuscular injection of 0.5mL.

Eligibility criteria

Inclusion Criteria: 1. Aged 6-59 months at the time of hospitalisation 2. Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c): 1. weight-for-length/height z-score \<-3; or 2. middle upper arm circumference \<11.5cm; or 3. bilateral pitting pedal oedema unexplained by other causes 3. Parent/carer is willing for their child to participate in the study and has provided written informed consent 4. Parent/carer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study Exclusion Criteria: 1. Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock. 2. Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial. 3. Suspected primary or secondary immunodeficiency or prolonged administration (\>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months. 4. Known terminal illness expected to result in death within 6 months. 5. Participants who, in the opinion of the site Principal Investigator, are unable to comply with the study protocol, including scheduled visits, assessments, and any other protocol-required procedures. 6. Previously enrolled in this trial.

Conditions

Severe Acute Malnutrition in Childhood Pneumococcal Disease Pneumococcal Vaccines Pneumococcal Infection Pneumonia in Children

Locations

Guido Valadares National Hospital (HNGV) — Dili, Timor-Leste

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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