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.
Aged 6-59 months at the time of hospitalisation
weight-for-length/height z-score <-3; or
middle upper arm circumference <11.5cm; or
bilateral pitting pedal oedema unexplained by other causes
Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock.
Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial.
Suspected primary or secondary immunodeficiency or prolonged administration (>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months.
Known terminal illness expected to result in death within 6 months.
Parallel
Pneumococcal conjugate vaccine
Biological/Vaccine10-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/VaccineTyphoid 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.
Serotype-specific immunoglobulin G (IgG) antibodies
Pneumosil serotype-specific (1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 23F) immunoglobulin G (IgG) geometric mean concentrations (GMCs).
Serotype-specific IgG antibodies
Pneumosil serotype-specific IgG GMCs
Proportion of participants with serotype-specific IgG antibody responses ≥ 0.35 μg/mL
Proportion of participants with Pneumosil serotype-specific IgG concentrations ≥ 0.35μg/mL
Functional antibody responses
Pneumosil serotype-specific pneumococcal geometric mean opsonisation indices (GMOIs)
Functional antibody responses
Proportion of participants with Pneumosil serotye-specfiic pneumococcal opsonisation indices (OIs) \>8
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Nick Fancourt
Lead sponsor
Menzies School of Health Research
Sponsor institution
Murdoch Childrens Research Institute
Collaborator
The University of Western Australia
Collaborator
University of Edinburgh
Collaborator
Timor-Leste Ministry of Health
Collaborator
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