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Clinical Trial NCT06817421 (OPTIMAL) for Severe Acute Malnutrition in Childhood, Pneumococcal Disease, Pneumococcal Vaccines, Pneumococcal Infection, Pneumonia in Children is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Opportunistic Pneumococcal Immunisation Trial in MALnutrition (OPTIMAL)
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).
Participants will be visited monthly at their homes for six months after vaccination, and then once more at 12 months after vaccination. At the end of their involvement in the study participants will be offered a dose of the vaccine they did not get while in hospital.
Participants will be randomised (1:1) to receive either a dose of a pneumococcal conjugate vaccine (Pneumosil, the intervention group) or a dose of a Typhoid conjugate vaccine (Typbar TCV, the control group). Stratification for randomisation will be done on (a) prior immunisation with a PCV (confirmed or unknown/unvaccinated); and (b) severity of malnurition (weight-for-height/length z-score <-4 or >=-4). Participants will be enrolled as soon as practical after admission to hospital, while randomisation and vaccine administration will occur once the participant is medically stable in the 'transition phase' of SAM care.
The primary objective is to demonstrate that immune responses to the 10 pneumococcal serotypes in Pneumosil are better in participants whoh receive Pneumosil, compared to those who receive Typbar TCV, when measured 6 months after vaccination.
Immunogenicity of Opportunistic Pneumococcal Conjugate Vaccination (Pneumosil®) Versus Control (Typhoid Conjugate Vaccine, Typbar TCV®) in Children Aged 6-59 Months Hospitalised with Severe Acute Malnutrition: a Single-centre, Double-blind, Randomised Controlled Trial in Timor-Leste
- OPTIMAL
- MENTL2024-4996
- U1111-1312-6848 (Other Identifier) (WHO)
Severe Acute Malnutrition in childhood
Pneumococcal vaccine
Pneumosil
Pneumococcal disease
Pneumococcal infection
Pneumonia
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTreatment Arm: Pneumosil | Pneumococcal Conjugate Vaccine 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. |
OtherControl Arm: Typbar TCV | Typhoid Conjugate Vaccine 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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 6 months after vaccination |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Serotype-specific IgG antibodies | Pneumosil serotype-specific IgG GMCs | 4 weeks and 12 months after vaccination |
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 | 4 weeks, 6 months, and 12 months after vaccination |
Functional antibody responses | Pneumosil serotype-specific functional antibody responses measured by opsonophagocytic assays (OPAs) | 4 weeks and 6 months after vaccination |
Salivary IgG antibodies | Serotype-specific salivary IgG (μg/ml) for Pneumosil serotypes and non-vaccine types 3, 4, 11A, and 18C | 4 weeks and 6 months after vaccination |
Salivary immunoglobulin A (IgA) antibodies | Serotype-specific salivary IgA (μg/ml) for Pneumosil serotypes and non-vaccine types 3, 4, 11A, and 18C | 4 weeks and 6 months after vaccination |
Nasopharyngeal carriage of pneumococcus | Frequency and proportion of participants with nasopharyngeal carriage of Pneumosil vaccine-type pneumococci and their antimicrobial resistance patterns | 4 weeks, 6 months, and 12 months after vaccination |
Lower respiratory tract infection | Lower respiratory tract infection episodes determined by medical records and standardised parent questionnaire. | Reviewed at all study visits until completion (12 months after vaccination) |
Hospitalisation | Admission to hospital as confirmed by medical records | Reviewed at all study visits until completion (12 months after vaccination) |
Severe acute malnutrition recovery | Weight-for-height/length z-score \>= -2 | Reviewed at all study visits until completion (12 months after vaccination) |
Mortality | Deaths as reported. Investigated with verbal autopsy and/or medical record review | Reviewed at all study visits until completion (12 months after vaccination) |
Composite illness or mortality | Lower respiratory tract infection(s), repeat hospitalisation(s), or death. | Reviewed at all study visits until completion (12 months after vaccination) |
Aged 6-59 months at the time of hospitalisation
Hospitalised with severe acute malnutrition:
- weight-for-length/height z-score <-3; or
- middle upper arm circumference <11.5cm; or
- bilateral pitting pedal oedema unexplained by other causes
Parent/carer is willing for their child to participate in the study and has provided informed consent
Parent/carer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study
- 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.
- 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.
- Previously enrolled in this trial.
Nick Fancourt- 🔬Murdoch Childrens Research Institute
- 🎓The University of Western Australia
University of Edinburgh104 active trials to explore- ⚕️Timor-Leste Ministry of Health
Timor-Leste