Opportunistic Pneumococcal Immunisation Trial in MALnutrition

NCT06817421 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: MENTL2024-4996U1111-1312-6848
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Pneumococcal; Severe Acute Malnutrition in childhood; Pneumococcal vaccine; Pneumosil; Pneumococcal disease; Pneumococcal infection; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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).

  4 weeks after vaccination

Secondary Outcomes (12)

• Serotype-specific IgG antibodies

  4 weeks and 3 months after vaccination

• Proportion of participants with serotype-specific IgG antibody responses ≥ 0.35 μg/mL

  4 weeks and 3 months after vaccination

• Functional antibody responses

  4 weeks and 3 months after vaccination

• Functional antibody responses

  4 weeks and 3 months after vaccination

• Salivary IgG antibodies

  4 weeks and 3 months after vaccination

Study Arms (2)

Treatment Arm: Pneumosil

EXPERIMENTAL

Biological: Pneumococcal conjugate vaccine

Control Arm: Typbar TCV

OTHER

Biological: Typhoid conjugate vaccine

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.

Treatment Arm: Pneumosil

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.

Control Arm: Typbar TCV

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6-59 months at the time of hospitalisation
• Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c):
• 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 written 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nick Fancourt: lead
• Murdoch Childrens Research Institute: collaborator
• The University of Western Australia: collaborator
• University of Edinburgh: collaborator
• Timor-Leste Ministry of Health: collaborator

Study Sites (1)

Guido Valadares National Hospital (HNGV)

Dili, Timor-Leste, Timor-Leste

Location

Related Links

• Pneumosil product information
• Typbar-TCV product information

MeSH Terms

Conditions

Pneumococcal Infections; Pneumonia

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Nicholas S. S. Fancourt, PhD

CONTACT

+61889468600; nick.fancourt@menzies.edu.au

Jane N Nelson, Bachelor of Nursing

CONTACT

+61889468600; jane.nelson@menzies.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: A prospective, single-centre, double-blind, phase 4, randomised, controlled trial in children aged 6-59 months hospitalised with severe acute malnutrition.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

TI (1)