Opportunistic Pneumococcal Immunisation Trial in MALnutrition

Launched by NICK FANCOURT · Feb 4, 2025

Keywords

ClinConnect Summary

The Opportunistic Pneumococcal Immunisation Trial in MALnutrition (OPTIMAL) is a research study aimed at understanding how well a pneumonia vaccine works in young children who are severely malnourished and in the hospital. The study will compare two groups: one group will receive the pneumonia vaccine called Pneumosil, while the other group will receive a different vaccine for typhoid. The main goal is to see if the pneumonia vaccine helps these children build a strong immune response to fight off infections.

To be eligible for this study, children aged 6 to 59 months must be hospitalized for severe acute malnutrition, which can be identified by certain criteria like low weight or swollen limbs. If a child participates, their family will be visited at home every month for six months after vaccination, and then again a year later, to monitor their health. At the end of the study, families will have the option to receive the vaccine they did not get while in the hospital. This trial is not yet recruiting participants, but it aims to help improve health outcomes for malnourished children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 6-59 months at the time of hospitalisation
• 2. Hospitalised with severe acute malnutrition:
• • 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 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.