Mucosal and Systemic Immunity and Protection Against Flu in 2- to 5-Year-Olds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers in South Africa will follow healthy children 2–5 years old through the influenza season, collecting nasal swabs three times per week and weekly symptom data, with blood samples taken before, during, and after the season to study immune markers in blood and mucosal tissues. They will compare immune responses between children who become infected with influenza or other respiratory viruses and those who remain uninfected. The study aims to identify correlates of protection that may help explain indirect vaccine effects and guide future vaccine strategies. This is an observational effort to understand natural immune responses rather than test a vaccine or a treatment. Results could inform how immune markers relate to protection and transmission in young children."

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children aged 2-5 years of age (i.e. from the second birthday until 5 years and 11 months of age) at the time of enrolment.

  * Healthy children as established by medical history and clinical examination before entering the study.
  * Parent availability and willingness to provide written informed consent to all study procedures
  * Child planning to reside in the selected community for the duration of the study.

Exclusion Criteria:

* Presence of malnutrition (defined as z score for age \<-2 based on WHO child grown standard at time of screening for eligibility).

  * Presence of any serious systemic disorder determined by medical history and/or physical examination that would compromise the participant's health or is likely to result in non-conformance to the protocol or a child who is on treatment for any chronic medical condition.
  * Prior history of receiving influenza vaccination.
  * Not providing consent for storage and shipment of samples for immunological testing.
  * Parent of participating child not able, available or willing to accept active weekly follow-up by the study staff, performing a twice-weekly caregiver swab and completing symptom diary on an electronic device or any medical condition in the parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parent's ability to give informed consent. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids, in the last 6 months (those on inhaled or topical steroids may be permitted to participate in the study.
  * Child is HIV-infected as identified by self-report or if screening of study eligibility identifies that the child is HIV-infected.

Where it's running

• Peri Natal HIV Research Unit
  Jouberton, North West, South Africa Recruiting

Study contacts

• Principal investigator: Cheryl Cohen — MBBCh, FCPath(SA) Micro, PhD
• Study coordinator: Cheryl Cohen, MBBCh, FCPath(SA) Micro, PhD
• Email: cherylc@nicd.ac.za
• Phone: +27 11 3866593

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.