Clinical trial NCT06153979: Investigation of Immune Amnesia Following Measles Infection in Select African Regions
Official title: Investigation of Immune Amnesia Following Measles Infection in Select African Regions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Measles Infection
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 2023-12-01
Enrollment: 256
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specific study sites within each country will be in areas experiencing measles outbreaks.

Brief summary: The goal of this observational study is to investigate the effects of measles virus (MeV) infection on pre-existing immunity, vaccine response, and susceptibility to subsequent illness in children aged 1-15 either with or without acute MeV infection.

Detailed description: This is a prospective, observational, longitudinal study to be conducted in West Africa. Eligible children will be enrolled into 1 of 2 arms: acute MeV infection (cases) or no acute MeV infection (controls) as assessed using upper respiratory specimens and blood samples. Blood samples will be collected at screening/enrollment (Day 0) and follow-up visits on Day 14, Week 13, and Week 52, and tested for humoral and cellular immune responses to endemic pathogens to determine changes in antibody diversity and antibody secreting cells (ASCs). All children in each arm will receive rabies vaccination (standard 3-dose series given as pre-exposure prophylaxis \[PrEP\]), with the first dose randomized to either Week 8 or Week 47 after enrollment. Biological samples will be collected after vaccination to assess if the immune stimulus (rabies vaccine) response differs: 1) between children with and without MeV infection, and 2) based on the timing of the receipt of the rabies vaccine.

Eligibility criteria: Inclusion Criteria:

* Aged 1 to 15 years.
* Ability of the participant's legal or culturally acceptable representative to provide informed consent.
* Ability to give assent, as appropriate.
* Stated willingness of parent/guardian and participant as appropriate, to comply with all study procedures.
* Willingness to receive rabies vaccine.
* Meet the criteria for assignment to Group 1 or Group 2, as follows:
* Group 1, cases (acute MeV infection):
* Clinical signs and symptoms suggestive of acute MeV infection (Koplik spots or skin rash) AND
* Laboratory confirmed measles:
* Upper respiratory specimen (swab) PCR for measles positive, OR
* Serum IgM for measles positive.
* Group 2, controls (no acute MeV infection):
* No clinical signs and symptoms suggestive of acute MeV infection (Koplik spots or skin rash) AND
* Upper respiratory specimen (swab) PCR negative for MeV AND
* Serum measles IgM negative AND
* Serum measles IgG positive and previously vaccinated for measles (2nd dose will be offered if appropriate). If serum measles IgG is negative, participant must be willing to be vaccinated regardless of prior measles vaccine history to meet this criterion.

Exclusion Criteria:

* HIV infection or any other immunosuppressive condition or medications.
* Pregnant or lactating.
* History of prior measles or immunologic evidence of prior measles in the absence of prior measles vaccination.
* Severe anemia, defined as hemoglobin less than 8 g/dL.
* Any acute or chronic condition which, in the opinion of the investigator, constitutes a contraindication to participation in this study.

Primary outcomes:
measure: Change in pre-existing immunity
timeFrame: Week 13 after baseline
measure: Effect of MeV infection on immune response to a controlled immune stimulus (rabies vaccination)
timeFrame: 14 days after last PrEP regimen vaccination
measure: Effect of MeV infection on immune response to a controlled immune stimulus
timeFrame: 5-6 weeks after the first rabies vaccine dose
measure: Effect of MeV infection on immune response to a controlled immune stimulus
timeFrame: 5-6 weeks after the first rabies vaccine dose
Secondary outcomes:
measure: Change in healthcare system encounters
timeFrame: 1 year following enrollment
measure: Change in pre-existing immunity
timeFrame: Week 52 after baseline
Other outcomes:
Locations:
city: Conakry
country: Guinea
facility: Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI)
city: Bamako
country: Mali
facility: University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Sally Hunsberger, Ph.D.
role: STUDY_DIRECTOR
References: