Measles InfectionNCT06153979
Investigation of Immune Amnesia Following Measles Infection in Select African Regions
An observational study of Measles Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Measles Infection
- What is being tested?
- Verorab
- Type of treatment
- Vaccines
- How many people
- 264 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jan 2024to 16 Apr 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Specific study sites within each country will be in areas experiencing measles outbreaks.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Guinea1 site
Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI)
Conakry
Mali1 site
University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako
Bamako
About this study
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.
Read the 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.
- Conditions
- Measles Infection
- Being tested
- Verorab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerorabBiological
Participants in each group will receive rabies vaccination (standard 3-dose series given as PrEP), with the first dose randomized to either Week 8 or Week 47 after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Actue MeV Infection | Participants have acute MeV infection. Receives: Biological: Verorab | |
| Group 2 - No Actue MeV Infection | Participants do not have acute MeV infection. Receives: Biological: Verorab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pre-existing immunity
Mean change in a panel of antibody levels over 13 weeks as measured by multiplex serological methods and targeted ELISAs for confirmation.
Measured: Week 13 after baseline
Effect of MeV infection on immune response to a controlled immune stimulus (rabies vaccination)
Proportion of subjects with rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test
Measured: 14 days after last PrEP regimen vaccination
Effect of MeV infection on immune response to a controlled immune stimulus
Proportion of subjects with an RVNA titer ≥ lower limit of quantification
Measured: 5-6 weeks after the first rabies vaccine dose
Effect of MeV infection on immune response to a controlled immune stimulus
Geometric mean RVNA titer
Measured: 5-6 weeks after the first rabies vaccine dose
Secondary outcomes (2)
Change in healthcare system encounters
Mean number of non-study sick visit healthcare system encounters during the 1-year follow-up.
Measured: 1 year following enrollment
Change in pre-existing immunity
Mean change in a panel of antibody levels over 52 weeks as measured by multiplex serological methods and targeted ELISAs for confirmation.
Measured: Week 52 after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start16 Jan 2024
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Measles InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Sally Hunsberger, Ph.D., Study director, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153979
- Sponsor's protocol ID
- Measles West Africa 01
- Status last verified
- May 2026
- First submitted
- 25 Oct 2023
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tchos KF, Ridzon R, Haidara MC, Dabitao D, Akpa E, Camara D, Vallee D, Coulibaly M, Camara S, Aboulhab J, Diakite M, Diarra B, Diarra S, Dicko I, Francis A, Kolie CF, Koropogui M, Lim C, Samake S, Hunsberger S, Sidibe M, Chen RY, Konate I, Doumbia S, Beavogui AH, Shaw-Saliba K. Investigating immune amnesia after measles virus infection in two West African countries: A study protocol. PLoS One. 2025 Jun 26;20(6):e0314828. doi: 10.1371/journal.pone.0314828. eCollection 2025.
PubMed 40569945