## Protocol Section
### Identification Module
**NCT ID:** NCT06153979

**Brief Title:** Investigation of Immune Amnesia Following Measles Infection in Select African Regions

**Official Title:** Investigation of Immune Amnesia Following Measles Infection in Select African Regions

#### Organization Study ID Info
**ID:** Measles West Africa 01
#### Organization
**Class:** NIH
**Full Name:** National Institute of Allergy and Infectious Diseases (NIAID)
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-08

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-06

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-16

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-25
**Study First Submit QC Date:** 2023-11-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Johns Hopkins University

#### Lead Sponsor

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Measles Infection

### Design Module

#### Bio Spec

**Description:** Blood samples and upper respiratory specimens will be stored for analysis in repositories in each participating country.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 256

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants have acute MeV infection.

**Intervention Names:**

- Biological: Verorab

**Label:** Group 1 - Actue MeV Infection

#### Arm Group 2

**Description:** Participants do not have acute MeV infection.

**Intervention Names:**

- Biological: Verorab

**Label:** Group 2 - No Actue MeV Infection

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1 - Actue MeV Infection

- Group 2 - No Actue MeV Infection

**Description:** 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.

**Name:** Verorab

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Mean change in a panel of antibody levels over 13 weeks as measured by multiplex serological methods and targeted ELISAs for confirmation.

**Measure:** Change in pre-existing immunity

**Time Frame:** Week 13 after baseline

**Description:** Proportion of subjects with rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test

**Measure:** Effect of MeV infection on immune response to a controlled immune stimulus (rabies vaccination)

**Time Frame:** 14 days after last PrEP regimen vaccination

**Description:** Proportion of subjects with an RVNA titer ≥ lower limit of quantification

**Measure:** Effect of MeV infection on immune response to a controlled immune stimulus

**Time Frame:** 5-6 weeks after the first rabies vaccine dose

**Description:** Geometric mean RVNA titer

**Measure:** Effect of MeV infection on immune response to a controlled immune stimulus

**Time Frame:** 5-6 weeks after the first rabies vaccine dose

#### Secondary Outcomes

**Description:** Mean number of non-study sick visit healthcare system encounters during the 1-year follow-up.

**Measure:** Change in healthcare system encounters

**Time Frame:** 1 year following enrollment

**Description:** Mean change in a panel of antibody levels over 52 weeks as measured by multiplex serological methods and targeted ELISAs for confirmation.

**Measure:** Change in pre-existing immunity

**Time Frame:** Week 52 after baseline

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 15 Years

**Minimum Age:** 1 Year

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Specific study sites within each country will be in areas experiencing measles outbreaks.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** karine.fouthtchos@nih.gov

**Name:** Karine G Fouth Tchos, M.D., M.Ph.

**Phone:** 240-627-3641

**Role:** CONTACT

**Contact 2:**

**Email:** esther.akpa@nih.gov

**Name:** Esther Akpa, MSN, MPH, RN

**Phone:** 301-761-7677

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Conakry

**Country:** Guinea

**Facility:** Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI)

**Status:** RECRUITING

**Location 2:**

**City:** Bamako

**Country:** Mali

**Facility:** University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** National Institute of Allergy and Infectious Diseases (NIAID)

**Name:** Katy Saliba, Sc.M., Ph.D.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000018185

- Term: Morbillivirus Infections

- ID: D000018184

- Term: Paramyxoviridae Infections

- ID: D000018701

- Term: Mononegavirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000008569

- Term: Memory Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M11440

- Name: Measles

- Relevance: HIGH

- As Found: Measles

- ID: M3985

- Name: Amnesia

- Relevance: HIGH

- As Found: Amnesia

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M20330

- Name: Paramyxoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20778

- Name: Mononegavirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11552

- Name: Memory Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T3653

- Name: Measles

- Relevance: HIGH

- As Found: Measles

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000008457

- Term: Measles

- ID: D000000647

- Term: Amnesia

### Misc Info Module

- Version Holder: 2024-05-24
