Maternal Determinants of Immunity to Influenza (MADI-01)

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Completed; Phase 4

Conditions: Immunoglobulins; Influenza; Maternal-Fetal Relations; Vaccination; Infection

Treatments: Biological: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06716567

B762020201013

Details and patient eligibility

About

The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.

Full description

The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims:

1. To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;
2. To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;
3. To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;

Enrollment: 109 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age over 18 and under 40 years.

Exclusion criteria

• Grade III/IV anemia
• Human Immunodeficiency Virus (HIV) infection
• Active bacterial infection
• Opportunistic infection (Tuberculosis, cytomegalovirus (CMV), toxoplasmosis, etc)
• Inability to understand the nature and extent of the study and the procedures required
• Current or recent use of immunosuppressive drugs (corticosteroids, anti-tumor necrosis factors (anti-TNF), methotrexate, etc)
• Active neoplasia

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

Pregnant women

Active Comparator group

Description:

Pregnant women receive one dose of influenza-containing vaccine during pregnancy.

Treatment:

Biological: Influenza vaccine

Non-pregnant women

Active Comparator group

Description:

Non-pregnant women receive one dose of influenza-containing vaccine.

Treatment:

Biological: Influenza vaccine