Maternal Determinants of Immunity to Influenza (MADI-01)
Overview
- Phase
- Phase 4
- Intervention
- Influenza vaccine
- Conditions
- Vaccination; Infection
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Haemagglutination Inhibition Assay titre
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.
Detailed 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;
Investigators
Nicolas Dauby
Clinical Professor, Infectious Disease Department
Centre Hospitalier Universitaire Saint Pierre
Eligibility Criteria
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
Arms & Interventions
Pregnant women
Pregnant women receive one dose of influenza-containing vaccine during pregnancy.
Intervention: Influenza vaccine
Non-pregnant women
Non-pregnant women receive one dose of influenza-containing vaccine.
Intervention: Influenza vaccine
Outcomes
Primary Outcomes
Haemagglutination Inhibition Assay titre
Time Frame: At delivery
Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of \>=40 is considered protective in adults. HAI titres will be measured in : * Pregnant women * In umbilical cord blood
Secondary Outcomes
- Haemagglutination inhibition assay titre(up to 11 months after vaccination)
- Micro neutralization assay titre(up to 11 months after vaccination)
- Influenza virus specific IgG titre(up to 11 month after vaccination)
- Influenza virus specific IgG antibody avidity(up to 11 months after vaccination)