Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies (ImmRubVac)

Hopital Foch

Status: Completed

Conditions: Pregnancy

Treatments: Biological: Determination of Anti-Rubella Antibody, E1

Study type: Interventional

Funder types: Other

Identifiers

NCT02934295

2011/61

2011-A01445-36 (Other Identifier)

Details and patient eligibility

About

The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.

Enrollment: 192 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women over 18
• Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
• Accepting the rubella vaccination after the childbirth;
• Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
• Affiliated to a social security scheme
• Having given a written consent

Exclusion criteria

• Rubella contracted since the first serology realized during the first prenatal consultation
• Autoimmune pathologies
• Intolerance / allergy known about a previous vaccination whatever it is
• Immunosuppression (HIV, transplants)
• Injection of multivalent immunoglobulins (except anti-D)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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192 participants in 1 patient group

Pregnant women

Experimental group

Treatment:

Biological: Determination of Anti-Rubella Antibody, E1