Pregnant women on immunosuppressive therapy
Conditions
Interventions
Administer subcutaneous DTaP vaccination to pregnant women under immunosuppression between 28 and 36 weeks of gestation
Sponsors
Fujio Keishi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The study will include participants who meet all of the following eligibility criteria: (1)Females aged 18 years or older at the time of obtaining informed consent. (2)Gestational age between 24 and 36 weeks at the time of obtaining informed consent. (3)Individuals with clearly confirmed gestational age. (4)Individuals currently receiving immunosuppressive therapy for autoimmune diseases (any type of immunosuppressant, including systemic corticosteroids). (5)Individuals planning to deliver at this hospital. (6)Individuals in whom no major congenital anomalies affecting prognosis have been identified on routine fetal ultrasound examinations. (7)Individuals who have received sufficient explanation regarding participation in this study, have adequately understood the information, and have provided written informed consent voluntarily. (8)Individuals who are able to attend outpatient visits in accordance with the study schedule.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following exclusion criteria will be excluded from the study: (1)Individuals with confirmed or suspected pertussis infection within the past five years. (2)Individuals who have received a subcutaneous pertussis vaccination within the past five years. (3)Individuals with a history of allergy to pertussis vaccines. (4)Individuals with known immunodeficiency, or those who have a close relative with congenital immunodeficiency. (5)Individuals with a history of severe drug allergy, such as anaphylactic shock, or a history of serious adverse drug reactions. (6)Individuals who are in a condition in which vaccination is considered inappropriate, including those with evident fever or serious acute illness at the time of subcutaneous injection. (7)Individuals with underlying diseases such as cardiovascular, renal, hepatic, or hematologic disorders, who are deemed inappropriate for participation by the physician. (8)Individuals deemed inappropriate for participation by the principal investigator or sub-investigator due to high-risk pregnancy. (9)Individuals with multiple gestation. (10)Individuals with a history of seizures. (11)Any other individuals deemed inappropriate for participation by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The fold increase in maternal anti-PT IgG antibody titers from pre-injection to delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Changes in maternal anti-PT IgG antibody titers over time (2)The fold increase in maternal anti-FHA IgG antibody titers from before subcutaneous injection to the time of delivery (3)Changes in maternal anti-FHA IgG antibody titers over time (4)Evaluation of the correlation between the interval from subcutaneous injection to delivery and maternal antibody titers (5)Incidence of pertussis infection in infants up to 2 months of age (6)Infant safety (birth length, birth weight, Apgar score) (7)Maternal safety (injection-site reactions, systemic adverse reactions, serious adverse events, and obstetric complications) (8)Correlation between the type and dose of immunosuppressive agents and antibody titers (9)Changes in peripheral blood immune cell counts | — |
Contacts
Public ContactSaeko Yamada
The University of Tokyo Hospital
Outcome results
None listed