Research to inform the impact of immunosuppressive medications taken during pregnancy on maternal and infant immune responses to vaccines

Not Applicable

Recruiting

• Conditions: Autoimmune disease; Inflammatory bowel disease; Lupus; Inflammatory and Immune System - Autoimmune diseases; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12619001322123
• Lead Sponsor: Associate Professor Nicholas Wood

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-27
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Meets criteria for one of the study groups:
a. Group 1: receiving any bDMARD at any time during pregnancy
b. Group 2: receiving a non-biological DMARD at any time during pregnancy
c. Group 3: has autoimmune disease and is not receiving any immunosuppressive in pregnancy
d. Group 4: pregnant women who are generally well or any medical conditions are stable and well-controlled

2. Has provided written informed consent and is willing and able to comply with the scheduled visits and study procedures

3. Aged 18 to greater than or equal to 45 years.

4. English speaking with a good understanding of English language.

5.Available for the entire study period

Exclusion Criteria

Has received or will receive immunoglobulins and/or any blood products during the study period
2. Allergy to a vaccine component
3. Any other significant acute or chronic medical condition that in the opinion of the investigator may interfere with the interpretation of study results or place the participant at increased risk if they participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified