None listed
Conditions
Brief summary
Vaccination against pertussis whooping cough and influenza are recommended during pregnancy to protect both the mother and baby from these diseases. A group of medications called biological disease-modifying antirheumatic drugs (bDMARDs) are increasingly being used in pregnant women in autoimmune diseases, and the impact of these medications on the immune response to vaccines in mothers and in their babies is not yet known. We hypothesise that the immune response to some vaccines may be lower in babies who were exposed to these medications during pregnancy. We will compare the immune response to vaccines in mothers and babies in four groups; women who took bDMARDs during pregnancy; women who took other types of immune-suppressing medications; women who have autoimmune disease but did not take any immune-suppressing medications during pregnancy; and healthy pregnant women.
Interventions
This is an observational study assessing the safety and immunogenicity of influenza and pertussis vaccination in pregnant women exposed to biological disease-modifying anti-rheumatic drugs, and assessing immune responses to vaccines in their infants.
Exposures:
Group 1: Pregnant women with autoimmune disease exposed to biological disease-modifying anti-rheumatic drugs
Group 2: Pregnant women with autoimmune disease exposed to non-biological disease-modifying anti-rheumatic drugs
Group 3: Pregn
This is an observational study assessing the safety and immunogenicity of influenza and pertussis vaccination in pregnant women exposed to biological disease-modifying anti-rheumatic drugs, and assessing immune responses to vaccines in their infants. Exposures: Group 1: Pregnant women with autoimmune disease exposed to biological disease-modifying anti-rheumatic drugs Group 2: Pregnant women with autoimmune disease exposed to non-biological disease-modifying anti-rheumatic drugs Group 3: Pregnant women with autoimmune disease who are not taking any immunosuppressive medications What is required of participants: * Consent to access records and share medical history * Two blood tests for maternal participants * Two blood tests for infant participants Duration of observation for maternal participants is 5 months, and for infant participants is 7 months. All pregnant women in Australia are routinely offered pertussis vaccination in each pregnancy, and influenza vaccination in each pregnancy where it is available (i.e. depending on seasonal availability of the vaccine). The women in our study would have been routinely offered these vaccines regardless of their involvement in this study. Pertussis vaccine is given between 20 and 32 weeks gestation, in accordance with national guidelines. Influenza vaccine can be given at any time in pregnancy, and depends on availability of the vaccine. In this study, participants will receive the vaccine through their regular healthcare provider at the routine timepoints described above.
Sponsors
Associate Professor Nicholas Wood
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Outcome results
None listed