None listed
Conditions
Brief summary
Bordetella pertussis is bacteria infecting the respiratory tract and leading to a range of symptoms from mild cough, to clinically typical whooping cough, to death. Antibiotic treatment is ineffective after the cough develops, so prevention by effective vaccines is essential to protect the most vulnerable. Maternal pertussis (whooping cough) immunisation is an effective way of reducing severe disease in young infants. In Australia, vaccinating pregnant mothers with adult formulation diphtheria-tetanus-acellular pertussis vaccine (dTap) is recommended for every pregnancy with ~50% uptake. However, dTap is not licensed for use in pregnancy and in a number of countries it has been found that infants whose mothers received pertussis immunisation during pregnancy had lower antibody responses to their infant vaccinations, although they remain protected. It is not known how long maternal immunity lasts after immunisation in pregnancy or if repeated doses have any effect on infant vaccine responses. This study involving 400 mothers and babies (mother and infant pairs) will be conducted in Western Australian and New South Wales. It will evaluate maternal immunity and the effect of pertussis vaccination in pregnancy on infant antibody responses to the routine vaccinations given at 6 weeks and 4, 6, 12 and 18 months of age. Infants will have a blood sample at 6 to10 weeks of age prior to their routine infant vaccines, Infanrix-hexa (DTaP-IPB-HBV/Hib), Prevenar13 (PCV13) and rotavirus vaccine with subsequent doses at 4 and 6 months of age. Blood samples will also be taken at 7 months, 18 months and 19 months of age to measure antibody responses to pertussis antigens, diphtheria and tetanus toxoids, Haemophilus influenzae type b (Hib) and pneumococcal serotypes contained in PCV13. Responses will be compared between children whose mothers received a pertussis vaccine during pregnancy with those whose mothers were not vaccinated. We will also evaluate the frequency of local and generalised reactions to vaccination and the development of allergies, eczema and asthma. Infant participants will have a swab collected from the inside of their nose (nasal swab) at 7, 12 and 19 months of age Mother’s will have their blood collected to measure their antibody levels 6 weeks and 18 months after giving birth. Responses will be compared between mothers who received a pertussis vaccine during pregnancy with who were not vaccinated. We will also compare antibody responses between mothers who received their first pertussis immunisation during pregnancy with those who received their second or subsequent dose. This study will provide important information to inform providers, parents and national policy and will be relevant to other countries using maternal pertussis immunisation and potentially future vaccine development.
Interventions
This study aims to determine the degree to which maternal diphtheria, tetanus and acellular pertussis vaccine (dTap) vaccine in pregnancy affects Australian infants’ humoral and cell-mediated immune responses to routine immunisations given at 6 weeks, 4, 6, 12 and 18 months of age.
We will document whether the mother has had the Pertussis vaccine in pregnancy and the date this occurred but we will not be giving this vaccine as part of this study.
All routine childhood vaccinations will be admi
This study aims to determine the degree to which maternal diphtheria, tetanus and acellular pertussis vaccine (dTap) vaccine in pregnancy affects Australian infants’ humoral and cell-mediated immune responses to routine immunisations given at 6 weeks, 4, 6, 12 and 18 months of age. We will document whether the mother has had the Pertussis vaccine in pregnancy and the date this occurred but we will not be giving this vaccine as part of this study. All routine childhood vaccinations will be administered to the infant by immunisation certified nurses during the course of this study. Blood samples will be taken as follows: maternal blood at visit 1 (6 to =10 weeks post-partum) and visit 2 (18 to <19 months post-partum). Infant blood at visit 1 (6 to =10 weeks of age), visit 4 (28 to 42 days post-visit 3), visit 6 (18 to <19 months) and visit 7 (28 to 42 days post-visit 6). Nasopharyngeal swabs will be collected from infants at visit 4 (28 to 42 days post-visit 3), visit 5 (12 to <14 months) and visit 7 (28 to 42 days post-visit 6). In addition, with parental consent a sample from the infant participant’s newborn screening blood test (also known as the “Guthrie Test”) will be requested from the local newborn screening program laboratories and will be used to measure pertussis IgG levels at birth.
Sponsors
The Kids Research Institute Australia
Eligibility
Sex/Gender
All
Age
6 Weeks to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Maternal Inclusion Criteria Maternal participants must meet all of the following to be eligible to participate in the study: 1. Has provided written informed consent and is willing and able to comply with the scheduled visits and study procedures. 2. Generally well or any medical conditions are stable and well-controlled. 3. Aged 18 to less than or equal to 45 years. 4. English speaking with a good understanding of the English language. 5. Has received: i) no adult dTap vaccination during their most recent pregnancy OR ii) first adult dTap booster vaccination during their most recent pregnancy and at least 4 weeks prior to delivery OR iii) second or subsequent adult dTap vaccination during their most recent pregnancy and at least 4 weeks prior to delivery. Note: women who have received a dTap vaccination during the last 10 years, but not during their most recent pregnancy are eligible to participate as per inclusion criteria 5 i). 6. Their newborn infant is eligible to participate in the study (ie meets all of the infant inclusion criteria and none of the exclusion criteria). 7. Available for the entire study period. Infant Inclusion Criteria Infant participants must meet all of the following criteria to be eligible to participate in the study: 1. The infant’s parent has given written informed consent and is willing and able to comply with the scheduled visits and study procedures. 2. Is a healthy male or female infant born at term (equal to or greater than 37 weeks gestation) 3. Is available for the entire study period. 4. The infant’s mother is eligible to participate in the study (ie meets all of the maternal inclusion criteria and none of the exclusion criteria).
Exclusion criteria
Infant participants presenting with any of the following will not be eligible to participate in the study: 1. Already received their 6 week vaccinations (as recommended by the national immunisation schedule) prior to study visit 1. 2. Has received or plans to receive a Meningococcal ACWY conjugate vaccine prior to completing study visit 4 (28-42 days post-visit 3). 3. Has a diagnosed or suspected major congenital anomaly, genetic disorders or serious chronic illness. 4. Has a confirmed or suspected immunosuppressive or immunodeficient condition. 5. Has received immunoglobulins or any blood products since birth or planned administration during the study period. 6. Chronic administration of immunosuppressants since birth, including high-dose oral or parenteral corticosteroid therapy > 2mg/kg per day prednisolone for more than 2 weeks. Inhaled and topical corticosteroids are permitted. 7. Any contraindications to vaccination as listed in the current edition of the NHMRC Australian Immunisation Handbook. 8. Parent/legal guardian does not agree for their infant to be vaccinated as per the current national immunisation schedule, with the only exception being receipt of a third dose of pneumococcal vaccine at 6 months of age and a booster dose at 18 months of age (instead of 12 months of age) or planned administration of additional vaccinations (e.g. influenza, meningococcal B) within 2 weeks of the routine vaccinations administered during the study Note: an infant is eligible to participate if they have not received a birth dose of Hepatitis B vaccine. 9. Current or planned participation in an investigational study (participation in observational studies is permitted) during the study period. 10. Has received any investigational or non-registered drugs, vaccines or devices since birth or planned during the study period. 11. 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