None listed
Conditions
Brief summary
Pregnant women are at greater risk of complications from influenza infection and vaccination provides the best protection against influenza to pregnant women and their infants. Since 2010, the Australian Government has provided free seasonal influenza vaccine to all pregnant women (in any trimester). Whilst there are numerous data suggesting that influenza vaccination during pregnancy is beneficial to the mother and infant, there is limited data on factors that could potentially reduce the effectiveness of the influenza vaccine response in pregnant women. It is possible factors such as body mass index (BMI), may influence the immune response to influenza vaccine. Studies have shown that obese adults are at increased risk of severe disease from influenza and the immune response to some inactivated vaccines is reduced. The main objective of this study is to determine whether there is any relationship between BMI and the effectiveness of influenza vaccination in pregnant women. Approximately 300 pregnant women will be enrolled in this study at Women’s and Children’s Hospital over two influenza seasons (2014 and 2015). Approximately 150 obese and 150 non-obese participants will be enrolled. Licensed 2014 or 2015 seasonal influenza vaccines will be provided to all participants, with the vaccine administered during ultrasound imaging for a subset of pregnant women (n=70) to determine exact location of vaccine deposition. Two blood samples will be collected from all participants during the study (at baseline and at approximately 28 days post vaccination) in order to assess antibody responses to the vaccine. We will also measure cytokines (IL6 + TNFa) to determine associations with obesity and immunogenicity. In addition, for influenza vaccines we don’t know whether the immune response is different for people who receive the influenza vaccine subcutaneously vs intramuscularly. We will investigate whether obesity is associated with a lower likelihood of intramuscular vaccination and the implication of this for immune response. As it is likely that many pregnant women do not receive the influenza vaccine (standard fixed 16mm needle) intramuscularly. This study will inform vaccine policy and guidelines by providing evidence on the impact of BMI on influenza vaccine response for pregnant women.
Interventions
Approximately 300 pregnant women will be enrolled in this study at the Women’s and Children’s Hospital over two influenza seasons. Whilst recruitment will not be targeting any specific BMI of potential participants, we expect that approximately 150 obese and non-obese participants will be enrolled in 2014 and 2015. This is a prospective cohort study including obese and non-obese pregnant women to assess difference in seroprotective status after a seasonal influenza vaccination given according
Approximately 300 pregnant women will be enrolled in this study at the Women’s and Children’s Hospital over two influenza seasons. Whilst recruitment will not be targeting any specific BMI of potential participants, we expect that approximately 150 obese and non-obese participants will be enrolled in 2014 and 2015. This is a prospective cohort study including obese and non-obese pregnant women to assess difference in seroprotective status after a seasonal influenza vaccination given according to standard practice. All pregnant women will be administered 1 (0.5ml) dose of the licensed influenza vaccine into the upper deltoid muscle of the arm. Group 1: Participants with a BMI >=30kg/m2 Group 2: Participants with a BMI <30kg/m2 All participants will have a follow-up 28 days after vaccination to assess antibody responses.
Sponsors
Women's and Children's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
*Pregnant women aged 18 to 40 years (inclusive) at the time of the vaccination. *Written informed consent obtained from the participant. *Ability to understand the information sheet and provide informed consent *Participants who in the opinion of the study staff can and will comply with the requirements of the protocol (eg return for follow-up visits, blood collection)
Exclusion criteria
*Any major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study, or interfere with the evaluation of the study objectives. *History of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes mellitus requiring treatment with insulin). *History of seasonal influenza vaccination within the last six months prior to enrolment. *History of any immunosuppressive condition (eg HIV infection) or on immunosuppressing medication. *Any contraindication to influenza immunisation according to the Australian Immunisation Handbook. *Anaphylaxis following a previous dose of any influenza vaccine *Anaphylaxis following any vaccine component. *History of egg allergy. *History of Gullain Barre syndrome. *Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw, including participants taking anticoagulant medications or antiplatelet therapy (except for low dose daily aspirin therapy) within 30 days before enrolment.
Outcome results
None listed