Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy

Respiratory Syncytial Virus (RSV) Clinical Trial

Official title:

Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096574
• Other study ID #: IRAS project ID: 220968
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: November 2019

Study information

• Verified date: November 2018
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: Christopher Wilcox
• Phone: 02381204956
• Email: christopher.wilcox[@]soton.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy (maternal vaccination), which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection.

There are two main aims to this study:

1. To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.

2. We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)

The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at English teaching hospitals and GP practices. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination

Description:

Respiratory Syncytial Virus (RSV) is a very common virus that causes infection of the airways and lungs. It is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. Lots of research trials are being done into ways of preventing and treating RSV, however there is still no RSV vaccine approved for routine use. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy, which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection. There are two vaccines that are currently being tested in pregnant women around the world, including the UK.

There are two main aims to this study:

1. To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.

2. We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)

The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at four English teaching hospitals. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1025
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

1. Pregnant women

Inclusion Criteria:

• Over the age of 16

• Under the care of staff working in: University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust

• Able to read and write in English and give fully informed consent

Exclusion Criteria:

• Women in active labour

• Women deemed acutely unwell or distressed

2. Maternity healthcare professionals

Inclusion Criteria:

• Over the age of 18

• Working in obstetrics or midwifery who regularly care for women in pregnancy at University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust

• Able to read and write in English and give fully informed consent

3. General practitioners

• Fully-qualified and working in the UK

• Able to read and write in English and give fully informed consent

Related Conditions & MeSH terms

• Attitude
• Maternal Vaccine Exposure
• Respiratory Syncytial Virus (RSV)

Intervention

Other:
• Questionnaire
The participants will be approached by a member of the study team and, following recruitment, participants will be asked to fill in a short paper or online questionnaire. Our estimated time for completion is 5-10 minutes, and this time will be stated at the start of the questionnaire. Having completed the questionnaire they will be free to leave without further follow up, and given the contact details of the investigators/research governance office whom they can contact if they have further questions or concerns.

Locations

Country	Name	City	State
United Kingdom	Bristol University Hospitals	Bristol
United Kingdom	St Georges Hospital	London
United Kingdom	Oxford University Hospitals	Oxford
United Kingdom	University Hosital Southampton NHS Foundation Trust	Southampton

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	Oxford University Hospitals NHS Trust, St George's Healthcare NHS Trust, University Hospitals Bristol NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Answers to questionnaires	The answers to the questionnaires will be analysed using statistical software to assess their knowledge of RSV, and identify factors that might affect their understanding of RSV and attitudes to being involved in hypothetical future trials and receiving the RSV vaccination.	Until data collection complete (December 2017)