Pregnancy RelatedNCT03284515
Vaccination In Pregnancy Gene Signature: VIP Signature Study
An observational study of Pregnancy Related and Vaccination, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
A study investigating gene expression profiles in pregnant women in response to a pertussis containing vaccination in pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Vaccination
- What is being tested?
- Vaccination with a pertussis containing vaccine
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2017to 21 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women at between 16-32 weeks gestation who have not yet received the pertussis vaccination in pregnancy.
Who may be able to join
- Pregnant at a gestation of 16-32 weeks
- No contraindications to vaccination according to the green book
- No known immunodeficiency
- Able to understand the details of the study and willing to provide informed consent
Who cannot join
- Having received a pertussis containing vaccine within the last 12 months
- Contraindications to vaccination according to the green book
Trial locations and contacts
1 site in 1 country.
About this study
A study investigating gene expression profiles in pregnant women in response to a pertussis containing vaccination in pregnancy.
Read the detailed description
Vaccinations are a vital part of ensuring population health, but there is a continued need for new and improved vaccines to be developed and this process of design and development can be both slow and expensive. Vaccination in pregnancy against pathogens such as pertussis, influenza and tetanus is a routine part of antenatal care in many countries. The principle behind this approach is that through vaccination the amount of disease specific antibody is increased in the woman and there is therefore an increase in transplacental transfer to the fetus providing protection for infants after birth. In the UK vaccination against pertussis is recommended from 16 weeks gestation and against influenza at any gestation within the influenza season. There is evidence that pertussis vaccination in pregnancy is highly effective against pertussis in infants too young to be protected by the routine infant immunisation programme (Amirthalingam G et al, 2014, Dabrera G et al, 2015). There is also evidence that this is a safe strategy in pregnancy to protect newborn infants (Donegan K et al, 2014) with no evidence of adverse clinical outcomes for mother or infant.
The BioVacSafe project has been designed to develop techniques which can be used to understand more about biomarkers of safety in individuals' response to vaccines. This will improve our understanding of how reactogenicity can be identified earlier, how adverse reactions can be identified and classified and how individuals interact with vaccines, specifically in conditions of health and disease. Since the start of the BioVacSafe project the importance of vaccination in pregnancy has become better understood and it has become important to include pregnant women as participants in this project. Pregnancy is a time of altered immunity and it may be that there are differences in gene signatures following vaccination in pregnant women compared with non-pregnant women. Insights into this could be extremely important in the development of new vaccines for this population.
Safety of vaccination in pregnancy is of primary importance to pregnant women and their partners, clinical trials investigators, ethics committees, vaccine manufacturers and regulators. Determining specific genetic signatures following vaccination may accelerate vaccine development by predicting possible adverse events early in the development process.
- Conditions
- Pregnancy Related, Vaccination
- Being tested
- Vaccination with a pertussis containing vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with a pertussis containing vaccineBiological
Vaccination with a pertussis containing vaccine
| Study group | Role | What they receive |
|---|---|---|
| All women | Women who are between 16-32 weeks gestation and who have not previously received a pertussis vaccination in pregnancy. Receives: Biological: Vaccination with a pertussis containing vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression profiles
Gene expression profiles in blood samples from pregnant women following vaccination.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start7 Sep 2017
- Primary completion31 Jan 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicine Initiative, Max Planck Institute for Infection Biology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284515
- Sponsor's protocol ID
- 17.0060
- Status last verified
- Jan 2021
- First submitted
- 13 Sep 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal details of the participants will be collected to allow us to contact them if necessary. This information will be stored securely and will not leave St. George's, University of London. Some limited demographic and medical information may be shared with researchers at Imperial College London and the Max Planck Institute for Infection Biology both of which are part of this study and the wider BioVacSafe consortium.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination In Pregnancy Gene Signature: VIP Signature Study
- ClinicalTrials.gov ID
- NCT03284515
- Acronym / sponsor ID
- 17.0060
- Conditions
- Pregnancy Related, Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Innovative Medicine Initiative, Max Planck Institute for Infection Biology
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study investigating gene expression profiles in pregnant women in response to a pertussis containing vaccination in pregnancy.
Detailed description
Vaccinations are a vital part of ensuring population health, but there is a continued need for new and improved vaccines to be developed and this process of design and development can be both slow and expensive. Vaccination in pregnancy against pathogens such as pertussis, influenza and tetanus is a routine part of antenatal care in many countries. The principle behind this approach is that through vaccination the amount of disease specific antibody is increased in the woman and there is therefore an increase in transplacental transfer to the fetus providing protection for infants after birth. In the UK vaccination against pertussis is recommended from 16 weeks gestation and against influenza at any gestation within the influenza season. There is evidence that pertussis vaccination in pregnancy is highly effective against pertussis in infants too young to be protected by the routine infant immunisation programme (Amirthalingam G et al, 2014, Dabrera G et al, 2015). There is also evidence that this is a safe strategy in pregnancy to protect newborn infants (Donegan K et al, 2014) with no evidence of adverse clinical outcomes for mother or infant.
The BioVacSafe project has been designed to develop techniques which can be used to understand more about biomarkers of safety in individuals' response to vaccines. This will improve our understanding of how reactogenicity can be identified earlier, how adverse reactions can be identified and classified and how individuals interact with vaccines, specifically in conditions of health and disease. Since the start of the BioVacSafe project the importance of vaccination in pregnancy has become better understood and it has become important to include pregnant women as participants in this project. Pregnancy is a time of altered immunity and it may be that there are differences in gene signatures following vaccination in pregnant women compared with non-pregnant women. Insights into this could be extremely important in the development of new vaccines for this population.
Safety of vaccination in pregnancy is of primary importance to pregnant women and their partners, clinical trials investigators, ethics committees, vaccine manufacturers and regulators. Determining specific genetic signatures following vaccination may accelerate vaccine development by predicting possible adverse events early in the development process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All women | – | Biological: Vaccination with a pertussis containing vaccineWomen who are between 16-32 weeks gestation and who have not previously received a pertussis vaccination in pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women at between 16-32 weeks gestation who have not yet received the pertussis vaccination in pregnancy.
Key inclusion criteria (4 listed)
- Pregnant at a gestation of 16-32 weeks
- No contraindications to vaccination according to the green book
- No known immunodeficiency
- Able to understand the details of the study and willing to provide informed consent
Key exclusion criteria (2 listed)
- Having received a pertussis containing vaccine within the last 12 months
- Contraindications to vaccination according to the green book
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination with a pertussis containing vaccineVaccination with a pertussis containing vaccine | Biological | All women |
Primary outcome
Gene expression profiles
Time frame: 24 hours
Gene expression profiles in blood samples from pregnant women following vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: No. Personal details of the participants will be collected to allow us to contact them if necessary. This information will be stored securely and will not leave St. George's, University of London. Some limited demographic and medical information may be shared with researchers at Imperial College London and the Max Planck Institute for Infection Biology both of which are part of this study and the wider BioVacSafe consortium.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Vaccination, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression profiles (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.