ObesityOPTIWINNCT03457194
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
An observational study of Obesity, run by Women's and Children's Hospital, Australia at 1 site in Australia.
Trial summary
This study has been designed to investigate if: 1. BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy. 2. If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine. 3. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Quadrivalent Influenza Vaccine and DTP Vaccine (Multiple Actives)
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 73 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Aug 2018to 1 Mar 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 150 healthy pregnant women
Who may be able to join
- 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 etc).
- Pregnant women aged 18 years and over at the time of vaccination.
- Able to understand the information sheet and provide a written informed consent.
Who cannot join
- 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 requiring treatment with insulin).
- History of seasonal influenza or dTpa vaccination within the last 6 months prior to enrolment.
- History of any immunosuppressive condition or currently on immunosuppressive medication.
- Any contraindication to influenza or dTpa immunisation.
- Anaphylaxis following a previous dose of any influenza or pertussis containing vaccine.
Show all 10Show fewer
- History of anaphylaxis to egg.
- Past history of Guillain Barre Syndrome.
- Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw.
- Receipt of immunoglobulins, blood or blood products within the past 6 months.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Women's and Children's Hospital
North Adelaide, South Australia, 5006
About this study
This study has been designed to investigate if:
- BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy.
- If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine.
- If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.
Read the detailed description
A clinical observation study to determine whether obesity during pregnancy is associated with altered immunogenicity of influenza and pertussis vaccines during pregnancy. The study will also assess vaccine specific antibody concentrations in cord blood collected from vaccinated women at the time of delivery to estimate any effect of obesity on transplacental transfer of antibodies and will measure and compare cytokine profiles between obese and non-obese participants to determine any correlation with immune responses. This study will enrol 150 pregnant women (50 obese and 100 non-obese) during 2017-2019 to receive a recommended, licensed influenza vaccine (FluQuadri) as well as pertussis vaccination (Adacel) for women enrolled in their third trimester, as part of routine antenatal care. Local and systemic adverse events will be captured using a 7 day diary card and unexpected or serious adverse events will be recorded for the duration of the study. Blood samples will be collected to measure antigen specific vaccine antibody responses. The proportion of influenza vaccine recipients achieving seroprotective antibody titres at 4 weeks post vaccination and persisting at 6 months post vaccination be compared between obese and non-obese recipients.
- Conditions
- Obesity
- Being tested
- Quadrivalent Influenza Vaccine, DTP Vaccine (Multiple Actives)
- Keywords
- Obesity, Vaccination, Pregnancy, Influenza, Pertussis, Maternal antibodies
- Medical subject headings
- Obesity, Influenza, Human, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Influenza VaccineBiological
Also called FluQuadri
Inactivated quadrivalent influenza vaccine that is used for active immunisation against influenza A, B virus strains (contained in vaccine). Single dose administration by intramuscular injection to all enrolled pregnant women as part of routine antenatal care.
DTP Vaccine (Multiple Actives)Biological
Also called Adacel
Pertussis vaccine acellular combined with diphtheria and tetanus toxoids. Single dose administration by intramuscular injection, to all enrolled pregnant women who are 28 weeks or greater gestation at time of enrolment, as part of routine antenatal care.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | 150 participants (pregnant women at least 18 years of age and meeting eligibility criteria) will be enrolled and administered the FluQuadri, the quadrivalent influenza vaccine which will be administered by single-dose intramuscular injection.
Single-dose intramuscular injection of Adacel - DTP vaccine (multiple actives) will also be administered to all enrolled pregnant women who are at gestation 28 weeks or greater at the time of enrolment.
Where the vaccines are to be co-administered, FluQuadri will be administered into the dominant arm and Adacel into the non-dominant arm.
Pregnant women will be at a gestation of 20 weeks or greater at the time of enrolment. The vaccines administered are currently licensed and recommended in Australia to be given during pregnancy. Receives: Biological: Quadrivalent Influenza Vaccine; Biological: DTP Vaccine (Multiple Actives) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity against the 4 influenza strains included in the 2017-2019 Southern Hemisphere Influenza vaccine pre and post vaccination in obese and non-obese women
- Hl titres (as measured by Haemagglutination Inhibition Assay).
- Proportion with antibody titres (HI>=40) following vaccination.
Measured: 1 month post vaccination
Secondary outcomes (3)
Antibodies to pertussis antigens
- antibody titres to PRN, PT, FHA (measured by ELISA)
Measured: 1 month post vaccination compared with baseline (pre vaccination).
Persistence of antibodies to pertussis antigens
- antibody titres to PRN, PT, FHA (measured by ELISA)
Measured: 6 months post vaccination.
Persistence of antibodies to the 4 influenza strains included in the 2017-2019
- Hl titres (as measured by Haemagglutination Inhibition Assay).
- Proportion with antibody titres (HI>=40) following vaccination.
Measured: 6 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start28 Aug 2018
- Primary completion29 Sep 2023
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's and Children's Hospital, Australia
- Sponsor type
- Other government
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Principal investigator, Professor Helen Marshall, Women's and Children's Hospital, Australia
- Investigators
- Helen S Marshall, MBBS,MD,MPH, Principal investigator, Vaccinology and Immunology Research Trials Unit (VIRTU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457194
- Sponsor's protocol ID
- HREC/17/WCHN/63
- Acronym
- OPTIWIN
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2017
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to share with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
- ClinicalTrials.gov ID
- NCT03457194
- Acronym / sponsor ID
- OPTIWIN / HREC/17/WCHN/63
- Conditions
- Obesity
- Keywords
- Obesity, Vaccination, Pregnancy, Influenza, Pertussis, Maternal antibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Women's and Children's Hospital, AustraliaOther government
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 7 Mar 2018 (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.
This study has been designed to investigate if:
- BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy.
- If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine.
- If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.
Detailed description
A clinical observation study to determine whether obesity during pregnancy is associated with altered immunogenicity of influenza and pertussis vaccines during pregnancy. The study will also assess vaccine specific antibody concentrations in cord blood collected from vaccinated women at the time of delivery to estimate any effect of obesity on transplacental transfer of antibodies and will measure and compare cytokine profiles between obese and non-obese participants to determine any correlation with immune responses. This study will enrol 150 pregnant women (50 obese and 100 non-obese) during 2017-2019 to receive a recommended, licensed influenza vaccine (FluQuadri) as well as pertussis vaccination (Adacel) for women enrolled in their third trimester, as part of routine antenatal care. Local and systemic adverse events will be captured using a 7 day diary card and unexpected or serious adverse events will be recorded for the duration of the study. Blood samples will be collected to measure antigen specific vaccine antibody responses. The proportion of influenza vaccine recipients achieving seroprotective antibody titres at 4 weeks post vaccination and persisting at 6 months post vaccination be compared between obese and non-obese recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Biological: Quadrivalent Influenza Vaccine, Biological: DTP Vaccine (Multiple Actives)150 participants (pregnant women at least 18 years of age and meeting eligibility criteria) will be enrolled and administered the FluQuadri, the quadrivalent influenza vaccine which will be administered by single-dose intramuscular injection. Single-dose intramuscular injection of Adacel - DTP vaccine (multiple actives) will also be administered to all enrolled pregnant women who are at gestation 28 weeks or greater at the time of enrolment. Where the vaccines are to be co-administered, FluQuadri will be administered into the dominant arm and Adacel into the non-dominant arm. Pregnant women will be at a gestation of 20 weeks or greater at the time of enrolment. The vaccines administered are currently licensed and recommended in Australia to be given during pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 healthy pregnant women
Key inclusion criteria (3 listed)
- 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 etc).
- Pregnant women aged 18 years and over at the time of vaccination.
- Able to understand the information sheet and provide a written informed consent.
Key exclusion criteria (10 listed)
- 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 requiring treatment with insulin).
- History of seasonal influenza or dTpa vaccination within the last 6 months prior to enrolment.
- History of any immunosuppressive condition or currently on immunosuppressive medication.
- Any contraindication to influenza or dTpa immunisation.
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 |
|---|---|---|
| Quadrivalent Influenza VaccineAlso: FluQuadriInactivated quadrivalent influenza vaccine that is used for active immunisation against influenza A, B virus strains (contained in vaccine). Single dose administration by intramuscular injection to all enrolled pregnant women as part of routine antenatal care. | Biological | Pregnant women |
| DTP Vaccine (Multiple Actives)Also: AdacelPertussis vaccine acellular combined with diphtheria and tetanus toxoids. Single dose administration by intramuscular injection, to all enrolled pregnant women who are 28 weeks or greater gestation at time of enrolment, as part of routine antenatal care. | Biological | Pregnant women |
Primary outcome
Immunogenicity against the 4 influenza strains included in the 2017-2019 Southern Hemisphere Influenza vaccine pre and post vaccination in obese and non-obese women
Time frame: 1 month post vaccination
1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI>=40) following vaccination.
3 secondary outcomes
Antibodies to pertussis antigens
Time frame: 1 month post vaccination compared with baseline (pre vaccination).
Persistence of antibodies to pertussis antigens
Time frame: 6 months post vaccination.
Persistence of antibodies to the 4 influenza strains included in the 2017-2019
Time frame: 6 months post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to share with other researchers
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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.
Helen S Marshall, MBBS,MD,MPH principal investigator
Vaccinology and Immunology Research Trials Unit (VIRTU)
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 Obesity, run by Women's and Children's Hospital, Australia at 1 site in Australia.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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 Australia. 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?
Results are not available in the source record.
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?
Immunogenicity against the 4 influenza strains included in the 2017-2019 Southern Hemisphere Influenza vaccine pre and post vaccination in obese and non-obese women (time frame: 1 month post vaccination). 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 31 Jan 2024.