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Optimising Protection for Pregnant Women and Infants With Maternal Vaccination (OPTIWIN)

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ClinicalTrials.gov Identifier: NCT03457194
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Professor Helen Marshall, Women's and Children's Hospital, Australia

Brief 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. If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.

Condition or disease Intervention/treatment
Obesity Biological: Quadrivalent Influenza Vaccine Biological: DTP Vaccine (Multiple Actives)

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 Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 30, 2021


Group/Cohort Intervention/treatment
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.

Biological: Quadrivalent Influenza Vaccine
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.
Other Name: FluQuadri

Biological: DTP Vaccine (Multiple Actives)
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.
Other Name: Adacel




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Antibodies to pertussis antigens [ Time Frame: 1 month post vaccination compared with baseline (pre vaccination). ]
    1. antibody titres to PRN, PT, FHA (measured by ELISA)

  2. Persistence of antibodies to pertussis antigens [ Time Frame: 6 months post vaccination. ]
    1. antibody titres to PRN, PT, FHA (measured by ELISA)

  3. Persistence of antibodies to the 4 influenza strains included in the 2017-2019 [ Time Frame: 6 months post vaccination ]

    1. Hl titres (as measured by Haemagglutination Inhibition Assay).

    1. Proportion with antibody titres (HI>=40) following vaccination.



Other Outcome Measures:
  1. Serum cytokines [ Time Frame: 1 month post vaccination ]
    Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array).

  2. Serum cytokines [ Time Frame: 6 month post vaccination. ]
    Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array)

  3. birthweight [ Time Frame: delivery of infant ]
    weight in grams

  4. haemagglutination Inhibition Antibody Titres in cord blood [ Time Frame: at delivery of infant ]
    HI Titre (as measured by Haemagglutination Inhibition Assay)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 150 healthy pregnant women
Criteria

Inclusion Criteria:

  • 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.

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 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457194


Contacts
Contact: Michelle F Clarke, MLS,GDSC,MPH (08) 81618105 michelle.clarke@adelaide.edu.au

Sponsors and Collaborators
Women's and Children's Hospital, Australia
Sanofi Pasteur, a Sanofi Company
Investigators
Principal Investigator: Helen S Marshall, MBBS,MD,MPH Vaccinology and Immunology Research Trials Unit (VIRTU)

Responsible Party: Professor Helen Marshall, Senior Medical Officer, Director Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Australia
ClinicalTrials.gov Identifier: NCT03457194     History of Changes
Other Study ID Numbers: HREC/17/WCHN/63
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be made available to share with other researchers

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Professor Helen Marshall, Women's and Children's Hospital, Australia:
Obesity
Vaccination
Pregnancy
Influenza
Pertussis
Maternal antibodies

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs