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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: 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
• Enrollment (Actual): 73

Contacts and Locations

• Study Contact: Name: Michelle F Clarke, MLS,GDSC,MPH; Phone Number: (08) 81618105; Email: michelle.clarke@adelaide.edu.au

Study Locations

• Australia
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A total of 150 healthy pregnant women

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: 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 Names: Adacel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI>=40) following vaccination.	1 month post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibodies to pertussis antigens	1. antibody titres to PRN, PT, FHA (measured by ELISA)	1 month post vaccination compared with baseline (pre vaccination).
Persistence of antibodies to pertussis antigens	1. antibody titres to PRN, PT, FHA (measured by ELISA)	6 months post vaccination.
Persistence of antibodies to the 4 influenza strains included in the 2017-2019	1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI>=40) following vaccination.	6 months post vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum cytokines	Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array).	1 month post vaccination
Serum cytokines	Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array)	6 month post vaccination.
birthweight	weight in grams	delivery of infant
haemagglutination Inhibition Antibody Titres in cord blood	HI Titre (as measured by Haemagglutination Inhibition Assay)	at delivery of infant

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): September 29, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; Influenza; Vaccination; Pertussis; Maternal antibodies
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: HREC/17/WCHN/63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be made available to share with other researchers

Drug and device information, study documents

• 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