Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

NCT ID: NCT03457194

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2024-03-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Quadrivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

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)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

FluQuadri; Adacel

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Women's and Children's Hospital, Australia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Professor Helen Marshall

Senior Medical Officer, Director Vaccinology and Immunology Research Trials Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen S Marshall, MBBS,MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Vaccinology and Immunology Research Trials Unit (VIRTU)

Locations

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

HREC/17/WCHN/63

Identifier Type: -

Identifier Source: org_study_id