Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

NCT03457194 | Unknown FDA Drug

• 1 other identifier: HREC/17/WCHN/63
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed to investigate if:

1. 1.BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy.
2. 2.If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine.
3. 3.If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.

Conditions

Obesity

Keywords

Obesity; Vaccination; Pregnancy; Influenza; Pertussis; Maternal antibodies

Outcome Measures

Primary Outcomes (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

  1\. Hl titres (as measured by Haemagglutination Inhibition Assay). 1\. Proportion with antibody titres (HI\>=40) following vaccination.

  1 month post vaccination

Secondary Outcomes (3)

• Antibodies to pertussis antigens

  1 month post vaccination compared with baseline (pre vaccination).

• Persistence of antibodies to pertussis antigens

  6 months post vaccination.

• Persistence of antibodies to the 4 influenza strains included in the 2017-2019

  6 months post vaccination

Other Outcomes (4)

• Serum cytokines

  1 month post vaccination

• Serum cytokines

  6 month post vaccination.

• birthweight

  delivery of infant

Study Arms (1)

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; Biological: DTP Vaccine (Multiple Actives)

Interventions

Quadrivalent Influenza Vaccine 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.

Also known as: FluQuadri

Pregnant women

DTP Vaccine (Multiple Actives) 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.

Also known as: Adacel

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 150 healthy pregnant women

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's and Children's Hospital, Australia: lead
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

MeSH Terms

Conditions

Obesity; Influenza, Human; Whooping Cough

Interventions

Influenza Vaccines; Diphtheria-Tetanus-Pertussis Vaccine; adacel

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined

Study Officials

• Helen S Marshall, MBBS,MD,MPH

  Vaccinology and Immunology Research Trials Unit (VIRTU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Officer, Director Vaccinology and Immunology Research Trials Unit

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: March 7, 2018
• Study Start: August 28, 2018
• Primary Completion: September 29, 2023
• Study Completion: March 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)