Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

Obesity Clinical Trial

— OPTIWIN  

Official title:

Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03457194
• Other study ID #: HREC/17/WCHN/63
• Status: Active, not recruiting
• Start date: August 28, 2018
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Women's and Children's Hospital, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: March 1, 2024
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Women's and Children's Hospital	North Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Women's and Children's Hospital, Australia	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum cytokines	Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array).	1 month post vaccination
Other	Serum cytokines	Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array)	6 month post vaccination.
Other	birthweight	weight in grams	delivery of infant
Other	haemagglutination Inhibition Antibody Titres in cord blood	HI Titre (as measured by Haemagglutination Inhibition Assay)	at delivery of infant
Primary	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	Antibodies to pertussis antigens	1. antibody titres to PRN, PT, FHA (measured by ELISA)	1 month post vaccination compared with baseline (pre vaccination).
Secondary	Persistence of antibodies to pertussis antigens	1. antibody titres to PRN, PT, FHA (measured by ELISA)	6 months post vaccination.
Secondary	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