Immunisation for Adolescents Against Serious Communicable Diseases (B Part of it NT)

NCT04398849 | Unknown DMC

• 1 other identifier: Menzies HREC/2019-3507-V1.7
• Study Type: observational
• Target: 7,100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to implement a targeted 4CMenB immunisation program in young people aged 14-19 years in the Northern Territory (NT). As part of the NT program consenting 14-19 year olds will receive 2 doses of the licensed 4CMenB vaccine. An oropharyngeal swab will be collected on the same day as the first dose of the vaccine and 12 months later to assess carriage of Neisseria meningitidis. The first swab will assess baseline carriage prevalence among 14-19 year olds in the NT. The swab taken 12 months later will provide data on the change in carriage that may occur after implementation of the immunisation program. Emerging evidence suggests that the 4CMenB vaccine may be protective against gonorrhea. Therefore, vaccine effect (impact and effectiveness) against both invasive meningococcal disease (IMD) and gonorrhea in the NT will be assessed using data from the above study comparing notifications between vaccinated and unvaccinated as well as comparing pre and post implementation periods.

Conditions

Gonorrhea; Meningococcal Disease

Outcome Measures

Primary Outcomes (2)

• 1. 4CMenB vaccination status in the population with gonorrhoea compared to randomly selected Chlamydia controls (Case-control)

  Vaccination status among 15-19 year olds diagnosed with gonorrhoea compared to vaccination status of 15 - 19 year olds diagnosed with Chlamydia

  3 years

• Effect of 4CMenB vaccine on carriage of all N.meningitidis

  Prevalence of all N. meningitidis in the pharynx among 14-19 year olds as measured by PCR at baseline compared to 12 months

  12 months

Secondary Outcomes (17)

• 4CMenB vaccination status in the population with gonorrhoea compared to randomly selected controls from the Australian Immunisation Register (Case-control)

  3 years

• 4CMenB vaccination status in the population with gonorrhoea compared to the general population (Screening method)

  3 years

• All laboratory confirmed notifications of gonorrhoea in the six years preceding 4CMenB vaccination compared to three years post vaccination (Interrupted time series analysis)

  7 years

• All laboratory confirmed notifications of gonorrhoea in 15-19 year olds in the vaccinated population compared to the unvaccinated population

  3 years

• All laboratory confirmed notifications of gonorrhoea in the vaccinated population compared to the unvaccinated population stratified by gender

  3 years

Other Outcomes (3)

• Whole genome sequencing of all carriage isolates

  12 months

• Whole genome sequencing of all disease causing carriage isolates

  12 months

• Awareness of STIs and STI testing among young adults

  12 months

Study Arms (1)

14-19 year olds residing in the Northern Territory

All consenting 14-19 year olds residing in the Northern Territory in 2020-2021

Biological: Licenced 4CMenB Vaccine

Interventions

Licenced 4CMenB Vaccine BIOLOGICAL

Two doses (0.5 mL each) of Bexsero ® vaccine at least 2 months apart to be given to consenting 14-19 year olds

14-19 year olds residing in the Northern Territory

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All consenting 14-19-year-olds residing in the Northern Territory who do not have any of the above exclusion criteria

You may qualify if:

• All consenting 14-19 year olds residing in the Northern Territory in 2020-2021

You may not qualify if:

• Anaphylaxis following any component of Bexsero® vaccine
• Previous receipt of MenB vaccine (Bexsero® (Previous receipt of MenNZBTM is allowed).
• Known pregnancy
• Clinical conditions representing a contraindication to intramuscular vaccination and venipuncture
• Any clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study

Sponsors & Collaborators

• University of Adelaide: lead
• The University of New South Wales: collaborator
• Menzies School of Health Research: collaborator
• University of Sydney: collaborator
• The University of Western Australia: collaborator
• Northern Territory Government of Australia: collaborator
• SA Health: collaborator
• The University of Queensland: collaborator

Study Sites (1)

Northern Territory

Central Australia, Australia

RECRUITING

Related Publications (1)

• Marshall HS, Andraweera PH, Ward J, Kaldor J, Andrews R, Macartney K, Richmond P, Krause V, Koehler A, Whiley D, Giles L, Webby R, D'Antoine H, Karnon J, Baird R, Lawrence A, Petousis-Harris H, De Wals P, Greenwood-Smith B, Binks M, Whop L. An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia-Study Protocol. Vaccines (Basel). 2022 Feb 16;10(2):309. doi: 10.3390/vaccines10020309.

  PMID: 35214767 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oropharyngeal swab specimens

MeSH Terms

Conditions

Gonorrhea; Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Helen Marshall, MBBS,MD,MPH

CONTACT

+61 8 8161 8115; helen.marshall@adelaide.edu.au

Prabha Andraweera, MBBS,PhD

CONTACT

+61 8 8161 8117; prabha.andraweera@adelaide.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: March 4, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We estimate the data will be available from the start of 2025 for approximately 12 months
• Access Criteria: IPD will be made available on a case-by-case basis at the discretion of the International Scientific Advisory Committee and The NT Department of Health and Menzies School of Health Research and the Central Australian HREC. IPD data will only be available to achieve the aims in the approved proposal

Locations

AU (1)