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

NCT ID: NCT04398849

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 7100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2024-12-31

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.

Detailed Description

Meningococcal disease and gonorrhea cause severe morbidity in Australian adolescents, particularly among Aboriginal People. The two diseases are caused by bacteria that are genetically related, but very different in their patterns of transmission and pathogenesis. Bacterial meningitis and sepsis from Neisseria meningitidis (often called meningococcus) can have severe outcomes including long-term disability, arising from neurological deficits and from necrotic skin and gangrene of the limbs requiring amputations. The case fatality rate is ~10%. A multicomponent meningococcal B (4CMenB) vaccine (Bexsero®) is approved and licensed for use against MenB disease in Australia but not funded on the National Immunisation Program (NIP) due to failure to meet cost effectiveness criteria. New emerging data suggest 4CMenB may also protect against gonococcal infection, a sexually transmissible infection (STI) which can infect the urethra, cervix, rectum, conjunctiva, and throat. If left untreated, gonorrhoea can lead to pelvic inflammatory disease, tubal scarring and ultimately infertility in females, and swelling and scarring in the epididymis or testicles in males. In the NT, notification rates for gonorrhoea in 15-19 year olds range from 1924/100,000 to 17,022/100,000 in Aboriginal young people and from 106/100,000 to 1081/100,000 in non-Aboriginal young people over different areas of The Territory (averaged over 2014-2018). At present there is no vaccine against gonorrhoea. Emerging evidence shows that the 4CMenB vaccine may have some protection against gonorrhoea due to genetic similarities that exist between the two organisms that cause meningitis and gonorrhoea. If the effectiveness of the 4CMenB vaccine against gonorrhoea can be demonstrated at a population level it would have substantial health benefits to be gained world-wide, but particularly for Aboriginal People.

Consenting 14-19 year olds will be asked to complete a 1-2 page questionnaire to collect information on risk factors for meningococcal disease and meningococcal carriage. A throat swab will be obtained and the first dose of the 4CMenB vaccine will be administered. Two-three months after the first dose, participants will receive the second dose of the 4CMenB vaccine. One year after the first dose, the participants will be asked to come for the third visit, where they will be asked to complete the same questionnaire that was completed during visit one and a throat swab taken. Throat swabs will be tested to detect the meningococcus bacteria which is carried in the throat of around 10% of people. Research in South Australia has shown double the rates of carriage in Aboriginal People compared to non-Aboriginal People.

The effectiveness of the 4CMenB vaccine against meningococcal carriage, invasive meningococcal disease and gonorrhoea will be evaluated using results of meningococcal carriage and routine surveillance data on IMD and gonorrhoea obtained from the Centre for Disease Control (CDC), the data custodian for notifiable diseases in the NT. The evaluations will include comparisons between vaccinated vs unvaccinated and number of notifications in post vs pre study implementation periods. The data on IMD and gonorrhoea notifications in the NT will be obtained from the Communicable Disease Control in the NT. The main methodological approaches involve an Interrupted Time Series regression model, screening approaches, and case-control analyses with different sets of controls to estimate vaccine impact and effectiveness

Conditions

Gonorrhea; Meningococcal Disease

Study Design

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

Study Groups

14-19 year olds residing in the Northern Territory

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

Licenced 4CMenB Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

Licenced 4CMenB Vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of New South Wales

OTHER

Sponsor Role: collaborator

Menzies School of Health Research

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

The University of Western Australia

OTHER

Sponsor Role: collaborator

Northern Territory Government of Australia

OTHER_GOV

Sponsor Role: collaborator

SA Health

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: collaborator

University of Adelaide

OTHER

Sponsor Role: lead

Responsible Party

Helen Marshall

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northern Territory

Central Australia, , Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Helen Marshall, MBBS,MD,MPH

Role: CONTACT

helen.marshall@adelaide.edu.au

+61 8 8161 8115

Prabha Andraweera, MBBS,PhD

Role: CONTACT

prabha.andraweera@adelaide.edu.au

+61 8 8161 8117

Facility Contacts

Helen Marshall

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35214767 (View on PubMed)

Other Identifiers

Menzies HREC/2019-3507-V1.7

Identifier Type: -

Identifier Source: org_study_id