Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000738628
Ethics application status
Approved
Date submitted
12/06/2023
Date registered
7/07/2023
Date last updated
30/06/2024
Date data sharing statement initially provided
7/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
VIRGo – Vaccine-induced Immune Responses against Gonorrhoea: A study to investigate immune response induced by the 4CMenB vaccine against gonorrhoea
Scientific title
VIRGo – Vaccine-induced Immune Responses against Gonorrhoea: A study to investigate immune response induced by the 4CMenB vaccine against gonorrhoea in healthy adults
Secondary ID [1] 309880 0
Nil known
Universal Trial Number (UTN)
U1111-1293-6807
Trial acronym
VIRGo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gonorrhoea 330337 0
Condition category
Condition code
Infection 327185 327185 0 0
Sexually transmitted infections
Inflammatory and Immune System 327232 327232 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of 0.5mL 4CMenB vaccine intramuscularly at baseline and 2 months. A pre-vaccination checklist will be used to ensure safe administration of vaccine. Administration of vaccine including batch and expiry dates and recording immediate adverse events will be recorded in the participant's clinical electronic record and in the electronic case report form. Optional consent will be sought to record administration of vaccine in the Australian Immunisation Register.
Intervention code [1] 326303 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335062 0
Antibody killing of N. gonorrhoeae measured by serum bactericidal activity (SBA) assays
Timepoint [1] 335062 0
3 and 6 months from baseline
Primary outcome [2] 335119 0
Antibody function blocking activity measured as percentage inhibition of adherence to, and invasion of N. gonorrhoeae to epithelial cells, assessed as a composite outcome
Timepoint [2] 335119 0
3 and 6 months from baseline
Primary outcome [3] 335241 0
Antibody killing of N. gonorrhoeae measured by serum opsonophagocytic (OPA) assays
Timepoint [3] 335241 0
3 and 6 months from baseline
Secondary outcome [1] 422893 0
Antibody levels (measured in titres) against whole cell N. gonorrhoeae, outer membrane vesicles (OMV), and Neisserial Heparin Binding Antigen (NHBA) measured by Enzyme Linked Immunosorbent Assays (ELISA) pre- and post- vaccination, assessed as a composite outcome
Timepoint [1] 422893 0
3 and 6 months from baseline (1 and 4 months from completion of vaccine course)
Secondary outcome [2] 423114 0
Antigen-specific memory B cells and T-cell responses measured by flow cytometry, ELISPOT and cytokine assays, assesssed as a composite outcome
Timepoint [2] 423114 0
3 and 6 months from baseline

Eligibility
Key inclusion criteria
i. Are between 18 to 50 years of age
ii. Are able to understand spoken and written English
iii. Are able to participate in study procedures including attending for all study visits
iv. Agree to be contacted via phone/ email by the study team
v. Have sexual partners of the opposite sex only
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i. Documented allergy to latex and/ or kanamycin
ii. Confirmed previous history of vaccination for Meningococcal B with 4CMenB vaccine)
iii. Contraindications to receiving the Meningococcal B vaccine which include:
a) Anaphylaxis following a previous dose of any meningococcal vaccine
b) Anaphylaxis following any vaccine component
iv. Pregnant or intending to become within the next 3 months
v. Currently breast-feeding
vi. Received a COVID vaccine within the last 7 days
vii. Patients who are currently recommended and funded to received 4CMenB vaccine including:
a) Sickle cell disease or other haemoglobinopathies
b) Congenital or acquired asplenia (e.g. Splenectomy or hyposplenia)
c) Defects in, or deficiency of, complement components including factor H, factor D or properdin deficiency
d) Current or future treatment with eculizumab (a monoclonal antibody directed against complement component C5)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Serum bactericidal activity (SBA) is the primary outcome. From preliminary SBA assays of 26 men at baseline and 6 months of which 16 were vaccinated with 4CMenB it was observed that baseline or unvaccinated men had titres of 4 or less while bactericidal activity could be reliably ascertained at titres of 8 or greater. Thus the minimal clinically important difference to detect a bactericidal effect is between a titre of 4 and 8 or, as titres are to be Log2 transformed, between log-titres of 2 and 3. Based on the 52 assays mentioned, the standard deviation (SD) of log-titres of non-bactericidal sera was estimated as 0.4 and for bactericidal sera as 1.1. Using these SDs and the defined minimal clinically important difference and based on a two-sample t-test we will need 12 participants in each group to detect this difference with 80% power at a significance level of 0.05. As we are interested in four groups (Male, Female, gonorrhea exposed, non-exposed) we will need a minimum of 48 participants. If two groups both show bactericidal activity but at different levels, ie both groups have log-titres above 1, 12 participants per group will allow us to detect a difference in mean log-titre of 1.4 (a titre fold change of 2.6). To allow for attrition, we plan to recruit 15 participants per group for a total of 60.
Log(base2) transformed antibody, SBA, OPA and neutralisation titres for each of the 0, 3, and 6-month time points will be, initially, compared pre- and post vaccination by linear regression with log2-titre at time 0 as a covariate. Other clinical and demographic covariates will also be tested, along with vaccination status. Variables will be considered as covariates and retained in the model if P<0.05. Finally, a mixed effects analysis of the trajectory of the log2-titres over the 6-month duration of the study will be performed with participant number as a random effect and vaccination status as the fixed effect of interest. Again, other clinical and demographic variables will be tested as covariates. Simple antibody titres will be similarly analysed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24894 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 40544 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 314064 0
Government body
Name [1] 314064 0
National Health and Medical Research Council
Country [1] 314064 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard
Southport 4215
Queensland
Country
Australia
Secondary sponsor category [1] 315968 0
None
Name [1] 315968 0
Address [1] 315968 0
Country [1] 315968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313200 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313200 0
Ethics committee country [1] 313200 0
Australia
Date submitted for ethics approval [1] 313200 0
16/03/2023
Approval date [1] 313200 0
26/05/2023
Ethics approval number [1] 313200 0
HREC/2023/QGC/94612

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127326 0
Dr Caroline Thng
Address 127326 0
Gold Coast Sexual Health Service
Southport Health Precinct
Level 4, 16-30 High Street
Southport 4215
Queensland
Country 127326 0
Australia
Phone 127326 0
+61 756879333
Fax 127326 0
+61756879212
Email 127326 0
[email protected]
Contact person for public queries
Name 127327 0
Caroline Thng
Address 127327 0
Gold Coast Sexual Health Service
Southport Health Precinct
Level 4, 16-30 High Street
Southport 4215
Queensland
Country 127327 0
Australia
Phone 127327 0
+61 756879200
Fax 127327 0
+61756879212
Email 127327 0
[email protected]
Contact person for scientific queries
Name 127328 0
Caroline Thng
Address 127328 0
Gold Coast Sexual Health Service
Southport Health Precinct
Level 4, 16-30 High Street
Southport 4215
Queensland
Country 127328 0
Australia
Phone 127328 0
+61 756879200
Fax 127328 0
+61756879212
Email 127328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Raw line by line data will contain confidential health information which cannot be shared publicly


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19425Ethical approval    386067-(Uploaded-12-06-2023-11-46-38)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.