Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009774604118 Date of Approval: 03/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Gonococcal vaccine study in key populations in Kenya
Official scientific title Use of Bexsero immunization to detect cross-reactive antigens and anti-gonococcal antibodies in key populations in Kenya
Brief summary describing the background and objectives of the trial Gonorrhoea is a sexually transmitted infection that can infect both men and women. It can cause infections in the genitals, rectum, and throat. It is a very common infection, especially among young people aged 18-25 years. Meningococcal disease and gonorrhoea are caused by bacteria that are closely related but cause different diseases that are spread in different ways. New evidence suggests that the Meningococcal B vaccine (Bexsero®) licensed outside of Kenya against meningococcal B disease may also be effective against gonorrhoea due to genetic similarities between the two organisms causing the two diseases. The aim of this study is to generate data to develop a gonorrhoea vaccine, using an existing vaccine against meningococcal disease.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied gonorrhoea
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/10/2020
Actual trial start date
Anticipated date of last follow up 31/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL https://clinicaltrials.gov/ct2/show/NCT04297436
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 4CMenB vaccine 4CMenB vaccine (Bexsero®; 0.5mL). The vaccine is given, twice and approximately two months apart. To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) elicits humoral and T cell cross-reactive responses against Ng. We will exploit Bexsero as an immunological probe to identify antigens that elicit humoral cross-reactive responses against Ng. We will examine IgG reactivity against these Ng proteins in microarrays with sera from Bexsero vaccinated individuals with high Ng exposure. Comparison of the pre/post immunization sera will provide a comprehensive overview of Bexsero antigens which induce Ng-cross reactive IgG responses and could therefore be responsible for Nm OMV-mediated protection against Ng. This approach is likely to be more informative than comparing results between control and immunized subjects, as individuals’ exposure and responses to Ng are likely to differ. Screening will be performed on plasma taken at enrolment, approximately 2 weeks post first immunization, approximately 2 weeks post second immunization and at 6 months. 50
Control Group 4CMenB vaccine N/A N/A N/A 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Minimum Age: 18 Years Maximum Age: 25 Years Sex: All Gender Based: No Accepts Healthy Volunteers: Yes Criteria: Inclusion Criteria: • Healthy male and female as assessed by a medical history, physical exam, and laboratory tests. • HIV-positive participants who are adherent to ART and virally suppressed (viral load <200 copies per ml) are considered healthy . • At least 18 years of age on the day of screening and will not reach 26th birthday on the day of the second vaccination (approximately 6 weeks after enrolment) • Willing and able to give informed consent for participation in the trial before any study-related procedures are performed. • Willing to donate blood samples for immunogenicity assessments. Exclusion Criteria: • Any clinically significant acute or chronic medical condition that is considered progressive that, in the opinion of the Principal Investigator or designee, makes the volunteer unsuitable for participation in the trial • Pregnancy • Participation in another clinical trial (i.e. investigational HIV vaccine candidate), within the previous 3 months or expected participation during the study • Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions). • History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema). Adult: 19 Year-44 Year 18 Year(s) 25 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/07/2020 KEMRI SCIENTIFIC ETHICS REVIEW UNIT
Ethics Committee Address
Street address City Postal code Country
P.O Box 54840 Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/06/2020 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Oxford, Research Services, University Offices Wellington Square, Oxford OX1 2JD Oxford 0X1 2JD United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) elicits humoral and T cell cross-reactive responses against Ng. Screening will be performed on plasma taken at enrolment, approximately 2 weeks post first immunization, approximately 2 weeks post second immunization and at 6 months.
Secondary Outcome To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) differs between HIV negative and positive participants. Screening will be performed on plasma taken at enrolment, approximately 2 weeks post first immunization, approximately 2 weeks post second immunization and at 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institute CGMRC Off Hospital Road, P.O Box 230 Kilifi 80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
WELLCOME TRUST 215 Euston Road London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Office Block 60 Churchill Hospital Old Road Headington Oxford OX3 7LE Oxford United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Prof Christoph Tang Sir William Dunn School of Pathology, University of Oxford, South Parks Road, Oxford, OX1 3RE Oxford OX1 3RE United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eduard Sanders Esanders@kemri-wellcome.org +254723593762 Off Hospital Road, P.O Box 230
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Kenya Medical Research Institute CGMRC
Role Name Email Phone Street address
Scientific Enquiries Eduard Sanders ESanders@kemri-wellcome.org +254723593762 Off Hospital Rd, P. O Box 230
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Kenya Medical Research Institute CGMRC
Role Name Email Phone Street address
Public Enquiries Clara Agutu CAgutu@kemri-wellcome.org +254720735000 Off Hospital Road, P.O Box 230
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Kenya Medical Research Institute CGMRC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After the study period, once the primary results are published, a de-identified copy of the data will be prepared for deposition in the KWTRP data repository (https://dataverse.harvard.edu/) under managed access through the KWTRP Data Governance Committee (Data_Governance_Committee@kemri-wellcome.org). Informed Consent Form,Study Protocol Following publication of the main study results Access will be managed through the KWTRP Data Governance Committee (Data_Governance_Committee@kemri-wellcome.org).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information