| Protocol No: | ECCT/20/11/01 | Date of Protocol: | 21-07-2020 |
| Study Title: | Protocol Title: USE OF BEXSERO IMMUNIZATION TO DETECT CROSS REACTIVE ANTIGENS AND ANTI-GONOCOCCAL ANTIBODIES IN KEY POPULATIONS IN KENYA. |
| Study Objectives: | To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) will enhance an immune response against Neisseria gonorrhoeae. Primary objective –To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) elicits humoral and T cell cross-reactive responses against Ng. Explorative objective – To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) differs between HIV negative and positive participants. 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. We will also explore if immune responses differ 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. |
| Laymans Summary: | What is the problem/background? 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.
What questions are we trying to answer? To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) will enhance an immune response against Neisseria gonorrhoeae.
Where is the study taking place, how many people does it involve and how are they selected? Approximately 50, young adults (aged 18 - 25 years old) who are enrolled in the KEMRI cohort studies (known as Open B, Three-site, N, or Sue; including HIV-uninfected and infected individuals) in the KEMRI clinic in Mtwapa will be able to participate in this study.
What does the study involve for those who are in it? Participants will make five study visits, including a screening visit, an enrolment visit and 3 follow up visits. We will offer vaccination with the Meningococcal B vaccine (Bexsero®) vaccine at the enrolment visit and approximately 2 months later. We will use socio-demographic and risk behavior data collected under the KEMRI cohort studies. We will collect a 24 ml blood sample (2 ½ table spoons) at enrolment, and a 70 ml blood sample (7 table spoons) following the second vaccination. At study completion (month 6), we will collect a 4ml (1 tea spoon) blood sample. We will collect a throat swab, a urine sample (for men), vaginal swab, and an anal swab at the enrolment, month 3 and month 6 visit to test for Chlamydiae and Gonorrhoea infection. What are the benefits and risks/costs of the study for those involved? In this study, the Meningococcal B vaccine (Bexsero®) is safe and is well tolerated, with over 17 million doses already given worldwide. There is the possibility of common side effects that are mild and may include a mild fever, soreness at the injection site, headache and generally feeling unwell for 1-2 days, similar to some other vaccines. As with all vaccines there is the possibility of rare and more serious reactions such as an allergic/ anaphylactic reaction to the vaccine.
For participants there are no direct benefits, as they will receive the same research services as in the KEMRI cohorts that they participate in already. Meningococcal B vaccine (Bexsero®) prevents only against the meningococcal B strain which is common in Europe, Australia, and the Unites States.
How will the study benefit society? Researchers hope to gain new insights on how the Meningococcal B vaccine (Bexsero®) can be improved upon to make a vaccine against gonorrhoeae. There is currently no vaccine available against N. gonorrhoeae.
When does the study start and finish? This study is anticipated to start in the fourth quarter of 2020, following ethical and regulatory approvals. Participants will be involved in the study for 6 months. The sample and data analysis will continue for 1-2 years and a report will be disseminated in 2022. |
| Abstract of Study: |
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. We will conduct a clinical trial of the Meningococcal B vaccine (Bexsero®) in approximately 50 male and female participants aged 18-25 years who are in follow up in KEMRI cohorts (including HIV-uninfected and infected individuals) at the KEMRI clinic in Mtwapa. This is not an efficacy trial. Instead, we will assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) elicits humoral and T cell cross-reactive responses against Neisseria gonorrhoeae (Ng). Participants will make five study visits, including a screening visit, an enrolment visit and 3 follow up visits. We will offer vaccination with the Meningococcal B vaccine (Bexsero®) vaccine at the enrolment visit and approximately 2 months later. We will collect a 20ml blood sample at enrolment, and a 70ml blood sample following the second vaccination. At study completion (month 6), we will collect a 4ml blood sample. We will collect a throat swab, a urine sample (for men), vaginal swab, and an anal swab at the enrolment, month 3 and month 6 visit to test for Chlamydiae and Gonorrhoea infection. Total study participation for participants is 6 months. Upon study completion, participants will continue to receive research care at the KEMRI clinic in Mtwapa. |