By: Jesca and Stephen
As part of MUWRP’s large research profile, we are conducting a Randomized Controlled Double-Blind Phase I/II Dose-escalation Clinical Trial to assess the safety, reactogenicity and immunogenicity of a candidate vaccine against intestinal schistosomiasis in healthy adult volunteers living in the S. Mansoni endemic areas in and around Kampala – Uganda.
The study has 2 parts, parts A and B. Part A of the Schistosomiasis study is intended to identify the ideal dose of 3 different doses and combinations of vaccine with 1 or 2 adjuvants (vaccine helper). This was successfully conducted, with the last follow-up visit anticipated to occur around August, 2021. Hepatitis B vaccine was used as a control, given similar reactogenicity (how the body responds to a vaccine). Part B of the study is expected to kick off in March, 2021 after a careful review of the safety and immunogenicity of the selected dose in Part A; and preparations are now underway.
In Part B of the Schistosomiasis study, the study team will target to enroll a total of 200 with evidence of intestinal Schistosomiasis (S.mansoni eggs in their stool) for the selected dose of vaccine combination. These participants will be given schistosomiasis treatment before enrollment in the clinical trial and will be randomly assigned to receive the selected dose or the control (Hepatitis B vaccine) in a 1:1 ratio.
The study plans to recruit participants from two landing sites on lake Victoria; Kasenyi landing site (on the northern shores of Lake Victoria, about 5.5km off Kampala-Entebbe main road) and Gaba landing site (on the shores of Lake Victoria, at the southern tip of the of Kampala, approximately 11 Kilometres from Kampala).
There are several activities at Kasenyi landing site that predisposes people to schistosomiasis infection most notably the all-day bare foot stepping in the infested water to hand -lift passengers and commodities to and from the boats.
The Community Outreach team is carrying out feasibility visits to the sites proposed for recruitment of participants into the study. Pre-screening to determine those with Schistosoma eggs in their stool (for screening efficiency) will be conducted in the field, and eligible participants will receive treatment (as per MoH guidelines); and referred for further screening and enrolment at MUWRP’s research clinic on Nakasero Road, Kampala.
