Phase 2 Trial to Assess the Immunogenicity and Safety of the ChAdOx1 RVF Vaccine Against Rift Valley Fever in Adults in Kenya

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to learn if ChAdOx1 RVF, a candidate vaccine against RVF, provides an adequate immune response and determine its safety among Kenyan adults. The main aims are: * To assess the proportion of individuals mounting an immune response following vaccination with a single dose of ChAdOx1 RVF * To monitor occurrence of any adverse events following vaccination * To assess whether two doses of ChAdOx1 RVF elicit an immune response that is more durable than that generated by a single dose of ChAdOx1 RVF Researchers will compare ChAdOx1 RVF vaccine to a rabies vaccine in 240 participants. Participants will be randomly allocated to one of three study groups and vaccinated with ChAdOx1 RVF or a control Rabies vaccine as follows. Group 1, composed of 120 participants, will receive a single dose of ChAdOx1 RVF vaccine at baseline and a single dose of rabies vaccine 3 months later. Group 2, composed of 60 adults, will receive two doses of ChAdOx1 RVF; the first dose at baseline and the second dose 3 months later. Group 3, composed of 60 adults, will receive two doses of rabies vaccine; the first dose at baseline and the second dose 3 months later. Participants will receive daily phone calls after each vaccination for the following six days to gather information on any symptoms they may experience. Participants will be instructed to contact the study team at any time should they experience any clinical symptoms. Blood samples will be collected at baseline (before vaccination) and at scheduled follow-up visits (8 visits over the duration of the study, i.e. days 7, 14, 28, 84, 91, 112, 365 and 540 after the first vaccination) for monitoring of immune responses. Up to 20mls of blood will be collected at each scheduled visit. Participants will be followed-up for 18 months from the first dose of vaccine. Adverse events following vaccination will be monitored throughout the study and reviewed by an independent Data and Safety Monitoring Board (DSMB)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Healthy adult aged 18-50 years

• For females only, willingness to practice continuous effective contraception up to one month following the second vaccination (i.e. duration of 4 months starting from enrolment) and a negative pregnancy test on the day(s) of screening. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device. Female participants will be asked for written confirmation of any family planning methods used by provision of health records. These records will be reviewed and counselling for adherence done at each study visit as per the protocol schedule of attendances. Participants who do not have adequate methods of contraception will be referred to their local dispensary where this will be dispensed for free or to Kilifi County Hospital (KCH). Costs incurred for obtaining contraception at KCH will be covered by the study.

• Agreement to refrain from blood donation during the course of the study

• Able and willing to provide written informed consent

• Plan to remain resident in the study area for 18 months following vaccination

Locations
Other Locations
Kenya
KEMRI-Wellcome Trust Research Programme
RECRUITING
Kilifi
Contact Information
Primary
George Warimwe, PhD
Gwarimwe@kemri-wellcome.org
+254709983000
Backup
Philip Bejon, PhD
philip.bejon@ndm.ox.ac.uk
+254709983549
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 240
Treatments
Experimental: Single dose ChAdOx1 RVF
Group 1, composed of 120 participants, will receive a single dose of ChAdOx1 RVF vaccine at baseline and a single dose of rabies vaccine 3 months later
Experimental: Double dose ChAdOx1 RVF
Group 2, composed of 60 adults, will receive two doses of ChAdOx1 RVF; the first dose at baseline and the second dose 3 months later.
Active_comparator: Rabies vaccine
Group 3, composed of 60 adults, will receive two doses of rabies vaccine; the first dose at baseline and the second dose 3 months later
Sponsors
Leads: University of Oxford

This content was sourced from clinicaltrials.gov

Similar Clinical Trials