A Phase 1 Study to Assess the Safety and Immunogenicity of R21/Matrix-M™ Administered in an Escalating Dose, Multi-prime Vaccination Schedule in Healthy Adults

NCT06320535 Phase 1 ACTIVE_NOT_RECRUITING

This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.

Details

Lead sponsor	University of Oxford
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	36
Start date	2024-03-25
Completion	2027-06

Conditions

• Malaria,Falciparum

Interventions

• R21/Matrix M™ (Group 1)
• R21/Matrix M™ (Group 2)
• R21/Matrix M™ (Group 3)
• Fine needle aspiration (FNA)

Primary outcomes

• Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of solicited adverse events in each group — 7 days post-vaccination
  Occurrence of solicited local and systemic reactogenicity signs and symptoms will be collected for 7 days following each vaccination. Solicited adverse event data will be tabulated, detailing frequency, duration and severity of the AEs.
• Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of unsolicited adverse events and laboratory adverse events in each group — 28 days post-vaccination.
  Occurrence of unsolicited adverse events and changes from baseline in laboratory safety measures will be collected for 28 days following each vaccination. Unsolicited AE data will be tabulated, detailing frequency, duration and severity of AEs. Hematological and biochemical laboratory values will be presented according to local grading scales.
• Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of serious adverse events in each group — For the follow-up period of the study, between 1-2 years
  Occurrence of serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawal due to AE(s)/SAE(s) will be described in detail.
• Humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule verus a standard prime-boost regimen in healthy UK adults — For the follow-up period of the study, between 1-2 years
  Antibody dynamics will be assessed by measuring NANP-IgG at baseline and various timepoints during the trial.

Countries

United Kingdom