A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313

NCT ID: NCT02532049

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-12
• Study Completion Date: 2017-05-25

Brief Summary

This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime.

All vaccines will be administered intramuscularly.

Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.

Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.

Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 1x10^8 pfu eight weeks later.

Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 2x10^8 pfu eight weeks later.

The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.

Healthy volunteers will be recruited in Oxford and Southampton, England.

Conditions

Malaria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

ChAd63 Pfs25-IMX313 (5x10\^9 vp)

Group Type: ACTIVE_COMPARATOR

ChAd63 Pfs25-IMX313

Intervention Type: BIOLOGICAL

Group 2A

ChAd63 Pfs25-IMX313 (5x10\^10 vp)

Group Type: ACTIVE_COMPARATOR

ChAd63 Pfs25-IMX313

Intervention Type: BIOLOGICAL

Group 2B

ChAd63 Pfs25-IMX313 (5x10\^10) and MVA Pfs25-IMX313 (1x10\^8 pfu) 8 weeks later

Group Type: ACTIVE_COMPARATOR

ChAd63 Pfs25-IMX313

Intervention Type: BIOLOGICAL

MVA Pfs25-IMX313

Intervention Type: BIOLOGICAL

Group 2C

ChAd63 Pfs25-IMX313 (5x10\^10) and MVA Pfs25-IMX313 (2x10\^8 pfu) 8 weeks later

Group Type: ACTIVE_COMPARATOR

ChAd63 Pfs25-IMX313

Intervention Type: BIOLOGICAL

MVA Pfs25-IMX313

Intervention Type: BIOLOGICAL

Interventions

ChAd63 Pfs25-IMX313

Intervention Type: BIOLOGICAL

MVA Pfs25-IMX313

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

The volunteer must satisfy all the following criteria to be eligible for the study:

• Healthy adults aged 18 to 50 years
• Able and willing (in the Investigator's opinion) to comply with all study requirements
• Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
• For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
• Agreement to refrain from blood donation during the course of the study
• Provide written informed consent

Exclusion Criteria

The volunteer may not enter the study if any of the following apply:

• Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
• Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
• Any history of anaphylaxis in relation to vaccination
• Pregnancy, lactation or willingness/intention to become pregnant during the study
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• History of serious psychiatric condition likely to affect participation in the study
• Any other serious chronic illness requiring hospital specialist supervision
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Suspected or known injecting drug abuse in the 5 years preceding enrolment
• Seropositive for hepatitis B surface antigen (HBsAg)
• Seropositive for hepatitis C virus (antibodies to HCV)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CCVTM, University of Oxford, Churchill Hospital

Oxford, , United Kingdom

NIHR Wellcome Trust Clinical Research Facility

Southampton, , United Kingdom

Countries

United Kingdom

References

de Graaf H, Payne RO, Taylor I, Miura K, Long CA, Elias SC, Zaric M, Minassian AM, Silk SE, Li L, Poulton ID, Baker M, Draper SJ, Gbesemete D, Brendish NJ, Martins F, Marini A, Mekhaiel D, Edwards NJ, Roberts R, Vekemans J, Moyle S, Faust SN, Berrie E, Lawrie AM, Hill F, Hill AVS, Biswas S. Safety and Immunogenicity of ChAd63/MVA Pfs25-IMX313 in a Phase I First-in-Human Trial. Front Immunol. 2021 Jul 14;12:694759. doi: 10.3389/fimmu.2021.694759. eCollection 2021.

Reference Type: DERIVED

PMID: 34335606 (View on PubMed)

Other Identifiers

VAC062

Identifier Type: -

Identifier Source: org_study_id