NCT02532049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 12, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

August 7, 2015

Last Update Submit

July 14, 2017

Conditions

Malaria

Keywords

MalariaVaccineImmune Response

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

    8 months

Secondary Outcomes (2)

  • Immunogenicity of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime.

    8 months

  • Ex-vivo efficacy of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime. The functional activity of the vaccine induced antibodies will be tested using membrane-feeding assays.

    8 months

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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

Biological: ChAd63 Pfs25-IMX313

Group 2A

ACTIVE COMPARATOR

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

Biological: ChAd63 Pfs25-IMX313

Group 2B

ACTIVE COMPARATOR

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

Biological: ChAd63 Pfs25-IMX313Biological: MVA Pfs25-IMX313

Group 2C

ACTIVE COMPARATOR

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

Biological: ChAd63 Pfs25-IMX313Biological: MVA Pfs25-IMX313

Interventions

ChAd63 Pfs25-IMX313BIOLOGICAL
Group 1Group 2AGroup 2BGroup 2C
MVA Pfs25-IMX313BIOLOGICAL
Group 2BGroup 2C

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CCVTM, University of Oxford, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

NIHR Wellcome Trust Clinical Research Facility

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34335606DERIVED

MeSH Terms

Conditions

Malaria

Interventions

ChAd63 Pfs25-IMX313 malaria vaccineMVA Pfs25-IMX313 malaria vaccine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 25, 2015

Study Start

October 12, 2015

Primary Completion

May 25, 2017

Study Completion

May 25, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

GB(2)