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CompletedNCT02181088Updated Dec 3, 2015

A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5

A Phase 1 interventional study of ChAd63 RH5 low dose and ChAd63 RH5 full dose in Malaria and Plasmodium Falciparum, sponsored by University of Oxford. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by University of Oxford · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.

02

Conditions studied

  • Malaria
  • Plasmodium Falciparum

Keywords

  • Malaria
  • Plasmodium falciparum
  • RH5
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 26 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 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

Exclusion Criteria:

  • 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 human immunodeficiency virus (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 reaction 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
  • 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)
  • History of clinical malaria (any species)
  • Travel to a malaria endemic region during the study period or within the previous six months
  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
  • Inability of the study team to contact the volunteer's general practitioner (GP) to confirm medical history and safety to participate
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Group 1 (ChAd63 RH5 low dose)

    1 dose of ChAd63 RH5 5 x 10\^9 vp intramuscularly

    Biological: ChAd63 RH5 low dose

  • Experimental
    Group 2A (ChAd63 RH5 full dose)

    1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly

    Biological: ChAd63 RH5 full dose

  • Experimental
    Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose)

    1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 1 x 10\^8 pfu 8 weeks later intramuscularly

    Biological: ChAd63 RH5 full dose · Biological: MVA RH5 low dose

  • Experimental
    Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose)

    1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 2 x 10\^8 pfu 8 weeks later intramuscularly

    Biological: ChAd63 RH5 full dose · Biological: MVA RH5 full dose

Interventions

  • BiologicalChAd63 RH5 low dose

    ChAd63 RH5 at 5 x 10\^9 vp

    Also known as: ChAd63 RH5

  • BiologicalChAd63 RH5 full dose

    ChAd63 RH5 at 5 x 10\^10 vp

    Also known as: ChAd63 RH5

  • BiologicalMVA RH5 low dose

    MVA RH5 at 1 x 10\^8 pfu

    Also known as: MVA RH5

  • BiologicalMVA RH5 full dose

    MVA RH5 at 2 x 10\^8 pfu

    Also known as: MVA RH5

06

What researchers measure

Primary outcomes

  1. To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5

    Occurrence of solicited and unsolicited adverse events will be monitored at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results.

    Time frame: 240 days

Secondary outcomes

  1. To assess the cellular and humoral immunogenicity of ChAd63 RH5 when administered alone, and in heterologous prime-boost with MVA RH5 in healthy volunteers.

    P. falciparum RH5-specific immunogenicity will be assessed by a variety of immunological assays. These may include ex vivo ELISpot assays for interferon gamma and flow cytometry assays, as well as antibody ELISAs, functional antibody assays and B cell analyses. Other exploratory immunological assays including cytokine analysis, other antibody assays, anti-adenovirus antibodies, DNA analysis of genetic polymorphisms potentially relevant to vaccine immunogenicity and gene expression studies amongst others may be performed at the discretion of the Investigators.

    Time frame: 240 days

07

Study locations

2 sites
  • Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
    Oxford, OX3 7LE, United Kingdom
  • Wellcome Trust CRF, Southampton General Hospital, University of Southampton
    Southampton, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02181088
Lead sponsor
University of Oxford
Collaborators
European Commission
Responsible party
Sponsor
First posted
Jul 3, 2014
Start date
Aug 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Dec 3, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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