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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02181088
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment Phase
Malaria Plasmodium Falciparum Biological: ChAd63 RH5 low dose Biological: ChAd63 RH5 full dose Biological: MVA RH5 low dose Biological: MVA RH5 full dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : August 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Group 1 (ChAd63 RH5 low dose)
1 dose of ChAd63 RH5 5 x 10^9 vp intramuscularly
Biological: ChAd63 RH5 low dose
ChAd63 RH5 at 5 x 10^9 vp
Other Name: ChAd63 RH5

Experimental: Group 2A (ChAd63 RH5 full dose)
1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly
Biological: ChAd63 RH5 full dose
ChAd63 RH5 at 5 x 10^10 vp
Other Name: ChAd63 RH5

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
ChAd63 RH5 at 5 x 10^10 vp
Other Name: ChAd63 RH5

Biological: MVA RH5 low dose
MVA RH5 at 1 x 10^8 pfu
Other Name: MVA RH5

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
ChAd63 RH5 at 5 x 10^10 vp
Other Name: ChAd63 RH5

Biological: MVA RH5 full dose
MVA RH5 at 2 x 10^8 pfu
Other Name: MVA RH5




Primary Outcome Measures :
  1. To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5 [ Time Frame: 240 days ]
    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.


Secondary Outcome Measures :
  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. [ Time Frame: 240 days ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181088


Locations
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United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, United Kingdom, OX3 7LE
Wellcome Trust CRF, Southampton General Hospital, University of Southampton
Southampton, United Kingdom
Sponsors and Collaborators
University of Oxford
European Commission

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02181088     History of Changes
Other Study ID Numbers: VAC057
2013-005458-31 ( EudraCT Number )
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by University of Oxford:
Malaria
Plasmodium falciparum
RH5

Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases