Trial document





This trial has been registered retrospectively.
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  DRKS00017462

Trial Description

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Title

Safety and protective efficacy of a simplified Plasmodium falciparum sporozoite chemoprophylaxis Vaccine (PfSPZ-CVac) regimen in healthy malaria-naïve adults in Germany

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Trial Acronym

CVac-Tü3

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Malaria vaccine study: Live malaria pathogens are administered to healthy volunteers for immunisation, whereby the parasites are simultaneously attenuated by a malaria drug (chloroquine). After the first immunization (day 0), this is repeated 5 and 28 days later. The number of pathogens is controlled by the administration of medication, so that only weak malaria symptoms can be expected or even avoided.
The success of this vaccination is tested by re-administration of the malaria pathogens, but without simultaneous administration of the malaria drug. If immunisation was successful, the subjects should not develop any symptoms (except for the control group). This so-called "challenge" is performed three times in total, 10, 26 and 52 weeks after the last immunization.

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Brief Summary in Scientific Language

A new regime of a malaria vaccine shall be tested, which is based on the administration of living Plasmodium falciparum sporozoites (PfSPZ, strain NF54), specially prepared for human use, and the simultaneous administration of the malaria drug chloroquine (resoquin) in healthy, voluntary, malaria-naïve volunteers.
The vaccination schedule envisages the administration of chemoprophylaxis and PfSPZ shortly after, on days 0, 5 and 28.
The vaccination success is tested 10 weeks after the last immunisation by administering a heterologous strain of PfSPZ, with no simultaneous chemoprophylaxis. The longevity of the vaccine protection is tested again using the same method 26 and 52 weeks after the last immunization.

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Organizational Data

  •   DRKS00017462
  •   2019/06/21
  •   [---]*
  •   yes
  •   Approved
  •   919/2018AMG1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   2018-004523-36 
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Health Condition or Problem studied

  •   Malaria vaccine study
  •   B50 -  Plasmodium falciparum malaria
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Interventions/Observational Groups

  •   Aseptic, purified, vialed, cryopreserved, fully infectious Plasmodium falciparum Sporocoites:
    110.000 PfSPZ (strain NF54, Sanaria Inc), under Chloroquin chemorporhylaxis (10 mg/kg/day) on days 0,5,28.

    3.200 PfSPZ (strain 7G8, Sanaria Inc) 10, 26 and 52 Wochen past day 28.

  •   Isotonic saline solution (0.9 % NaCl), 0.5 ml per injection on days 0, 5, 28.

    3.200 PfSPZ (strain 7G8, Sanaria Inc) 10, 26 and 52 Wochen past day 28.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Prevention
  •   Parallel
  •   I
  •   No
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Primary Outcome

Safety: at least possibly related Grade 3-4 Adverse Events;

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Secondary Outcome

Efficacy: proportion of protected volunteers, with protection defined as parasites absent from peripheral blood in a 28 days follow-up period after PfSPZ administration without chemoprophylaxis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/05/02
  •   21
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

Consent to all study procedures, healthy adults with BMI < 35, who are living in Tübingen or the surrounding area, in women: active contraception.

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Exclusion Criteria

History of P. falciparum, previous intake of a malaria vaccine, intake of other investigational products in the past 90 days, HIV, HepB or HepC positive, intake of medications that affect the immune system, recent or present pregnancy or breastfeeding, retinal or metabolic disease, blood count abnormalities, allergy to drugs to be used, serious chronic conditions, seizure or cancer, or risk of heart attack, or Cardiac arrhythmias in the medical history, abnormal ECG, 3 or more vaccinations in the last 4 weeks

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Addresses

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Sources of Monetary or Material Support

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    • DZIF - Deutsches Zentrum für Infektionsforschung
    • Inhoffenstraße 7
    • 38124  Braunschweig
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.