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Clinical Trials/PACTR201610001813366
PACTR201610001813366
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A Phase Ib Randomised, Controlled, Single-blind Study to Assess the Safety, Immunogenicity of the Malaria Vaccine Candidate R21 With Matrix-M1 Adjuvant in West African Adult Volunteers

Oxford University0 sites24 target enrollmentOctober 6, 2016
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ConditionsMalaria

Overview

Phase
未知
Intervention
Not specified
Conditions
Malaria
Sponsor
Oxford University
Enrollment
24
Status
Other
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 6, 2016
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Oxford University

Eligibility Criteria

Inclusion Criteria

  • •The volunteer must satisfy all the following criteria to be eligible for the study:
  • •Healthy adults ages 18 to 45 years.
  • •Willingness to remain in study area for the period of the study.
  • •Able and willing (in the Investigator's opinion) to comply with all study requirements.
  • •Women only: Must practice and show documented evidence of continuous effective contraception (e.g. depo\-progesterone) or must be willing to take contraceptive measures not to become pregnant for the duration of the study. Willing to have pregnancy tests at screening and vaccination time points.
  • •Agreement to refrain from blood donation during the course of the study.
  • •Written informed consent to participate in the trial.

Exclusion Criteria

  • •Hb less than 10\.0g/dl
  • •Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt 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.
  • •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant or other immune\-modifying drugs medication (for corticosteroids, this will mean prednisolone, or equivalent, ¿ 0\.5mg/kg/day) within the past 6 months (inhaled and topical steroids are allowed).
  • •Use of immunoglobulins or blood products within 3 months prior to enrolment.
  • •History of allergic disease or hypersensitivity reactions likely to be exacerbated by any component of the study vaccines.
  • •Any history of anaphylaxis post\-vaccination.
  • •History of clinically significant contact dermititis.
  • •Pregnancy, lactation or intention to become pregnant during the study.
  • •Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.

Outcomes

Primary Outcomes

Not specified

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