PACTR202201848463189RecruitingPhase 1
Phase 1 Dose Escalating, Double-Blind, Randomised Comparator Controlled Trial of the Safety and Immunogenicity of Different Adjuvant Formulations of R0.6C and ProC6C transmission blocking vaccines candidates against Plasmodium falciparum in Adults in Burkina Faso (TBVax1)
Not provided0 sites125 target enrollmentStarted: January 16, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 125
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19 Year(s) to 44 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1.Subject must sign/thumbprint written informed consent to participate in the trial.
- •2.Subject is a male or non-pregnant and non-lactating female age = 20 and = 45 years and in good health.
- •3.Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures
- •4.In the opinion of the investigator, the subject can and will comply with the requirements of the protocol.
- •5.Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -28 until day 180 (end of study).
- •6.The subject will remain within reasonable travelling distance from the study site from day 0 until day 7 after each administration.
- •7.The subject agrees to refrain from blood donation throughout the study period.
- •8.Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. All subjects of childbearing potential must agree to use continuous adequate contraception* until 2 months after completion of the study. Female subjects must agree not to breastfeed from 30 days prior to administration until 2 months after completion of the study. Female subject must have a negative pregnancy test at the inclusion visit.
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1.Acute or chronic disease at time of administration, clinically significant pulmonary, cardiovascular, hepatic, renal, neurological or immunological functional abnormality, as determined by medical history, physical examination or laboratory screening tests
- •2.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- •3.History of auto immune disease
- •4.Subjects with splenectomy
- •5.Chronic use of i) immunosuppressive drugs, ii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
- •6.History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- •7.Known history of Human Immunodeficiency Virus (HIV) (No test will be done by the study)
- •8.Screening tests positive for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV).
- •9.Use of any other investigational or non-registered product (drug or vaccine) during the study period.
- •10.Participation in any other clinical study involving an investigational product in the 30 days prior to the start of the study or during the study period.
- •11.Receipt of any other vaccination within 30 days prior to the first vaccination.
- •12.Any previous participation in any malaria (vaccine) study.
- •13.History of anaphylaxis or known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient)
- •14.Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Investigators
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