Status:
UNKNOWN
Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune Volunteers
Lead Sponsor:
Malaria Vaccine and Drug Development Center
Conditions:
Malaria, Vivax
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) vaccinated with three doses of a synthetic derivative of the C...
Detailed Description
This study is a prospective controlled, blinded clinical trial, designed to establish the protective efficacy induced by the vaccine PvCSP between human volunteers with and without history of malaria....
Eligibility Criteria
Inclusion
- Naïve group:
- Non-pregnant, healthy men and women between 18-45 years old.
- Freely and voluntarily sign an IC, accompanied by two witnesses who must also sign.
- Absence history of malaria infection.
- To have negative serology for the PvCS protein by the ELISA test.
- For women, not be pregnant.
- Use of an adequate contraceptive method from the beginning until the contraceptive restriction is lifted by a study doctor, at the end of the study.
- To accept not to travel to areas considered as endemic for malaria from the infectious challenge period and to the end of its follow-up (1 month).
- Be reachable by phone throughout the study period.
- To be Duffy positive (Fy +).
- Have Hemoglobin (Hb) levels\> 11 g / dl.
- Be willing to participate during the period in which the study will take place.
- Not be participating in another clinical study.
- Be affiliated with the general health social security system of Colombia, in any of its regimes (subsidized or contributory)
- Semi-immune group:
- Non-pregnant, healthy men and women between 18-45 years old,
- Freely and voluntarily sign an informed consent, accompanied by two witnesses who will also sign.
- Have a history of malaria infection (s) and positive serological tests (ELISA) for P. vivax.
- For women, not be pregnant or nursing.
- For women, use of adequate contraception from inception until the contraceptive restriction is lifted by a study physician.
- Be a permanent resident of the municipality of Quibdó during the study.
- Be reachable by phone throughout the study period.
- Availability to participate during the period in which the study will take place.
- Be affiliated with the general health social security system of Colombia, in any of its regimes (subsidized or contributory)
Exclusion
- Naïve group:
- Glucose 6 phosphate dehydrogenase deficiency (G-6-P-D).
- Present any hemoglobinopathy (eg HbS).
- Personal history of allergies to medications or insect bites.
- Have received vaccination against malaria.
- Clinical or laboratory abnormalities determined by the investigator (s).
- IFAT\> 1:20 for P. vivax in screening tests.
- Have lived in a malaria-endemic region during the 12 months before the study.
- Clinical or laboratory evidence of systemic disease, including kidney, liver, cardiovascular, pulmonary, psychiatric, or other diseases that may negatively impact and alter study results.
- Evidence of active hepatitis B or Hepatitis C infection
- Evidence of active HIV infection.
- History of transfusion of any blood product in the 6 (six) months before the study.
- Plan to have surgery from the recruitment period to the end of the post-challenge follow-ups.
- Presence or history of autoimmune disease (lupus, rheumatoid arthritis, thyroiditis, or other).
- Splenectomized volunteers.
- Volunteers in treatment with drugs with activity on the immune system (steroids, immunosuppressive agents, or immunomodulators).
- History of alcoholism or drug abuse defined as a habit that interferes with the normal social functioning of the individual.
- Any condition that may interfere with the ability to provide a free and voluntary IC.
- Not being affiliated with the general health social security system of Colombia, in any of its regimes (subsidized or contributory)
- Semi-immune group:
- IFAT negative (\<1:20) for P. vivax in screening tests.
- The other criteria used in the case of naïve volunteers, except the antecedent of having lived in the endemic area.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04739917
Start Date
June 1 2021
End Date
December 1 2022
Last Update
March 1 2021
Active Locations (1)
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1
Malaria Vaccine and Drug Development Center
Cali, Valle del Cauca Department, Colombia