Malaria Clinical Trial
— CHMI-SIKAOfficial title:
Controlled Human Malaria Infection (CHMI) to Assess Human Immunity to P. Falciparum Using Sporozoites Administered by Direct Venous Inoculation
The investigators wish to understand how resistance to malaria develops and how this affects the growth rate of malaria in individuals who have past exposure to malaria.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | November 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy adults aged 18 to 45 years. - Able and willing (in the Investigator's opinion) to comply with all study requirements. - Informed consent. - Use of effective method of contraception for duration of study (women only). The investigators will ask the female volunteers to come with their family planning records to verify. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject's entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository). Exclusion Criteria: - Use of systemic antibiotics with known antimalarial activity within 30 days of administration of PfSPZ Challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin). - Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period. - Current participation in another clinical trial or recent participation within 12 weeks of enrolment. - Prior receipt of an investigational malaria vaccine. - Any confirmed or suspected immunosuppressive or immunodeficient state, including 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). - Use of immunoglobulins or blood products within 3 months prior to enrolment. - Any serious medical condition reported or identified during screening that increases the risk of CHMI. - Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. - Women only; pregnancy, or an intention to become pregnant during the duration of the study. - Confirmed parasite positive by PCR a day before challenge i.e. at C-1. Exclusion Criterion on Day of Challenge: • Acute disease, defined as moderate or severe illness with or without fever (temperature >37.5°C). |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI Wellcome Trust Research Programme | Kilifi | Coast |
Kenya | KEMRI Centre for Clinical Research | Nairobi |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | KEMRI Centre for Clinical Research, KEMRI-Wellcome Trust Collaborative Research Program, Pwani University, Sanaria Inc., University of Cambridge, Wellcome Trust Sanger Institute |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infectivity of PfSPZ (malaria infection) as determined by quantitative PCR | day 7 to day 21 | Yes | |
Secondary | Safety profile of PfSPZ challenge via direct venous injection | day 0 to day 21 | Yes | |
Secondary | Parasite growth rates with respect to antibody responses to over 100 falciparum antigens | day 7 to day 21 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
Completed |
NCT02605720 -
Cardiac Safety of Repeated Doses of Dihydroartemisinin-Piperaquine for the Use in Mass Treatment Campaigns
|
Phase 3 |