Controlled Human Malaria Infection in Semi-Immune Kenyan Adults. (CHMI-SIKA)
CHMI-SIKA
2 other identifiers
interventional
200
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2016
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMay 30, 2016
May 1, 2016
3.7 years
April 13, 2016
May 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infectivity of PfSPZ (malaria infection) as determined by quantitative PCR
day 7 to day 21
Secondary Outcomes (2)
Safety profile of PfSPZ challenge via direct venous injection
day 0 to day 21
Parasite growth rates with respect to antibody responses to over 100 falciparum antigens
day 7 to day 21
Study Arms (1)
Plasmodium falciparum sprozoite (PfSPZ) challenge
EXPERIMENTALChallenge agent
Interventions
Plasmodium falciparum sporozoites
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- Acute disease, defined as moderate or severe illness with or without fever (temperature \>37.5°C).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- KEMRI-Wellcome Trust Collaborative Research Programcollaborator
- Sanaria Inc.collaborator
- KEMRI Centre for Clinical Researchcollaborator
- Pwani Universitycollaborator
- University of Cambridgecollaborator
- Wellcome Sanger Institutecollaborator
Study Sites (2)
KEMRI Wellcome Trust Research Programme
Kilifi, Coast, 80108, Kenya
KEMRI Centre for Clinical Research
Nairobi, Nairobi County, Kenya
Related Publications (6)
Kariuki SN, Macharia AW, Makale J, Nyamu W, Hoffman SL, Kapulu MC, Bejon P, Rayner JC, Williams TN; CHMI-SIKA Study Team. The Dantu blood group prevents parasite growth in vivo: Evidence from a controlled human malaria infection study. Elife. 2023 Jun 13;12:e83874. doi: 10.7554/eLife.83874.
PMID: 37310872DERIVEDLi K, Tsukasa Y, Kurio M, Maeta K, Tsumadori A, Baba S, Nishimura R, Murakami A, Onodera K, Morimoto T, Uemura T, Usui T. Belly roll, a GPI-anchored Ly6 protein, regulates Drosophila melanogaster escape behaviors by modulating the excitability of nociceptive peptidergic interneurons. Elife. 2023 Jun 13;12:e83856. doi: 10.7554/eLife.83856.
PMID: 37309249DERIVEDMusasia FK, Nkumama IN, Frank R, Kipkemboi V, Schneider M, Mwai K, Odera DO, Rosenkranz M, Furle K, Kimani D, Tuju J, Njuguna P, Hamaluba M, Kapulu MC, Wardemann H; CHMI-SIKA Study Team; Osier FHA. Phagocytosis of Plasmodium falciparum ring-stage parasites predicts protection against malaria. Nat Commun. 2022 Jul 14;13(1):4098. doi: 10.1038/s41467-022-31640-6.
PMID: 35835738DERIVEDKapulu MC, Kimani D, Njuguna P, Hamaluba M, Otieno E, Kimathi R, Tuju J, Sim BKL; CHMI-SIKA Study Team. Controlled human malaria infection (CHMI) outcomes in Kenyan adults is associated with prior history of malaria exposure and anti-schizont antibody response. BMC Infect Dis. 2022 Jan 24;22(1):86. doi: 10.1186/s12879-022-07044-8.
PMID: 35073864DERIVEDKapulu MC, Njuguna P, Hamaluba M, Kimani D, Ngoi JM, Musembi J, Ngoto O, Otieno E, Billingsley PF; Controlled Human Malaria Infection in Semi-Immune Kenyan Adults (CHMI-SIKA) Study Team. Safety and PCR monitoring in 161 semi-immune Kenyan adults following controlled human malaria infection. JCI Insight. 2021 Sep 8;6(17):e146443. doi: 10.1172/jci.insight.146443.
PMID: 34264864DERIVEDKapulu MC, Njuguna P, Hamaluba MM; CHMI-SIKA Study Team. Controlled Human Malaria Infection in Semi-Immune Kenyan Adults (CHMI-SIKA): a study protocol to investigate in vivo Plasmodium falciparum malaria parasite growth in the context of pre-existing immunity. Wellcome Open Res. 2019 Nov 14;3:155. doi: 10.12688/wellcomeopenres.14909.2. eCollection 2018.
PMID: 31803847DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Bejon, MD,PhD
KEMRI Wellcome Trust Research Programme and University of Oxford
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 15, 2016
Study Start
May 1, 2016
Primary Completion
January 1, 2020
Study Completion
November 1, 2020
Last Updated
May 30, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will share
Study information will be made available through an open repository. The information to be made available will be anonymized so that there is no link to participants and will include data on antibody responses, parasite growth rates and any other data generated from samples obtained in this study, both generated from this current protocol or any future studies which will require additional ethical approval.