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COMPLETED

NCT07816497

PHASE1

Controlled Human Malaria Infection by Mosquito Bites Using a Local Strain of Plasmodium Falciparum

Sponsor: Centre de Recherche Médicale de Lambaréné

View on ClinicalTrials.gov

Summary

The project aims to reproduce the malaria infection cycle using African mosquitoes, namely Anopheles gambiae and a local strain of Plasmodium parasites. The study will be conducted in two steps: (i) the production of infected mosquitoes and (ii) human infection with malaria parasites, known as Controlled Human Malaria Infection (CHMI). During the first step, Anopheles gambiae mosquitoes raised in the Centre de Recherches Médicales de Lambaréné (CERMEL) entomology laboratory in Lambaréné, Gabon, will be fed with blood collected from a person living in Lambaréné or the surrounding area who is positive for Plasmodium falciparum parasites, with the presence of asexual and sexual stages (responsible for malaria transmission) of the parasites in his/her blood. The Plasmodium-infected mosquitoes will be used two weeks later to infect healthy adult volunteers by mosquito bites under the supervision of the research team. After exposure, we will follow all exposed participants daily, starting on the fifth day after exposure. During the daily visits, we will perform malaria tests to detect the presence of malaria parasites in the blood of the participant. If participants test positive, they will receive usual antimalarial treatment if they simultaneously present malaria symptoms or if their parasitaemia is equal to or greater than 1,000 parasites per microlitre of blood. To ensure participants are effectively treated, we will perform two malaria tests after treatment, which should be negative. Otherwise, a different treatment will be administered. We will consider the process successful if we manage to infect (presence of malaria parasites in the blood) at least 50% of exposed participants. We also want the process to be safe, assuming that no unexpected clinical or biological events occur. Such an approach could contribute to a better assessment of the efficacy of antimalarial drugs and vaccine candidates, taking into account the specific characteristics of each endemic area.

Official title: Phase I Trial for the Establishment of Controlled Human Malaria Infection by Bites of Plasmodium Falciparum-infected Anopheles Gambiae in Lambaréné

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-18

Completion Date

2026-02-19

Last Updated

2026-09-11

Healthy Volunteers

Yes

Conditions

Malaria (Plasmodium Falciparum)

Interventions

BIOLOGICAL

Controlled Human Malaria Infection

Anopheles gambiae mosquitoes infected with a local strain of Plasmodium falciparum will be used to perform a CHMI by mosquito bites in healthy adult volunteers

Inclusion Criteria: * Healthy, adult volunteers aged 18 to 45 years old * Tympanic body temperature \< 37.5°C * Residence in Lambaréné or surroundings for the period of the trial * History of long-term residence (at least 5 years) in Gabon * Willingness to take two curative anti-malarial regimens * Reachable (24/7) by mobile phone during the CHMI and follow-up * A body mass index \<35 Exclusion Criteria: * Haemoglobin level \< 11 g/dl for female volunteers and \< 11.5 g/dl for male volunteers * 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 * Immunization with more than 3 other vaccines within the past month. * Positive for hepatitis B surface antigen (HBs-antigen) * Seropositive for hepatitis C virus (antibodies to HCV). * Positive HIV test * Abnormal level of transaminase (ALAT, ASAT) * Have been treated for malaria disease with an antimalarial drug or an antibiotic active on malaria parasites over the previous 28 days of the inoculation. * Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe and chronic (more than 14 days) infections, 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. * Sickle cell disease or any clinically relevant blood disorder. * History of a serious psychiatric condition that may affect participation in the study. * Positive urine pregnancy test or breastfeeding * Any other serious chronic illness requiring hospital specialist supervision * Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g per day. * Suspected or known injecting drug abuse in the 5 years preceding enrolment. * Contraindications to the use of the first-line anti-malarial medications: artemether/lumefantrine or atovaquone/proguanil. * Subjects unable to be closely followed for social, geographic or psychological reasons. * Any clinically significant abnormal finding on biochemistry or haematology blood tests, urine analysis or clinical examination. * History of seizure. * Any other significant disease, disorder or finding which, in the opinion of the Investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Locations (1)

Centre de Recherches Médicales de Lambaréné

Lambaréné, Moyen-Ogooué Province, Gabon