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Safety and Efficacy of NF135 CPS Immunization

NCT03813108 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-05-26

Study results available
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Summary

This is an open label, randomized, controlled clinical trial. The primary aim of this project is to determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxis against homologous and heterologous challenge infection.

Conditions

  • Malaria,Falciparum
  • Controlled Human Malaria Infection
  • Immunization; Infection

Interventions

BIOLOGICAL

CPS-immunization

Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.

BIOLOGICAL

malaria challenge infection, P. falciparum NF135.C10

Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.

BIOLOGICAL

malaria challenge infection, P. falciparum NF54

Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.

BIOLOGICAL

CPS-immunization (A/L)

Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes and receive presumptive treatment with artemether/lumefantrine initiated on day 7 after each immunization.

DRUG

Atovaquone / Proguanil Oral Tablet [Malarone]

All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection.

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Matthew BB McCall, MD PhD DTMH · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03813108 on ClinicalTrials.gov