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Coadministration of GA2 Sporozoites With Adjuvants

NCT05468606 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-02-10

No results posted yet for this study

Summary

This study will assess the coadministration of genetically attenuated Plasmodium falciparum ∆mei2 (GA2) sporozoites with adjuvants (BCG and YF-17D vaccination and imiquimod cream). Primary outcomes will be safety, tolerability and protective efficacy against CHMI.

Conditions

  • Malaria,Falciparum

Interventions

BIOLOGICAL

GA2

GA2 sporozoites administered by 50 mosquito bites

BIOLOGICAL

BCG

0.1 mL BCG vaccine intradermally

BIOLOGICAL

YF-17D (fractional ID dose)

0.1 mL YF17D vaccine intradermally

DRUG

Imiquimod

250mg imiquimod 5% cream topical

OTHER

Mock immunization

50 bites by uninfected mosquitoes

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Meta Roestenberg, MD, PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT05468606 on ClinicalTrials.gov