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Sequential Optimization of Dose and Schedule of PfSPZ Vaccine

NCT02704533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-02-01

No results posted yet for this study

Summary

MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization with PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10\^5, 1.35x10\^6, or 2.7x10\^6 PfSPZ per dose and a total dose between 2.7x10\^6 and 8.1x10\^6 PfSPZ followed by CHMI with 3,200 fully infectious PfSPZ (PfSPZ Challenge).

PfSPZ Challenge (7G8) to assess vaccine efficacy, safety, tolerability and infectivity of ascending PfSPZ doses will be assessed in healthy, malaria-naïve volunteers.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

Aseptic, purified, vialed, cryopreserved, radiation-attenuated, Plasmodium falciparum sporozoites, strain NF54

BIOLOGICAL

PfSPZ Challenge (NF54)

Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain NF54

BIOLOGICAL

PfSPZ Challenge (7G8)

Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain 7G8

OTHER

Normal saline

0.9% sodium chloride

Sponsors & Collaborators

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • German Center for Infection Research

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Benjamin Mordmüller, MD · Institute of Tropical Medicine, University of Tuebingen, Wilhelmstr. 27, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2018-10-19
Completion
2018-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT02704533 on ClinicalTrials.gov