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Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults

NCT02015091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

\- People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease if later exposed to normal malaria parasites. Scientists have discovered how to make the weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if people who receive the vaccine get malaria after being bitten in a controlled setting (a controlled human malaria infection, CHMI).

Objective:

\- To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting.

Eligibility:

\- Healthy adults 18 45 years old.

Design:

* Participants will be screened with medical history, physical exam, blood and lab tests, and EKG.
* Participants will be split into 8 groups, to be in the study for 3 12 months.
* Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or muscle.
* Participants will keep a health diary and be contacted by phone.
* For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5 minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be exposed to malaria more than once.
* After CHMI, participants will visit the clinic very frequently (including daily visits for 12 days) for 28 days.
* Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical history may also be repeated
* Participants who develop malaria will be treated immediately at the clinic. Standard treatment takes 72 hours. Malaria symptoms may last up to 3 days.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

The PfSPZ Vaccine is composed of radiation-attenuated Plasmodium falciparum sporozoites (PfSPZ) and is designed to prevent malaria in adults, children, and infants. It is formulated in phosphate buffered saline (PBS) with 1% human serum albumin (HSA). Sanaria Incorporated (Sanaria), Rockville, Maryland, developed and produced the PfSPZ Vaccine.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Julie E Ledgerwood, D.O. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-12
Primary Completion
2015-05-01
Completion
2016-09-08

Countries

  • United States

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 NCT02015091 on ClinicalTrials.gov