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Study of Safety and Effectiveness of Intravenous Immunization With PfSPZ Vaccine in Healthy African Adults

NCT01988636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2019-12-03

No results posted yet for this study

Summary

Background:

\- Malaria is caused by small germs carried by mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year. About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to find a safe vaccine that helps prevent malaria.

Objectives:

\- To see if a new malaria vaccine is well tolerated and effective.

Eligibility:

\- Healthy adults 18 35 years old who are not pregnant and live in Mali.

Design:

* Participants will be screened with medical history, physical exam, and blood test. They will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals.
* Study participation will last about 1 year.
* Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses of placebo.
* Doses will be given through a needle in the arm directly into the bloodstream. Then participants must stay at the clinic for 2 hours.
* After each dose, participants will return to the clinic several times for blood tests and physical exam.
* A week before the first dose and 2 weeks after the last, participants will take a full course of anti-malaria drugs.
* If a participant gets malaria during the study, they will take another course of anti-malaria drugs.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

Aseptic, purified, vialed, cryopreserved, radiation attenuated NF54 p.falciparum sporozoites produced by Sanaria, Inc.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • Sanaria Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sara A Healy, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2013-10-29
Primary Completion
2015-08-20
Completion
2015-08-20

Countries

  • Mali

Study Locations

More Related Trials

Entities

Drugs
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 NCT01988636 on ClinicalTrials.gov