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Phase 1 Study of the Safety, Reactogenicity, and Immunogenicity of AMA1-C1/ISA 720: Blood Stage Vaccine for Plasmodium Falciparum

NCT00487916 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA. Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500 million malaria cases worldwide each year. About 2 to 3 million deaths annually are from malaria alone or along with other diseases. Researchers hope to find a vaccine to fight malaria.

Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no history of malaria, and have not lived for more than 1 month in an area where malaria is prevalent may be eligible for this study. There will be 28 participants, each assigned to one of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1 formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and causing disease. This study is the first time the vaccine will be given to human beings for testing.

Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests. The study will last 48 weeks. One or two vaccinations are given by injection, at least 12 weeks apart. After each vaccination, patients will be asked to stay in the clinic for at least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and 56 after each vaccination. There will be a check of vital signs, brief physical exam, history of symptoms and medications taken since the last visit, and blood tests to check for vaccine safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients will receive a thermometer, diary card, and plastic measuring device. Each day they will record their temperatures and any symptoms, and measure the size of any reactions at the vaccination site. They will be asked to do this for 27 days after vaccinations.

After injections, there may be pain, swelling, and redness at the vaccination site, and limitation of arm movement. General side effects from the vaccine may be fever, chills, headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have researchers keep any unused serum samples, for use only in research into malaria and other diseases. Genetic testing would not be done on those samples. Stored samples will be labeled with a code, and information is kept private.

Conditions

Interventions

DRUG

AMA1-C1/ISA 720

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-13
Primary Completion
2009-02-05
Completion
2009-02-05

Countries

  • Australia

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 NCT00487916 on ClinicalTrials.gov