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NCT00340431 · ClinicalTrials.gov registry record · Phase 1
Experimental Vaccine for Plasmodium Falciparum Malaria
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
NCT00340431 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID).
The verdict
NCT00340431, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
This study will evaluate the safety of two experimental malaria vaccines in healthy volunteers and examine their immune response to them. Safety will be assessed by comparing vaccine side effects in groups of volunteers who receive increasing doses of the same vaccine (dose-escalating study). Immune response will be evaluated by comparing the levels of antibody production with each dose. (Antibodies are infection-fighting proteins produced by the immune system.) The two vaccines in this study contain different types of a malaria protein called MSP1: one type is MSP142FVO and the other is MSP1423D7. Malaria parasites are spread from person to person by mosquitoes. There are four types of malaria parasites. The vaccine tested in this study is designed to work against Plasmodium falciparum, the parasite responsible for most deaths in children due to malaria in sub-Saharan Africa. The vaccine stimulates the body to produce antibodies that prevent P. falciparum from entering the person's red blood cells. Healthy normal volunteers between 18 and 50 years of age may be eligible for this 12-month study, conducted at Quintiles Phase 1 Services in Lenexa, Kansas. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants receive three doses of the vaccine-on the first day of the study (day 0), at 1 month (day 28), and at 6 months (day 180) -through injection into an arm muscle. The first group of subjects receives 5 micrograms of vaccine, the second group receives 20 micrograms, and the third group receives 80 micrograms. All participants are observed in the clinic for 30 minutes after each immunization for immediate reactions to the vaccine and keep a record of their temperature and of any reactions and side effects they experience for 6 days after the vaccination. At various intervals throughout the study, participants undergo a brief physical examination and blood tests. Women of childbearing potential have a urine preg
Interventions
- DRUG MSP1(42)-FVO & MSP1(42)-3D7
Trial Details
| Field | Value |
|---|---|
| Start Date | 2004-06-09 |
| Est. Completion | 2008-02-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340431
The ClinicalTrials.gov registry entry for NCT00340431 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MSP1(42)-FVO & MSP1(42)-3D7 is the first listed.
NCT00340431 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00340431 about?
NCT00340431 is a clinical study titled "Experimental Vaccine for Plasmodium Falciparum Malaria". This study will evaluate the safety of two experimental malaria vaccines in healthy volunteers and examine their immune response to them. Safety will be assessed by comparing vaccine side effects in groups of volunteers who receive increasing doses of the same vaccine (dose-escalating study). Immune...
What is the current status of trial NCT00340431?
This trial is currently completed. It is a Phase 1 study. The study started on 2004-06-09. Estimated completion is 2008-02-06.
What interventions are being tested in trial NCT00340431?
The interventions under investigation include: MSP1(42)-FVO & MSP1(42)-3D7 (DRUG).
Who is sponsoring clinical trial NCT00340431?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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