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NCT00295581 · ClinicalTrials.gov registry record · Phase 1
PpPfs25/ISA51 and ScPvs25/ISA51 Vaccines for Malaria
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
NCT00295581 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID).
The verdict
NCT00295581, 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, conducted at Johns Hopkins University Center for Immunization Research in Washington DC, will test the safety and immune response of healthy volunteers to two experimental malaria vaccines. Malaria is a disease of red blood cells caused by a parasite that spreads from person to person by mosquitoes. It affects people of all ages, but is particularly severe in children. Patients may have a high fever, chills and muscle aches. They sometimes can have severe complications that may even result in death. The vaccines in this study are called "transmission blocking" vaccines. These vaccines stimulate the person's immune system to produce antibodies against malaria. When a mosquito bites a vaccinated person, it ingests some of the person's blood. The antibodies in the ingested blood stop the malaria parasite from developing inside the mosquito. The mosquito would not be able to transmit malaria to other people. PpPfs25/ISA51 (Vaccine A) stimulates production of antibodies against the malaria parasite Plasmodium falciparum, and ScPvs25/ISA51 (Vaccine B) stimulates antibodies against the malaria parasite Plasmodium vivax. The vaccines also contain a substance called Montanide ISA51, which boosts the immune response to the vaccine. Healthy volunteers between 18 and 50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Women who are able to become pregnant have a urine pregnancy test before each immunization. Participants are randomly assigned to receive two injections, spaced 4 months apart, of either Vaccine A or Vaccine B at one of three doses-high, medium, or low. Two subjects in each dose group additionally serve as "controls" and receive only Montanide ISA51 mixed with saline. The vaccine is injected into the muscle of the upper arm. Subjects are monitored for 30 minutes after each injection for possible side effects and take home a diary card to record their tempera
Interventions
- DRUG PpPfs25/ISA51 & ScPvs25/ISA51
Trial Details
| Field | Value |
|---|---|
| Start Date | 2005-03-07 |
| Est. Completion | 2008-06-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00295581
The ClinicalTrials.gov registry entry for NCT00295581 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 PpPfs25/ISA51 & ScPvs25/ISA51 is the first listed.
NCT00295581 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00295581 about?
NCT00295581 is a clinical study titled "PpPfs25/ISA51 and ScPvs25/ISA51 Vaccines for Malaria". This study, conducted at Johns Hopkins University Center for Immunization Research in Washington DC, will test the safety and immune response of healthy volunteers to two experimental malaria vaccines. Malaria is a disease of red blood cells caused by a parasite that spreads from person to person by...
What is the current status of trial NCT00295581?
This trial is currently completed. It is a Phase 1 study. The study started on 2005-03-07. Estimated completion is 2008-06-17.
What interventions are being tested in trial NCT00295581?
The interventions under investigation include: PpPfs25/ISA51 & ScPvs25/ISA51 (DRUG).
Who is sponsoring clinical trial NCT00295581?
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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