Improving the Efficacy of Experimental Malaria Vaccine AMA1-C1/Alhydrogel® (Registered Trademark)
Public ClinicalTrials.gov record NCT00340574. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Study of the Safety and Immunogenicity of AMA-1-C1/Alhydrogel + CPG 7909, An Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the safety and efficacy of the experimental malaria vaccine AMA1-C1/Alhydrogel® (Registered Trademark) and determine whether a new, additional component of the vaccine may increase its effectiveness. Malaria is a debilitating and potentially fatal blood disease transmitted by a parasite found in certain mosquitoes. The AMA1-C1 vaccine has been designed to create an immune response against the parasite and prevent the disease. The purpose of the study is to determine whether the additional component-protein pieces known as CpG- improves the immune response to the vaccine without causing problematic side effects. Volunteers must be healthy adults between 18 and 45 years old. Individuals who have had malaria in the past or have recently traveled to areas where malaria is endemic will be excluded from the study. Candidates will be screened with a physical examination, blood tests, and medical history. Participants will be involved in a three-stage study. In the first stage, a group of participants will receive either a high dose of the vaccine alone or a low dose combined with the CpG protein. In the second stage, a different group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. In the third stage, a larger group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. The vaccine will be injected into the muscle of the upper arm, and all participants will receive three doses of the vaccine with 28 days between doses to monitor possible reactions and side effects. Participants will be monitored for 30 minutes after each injection and will record any symptoms they experience over the six days after receiving their dose. In addition, participants will be examined over the course of six months during and after the trial with physical exams and blood and urine tests.
Study identification
- NCT ID
- NCT00340574
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 7, 2005
- Primary completion
- Not listed
- Completion
- Jul 1, 2008
- Last update posted
- Jul 1, 2017
2005 – 2008
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi | Bethesda | Maryland | 20892 | — |
| University of Rochester | Rochester | New York | 14642 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00340574, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00340574 live on ClinicalTrials.gov.