Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT00312702
Brief Summary:
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
Detailed Description:
* Controlled challenge, Phase I/IIa WRAIR study.
* Healthy, malaria-naive adults aged 18 - 50 years.
* 2 groups, 5 subjects in group A (10µg dose) and 15 subjects in group B (50µg dose).
* Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed.
* Vaccination schedule of 0, 1 months.
* Challenge of up to 15 subjects in Group B.
* Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine.
* Self-contained study.
* Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge).
* Data collection will be by done at the site.
Study:
NCT00312702
Study Brief:
Protocol Section:
NCT00312702