MedTrace Logo

Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)

NCT01434381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-02-11

No results posted yet for this study

Summary

Background:

\- The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people from getting sick with malaria. Researchers want to test the safety of and response to this vaccine.

Objectives:

\- To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel.

Eligibility:

\- Healthy volunteers between 18 and 50 years of age.

Design:

* Participants will be screened with a medical history, physical exam, and blood tests.
* They will be assigned to a study group to have either two or three doses of the vaccine. Participants will have checkups after each dose of vaccine,
* The additional doses will be given 2 months or 2 and 4 months after the first vaccine.
* Participants will have regular blood tests to check the level of the response to the vaccine.
* They will be followed for up to 1 year after the last vaccine to have any additional tests as needed.

Conditions

Interventions

BIOLOGICAL

Pfs25-EPA/Alhydrogel

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Patrick Duffy, MD · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

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 NCT01434381 on ClinicalTrials.gov