NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1

Completed · Phase 1/Phase 2

Conditions studied: Plasmodium Falciparum

In brief

The purpose of this study is to determine whether a new investigational malaria vaccine is safe, well tolerated and effective against experimental exposure to malaria when given to healthy people with no previous exposure to malaria. The vaccine consists of a modified form of a relatively common virus, adenovirus, that has been rendered incapable of replicating itself and modified to deliver the malaria gene of interest to the body's cells allowing the cell to manufacture the protein encoded by the gene and present it to the body's immune system in a more natural and presumably effective way.

Key facts

Study ID

NCT00392015

Run by

U.S. Army Medical Research and Development Command

People needed

59

Starts

2006-10-12

Expected to finish

2017-09-25

Last updated by the study team

2021-05-21

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Between the ages of 18-50 (inclusive)
• Negative results of HIV ELISA, HbSAg, anti-HCV antibody, and no other clinically significant abnormal laboratory results from screening.
• Adenovirus serotype 5 (Ad5) titer <1:500
• Able to provide written informed consent.
• Complete an Assessment of Understanding and verbalize an understanding of any questions answered incorrectly.
• In good general health without clinically significant medical history or physical exam abnormalities at screening.
• Willing to continue immunogenicity and clinical follow-ups for one year and telephone or mail (electronic/U.S. Postal) contact as long term safety monitoring provision for an additional four years (totaling five years of participation; immunized volunteers only).
• Male and female participants being immunized and female participants being challenged agree to use effective means of birth control (an FDA approved contraceptive, abstinence) between screening and 60 days following last clinical study visit or able to provide evidence of no reproductive capability.

You may not qualify if…

• Have a history of malaria infection, exposure to malaria infection(i.e. you have been to an area that has malaria within the past two years),lived in a country with malaria for more than 5 years or receipt of certain candidate malaria vaccines
• Known immune system disease
• Known blood, heart, liver, kidney disease
• At known significant risk for developing heart disease
• A positive result on HIV testing at screening
• A positive result on Hepatitis B or C testing at screening
• Removal of your spleen
• Taking medication that suppresses the immune system within 30 days of immunization.
• Received or will be receiving another vaccine within 30 days of immunization
• Received blood products (e.g. transfused with blood cells, platelets, plasma or serum) within 120 days of the immunization
• Have had serious adverse reactions to other vaccines including hives, anaphylaxis, respiratory difficulty, tongue/mouth/neck/throat/body swelling or abdominal pain
• Pregnant, breastfeeding, or planning to become pregnant during the next year
• Plan to participate (or have participated in the last 30 days) in any other research study including an investigational drug or device
• Unwilling or unable to participate/complete all study elements
• Evidence of previous infection with adenovirus 5 or prior receipt of an adenovirus containing vaccine.

Where it is running

• Naval Medical Research Center (NMRC) Clinical Trials Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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