Status:
COMPLETED
NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
United States Agency for International Development (USAID)
Congressionally Directed Medical Research Programs
Conditions:
Plasmodium Falciparum
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
The vaccine, called NMRC-M3V-Ad-PfCA (key: NMRC + Multi-antigen Multi-stage, Malaria Vaccine + Adenovectored + P. falciparum CSP \& AMA1 antigens), is a combination of two recombinant adenovirus-deriv...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
October 12 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2017
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00392015
Start Date
October 12 2006
End Date
September 25 2017
Last Update
May 21 2021
Active Locations (1)
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1
Naval Medical Research Center (NMRC) Clinical Trials Center
Bethesda, Maryland, United States, 20889-5607