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Trial details imported from ClinicalTrials.gov
Ethics application status
Phase 1 Study of the Safety, Reactogenicity, and Immunogenicity of AMA1-C1/ISA 720: Blood Stage Vaccine for Plasmodium Falciparum
Phase 1 Study of the Safety, Reactogenicity and Immunogenicity of AMA1-C1/ISA 720: A Blood Stage Vaccine for Plasmodium Falciparum
Universal Trial Number (UTN)
Other infectious diseases
Studies of infection and infectious agents
Description of intervention(s) / exposure
Treatment: Drugs - AMA1-C1/ISA 720
Treatment: Drugs: AMA1-C1/ISA 720
Intervention code 
Comparator / control treatment
Primary outcome 
Assessment of the safety and reactogenicity of the AMA1-C1/ISA 720 vaccine; and to determine the frequency of systemic and local AEs as recorded for 28 days following each vaccination.
Secondary outcome 
Assessment of the level, kinetics and the in-vitro biological activity of the antibody response to AMA1-FVO and AMA1-3D7.
Key inclusion criteria
- INCLUSION CRITERIA:
1. Males or females between 18 and 45 years, inclusive.
2. Good general health as determined by means of the screening procedure.
3. Available for the duration of the trial (48 weeks).
4. Willingness to participate in the study as evidenced by signing the informed
5. For female subjects: Negative pregnancy tests at Screening and Day 0, in
conjunction with a history indicating a low probability of pregnancy in the
opinion of the physician. Sexually active females of childbearing potential will
be required to be correctly using an efficacious method of contraception for at
least 1 month before randomization and during the on-study phase to Month 7.
Female subjects unable to become pregnant must have this documented (e.g. tubal
ligation, hysterectomy, or postmenopausal [at least one year since last menstrual
1. History of malaria, residence for more than 1 month in a malaria endemic area (as
determined by interview), or plans to visit a malaria endemic area during the study
2. For female subjects: Positive pregnancy test at screening or Day 0, as well as those
currently lactating and breast feeding.
3. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic,
rheumatologic, chronic infectious or renal disease by history, physical examination,
and/or laboratory studies including urinalysis.
4. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator
affects the ability of the volunteer to understand and cooperate with the study
5. Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25
times the upper limit of normal of the testing laboratory).
6. Laboratory evidence of renal disease (serum creatinine greater than the upper limit of
normal of the testing laboratory, or more than trace protein or blood on urine
dipstick testing confirmed by repeat testing of clean-catch, midstream sample). (More
than trace blood on urine dipstick will not exclude a female who is actively
7. Laboratory evidence of hematologic disease (absolute leukocyte count less than
3000/mm(3) or greater than 11,500/mm(3); hemoglobin less than 0.9 times the lower
limit of normal of the testing laboratory, by gender; absolute granulocyte count less
than 1300/mm(3); absolute lymphocyte count less than 1000/mm(3); or platelet count
less than 11,000/mm(3)).
8. Other condition that, in the opinion of the investigator, would jeopardize the safety
or rights of a volunteer participating in the trial or would render the subject unable
to comply with the protocol.
9. Participation in another investigational vaccine or drug trial within 30 days of
starting this study, or while this study is ongoing.
10. Volunteer has had medical, occupational, or family problems as a result of alcohol or
illicit drug use during the past 12 months.
11. History of a severe allergic reaction or anaphylaxis.
12. Severe asthma. This will be defined as:
- Asthma that is unstable or required emergent care, urgent care, hospitalization
or intubation during the past two years or that requires the use of oral or
- Clinically significant reactive airway disease that does not respond to
13. Positive ELISA for anti-HCV.
14. Positive hepatitis B surface antigen (HBsAg) by ELISA.
15. Positive ELISA for anti-HIV.
16. Use of systemic corticosteroids (excluding topical or nasal) or immunosuppressive
drugs within 30 days of starting this study.
17. Receipt of a live vaccine within past 4 weeks or non-live vaccine within past 2 weeks
prior to entry into the study.
18. History of a surgical splenectomy.
19. Receipt of blood products within the past 6 months.
20. Previous receipt of an investigational malaria vaccine.
21. History of a known allergy to nickel.
Both males and females
Can healthy volunteers participate?
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
QIMR - CLive Berghofer Cancer Research Centre - Herston
Recruitment postcode(s) 
National Institute of Allergy and Infectious Diseases (NIAID)
Ethics application status
This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA.
Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500
million malaria cases worldwide each year. About 2 to 3 million deaths annually are from
malaria alone or along with other diseases. Researchers hope to find a vaccine to fight
Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no
history of malaria, and have not lived for more than 1 month in an area where malaria is
prevalent may be eligible for this study. There will be 28 participants, each assigned to one
of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1
formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and
causing disease. This study is the first time the vaccine will be given to human beings for
Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests.
The study will last 48 weeks. One or two vaccinations are given by injection, at least 12
weeks apart. After each vaccination, patients will be asked to stay in the clinic for at
least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and
56 after each vaccination. There will be a check of vital signs, brief physical exam, history
of symptoms and medications taken since the last visit, and blood tests to check for vaccine
safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients
will receive a thermometer, diary card, and plastic measuring device. Each day they will
record their temperatures and any symptoms, and measure the size of any reactions at the
vaccination site. They will be asked to do this for 27 days after vaccinations.
After injections, there may be pain, swelling, and redness at the vaccination site, and
limitation of arm movement. General side effects from the vaccine may be fever, chills,
headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have
researchers keep any unused serum samples, for use only in research into malaria and other
diseases. Genetic testing would not be done on those samples. Stored samples will be labeled
with a code, and information is kept private.
Trial related presentations / publications
Narum DL, Thomas AW. Differential localization of full-length and processed forms of PF83/AMA-1 an apical membrane antigen of Plasmodium falciparum merozoites. Mol Biochem Parasitol. 1994 Sep;67(1):59-68.
Crewther PE, Culvenor JG, Silva A, Cooper JA, Anders RF. Plasmodium falciparum: two antigens of similar size are located in different compartments of the rhoptry. Exp Parasitol. 1990 Feb;70(2):193-206.
Waters AP, Thomas AW, Deans JA, Mitchell GH, Hudson DE, Miller LH, McCutchan TF, Cohen S. A merozoite receptor protein from Plasmodium knowlesi is highly conserved and distributed throughout Plasmodium. J Biol Chem. 1990 Oct 15;265(29):17974-9.