| City: |
|
Stanford |
|
State:
|
|
CA |
| Zip Code: |
|
94305 |
| Conditions: |
|
Plasmodium Falciparum Malaria |
| Purpose: |
|
Malaria is caused by a parasite carried by a mosquito. Currently, there is no vaccine
licensed to prevent malaria. The purpose of this study is to find the most effective and
safest dose of an experimental vaccine for the treatment of malaria. Participants will
include 72 healthy adults, ages18 to 45, enrolled at Vanderbilt University Medical Center
and Stanford University. Volunteers will receive 3 doses of either the malaria vaccine or
placebo (contains no vaccine) by injection into a muscle at 0, 1 and 6 months. Investigators
will evaluate how the body responds to increasing dosage strengths of the vaccine. Study
procedures include physical exam, multiple blood draws, and completion of a memory aid
(diary). Each participant will be actively involved in the study for about 12 months. Then,
an annual phone call will be made to check for any serious illness events for a period of 5
years.
|
| Study summary: |
|
Malaria currently represents one of the most prevalent infections in tropical and
subtropical areas throughout the world. Each year, malaria affects around 300 million people
and kills 1 to 3 million people in developing countries. The widespread occurrence and the
growing incidence of malaria are a consequence of the increasing numbers of drug-resistant
parasites and insecticide-resistant parasite vectors. Other factors include environmental
and climatic changes, civil disturbances and increased mobility of populations. It is
hypothesized that the Ad35.CS.01 vaccine will prevent the Plasmodium (P.) falciparum
parasite, which causes malaria, from entering and developing within the liver of those who
become infected. Ad35.CS.01 would therefore be expected to reduce malaria-attributable
morbidity and mortality. The purpose of this phase I, randomized, controlled,
dosage-escalation trial is to evaluate the immunogenicity, safety, and reactogenicity of an
Adenovirus Type 35 based circumsporozoite malaria vaccine in 72 healthy adults 18 to 45
years of age in the United State. Subjects will be randomized in a 5:1 ratio to receive 3
doses of the Adenovirus Type 35 circumsporozoite malaria vaccine (Ad35.CS.01) or normal
saline placebo control by the intramuscular route at 0, 1 and 6 months. The safety,
reactogenicity, and immunogenicity of ascending dosages of the vaccine will be assessed.
Fifteen subjects will receive vaccine at each of the following dosage levels: 10^8 viral
particles (vp)/milliliters (ml), 10^9 vp/ml, 10^10 vp/ml and 10^11 vp/ml with 3 subjects
receiving control at each of these dosage levels. Dosage escalation will proceed only after
review of the safety data by the Safety Monitoring Committee of the prior dosage level. The
primary objective is to assess the safety and reactogenicity of ascending dosages of
Adenovirus Type 35 based circumsporozoite malaria vaccine among healthy subjects given in 3
intramuscular doses at 0, 1 and 6 months. The secondary objective is to evaluate the
immunogenicity of the Adenovirus Type 35 based circumsporozoite malaria vaccine through
performance of Humoral Immune Assays [ELISA (enzyme-linked immunosorbent assay)] for
antibodies to circumsporozoite antigen and Adenovirus Neutralization Assay for neutralizing
antibodies to Adenovirus type 35) and Cellular Immune Assays (Elispot and Flow Cytometry)
for CS-specific CD4+ and CD8+ T cell responses. |
| Criteria: |
|
Inclusion Criteria:
- Provision of informed consent before any protocol procedures are performed.
- Males and non-pregnant females between the ages of 18 and 45 years, inclusive.
- Females and males must agree to practice adequate contraception until at least 28
days following their last immunization dose (including abstinence; hormonal
contraception; condoms with spermicidal agents; post-menopausal; or surgical
sterilization/vasectomy).
- Participants must agree to avoid high risk sexual behavior for exposure to human
immunodeficiency virus (HIV).
- In good health as determined by screening medical history, physical examination (PE),
and laboratory assessments.
- Willingness to comply with protocol requirements.
- Willingness to be contacted annually for five years for assessment of serious adverse
events.
- Must have access to a cell phone.
Exclusion Criteria:
- Current or recent (within the last four weeks) treatment with parenteral, inhaled, or
oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive
agents, or chemotherapy.
- History of splenectomy.
- Abnormal screening laboratory values. Any abnormal screening value for any screening
test will exclude the subject from the study. Abnormal screening labs will not be
repeated with the exception of high glucose levels will be repeated at a fasting
state.
- Detectible neutralizing antibody titer against adenovirus serotype 35.
- History of intravenous (IV) drug abuse.
- History of, or current medical, occupational, social or family problems as a result
of alcohol or illicit drug use.
- History of moderate to severe mental illness, as defined by symptoms interfering with
social or occupational function or suicidal thoughts/attempts.
- History of receiving blood or blood products (such as blood transfusion, platelet
transfusion, immunoglobulins, hyperimmune serum) in the previous 6 months.
- Vaccination with a live vaccine within the past 30 days or with a nonreplicating,
inactivated, or subunit vaccine within the last 14 days.
- Known hypersensitivity to components of the vaccine.
- History of acute or chronic medical conditions including, but not limited to,
disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or
autoimmune/inflammatory conditions.
- History of coagulation defect or bleeding from (bruising at) multiple sites that
cannot be linked to trauma or surgery.
- History of anaphylaxis or severe hypersensitivity reaction.
- Severe asthma, as defined by an emergency room visit or hospitalization within the
last 12 months.
- Pregnant or breastfeeding women.
- Acute illness, including temperature greater than 100 degrees Fahrenheit within one
week prior to vaccination.
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B surface antigen (HBsAg).
- Concurrent participation in other investigational protocols or receipt of an
investigational product within the previous 30 days or planned receipt of an
investigational product within 28 days following the last immunization dose.
- Identification of any condition that, in the opinion of the investigator, would
affect the ability of the subject to understand or comply with the study protocol or
would jeopardize the safety or rights of a subject participating in the study.
- History of malignancy, including hematologic and skin cancers (except for a localized
basal cell carcinoma), or known immunodeficiency syndrome.
- History of malaria infection or previous receipt of a malaria vaccine.
- History of travel to malaria-endemic area or receipt of antimalarial prophylaxis in
the past 12 months.
- Planned travel to a malaria-endemic area prior to Visit 16 (Day 208).
- Pre-medication with analgesic or antipyretic agents in the 6 hours prior to
vaccination, or planned medication with analgesic or antipyretic in the 24 hours
following vaccination. This criterion should not preclude subjects receiving such
medication if the need arises.
- Receipt of a recombinant adenovirus vector vaccine in a prior study. |
|
|
|
|
|
|
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
January 19, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|