Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands
- Conditions
- Malaria infectiePlasmodium falciparummalaria10037072
- Registration Number
- NL-OMON44351
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
1. Subject is aged >= 18 and <= 35 years and in good health.
2. Subject has adequate understanding of the procedures of the study and agrees
to abide strictly thereby.
3. Subject is able to communicate well with the investigator and is available
to attend all study visits.
4. The subject will remain within the Netherlands during the challenge period,
not travel to a malaria-endemic area during the study period, and is reachable
(24/7) by mobile telephone throughout the entire study period.
5. Subject agrees to inform his/her general practitioner about participation in
the study and to sign a request to release by the General Practitioner (GP),
and medical specialist when necessary, any relevant medical information
concerning possible contra-indications for participation in the study.
6. The subject agrees to refrain from blood donation to Sanquin or for other
purposes throughout the study period and for a defined period thereafter
according to current Sanquin guidelines.
7. For female subjects: subject agrees to use adequate contraception and not to
breastfeed for the duration of study. Acceptable forms of contraception
include: established use of oral, injected or implanted hormonal
contraceptives; intrauterine device or intrauterine system; barrier methods
(condoms or diaphragm with additional spermicide); male partner*s sterilisation
(with appropriate post-vasectomy documentation of absence of sperm in the
ejaculate); true abstinence when this is in line with the preferred and usual
lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable
methods of contraception.
8. Subject agrees to refrain from intensive physical exercise (disproportionate
to the subjects usual daily activity or exercise routine) during the malaria
challenge period.
9. Subject agrees to avoid additional triggers that may cause elevations in
liver enzymes including alcohol from baseline up to 1 week post treatment.
10. Subject has signed informed consent.
1. Any history, or evidence at screening, of clinically significant symptoms,
physical signs or abnormal laboratory values suggestive of systemic conditions,
such as cardiovascular, pulmonary, renal, hepatic, neurological,
dermatological, endocrine, malignant, haematological, infectious,
immunodeficient, psychiatric and other disorders, which could compromise the
health of the volunteer during the study or interfere with the interpretation
of the study results. These include, but are not limited to, any of the
following.
1.1 Body weight <50 kg or Body Mass Index (BMI) <18 or >30 kg/m2 at screening.
1.2 A heightened risk of cardiovascular disease, as determined by: an estimated
ten year risk of fatal cardiovascular disease of >=5% at screening, as
determined by the Systematic Coronary Risk Evaluation (SCORE); history, or
evidence at screening, of clinically significant arrhythmia*s, prolonged
QT-interval or other clinically relevant ECG abnormalities; or a positive
family history of cardiac events in 1st or 2nd degree relatives <50 years old.
1.3 A medical history of functional asplenia, sickle cell trait/disease,
thalassaemia trait/disease or G6PD deficiency.
1.4 History of epilepsy in the period of five years prior to study onset, even
if no longer on medication.
1.5 Screening tests positive for Human Immunodeficiency Virus (HIV), or active
Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics or
antimalarials, iii) or other immune modifying drugs within three months prior
to study onset (inhaled and topical corticosteroids and oral anti-histamines
exempted) or expected use of such during the study period.
1.7 History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin), treated or untreated, within the past 5 years.
1.8 Any history of treatment for severe psychiatric disease by a psychiatrist
in the past year.
1.9 History of drug or alcohol abuse interfering with normal social function in
the period of one year prior to study onset, positive urine toxicology test for
cocaine or amphetamines at screening or inclusion, or positive urine toxicology
test for cannabis at inclusion.
2. For female subjects: positive urine pregnancy test at screening or at
inclusion.
3. Any history of malaria, positive serology for P. falciparum, or previous
participation in any malaria (vaccine) study.
4. Known hypersensitivity to or contra-indications (including co-medication)
for use of Mefloquine, Malarone or artemether-lumefantrine, or history of
severe (allergic) reactions to mosquito bites.
5. Receipt of any vaccinations in the 3 months prior to the start of the study
or plans to receive any other vaccinations during the study period or up to 90
days thereafter.
6. Participation in any other clinical study in the 30 days prior to the start
of the study or during the study period.
7. Being an employee or student of the department of Medical Microbiology of
the Radboudumc or the department of Internal Medicine.
8. Any other condition or situation that would, in the opinion of the
investigator, place the subject at an unacceptable risk of injury or render the
subject unable to meet the requirements of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Frequency and magnitude of adverse events after NF135.C10 CPS immunization</p><br>
- Secondary Outcome Measures
Name Time Method