Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01783340
Other study ID # MMV
Secondary ID NL42517.000.12
Status Withdrawn
Phase Phase 1/Phase 2
First received January 31, 2013
Last updated November 12, 2014
Start date April 2013
Est. completion date April 2014

Study information

Verified date November 2014
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.


Description:

This study assesses the superiority of protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

1. Age = 18 and = 35 years healthy volunteers (males or females)

2. Good health based on history and clinical examination

3. Negative pregnancy serum test

4. For females who are sexually active: use of adequate contraception (incl. condom use)

5. Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study

6. Agreement to inform the general practitioner and to sign a request to release medical information concerning contra-indications for participation in the study

7. Willingness to undergo a Pf controlled infection through mosquito bites

8. Agreement to stay in a hotel room close to the trial centre during a part of the study (Day 7 till day 15 after challenge)

9. Reachable (24/7) by mobile phone during the whole study period

10. Available to attend all study visits

11. Agreement to refrain from blood donation or for other purposes, during the whole study period

12. Willingness to undergo HIV, hepatitis B and hepatitis C tests

13. Negative urine toxicology screening test at screening visit and the day before challenge

14. Willingness to take a prophylactic regime of chloroquine or chloroquine/azithromycin combination and a curative regimen of Malarone® after challenge.

Exclusion Criteria:

1. History of malaria

2. Plans to travel to malaria endemic areas during the study period

3. Plans to travel outside of the Netherlands during the challenge period

4. History of stay in malaria endemic areas for more than 6 months

5. Previous participation in any malaria vaccine study and/or positive serology for Pf

6. Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteer

7. History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)

8. History of arrhythmias or prolonged QT-interval

9. Positive family history in 1st and 2nd degree relatives for cardiac events < 50 years old

10. An estimated, ten year risk of fatal cardiovascular disease of =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system

11. Clinically significant abnormalities in electrocardiogram (ECG) at screening

12. Body Mass Index (BMI) below 18 or above 30 kg/m2

13. Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis

14. Positive HIV, HBV or HCV tests

15. Participation in any other clinical study within 30 days prior to the onset of the study

16. Enrolment in any other clinical study during the study period

17. Pregnancy or lactation for women

18. Volunteers unable to give written informed consent

19. Volunteers unable to be closely followed for social, geographic or psychological reasons

20. History of (soft) drugs or alcohol abuse interfering with normal social function

21. A history of treatment for psychiatric disease

22. A history of epileptic insults in the volunteer

23. Contra-indications for use of Malarone®, chloroquine or azithromycin. This includes hypersensitivity or treatment taken by the volunteer that interferes with mentioned study drugs.

24. The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (topical corticosteroids and oral anti-histaminic are allowed) and during the study period

25. Any confirmed or suspected immunosuppressive or immunodeficient condition, including (functional) asplenia

26. Co-workers or trainees of the departments of Medical Microbiology, Parasitology, or Internal Medicine of the Leiden University Medical Centre

27. A history of sickle cell anaemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin capsules
Azithromycin capsules will be administered at each immunization
Placebo
Placebo capsules will be administered at each immunization
Biological:
Immunization with falciparum
three inoculations with 5 infected mosquito bites

Locations

Country Name City State
Netherlands Leiden University Medical Centre Leiden

Sponsors (3)

Lead Sponsor Collaborator
Radboud University Leiden University Medical Center, Medicines for Malaria Venture

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Roestenberg M, McCall M, Hopman J, Wiersma J, Luty AJ, van Gemert GJ, van de Vegte-Bolmer M, van Schaijk B, Teelen K, Arens T, Spaarman L, de Mast Q, Roeffen W, Snounou G, Rénia L, van der Ven A, Hermsen CC, Sauerwein R. Protection against a malaria chall — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Volunteers falciparum positive by thick smear Percentage of P. falciparum thick smear negative volunteers on day 21 (protection against challenge infection) One year No
Secondary Duration of pre-patent period by thick smear Duration of pre-patent period after challenge infection as measured by microscopy (thick smear) One year No
Secondary Kinetics of parasitemia by PCR Development of parasitemia as measured by PCR One year No
Secondary Adverse events Frequency of adverse events in study groups One year Yes
Secondary Immune responses Immune responses between study groups One year No
See also
  Status Clinical Trial Phase
Completed NCT02329301 - Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia N/A
Recruiting NCT01944189 - Artemether/ Lumefantrine: A Study of the Effect of Local Food on Pharmacokinetics and Population Pharmacokinetics Phase 4
Completed NCT01325974 - Time to Become Negative of Three Rapid Diagnostic Tests for Malaria N/A
Terminated NCT01442168 - Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria Phase 1/Phase 2
Completed NCT00375128 - Sporozoite Challenge of Polyprotein Vaccinees Phase 1/Phase 2
Terminated NCT00374205 - Randomized Trial on Effectiveness of ACTs in Ghana Phase 4
Completed NCT04609098 - Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2) Phase 2
Completed NCT02851108 - Methylene Blue Against Falciparum Malaria in Burkina Faso Phase 2
Terminated NCT02281344 - MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants Phase 1
Completed NCT02434952 - Safety and Tolerability of Low Dose Primaquine Phase 4
Completed NCT01213966 - Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection Phase 2
Completed NCT00479206 - Artemisinin Resistance in Cambodia N/A
Completed NCT00126906 - Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi N/A
Completed NCT01019408 - Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan Phase 4
Completed NCT00529867 - Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria Phase 4
Completed NCT00137553 - The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children Phase 4
Completed NCT02637128 - In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria Phase 4
Completed NCT01222962 - Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers Phase 1
Unknown status NCT00152204 - The Community Effectiveness of IPTi in Southern Tanzania Phase 3
Terminated NCT00084240 - Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia Phase 2/Phase 3