Controlled Human Malaria Infection by Intradermal Injection of Plasmodium Falciparum Sporozoites in Tanzanian Adults

NCT01540903 | Completed Phase 1 DMC

• 1 other identifier: BSPZC1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed trial will evaluate whether relatively non immune populations in endemic countries can be effectively infected with aseptic, purified, cryopreserved sporozoites (PfSPZ Challenge) given intradermally.

Conditions

Malaria

Keywords

Malaria Challenge; Plasmodium falciparum; PfSPZ Challenge; Controlled; human; malaria infection

Outcome Measures

Primary Outcomes (1)

• Number of volunteers positive in each group through day 28 of follow up.

  Thick smears will be performed according to a standard operating procedure. In short, 15 μL of whole blood will be distributed on standardized 3-well slides, providing an equal slide thickness for all smears. Slides are dried and stained with Giemsa. 200 fields per slide will be read at 1000X. Slides are considered positive if they contain 2 or more parasites per 200 fields.

  5 to 28 days

Secondary Outcomes (4)

• Time from inoculation until first positive parasitemia by thick smear in each volunteer in the two groups.

  5-28 days

• Time from inoculation to until first positive parasitemia by qRT-PCR in each volunteer in the two groups.

  5-28 days

• Kinetics of parasitemia in positive volunteers in the two groups as measured by qRT-PCR.

  5-28 days

• Occurrence or intensity of signs or symptoms in the two groups of volunteers

  5 days to 6 months

Study Arms (3)

Group 1 10,000 PfSPZ

EXPERIMENTAL

12 volunteers, ID PfSPZ Challenge total dose 10,000 PfSPZ administered by 2 injections of 50µL each.

Biological: PfSPZ Challenge

Group 2 25,000 PfSPZ

EXPERIMENTAL

12 volunteers, ID PfSPZ Challenge total dose 25,000 PfSPZ administered in 4 injections of 10µL each.

Biological: PfSPZ Challenge

Controls - saline

PLACEBO COMPARATOR

4 Volunteers, ID saline administered in 2 injections of 50µL each and 2 volunteers, ID saline administered in 4 injections of 10µL each.

Biological: Saline

Interventions

PfSPZ Challenge BIOLOGICAL

Aseptic, purified, vialed, cryopreserved, fully infectious NF54 Plasmodium falciparum sporozoites (PfSPZ Challenge)

Also known as: Plasmodium falciparum sporozoites

Group 1 10,000 PfSPZ; Group 2 25,000 PfSPZ

Saline BIOLOGICAL

Saline

Controls - saline

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Male aged between 20-35 years, healthy volunteers
• Good Health status based on history \& clinical examination
• Residing in or near DaresSalaam
• Willing to contribute to science in Tanzania
• Free from malaria parasite by blood smear \& qRT-PCR
• Not suffering from any chronic illness including HIV/AIDS
• No documented history of malaria infection for the past 5 yrs
• Able \& willing to come for complete one year follow up including minimum of three weeks of hospitalization
• All volunteers must sign the informed consent form \& answer correctly 15 out 15 questions demonstrating their understanding of the meaning \& procedures of the study
• Volunteer agrees to inform study doctor \& agrees to release medical information concerning contra-indications for participation in the study
• Living with a third party that will contact the study team if in case of alteration of consciousness during the first month of the study
• Willing to undergo a Pf sporozoite challenge.
• Willing to take curative treatment for malaria (Coartem®) \& any other medication which may be prescribed by a study doctor during study period
• All volunteers agree to stay in the hospital during parts of the study (overnight after challenge, up to 15 days during follow up \& 3 days of Coartem® treatment)
• Reachable (24/7) by mobile phone during the whole study period

You may not qualify if:

• History of malaria in the past 5 yrs
• Plans to travel outside the Dar-es-salaam or Coast Region in first month (day 0-28) of the study
• Plans to travel to highly malarious areas in the 6 months following the study period
• Previous participation in malaria vaccine study \&/or positive serology for Plasmodium falciparum asexual crude extract antibodies above acceptable cut off established for the site.
• History of arrhythmias or prolonged QT-interval or other cardiac disease
• Positive family history of in the 1st \& 2nd degree relative for cardiac disease \<50 yrs old.
• Volunteers unable to read \& write in English \& give written informed consent
• Previous history of drug or alcohol abuse interfering with normal social function
• A history of psychiatric disease
• The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled \& topical corticosteroids are allowed) \& during the study period
• A history or confirmed sickle cell anemia, sickle cell trait, thalassemia , thalassemia trait or G6PD deficiency
• Co-worker of the Ifakara Health Institute
• Symptoms, physical signs \& laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, \& other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
• History of diabetes mellitus or cancer
• An estimated, ten year risk of fatal cardiovascular disease of \<5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system

Sponsors & Collaborators

• Sanaria Inc.: lead
• Ifakara Health Research and Development Centre: collaborator
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Bagamoyo Research and Training Center, Ifakara Health Institute

Bagamoyo, Tanzania

Location

Related Publications (1)

• Shekalaghe S, Rutaihwa M, Billingsley PF, Chemba M, Daubenberger CA, James ER, Mpina M, Ali Juma O, Schindler T, Huber E, Gunasekera A, Manoj A, Simon B, Saverino E, Church LWP, Hermsen CC, Sauerwein RW, Plowe C, Venkatesan M, Sasi P, Lweno O, Mutani P, Hamad A, Mohammed A, Urassa A, Mzee T, Padilla D, Ruben A, Sim BKL, Tanner M, Abdulla S, Hoffman SL. Controlled human malaria infection of Tanzanians by intradermal injection of aseptic, purified, cryopreserved Plasmodium falciparum sporozoites. Am J Trop Med Hyg. 2014 Sep;91(3):471-480. doi: 10.4269/ajtmh.14-0119. Epub 2014 Jul 28.

  PMID: 25070995 RESULT

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Salim Abdulla, MD, PhD

  Ifakara Health Institute (IHI), Tanzania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: August 1, 2013
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

TA (1)