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Malaria, FalciparumPhase 1/2MMVNCT01783340

Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine or Chloroquine/Azithromycin Prophylaxis

A Phase 1/2 study testing Azithromycin capsules and Immunization with falciparum in people with Malaria, Falciparum, run by Radboud University Medical Center at 1 site in Netherlands.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Malaria, Falciparum
What is being tested?
Azithromycin capsules and Immunization with falciparum
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteNetherlands
Study dates
Apr 2013to Apr 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age ≥ 18 and ≤ 35 years healthy volunteers (males or females)
  • Good health based on history and clinical examination
  • Negative pregnancy serum test
  • For females who are sexually active: use of adequate contraception (incl. condom use)
  • Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
  • Agreement to inform the general practitioner and to sign a request to release medical information concerning contra-indications for participation in the study
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  • Willingness to undergo a Pf controlled infection through mosquito bites
  • 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)
  • Reachable (24/7) by mobile phone during the whole study period
  • Available to attend all study visits
  • Agreement to refrain from blood donation or for other purposes, during the whole study period
  • Willingness to undergo HIV, hepatitis B and hepatitis C tests
  • Negative urine toxicology screening test at screening visit and the day before challenge
  • Willingness to take a prophylactic regime of chloroquine or chloroquine/azithromycin combination and a curative regimen of Malarone® after challenge.

Who cannot join

  • History of malaria
  • Plans to travel to malaria endemic areas during the study period
  • Plans to travel outside of the Netherlands during the challenge period
  • History of stay in malaria endemic areas for more than 6 months
  • Previous participation in any malaria vaccine study and/or positive serology for Pf
  • 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
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  • History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
  • History of arrhythmias or prolonged QT-interval
  • Positive family history in 1st and 2nd degree relatives for cardiac events < 50 years old
  • An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
  • Clinically significant abnormalities in electrocardiogram (ECG) at screening
  • Body Mass Index (BMI) below 18 or above 30 kg/m2
  • Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
  • Positive HIV, HBV or HCV tests
  • Participation in any other clinical study within 30 days prior to the onset of the study
  • Enrolment in any other clinical study during the study period
  • Pregnancy or lactation for women
  • Volunteers unable to give written informed consent
  • Volunteers unable to be closely followed for social, geographic or psychological reasons
  • History of (soft) drugs or alcohol abuse interfering with normal social function
  • A history of treatment for psychiatric disease
  • A history of epileptic insults in the volunteer
  • Contra-indications for use of Malarone®, chloroquine or azithromycin. This includes hypersensitivity or treatment taken by the volunteer that interferes with mentioned study drugs.
  • 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
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including (functional) asplenia
  • Co-workers or trainees of the departments of Medical Microbiology, Parasitology, or Internal Medicine of the Leiden University Medical Centre
  • A history of sickle cell anaemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Leiden University Medical Centre

    Leiden, Leiden, 2333ZA

Other trials in Netherlands

About this study

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.

Read the detailed 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.

Being tested
Azithromycin capsules, Placebo, Immunization with falciparum
Keywords
Malaria, P falciparum, Chloroquine, Azithromycin, Immunization
Medical subject headings
Malaria, Falciparum, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azithromycin capsulesDrug

    Also called Zithromax

    Azithromycin capsules will be administered at each immunization

  • PlaceboDrug

    Placebo capsules will be administered at each immunization

  • Immunization with falciparumBiological

    three inoculations with 5 infected mosquito bites

Study groups in NCT01783340
Study groupRoleWhat they receive
CQ and falciparum immunizationActive comparatorThis arm will receive chloroquine prophylaxis, a placebo during immunizations and three times 5 infected mosquito-bites (immunizations). Standard Chloroquine prophylactic regime: a loading dose of 300 mg on day 1 and day 3 and then 300 mg once a week, starting on day 7, for a total duration of 13 weeks. Placebo capsules daily on three consecutive days starting on each of three immunization days. Challenge: Exposure to the bites of 5 Plasmodium falciparum infected mosquitoes. When thick smear positive, of at day 21 after challenge, a standard 3 day treatment of Malarone will be given.
Receives: Drug: Placebo; Biological: Immunization with falciparum
CQ/AZM and falciparum immunizationExperimentalThis arm will receive chloroquine and azithromycin prophylaxis and three times 5 infected mosquito-bites (immunizations). Standard Chloroquine prophylactic regime: a loading dose of 300 mg on day 1 and day 3 and then 300 mg once a week, starting on day 7, for a total duration of 13 weeks. Azithromycin capsules 1000mg daily on three consecutive days starting on each of three immunization days. Challenge: Exposure to the bites of 5 Plasmodium falciparum infected mosquitoes. When thick smear positive, of at day 21 after challenge, a standard 3 day treatment of Malarone will be given.
Receives: Drug: Azithromycin capsules; Biological: Immunization with falciparum
CQ and AZM controlPlacebo comparatorThis arm will receive chloroquine and azithromycin prophylaxis and three times 5 uninfected mosquito-bites during immunization. Standard Chloroquine prophylactic regime: a loading dose of 300 mg on day 1 and day 3 and then 300 mg once a week, starting on day 7, for a total duration of 13 weeks. Azithromycin capsules 1000mg daily on three consecutive days starting on each of three immunization days. Challenge: Exposure to the bites of 5 Plasmodium falciparum infected mosquitoes. When thick smear positive, of at day 21 after challenge, a standard 3 day treatment of Malarone will be given.
Receives: Drug: Azithromycin capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volunteers falciparum positive by thick smear

    Percentage of P. falciparum thick smear negative volunteers on day 21 (protection against challenge infection)

    Measured: One year

Secondary outcomes (4)

  1. Duration of pre-patent period by thick smear

    Duration of pre-patent period after challenge infection as measured by microscopy (thick smear)

    Measured: One year

  2. Kinetics of parasitemia by PCR

    Development of parasitemia as measured by PCR

    Measured: One year

  3. Adverse events

    Frequency of adverse events in study groups

    Measured: One year

  4. Immune responses

    Immune responses between study groups

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2013 (estimated)
  4. Study completionApr 2014 (estimated)

Why it stopped: No funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01783340
Sponsor's protocol ID
MMV
Other IDs
NL42517.000.12
Acronym
MMV
Status last verified
Nov 2014
First submitted
31 Jan 2013
Last updated
13 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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, Renia L, van der Ven A, Hermsen CC, Sauerwein R. Protection against a malaria challenge by sporozoite inoculation. N Engl J Med. 2009 Jul 30;361(5):468-77. doi: 10.1056/NEJMoa0805832.

    PubMed 19641203

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Azithromycin capsules and Immunization with falciparum in people with Malaria, Falciparum, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volunteers falciparum positive by thick smear (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01783340, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.

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