MalariaPhase 1NCT02313376

Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes

A Phase 1 study testing GAP3KO in people with Malaria, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Study designed to evaluate safety and tolerability of a genetically attenuated P. falciparum (GAP3KO) that arrests early in the liver stage of the parasite life cycle. Study will also confirm the attenuation of the GAP3KO parasites using peripheral blood smears. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: GAP3KO
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Aug 2015
Phase: Phase 1
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Good general health
No hematologic, hepatic, or renal disease
Weight greater than 50 kg
Assessment of Understanding completed and passed prior to enrollment
Availability and reliable access to trial center
Females must use two forms of pregnancy prevention

Who cannot join

Recent (within 6 months) or planned travel to malaria endemic area
History of confirmed malaria diagnosis
Anticipated use of the following:
Investigational malaria vaccine at any time
Malaria chemoprophylaxis within 6 months
Chronic systemic immunosuppressive medications within 6 months

Show all 27Show fewer

Blood products or immunoglobulin within 120 days
Systemic antibiotics with antimalarial effects within 30 days
Investigational product or vaccine within 30 days
Live vaccine within 28 days; killed vaccine within 14 days of GAP3KO
Medications known to significantly interact with chloroquine or Malarone
History of:
Sickle cell trait or other hemoglobinopathies
Splenectomy or functional asplenia
Systemic anaphylaxis
Severe allergic reaction to mosquito bites or malaria treatment drugs
History of chronic or active neurologic disease
Cardiac disease or stroke
Clinically significant medical condition, abnormal lab results
Clinically significant abnormal ECG
Moderate or high risk for coronary heart disease
Acute illness
Pregnant or nursing female
HIV, Hepatitis B, or Hepatitis C
Psychiatric condition that precludes compliance with the protocol
Suspected or known alcohol or drug abuse
Staff with direct involvement in conduct of the study or GAP activities

Trial locations and contacts

1 site in 1 country.

United States1 site

Seattle Biomedical Research Institute Malaria Clinical Trial Center
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Trial to Assess the Safety, Attenuation and Immunogenicity of Genetically-attenuated p52-/p36-/sap1- Plasmodium Falciparum Parasites (GAP3KO) Administered Via Infected Anopheles Stephensi Mosquitoes to Malaria-Naïve Adults

Read the detailed description

This single arm, open-label, phase 1 safety study is designed to evaluate the safety and tolerability of a genetically attenuated P. falciparum (GAP3KO) that arrests early in the liver stage of the parasite life cycle. The study will also confirm the attenuation of the GAP3KO parasites using peripheral blood smears. The secondary objectives of the study are to evaluate the humoral immune responses to GAP3KO.

A total of 10 healthy, malaria-naïve adult subjects will be enrolled to receive GAP3KO via the bite of 150-200 GAP3K0-infected A. stephensi mosquitoes under controlled conditions. Subjects will be evaluated for safety, reactogenicity, and signs and symptoms of malaria to confirm attenuation for 28 days, including monitoring in a hotel setting 8-18 days post GAP 3KO administration.

Conditions: Malaria
Being tested: GAP3KO
Medical subject headings: Malaria

What participants receive

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

GAP3KOBiological
GAP3KO administered via the bite of 150-200 GAP3KO-infected A. stephensi mosquitoes under controlled conditions.

Study groups in NCT02313376
Study group	Role	What they receive
GAP3KO	Experimental	Not described Receives: Biological: GAP3KO

What is being measured

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

Safety assessed by frequency of AEs, SAEs, and patent parasitemia via peripheral blood smear
Measured: 28 Days

Secondary outcomes (2)

CSP antibody titer
Measured: 28 days
Percent inhibition of in vitro sporozoite
Measured: 28 days

Timeline

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

Dec 2014Aug 2015

First posted10 Dec 2014 (estimated)
Study startDec 2014
Primary completionFeb 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MalariaStudies of the same condition, open and under way.
More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02313376
Sponsor's protocol ID: MC-004
Status last verified: Nov 2015
First submitted: 8 Dec 2014
Last updated: 18 Nov 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum

All Malaria trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial to Assess the Safety, Attenuation and Immunogenicity of Genetically-attenuated p52-/p36-/sap1- Plasmodium Falciparum Parasites (GAP3KO) Administered Via Infected Anopheles Stephensi Mosquitoes to Malaria-Naïve Adults
ClinicalTrials.gov ID: NCT02313376
Acronym / sponsor ID: MC-004
Conditions: Malaria
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Seattle Children's HospitalUniversity, hospital or other
Study start: Dec 2014
Primary completion: Feb 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 10 Dec 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GAP3KO	Experimental	Biological: GAP3KO

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Good general health
No hematologic, hepatic, or renal disease
Weight greater than 50 kg
Assessment of Understanding completed and passed prior to enrollment
Availability and reliable access to trial center

Key exclusion criteria (27 listed)

Recent (within 6 months) or planned travel to malaria endemic area
History of confirmed malaria diagnosis
Anticipated use of the following:
History of:
Clinically significant medical condition, abnormal lab results

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GAP3KOGAP3KO administered via the bite of 150-200 GAP3KO-infected A. stephensi mosquitoes under controlled conditions.	Biological	GAP3KO

Primary outcome

Safety assessed by frequency of AEs, SAEs, and patent parasitemia via peripheral blood smear
Time frame: 28 Days

2 secondary outcomes

CSP antibody titer
Time frame: 28 days
Percent inhibition of in vitro sporozoite
Time frame: 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.

Related trials for Malaria

Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GAP3KO in people with Malaria, run by Seattle Children's Hospital at 1 site in United States.

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 6 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: finished, as of the sponsor's last update on 18 Nov 2015. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety assessed by frequency of AEs, SAEs, and patent parasitemia via peripheral blood smear (time frame: 28 Days). 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 NCT02313376.

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 18 Nov 2015.