Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine

October 4, 2019 updated by: Seattle Children's Research Institute (SCRI)

Phase 1/2a Trial to Assess the Safety, Immunogenicity and Efficacy of Genetically-attenuated Plasmodium Falciparum Parasites p52-/p36- (GAP) Vaccine, Administered by Bite of Infected Anopheles Mosquito to Malaria-naïve Adults Living in the United States.

The purpose of this study is to assess safety and tolerability of escalating doses of a genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy malaria-naive adults. The study will also assess preliminary efficacy of p52-/p36- GAP vaccine following primary experimental challenge with P. falciparum sporozoites. Lastly, the study will assess immunogenicity of p52-/p36- GAP in malaria-naïve healthy adults and preliminary efficacy of p52-/p36- GAP vaccine following primary experimental re-challenge with P. falciparum sporozoites.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Walter Reed Army Institute of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of enrollment
  • Free of significant health problems as established by medical history, laboratory assessment and clinical examination before entering into the study
  • Volunteers must have low cardiac risk factors according to the NHANES I criteria and a non-significant electrocardiogram (EKG) as determined by a expert consultant cardiologist
  • Available to participate for duration of study
  • Reproductive status: a female participant must:
  • not be of reproductive potential: i.e. be surgically, medically or physiologically sterile, or
  • if engages in sexual activity that could lead to pregnancy:
  • agrees to consistently use contraception until 2 months after the last protocol visit. Contraception is defined as using 1 of the following methods:
  • condoms (male or female) with or without a spermicide
  • diaphragm or cervical cap with spermicide
  • intrauterine device (IUD)
  • hormonal contraception
  • If the volunteer indicates he/she is active duty military (on the DCT sign-in page and intake form), approval from their supervisor through the Division Director using the Statement of Supervisor's Approval Form must be signed and on file prior to receipt of any test product
  • Written informed consent must be obtained from the subject before screening procedures
  • Prior to entry into this study, subjects must score at least 80% correct on a 10- question multiple-choice quiz that assesses their understanding of this study.

Exclusion Criteria:

  • Prior receipt of any investigational malaria vaccine
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
  • Administration of any vaccine within 30 days of first study vaccination Any past history of malaria
  • Planned travel to malarious areas during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • A family history of congenital or hereditary immunodeficiency
  • Moderate or high 5-year cardiovascular risk as determined by NHANES 1 model
  • An abnormal 12-lead electrocardiogram (EKG) suggestive of cardiac disease as determined by a clinician
  • Seropositive for HIV, Hepatitis C virus (antibodies to HCV) and/or HBsAg
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness
  • History of splenectomy
  • Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
  • History of psoriasis and porphyria
  • Acute or chronic, clinically significant pulmonary, cardiovascular, ocular, hematologic, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests and medical history review
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
  • Current chronic use of medications known to cause drug reactions with chloroquine and/or atovaquone/proguanil such as cimetidine and metoclopramide.
  • Current chronic use or use within one month prior to enrollment of antibiotics with anti-malarial effects such as tetracyclines for acne, sulfa drugs for recurrent urinary tract infections, etc.
  • Pregnant or lactating female
  • Female who is willing or intends to become pregnant during the study and for two (2) months after study completion
  • Any history of allergic reaction or anaphylaxis to previous vaccination
  • History of severe reactions to mosquito bites.
  • Inability to make follow-up visits or complete diary cards
  • Suspected or known current alcohol abuse/drug abuse as obtained by history and physical examination
  • Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: p52-p36- GAP Vaccine

p52-/p56- GAP Vaccine: Administered by five bites from GAP-infected Anopheles mosquito.

p52-/p56- GAP Vaccine: Administered by 200 bites from GAP-infected Anopheles mosquito.

Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
Biological: p52-/p36- GAP Vaccine
Administered by five bites from GAP-infected Anopheles mosquito
Biological: p52-p36- GAP Vaccine
Administered by 200 bites from GAP-infected Anopeles mosquito
Biological: p52-/p36- GAP Vaccine
Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
NO_INTERVENTION: Infectivity Control
Active Control: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum
EXPERIMENTAL: p52-p36- GAP Vaccine + Infectivity Challenge

p52-/p36- GAP Vaccine: Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito.

Challenge: Administered by five bites from Anopheles mosquitoes infected with wild type NF54 strain Plasmodium falciparum.
Biological: p52-/p36- GAP Vaccine
Administered by five bites from GAP-infected Anopheles mosquito
Biological: p52-/p36- GAP Vaccine
Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of Solicited Adverse Events (AE)
Time Frame: From administration of study vaccine through 7 days (± 1 days) post dosing
From administration of study vaccine through 7 days (± 1 days) post dosing
Occurrence of Unsolicited AEs
Time Frame: From administration of study vaccine through 28 days (± 4 days) post dosing
From administration of study vaccine through 28 days (± 4 days) post dosing
Occurrence of Laboratory Adverse Events (AE)
Time Frame: From administration of study vaccine through 7 days (± 1 days) post dosing
Volunteers with any laboratory abnormality.
From administration of study vaccine through 7 days (± 1 days) post dosing
Detection of Breakthrough Peripheral Parasitemia by Thick Blood Film
Time Frame: From 7 days after administration of vaccine through 28 days (+ 4 days) post-dosing
From 7 days after administration of vaccine through 28 days (+ 4 days) post-dosing
Occurrence of Serious Adverse Events (SAE)
Time Frame: baseline through 28 days
baseline through 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Development of Parasitemia and Time to Parasitemia After Primary Malaria Challenge Following Administration of GAP
Time Frame: From administration of study vaccine through the duration of the trial
From administration of study vaccine through the duration of the trial
Development of Parasitemia and Time to Parasitemia After Re-challenge Following Administration of GAP
Time Frame: From administration of study vaccine through the duration of the trial
From administration of study vaccine through the duration of the trial
P. Falciparum Specific Cell-mediated Immune Responses
Time Frame: From administration of study vaccine through the duration of the trial
From administration of study vaccine through the duration of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Research Institute (SCRI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michele Spring, M.D., Walter Reed Army Institute of Research (WRAIR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WR 1584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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