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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Occurrence of Solicited Adverse Events (AE)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Occurrence of Solicited Adverse Events (AE)
Time Frame: From administration of study vaccine through 7 days (± 1 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.
Occurrence of Unsolicited AEs
Time Frame: From administration of study vaccine through 28 days (± 4 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
Occurrence of Serious Adverse Events (SAE)
Time Frame: baseline through 28 days
Secondary Outcomes
- Development of Parasitemia and Time to Parasitemia After Primary Malaria Challenge Following Administration of GAP(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(From administration of study vaccine through the duration of the trial)
- P. Falciparum Specific Cell-mediated Immune Responses(From administration of study vaccine through the duration of the trial)