Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine (NCT01024686) | Clinical Trial Compass
TerminatedPhase 1/2
Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine
United States6 participantsStarted 2010-03
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Solicited Adverse Events (AE)
Timeframe: From administration of study vaccine through 7 days (± 1 days) post dosing
2
Occurrence of Unsolicited AEs
Timeframe: From administration of study vaccine through 28 days (± 4 days) post dosing
3
Occurrence of Laboratory Adverse Events (AE)
Timeframe: From administration of study vaccine through 7 days (± 1 days) post dosing
4
Detection of Breakthrough Peripheral Parasitemia by Thick Blood Film
Timeframe: From 7 days after administration of vaccine through 28 days (+ 4 days) post-dosing