A Phase 1 interventional study of PfSPZ Vaccine and Normal Saline Placebo in Malaria and Malaria,Falciparum, sponsored by Sanaria Inc.. Completed at 1 site in Tanzania. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by Sanaria Inc. · Phase 1, Interventional, and Prevention
This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10\^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV positive volunteers in Tanzania.
This trial is a single center trial designed to assess the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine (9.0x10\^5 PfSPZ given at 0, +2, +4, +6 and +28 days (Group 1, HIV negative, and Group 2, HIV positive)). Controls will receive parallel injections with normal saline (NS). All administrations of PfSPZ or NS will be by direct venous inoculation (DVI).
Twenty-one male and female adult volunteers, aged from 18 to 45 years, who live in and around the Bagamoyo township, will be enrolled based on pre-defined inclusion and exclusion criteria. 12/21 subjects will be HIV positive volunteers (who clinical stage 1) on stable anti-retroviral therapy (ART) for at least 3 months with a CD4+ cell count above 500 cells/μL at screening. The rest (9/21) will be healthy HIV negative adults.
Treatment allocation will be double-blind within Group 1 and 2b but not between the groups or subgroups. Immunizations will begin with healthy HIV negative volunteers first (Group 1), before inoculation of HIV positive volunteers (Groups 2a and 2b). Transitioning from immunization of HIV negative to immunization of HIV positive will begin by immunizing a sentinel group of 3 HIV positive individuals with a reduced vaccine dose of 4.5x10\^5 PfSPZ (Group 2a). This transition will be staggered by at least two (2) weeks, to allow for a safety data review. If the safety data do not meet pause criteria, this will signal a "go" for transitioning to immunizations of sentinel group of three (3) HIV positive volunteers. If pause criteria are met, there will be no immediate transition, and instead an ad-hoc meeting of the Safety Monitoring Committee (SMC) will be called for an independent review and recommendation. Transition from the unblinded HIV positive sentinel Group 2a to the full study cohort of double blinded placebo controlled HIV positive volunteers (Group 2b), will also be staggered for at least two (2) weeks. There will be a scheduled review by the SMC of safety data collected from the sentinel HIV positive group for up to 7 days after the fourth immunization. After the safety review, transition to the main HIV positive group (Group 2b) will take into account the SMC recommendation(s).
1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 21 is below the median of 220 across 1,041 interventional studies indexed under Malaria.
Browse Malaria studies →Sanaria Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Volunteers for enrollment into HIV positive sub-groups must have:
Exclusion Criteria:
Group 1: n=6, HIV negative vaccine recipients will receive 9.0x10\^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 1, n=9, where volunteers will be randomized in a 1:2 ratio to receive either normal saline placebo (NS) or PfSPZ Vaccine. Efficacy will be assessed by controlled human malaria infection (CHMI) at +3 weeks (+2 to +10 weeks) after the last dose of PfSPZ Vaccine. CHMI will be by DVI of 3,200 PfSPZ Challenge.
Biological: PfSPZ Vaccine · Biological: PfSPZ Challenge
Group 1: n=3, HIV negative NS placebo recipients will receive NS at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 1, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine. Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of NS. CHMI will be by DVI of 3,200 PfSPZ Challenge.
Other: Normal Saline Placebo · Biological: PfSPZ Challenge
Group 2a: n=3, HIV positive vaccine recipients will receive 4.5x10\^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days.
Biological: PfSPZ Vaccine
Group 2b: n=6, HIV positive vaccine recipients will receive 9.0x10\^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 2b, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine. Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of PfSPZ Vaccine. CHMI will be by DVI of 3,200 PfSPZ Challenge.
Biological: PfSPZ Vaccine · Biological: PfSPZ Challenge
Group 2b: n=3, HIV positive NS placebo recipients will receive NS at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 2b, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine. Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of NS. CHMI will be by DVI of 3,200 PfSPZ Challenge.
Other: Normal Saline Placebo · Biological: PfSPZ Challenge
Aseptic, purified, metabolically active, non-replicating, radiation-attenuated, cryopreserved Pf sporozoites.
0.9% sodium chloride solution
Aseptic, purified, live, infectious, cryopreserved Pf sporozoites.
Safety of PfSPZ Vaccine - solicited symptoms
Occurrence of solicited symptoms during a 7-day surveillance period after vaccination (day of vaccination (Vx) and +7 days post vaccination).
Time frame: From day of vaccination to 7-days post vaccination.
Safety of PfSPZ Vaccine - unsolicited symptoms
Occurrence of unsolicited symptoms during a 28-day surveillance period after each vaccination.
Time frame: From day of vaccination to 28-days post vaccination.
Safety of PfSPZ Vaccine - laboratory abnormalities
Occurrence of laboratory abnormalities including significant drops in CD4 T cell counts or increases in viral load.
Time frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
Safety of PfSPZ Vaccine - serious adverse events
Occurrence of serious adverse events during the study period.
Time frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
Safety of PfSPZ Vaccine - breakthrough infection
\- Occurrence of Pf infection of vaccine type detected at any point after the first vaccination (retrospectively determined).
Time frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PfSPZ Challenge