A Phase 1 interventional study of PfSPZ Vaccine and PfSPZ Challenge (7G8) for CHMI in Malaria, sponsored by Sanaria Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Sanaria Inc. · Phase 1, Interventional, and Prevention
This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI) conducted at varying time intervals after the third immunization (14, 42 or 70 days). The trial is designed to simulate pre-deployment immunization of military personnel. Prior studies with this regimen show high level protection (>80%) against CHMI at 21 days, but the onset and duration of protection have not been fully defined.
USSPZV6 is a single site, double-blind, randomized, placebo-controlled, clinical trial. Study groups will be randomized in a 14:4 ratio (vaccine to NS placebo) among healthy, malaria-naive adults aged 18-50 years. There will be three groups of subjects. Each of the 3 groups will have 14 subjects who receive 3 injections with 9 x 10\^5 PfSPZ of PfSPZ Vaccine and 4 subjects who receive 3 injections with normal saline placebo. Subjects who complete all immunizations will receive a total 2.7 x 10\^6 PfSPZ. VE will be assessed by exposure to PfSPZ Challenge (7G8) (cryopreserved infectious sporozoites originating from a Pf strain isolated in Brazil, and thus heterologous to the vaccine). The day of CHMI will vary per group with Groups A, B and C receiving PfSPZ Challenge (7G8) on days 14, 42 or 70 after Vaccination 3 (V3), respectively. Direct observation will be for 30 minutes following each dose of PfSPZ Vaccine or PfSPZ Challenge. A research/safety monitor and a Safety Monitoring Committee (SMC) will provide safety oversight. Clinical study monitoring will be the responsibility of Sanaria or Sanaria's designated and authorized representative. Screening will not precede enrollment by more than 90 days. For the second and third immunizations, allowable windows are assigned. The entire study will take approximately 8 months to complete, including 2 months of recruitment because the study will be conducted in two sequential cohorts. The period of follow-up for each immunized subject and placebo controls is through 8 weeks post-CHMI. Study participation will last between 99 and 154 days (not including screening) depending upon group assignment.
Case report forms (CRFs) will serve as the repository of source documents and other relevant data for each study subject. Only information that cannot be collected initially into the CRF (for instance, EKGs and AE medical records) will first be collected onto separate source documents before transcription into the CRF. Laboratory results will be entered from source documents directly into the database.
Solicited adverse events (AEs) will be collected for 7 days after each immunization. Unsolicited AEs will be collected from the first immunization (V1) until 28 days after the third immunization (V3) and for 28 days after CHMI. Physical exams and medical history will be assessed as indicated. Safety laboratories will be collected at screening, day of V1, 14 days after V2, 7 days after V3, day of CHMI and 28 days after CHMI. Surveillance for SAEs will occur for the duration of the study. Follow-up of AEs (including SAEs) occurs until resolution or stability.
If clinical laboratories expire (meaning they were obtained greater than 90 days prior to planned enrollment), specific safety labs will be repeated for screening purposes. Safety evaluation includes an electrocardiogram (ECG) performed at screening. Subjects with abnormal cardiovascular symptoms or findings that appear clinically significant will be excluded and if appropriate, referred to a cardiologist for further evaluation.Clinical laboratory testings will be conducted by Fred Hutchinson Cancer Research Center.
Detection of parasitemia post CHMI will be based upon qRT-PCR. Subjects who have 2 positive qRT-PCR results separated by greater than or equal to 12 hours or a single qRT-PCR result reading > 250 estimated parasites/mL will be treated with anti-malaria therapy. Anti-malarial therapy will consist of: First-line: Malarone, Second-line: Coartem.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 54 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Sanaria Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
14 volunteers will receive 3 doses of 9 x 10\^5 PfSPZ Vaccine on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 14 by DVI injection.
Biological: PfSPZ Vaccine · Biological: PfSPZ Challenge (7G8) for CHMI
14 volunteers will receive 9 x 10\^5 PfSPZ Vaccine on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 42 by DVI injection.
Biological: PfSPZ Vaccine · Biological: PfSPZ Challenge (7G8) for CHMI
14 volunteers will receive 9 x 10\^5 PfSPZ Vaccine on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 70 by DVI injection.
Biological: PfSPZ Vaccine · Biological: PfSPZ Challenge (7G8) for CHMI
4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 14 by DVI injection.
Biological: PfSPZ Challenge (7G8) for CHMI · Other: Normal Saline
4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 42 by DVI injection.
Biological: PfSPZ Challenge (7G8) for CHMI · Other: Normal Saline
4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 70 by DVI injection.
Biological: PfSPZ Challenge (7G8) for CHMI · Other: Normal Saline
Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)
Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain 7G8
normal saline placebo control
Vaccine efficacy (VE) of PfSPZ Vaccine against Pf malaria in adults
VE computed as one minus the estimated risk ratio for Pf infection (parasitemia) detected by qRT-PCR beginning 7 days after CHMI and censoring subjects at 28 days in the "modified Intention to Treat" (mITT) population
Time frame: 7-28 days after CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- solicited AEs
The differences in proportions of vaccinees compared to controls experiencing related solicited adverse events after vaccination.
Time frame: Day of first immunization until 8 weeks post CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- solicited AEs
The differences in proportions of vaccinees compared to controls experiencing related unsolicited adverse events after vaccination.
Time frame: Day of first immunization until 8 weeks post CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- SAEs
The differences in proportions of vaccinees compared to controls experiencing related serious adverse events (SAEs) after vaccination.
Time frame: Day of first immunization until 8 weeks post CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- Lab abnormalities
The differences in proportions of vaccinees compared to controls experiencing related laboratory abnormalities after vaccination.
Time frame: Day of first immunization until 8 weeks post CHMI
Antibody responses to PfCSP post-immunization/CHMI and correlation with protection in vaccinees vs controls
Antibody levels to PfCSP measured by ELISA comparing vaccinees to controls
Time frame: 2 weeks post Vaccination 2 until 4 weeks post CHMI
Antibody responses to PfCSP post-immunization/CHMI and correlation with protection in protected vs unprotected vaccinees
Antibody levels to PfCSP measured by ELISA comparing protected (no parasitemia occurring post CHMI) and non-protected (parasitemia occurring post CHMI) vaccinees.
Time frame: 2 weeks post Vaccination 2 until 4 weeks post CHMI
VE between different groups with CHMI at 14, 42 or 70 days after Vaccination 3
VE computed as one minus the estimated risk ratio for Pf infection (parasitemia) detected by qRT-PCR beginning 7 days after CHMI and censoring subjects at 28 days in the mITT population
Time frame: Day of first immunization until 8 weeks post CHMI
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanaria Inc.