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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02132299
Other study ID # BSPZV1
Secondary ID
Status Completed
Phase Phase 1
First received April 29, 2014
Last updated April 25, 2016
Start date April 2014
Est. completion date August 2015

Study information

Verified date April 2016
Source Sanaria Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationTanzania: Food & Drug AdministrationTanzania: National Institute for Medical ResearchSwitzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ Vaccine) administered intravenously (IV).


Description:

This is a single center, Phase 1, dose escalating, randomized, double blind, controlled trial. Seventy-three healthy male volunteers, aged 18 to 35 years will be recruited. The study will have 5 study groups that will include 49 volunteers who will be intravenously injected with PfSPZ Vaccine, 8 control volunteers who will receive normal saline and 16 additional control volunteers who will be recruited at the time of controlled human malaria infection (CHMI) at 3 and 24 weeks. The control volunteers will help better assess the occurrence of AEs compared to background disease patterns that occur in this tropical area, and the performance of the vaccine.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Biological:
PfSPZ Vaccine
Aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) cryopreserved Plasmodium falciparum sporozoites (PfSPZ)
Normal Saline (Placebo)

PfSPZ Challenge
Live, infectious, aseptic, purified, vialed, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) for CHMI

Locations

Country Name City State
Tanzania Bagamoyo Research and Training Center, Ifakara Health Institute, Kingani Estate, PO Box 74 Bagamoyo

Sponsors (4)

Lead Sponsor Collaborator
Sanaria Inc. Ifakara Health Institute, Swiss Tropical & Public Health Institute, Tanzania Commission for Science and Technology

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory Endpoints - Immune Responses Malaria specific immune responses in Groups 2, 3 and 4 as compared to the malaria naïve volunteers immunized at Vaccine Research Center of the NIH (protocol VRC 312) who received 1.35x10^5 PfSPZ/dose. 16 months No
Primary Safety and tolerability endpoints Solicited local (IV site) and systemic AEs (AEs) observed in the 7 days after each vaccination and each CHMI.
Unsolicited AEs observed after the first vaccination until day 28 after the last vaccination for volunteers who do not undergo CHMI#1 (e.g. Group 1, those who do not complete the CHMI portion in Groups 2 and 3, and volunteers in Group 4).
Unsolicited AEs observed after the first vaccination until day 28 after the CHMI#1 for volunteers who undergo CHMI#1 3 weeks after the last vaccination (e.g. Groups 2 and 3).
Unsolicited AEs observed from day CHMI#2 (which occurs 24 weeks after the last vaccination) until day 28 after CHMI#2 (e.g. Groups 2-5).
Vaccination to CHMI (or 28 days after last vaccination); CHMI to 28 days after CHMI Yes
Primary Protective Efficacy after CHMI with PfSPZ Challenge (NF54) - CHMI Endpoints Number of volunteers that remain parasite negative in each group through day 28 of follow up after CHMI with PfSPZ Challenge (NF54) IV inoculation.
Three weeks after their last immunization, volunteers in Groups 2 and 3 will under go their first CHMI with 3.2 x 10^3 PfSPZ Challenge (NF54) administered IV. Twenty-four weeks after the last immunization, volunteers from Groups 2 and 3 who underwent the first CHMI and did not become infected will have a second CHMI by IV injection of 3.2x10^3 PfSPZ Challenge (NF54). Volunteers in Groups 4 and 5 will only participate in the second CHMI assessment.
After CHMI, volunteers will be followed for evidence of infection with blood smears for 28 days.
CHMI to 28 days after CHMI No
Secondary Immune Responses after PfSPZ Vaccine Cellular and humoral immune responses will be assessed in the vaccinated volunteers and controls (including central and effector memory responses and breadth and specificity of malaria antibodies). 16 months No
Secondary Protective effect of the high dose PfSPZ Vaccine regimen Number of volunteers negative in Group 3 and Group 4 compared to Group 2 through day 28 of follow up after homologous PfSPZ Challenge (NF54) IV inoculation. CHMI to day 28 after CHMI No
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