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Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521973
Recruitment Status : Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research
Information provided by (Responsible Party):
Sanaria Inc.

Brief Summary:
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou Province in Gabon will be eligible for participation.

Condition or disease Intervention/treatment Phase
Malaria Biological: PfSPZ Vaccine Other: Normal Saline Phase 2

Detailed Description:

The trial will be performed in 200 healthy Gabonese children, recruited across three age-strata: 7-12, 3-6 and 1-2 years (12-35 months). Within each age-stratum, volunteers will be randomized in a 2:1 ratio to receive three doses via direct venous inoculation (DVI) of either PfSPZ Vaccine (0.9x10^6) or normal saline (NS) on days 0, 7 and 28 respectively; a minimum of 40 and a maximum of 100 volunteers are included in each of these age-strata.

In total, approximately 133 children will receive PfSPZ Vaccine and approximately 67 children will receive placebo. Randomization will be by block within each age-stratum (block sizes of 20). The start of inclusion into each age-stratum will be staggered, such that immunization of the first 3-6-year-olds will not commence until two weeks after start of immunization in the first 7-12-year-olds, and immunizations in the first 1-2-year-olds will not commence until two weeks after start of immunization in the first 3-6-year-olds. All volunteers will receive presumptive treatment with artemether-lumefantrine two weeks prior to final immunization (day 14). All volunteers will receive presumptive treatment with age-standardized 3-day course of oral artemether-lumefantrine (AL) ~two weeks prior to first immunization and again two weeks prior to final immunization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in 1-12 Year-old Gabonese Children Naturally Exposed to Malaria Parasites
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Group 1- PfSPZ-Vaccine

Children aged 7-12 years (inclusive) of age will be enrolled in this group.

N=44 will receive PfSPZ Vaccine; three doses of 9x10^6 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) given at 0, 7 and 28 day intervals.

Biological: PfSPZ Vaccine
Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)

Placebo Comparator: Group 2

Children aged 7-12 years (inclusive) of age will be enrolled in this group.

N=22 will receive normal saline; three doses of NS administered by DVI given at 0, 7 and 28 day intervals.

Other: Normal Saline
0.9% Sodium chloride
Other Name: NS

Experimental: Group 3

Children aged 3-6 years (inclusive) of age will be enrolled in this group.

N=44 will receive PfSPZ Vaccine; three doses of 9x10^6 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) given at 0, 7 and 28 day intervals; given 2 weeks after the first immunization of Group 1.

Biological: PfSPZ Vaccine
Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)

Placebo Comparator: Group 4

Children aged 3-6 years (inclusive) of age will be enrolled in this group.

N=22 will receive normal saline; three doses of NS administered by DVI given at 0, 7 and 28 day intervals; given 2 weeks after the first dose of NS of Group 2.

Other: Normal Saline
0.9% Sodium chloride
Other Name: NS

Experimental: Group 5

Children aged 1-2 years (inclusive) of age will be enrolled in this group.

N=44 will receive PfSPZ Vaccine; three doses of 9x10^6 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) given at 0, 7 and 28 day intervals; given 2 weeks after the first immunization of Group 3.

Biological: PfSPZ Vaccine
Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)

Placebo Comparator: Group 6

Children aged 1-2 years (inclusive) of age will be enrolled in this group.

N=22 will receive normal saline; three doses of NS administered by DVI given at 0, 7 and 28 day intervals; given 2 weeks after the first dose of NS of Group 4.

Other: Normal Saline
0.9% Sodium chloride
Other Name: NS




Primary Outcome Measures :
  1. Proportion of volunteers who become parasitemic will be recorded, detected by thick blood smear microscopy and/ or quantitative real time polymerase chain reaction (qPCR) [ Time Frame: From 2 weeks to 6 months and 104 weeks from the day of last PfSPZ Vaccine inoculation ]
    Time to event and proportional analysis of episodes of P. falciparum parasitemia, detected actively or passively by thick blood smear microscopy and/or qPCR

  2. The occurrence of adverse events (AEs) [ Time Frame: From the time of each PfSPZ Vaccine immunization until 7 days after each dose ]
    The occurrence of Grade 3 solicited adverse AEs (related or unrelated) after vaccination

  3. The occurrence of AEs [ Time Frame: From the time of first PfSPZ Vaccine immunization until 28 days after the last dose ]
    The occurrence of Grade 3 unsolicited adverse AEs (related or unrelated) after vaccination

  4. The occurrence of serious adverse events (SAEs) [ Time Frame: Around 27 months (from day of first immunization through study completion) ]
    The occurrence of SAEs (related or unrelated) after vaccination


Secondary Outcome Measures :
  1. Proportion of volunteers who develop P. falciparum parasitemia [ Time Frame: During the 26, 52 and 104 weeks from the day of last PfSPZ Vaccine inoculation and during the 22, 48 and 100 weeks beginning 4 weeks after the last immunization. ]
    Proportion of volunteers who develop P. falciparum parasitemia, detected actively or passively by thick blood smear microscopy and/or quantitative real time polymerase chain reaction (qPCR)

  2. Incidence of P. falciparum parasitemia by thick blood smear with clinical symptoms [ Time Frame: From 14 days after the last immunization through 26 (primary), 52, and 104 weeks after the last immunization ]
    Incidence of P. falciparum parasitemia by thick blood smear with clinical symptoms consistent with malaria by time to event and proportional analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children aged 1 to 12 years
  • Provision of written informed consent of a legal representative of age 18 or above and provision of informed assent by participants in concordance with Gabonese national guidelines.
  • Able and willing to comply with all study requirements
  • Residence in the area throughout the study period
  • Household member reachable by mobile phone during the immunization phase

Exclusion Criteria:

  • Receipt of an investigational product in the 30 days preceding enrollment
  • Prior receipt of a malaria vaccine
  • Immunization with more than 3 other vaccines or at least on elive vaccine within the past four weeks
  • Use of immunoglobulins or blood products within 3 months prior to enrollment
  • Known or suspected HIV infection or any other immunosuppressive state
  • Positive for hepatitis B surface antigen (HBs-antigen)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • A hemoglobin concentration <9 g/dl
  • History of non-febrile or atypical febrile seizures
  • Pregnancy or lactation
  • Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the child because of participation in the study or impair interpretation of the study data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521973


Locations
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Gabon
Centre de Recherches Médicales de Lambaréné (CERMEL)
Lambaréné, Moyen-Ogooué, Gabon
Sponsors and Collaborators
Sanaria Inc.
Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research
Investigators
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Principal Investigator: Selidji Agnandji, MD Centre de Recherches Médicales de Lambaréné (CERMEL)

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Responsible Party: Sanaria Inc.
ClinicalTrials.gov Identifier: NCT03521973    
Other Study ID Numbers: LaSPZV1
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanaria Inc.:
Plasmodium falciparum
PfSPZ Vaccine
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs