Title

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

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    200
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.
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 stratified by age-stratum, using permuted blocks of randomized size (3, 6, or 9). 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.
Study Started
Jun 14
2018
Primary Completion
May 18
2021
Study Completion
Aug 03
2021
Last Update
Oct 07
2021

Biological PfSPZ Vaccine

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

Other Normal Saline

0.9% Sodium chloride

  • Other names: NS

Group 1- PfSPZ-Vaccine Experimental

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.

Group 2 Placebo Comparator

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.

Group 3 Experimental

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.

Group 4 Placebo Comparator

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.

Group 5 Experimental

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.

Group 6 Placebo Comparator

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.

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 immunization with the investigational product
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 (applies at enrollment only)
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
No Results Posted