Safety, Tolerability and Efficacy of PfSPZ Vaccine in Healthy Children and Infants 5 Months - 9 Years Living in Kenya

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02687373
• Date of registration: 09/02/2016
• Prospective Registration: Yes
• Primary sponsor: Sanaria Inc.
• Public title: Safety, Tolerability and Efficacy of PfSPZ Vaccine in Healthy Children and Infants 5 Months - 9 Years Living in Kenya
• Scientific title: Safety, Tolerability and Efficacy of PfSPZ Vaccine Administered by Direct Venous Inoculation (DVI) to Healthy Children and Infants 5 Months Through 9 Years of Age Living in an Area of High Malaria Transmission in Western Kenya: Age De-escalation and Dose Escalation and a Double Blind, Randomized Placebo-Controlled Trial for Safety and Efficacy
• Date of first enrolment: July 21, 2016
• Target sample size: 337
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02687373
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Kenya

Contacts

• Name: Martina Oneko, MD
• Affiliation: Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy children 5 months - 9 years inclusive (Part 1) and healthy infants 5-12 months
inclusive (Part 2)

- HIV negative

- Able to participate for the duration of the study.

- Parents/guardians over the age of 18 years able and willing to provide informed
consent/permission. The consent/permission will be in writing. For adult parents or
guardians who are illiterate, an impartial witness can sign the consent/permission
form on behalf of the parent and the parent/guardian will provide a thumb print.

Exclusion Criteria:

- Positive HIV test or breastfeeding infants or children of a known HIV positive mother
(per Kenyan guidelines, these HIV exposed breastfeeding children should be on
cotrimoxazole)

- Refusal of HIV testing

- Elevated ALT (liver function test) =2x ULN ( ALT >84 U/L)

- Abnormal hematological parameters defined as: hemoglobin < 8 g/dl, WBC <1500 / mm3,
neutrophils <750/ mm3, platelet count <75.000/ mm3

- Abnormal renal function test with creatinine >0.9 mg/dL

- Known sickle cell disease and other inherited blood cell disorders like thalassemia
and G6PD deficiency

- Current use of systemic immunosuppressant pharmacotherapy

- Current significant medical condition (cardiac, hepatic, renal, or hematological) or
evidence of any other serious underlying medical condition identified by medical
history, physical examination, or laboratory examination

- History of a splenectomy

- History of neurologic disorder (including seizures, other than uncomplicated febrile
seizures)

- Known allergy to any component of the vaccine formulation, history of anaphylactic
response to mosquito-bites, or known allergy to first or second line anti-malarials
used to treat malaria

- Plan to participate in another investigational vaccine/drug research during or within
1 month of this study end

- Prior participation in a malaria vaccine trial

- Participation in the PfSPZ Vaccine Trial Part 1 (for Part 2 only)

- History of any other illness or condition which, in the investigator's judgment, may
substantially increase the risk associated with the subject's participation in the
protocol or compromise the scientific objectives

- Child/orphan in institutional care



Age minimum: 5 Months
Age maximum: 9 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Other: Normal Saline

Biological: PfSPZ Vaccine

Primary Outcome(s)

Part 2 - Assessment of Pf-specific antibodies in infants of 5-12 months to three vaccinations of PfSPZ Vaccine [Time Frame: Collected 1 week after the first and second vaccination and 2 weeks after the third vaccination.]

Part 2 - Ratio of Pf positive blood smear (+BS) in experimental arm to Pf +BS in placebo arm to determine efficacy of PfSPZ Vaccine during 6 months after last dose [Time Frame: 2 weeks to 6 months after the last vaccine dose]

Part 1 - Incidence and type of adverse events (AE) [Time Frame: Collected from day of each vaccination until day 28 post vaccination]

Part 1 - Assessment of Pf-specific antibodies in the different age categories and to the different vaccine doses [Time Frame: Collected 1 week after each vaccination]

Part 1 - Incidence and type of possibly/probably or definitely related serious adverse events (SAEs) [Time Frame: Collected from day of first vaccination until close out visit (28 days for 3 lower doses, 84 days for 2 higher doses)]

Part 2 - Incidence and type of possibly/probably or definitely related serious adverse events (SAEs) following administration of PfSPZ Vaccine [Time Frame: Collected from day of first vaccination through the 12-month follow-up period.]

Part 2 - Incidence and type of adverse events in infants 5-12 months of age following administration of PfSPZ Vaccine [Time Frame: Collected from day of each vaccination until day 28 post vaccination]

Secondary Outcome(s)

Part 2 - Assessment of Pf-specific antibodies, parasite-specific T cell responses and RNA sequencing. [Time Frame: Before the first vaccination, 1 week after vaccination 1 and 2, 2 weeks after vaccination 3 and at 6 months and 12 months after the last vaccination]

Part 2 - Ratio of Pf positive PCR in experimental arm to Pf positive PCR in placebo arm to determine efficacy against submicroscopic malaria infection of PfSPZ Vaccine following 6 and 12 months after the last dose [Time Frame: 2 weeks to 6 and 12 months after the last vaccine dose]

Part 2 - Assessment of Pf-specific antibodies, parasite-specific T cell responses and RNA sequencing to determine correlation of immune response with efficacy [Time Frame: Entire study period]

Part 2 - Ratio of Pf +BS in experimental arm to Pf +BS in placebo arm to determine efficacy of PfSPZ Vaccine during 12 months after last dose [Time Frame: 2 weeks to 12 months after the last vaccine dose]

Secondary ID(s)

KEMRI/SERU/CGHR/017/3129

CDC IRB Protocol #6787

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centers for Disease Control and Prevention

Kenya Medical Research Institute

National Institutes of Health (NIH)

University of Maryland, College Park