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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT03521973
• Date of registration: 26/04/2018
• Prospective Registration: Yes
• Primary sponsor: Sanaria Inc.
• Public title: Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
• Scientific 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
• Date of first enrolment: June 14, 2018
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03521973
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Gabon

Contacts

• Name: Selidji Agnandji, MD
• Affiliation: Centre de Recherches Médicales de Lambaréné (CERMEL)

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Other: Normal Saline

Biological: PfSPZ Vaccine

Primary Outcome(s)

Proportion of volunteers who become parasitemic with temperature =37.5°C or history of fever [Time Frame: From 2 weeks to 6 months after the third PfSPZ Vaccine immunization]

The occurrence and frequency of AEs [Time Frame: From the time of first PfSPZ Vaccine immunization until 28 days after the last dose]

The occurrence and frequency of adverse events (AEs) [Time Frame: From the time of each PfSPZ Vaccine immunization until 7 days after each dose]

The occurrence and frequency of serious adverse events (SAEs) [Time Frame: Around 27 months (from day of first immunization through study completion)]

Proportion of volunteers who become parasitemic will be recorded, detected by Thick Blood Smear (TBS) microscopy [Time Frame: From 2 weeks to 6 months after the third PfSPZ Vaccine immunization]

Secondary Outcome(s)

The occurrence of all related solicited AE [Time Frame: From the time of each PfSPZ Vaccine immunization until 7 days after each dose]

The occurrence of all related unsolicited AEs [Time Frame: From the time of first PfSPZ Vaccine immunization until 28 days after the last dose]

Secondary ID(s)

LaSPZV1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research