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

NCT03521973 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: LaSPZV1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Plasmodium falciparum; PfSPZ Vaccine

Outcome Measures

Primary Outcomes (5)

• Proportion of volunteers who become parasitemic will be recorded, detected by Thick Blood Smear (TBS) microscopy

  Time to event and proportional analysis of episodes of P. falciparum parasitemia, detected actively or passively by TBS microscopy. Vaccine efficacy will be measured in the mITT population.

  From 2 weeks to 6 months after the third PfSPZ Vaccine immunization

• Proportion of volunteers who become parasitemic with temperature ≥37.5°C or history of fever

  Time to event and proportional analysis of episodes of P. falciparum parasitemia with temperature ≥37.5°C or history of fever within the last 24 hours (P. falciparum malaria with clinical manifestations). Vaccine efficacy against P. falciparum malaria with clinical manifestations will be measured in the mITT population using hierarchical testing; the secondary will only be tested when the primary endpoint shows a significant difference.

  From 2 weeks to 6 months after the third PfSPZ Vaccine immunization

• The occurrence and frequency of adverse events (AEs)

  The occurrence and frequency of Grade 3 solicited adverse AEs (related or unrelated) after vaccination

  From the time of each PfSPZ Vaccine immunization until 7 days after each dose

• The occurrence and frequency of AEs

  The occurrence and frequency of Grade 3 unsolicited adverse AEs (related or unrelated) after vaccination

  From the time of first PfSPZ Vaccine immunization until 28 days after the last dose

• The occurrence and frequency of serious adverse events (SAEs)

  The occurrence and frequency of SAEs (related or unrelated) after vaccination

  Around 27 months (from day of first immunization through study completion)

Secondary Outcomes (2)

• The occurrence of all related solicited AE

  From the time of each PfSPZ Vaccine immunization until 7 days after each dose

• The occurrence of all related unsolicited AEs

  From the time of first PfSPZ Vaccine immunization until 28 days after the last dose

Study Arms (6)

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.

Biological: PfSPZ Vaccine

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.

Other: Normal Saline

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.

Biological: PfSPZ Vaccine

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.

Other: Normal Saline

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.

Biological: PfSPZ Vaccine

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.

Other: Normal Saline

Interventions

PfSPZ Vaccine BIOLOGICAL

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

Group 1- PfSPZ-Vaccine; Group 3; Group 5

Normal Saline OTHER

0.9% Sodium chloride

Also known as: NS

Group 2; Group 4; Group 6

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanaria Inc.: lead
• Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research: collaborator

Study Sites (1)

Centre de Recherches Médicales de Lambaréné (CERMEL)

Lambaréné, Moyen-Ogooué Province, Gabon

Location

Related Publications (1)

• Agnandji ST, Bok J, Alabi A, Kabwende AL, Mbouna A, Bie J, Moukiti E, Lalremruata A, Esen M, Kreidenweiss A, Kc N, Sim BKL, Richie TL, Preston Church LW, McCall MBB, Hoffman SL, Kremsner PG, Mordmuller B. Safety, tolerability, and protective efficacy of a radiation-attenuated, whole sporozoite malaria vaccine in children in Gabon: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2026 Jan;26(1):79-90. doi: 10.1016/S1473-3099(25)00434-7. Epub 2025 Sep 16.

  PMID: 40972633 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Selidji Agnandji, MD

  Centre de Recherches Médicales de Lambaréné (CERMEL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 11, 2018
• Study Start: June 14, 2018
• Primary Completion: May 18, 2021
• Study Completion: August 3, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Locations

GA (1)