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| Name | Class |
|---|---|
| Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Group 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PfSPZ Vaccine | Biological | Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of all related solicited AE | The occurrence of all related solicited AE after vaccination | From the time of each PfSPZ Vaccine immunization until 7 days after each dose |
| The occurrence of all related unsolicited AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selidji Agnandji, MD | Centre de Recherches Médicales de Lambaréné (CERMEL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherches Médicales de Lambaréné (CERMEL) | Lambaréné | Moyen-Ogooué Province | Gabon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40972633 | Derived | 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. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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. |
|
| Normal Saline | Other | 0.9% Sodium chloride |
|
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The occurrence of all related unsolicited AE after vaccination
| From the time of first PfSPZ Vaccine immunization until 28 days after the last dose |
| D000079426 |
| Vector Borne Diseases |