MalariaPhase 2NCT03521973
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
A Phase 2 study testing PfSPZ Vaccine and Normal Saline in people with Malaria, run by Sanaria Inc. at 1 site in Gabon.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- PfSPZ Vaccine and Normal Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGabon
- Study dates
- 14 Jun 2018to 3 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Centre de Recherches Médicales de Lambaréné (CERMEL)
Lambaréné, Moyen-Ogooué Province
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Malaria
- Being tested
- PfSPZ Vaccine, Normal Saline
- Keywords
- Plasmodium falciparum, PfSPZ Vaccine
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfSPZ VaccineBiological
Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)
Normal SalineOther
Also called NS
0.9% Sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Around 27 months (from day of first immunization through study completion)
Secondary outcomes (2)
The occurrence of all related solicited AE
The occurrence of all related solicited AE after vaccination
Measured: From the time of each PfSPZ Vaccine immunization until 7 days after each dose
The occurrence of all related unsolicited AEs
The occurrence of all related unsolicited AE after vaccination
Measured: From the time of first PfSPZ Vaccine immunization until 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start14 Jun 2018
- Primary completion18 May 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research
- Responsible party
- Sponsor
- Investigators
- Selidji Agnandji, MD, Principal investigator, Centre de Recherches Médicales de Lambaréné (CERMEL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521973
- Sponsor's protocol ID
- LaSPZV1
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2018
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40972633
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03521973
- Acronym / sponsor ID
- LaSPZV1
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, PfSPZ Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1- PfSPZ-Vaccine | Experimental | Biological: PfSPZ VaccineChildren 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 | Other: Normal SalineChildren 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 | Biological: PfSPZ VaccineChildren 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 | Other: Normal SalineChildren 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 | Biological: PfSPZ VaccineChildren 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 | Other: Normal SalineChildren 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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PfSPZ VaccineRadiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine) | Biological | Group 1- PfSPZ-Vaccine, Group 3, Group 5 |
| Normal SalineAlso: NS0.9% Sodium chloride | Other | Group 2, Group 4, Group 6 |
Primary outcome
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
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.
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
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.
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 Grade 3 solicited adverse AEs (related or unrelated) after vaccination
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 Grade 3 unsolicited adverse AEs (related or unrelated) after vaccination
The occurrence and frequency of serious adverse events (SAEs)
Time frame: Around 27 months (from day of first immunization through study completion)
The occurrence and frequency of SAEs (related or unrelated) after vaccination
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Derived from this study: PubMed 40972633Agnandji 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selidji Agnandji, MD principal investigator
Centre de Recherches Médicales de Lambaréné (CERMEL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PfSPZ Vaccine and Normal Saline in people with Malaria, run by Sanaria Inc. at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.