MalariaPhase 1NCT03420053
Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults
A Phase 1 study testing PfSPZ Vaccine and PfSPZ Challenge in people with Malaria and Malaria,Falciparum, run by Sanaria Inc. at 1 site in Tanzania.
Trial summary
This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV positive volunteers in Tanzania. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria,Falciparum
- What is being tested?
- PfSPZ Vaccine and PfSPZ Challenge
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTanzania
- Study dates
- 7 Feb 2018to 25 Aug 2018
- Phase
- Phase 1
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female adults, from 18 to 45 years of age
- Long term (at least two years) or permanent residence in the Bagamoyo district or nearby districts in Coastal and Dar-es-Salaam regions
- Availability through mobile phone 24 hours a day during the whole study period
- Ability and willingness to complete the study visit schedule for safety follow-up and protocol compliance
- Agreement to provide personal contact information and contact information of a third party household member or close friend to study team
- Agreement not to participate in any other clinical study involving investigational medicinal products during the study period, except enrollment in observational studies (such a co-enrollment must be approved by the PI)
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- Agreement to release medical and other information concerning contra-indications for participation in the study, and to be attended by a study clinician for physical examination and clinical investigations including electrocardiogram (ECG)
- Willingness to undergo all blood, urine and stool tests (as specified in the protocol) and additional tests that may be ordered by the study clinician to rule-out significant abnormality(ies)
- Female volunteers must be willing to take measures not to become pregnant if selected for participation in the trial and to undergo serum pregnancy test at screening and at defined time-points during the trial
- Volunteers for enrollment into HIV positive sub-groups must have:
- Documented HIV infection, be in general good health and on stable ART use for at least three (3) months, preferably six (6), prior to screening
- WHO clinical stage 1 of HIV disease
- CD4+ T-cell count >500 cells/μL at screening
- Attending a care and treatment centre (CTC) within the study area for medical management of HIV infection, and agreeing to maintain regular attendance to such care and treatment centre while participating in the study
- Agreement to allow the clinical team to contact and coordinate care with the volunteer's HIV CTC.
- Correctly answering 10 out of 10 questions during informed consent process to demonstrate the understanding of study design, study procedures, risks and benefits
- Signing and dating written informed consent, in accordance with local practice.
Who cannot join
- Previous receipt of an investigational malaria vaccine or drug in the last 5 years
- Receipt of standard vaccinations within 4 weeks prior to the first immunization with a PfSPZ product or are planning to take standard vaccinations during the trial through 4 weeks following the last injection with a PfSPZ product
- Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the onset of the study
- Clinically significant cardiac abnormalities as indicated by history, physical examination or clinically significant abnormalities in electrocardiogram (ECG)
- Positive family history in a 1st or 2nd degree relative for cardiac disease at age< 50 years old
- A history of psychiatric disease
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- History of afebrile seizures, atypical febrile seizures or epilepsy
- History of drug or alcohol abuse interfering with normal social function
- History of chronic immunodeficiency condition (other than HIV) or autoimmune disease
- The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months prior to study onset (ART and inhaled and topical corticosteroids are allowed)
- Meeting exclusion criteria based on the protocol algorithm for assessment of TB disease risk
- Currently on Co-Trimoxazole (trimethoprim/sulfamethoxazole) prophylactic treatment (CPT)
- Currently taking rifampin (isoniazid is not an exclusion criterion)
- Body mass index (BMI) of <18 or >30 Kg/m2
- Females who are pregnant (as indicated by positive serum pregnancy test), nursing, or plan on becoming pregnant or nurse within the duration of trial
- Newly diagnosed with positive HIV infection at screening
- Positive hepatitis (B or C virus) tests
- Symptoms, physical signs and laboratory values suggestive of clinically significant systemic disorders or any other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
- Medical, social condition or occupational reason that, in the judgment of the investigator, is a contraindication to protocol participation, may impair the volunteer's ability to give informed consent or effectively participate in the study, may significantly increase the risk to the volunteer because of participation in the study or may impair interpretation of the study data.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Bagamoyo Research and Training Center of the Ifakara Health Institute
Bagamoyo
About this study
Official title: Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of Direct Venous Inoculation of Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in HIV Negative and HIV Positive Tanzanian Adults
This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV positive volunteers in Tanzania.
Read the detailed description
This trial is a single center trial designed to assess the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine (9.0x10^5 PfSPZ given at 0, +2, +4, +6 and +28 days (Group 1, HIV negative, and Group 2, HIV positive)). Controls will receive parallel injections with normal saline (NS). All administrations of PfSPZ or NS will be by direct venous inoculation (DVI).
Twenty-one male and female adult volunteers, aged from 18 to 45 years, who live in and around the Bagamoyo township, will be enrolled based on pre-defined inclusion and exclusion criteria. 12/21 subjects will be HIV positive volunteers (who clinical stage 1) on stable anti-retroviral therapy (ART) for at least 3 months with a CD4+ cell count above 500 cells/μL at screening. The rest (9/21) will be healthy HIV negative adults.
Treatment allocation will be double-blind within Group 1 and 2b but not between the groups or subgroups. Immunizations will begin with healthy HIV negative volunteers first (Group 1), before inoculation of HIV positive volunteers (Groups 2a and 2b). Transitioning from immunization of HIV negative to immunization of HIV positive will begin by immunizing a sentinel group of 3 HIV positive individuals with a reduced vaccine dose of 4.5x10^5 PfSPZ (Group 2a). This transition will be staggered by at least two (2) weeks, to allow for a safety data review. If the safety data do not meet pause criteria, this will signal a "go" for transitioning to immunizations of sentinel group of three (3) HIV positive volunteers. If pause criteria are met, there will be no immediate transition, and instead an ad-hoc meeting of the Safety Monitoring Committee (SMC) will be called for an independent review and recommendation. Transition from the unblinded HIV positive sentinel Group 2a to the full study cohort of double blinded placebo controlled HIV positive volunteers (Group 2b), will also be staggered for at least two (2) weeks. There will be a scheduled review by the SMC of safety data collected from the sentinel HIV positive group for up to 7 days after the fourth immunization. After the safety review, transition to the main HIV positive group (Group 2b) will take into account the SMC recommendation(s).
- Conditions
- Malaria, Malaria,Falciparum
- Being tested
- PfSPZ Vaccine, Normal Saline Placebo, PfSPZ Challenge
- Keywords
- PfSPZ Vaccine, HIV+, Plasmodium falciparum, Sporozoites
- 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
Aseptic, purified, metabolically active, non-replicating, radiation-attenuated, cryopreserved Pf sporozoites.
Normal Saline PlaceboOther
0.9% sodium chloride solution
PfSPZ ChallengeBiological
Aseptic, purified, live, infectious, cryopreserved Pf sporozoites.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 HIV- vaccine recipients | Experimental | Group 1: n=6, HIV negative vaccine recipients will receive 9.0x10^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 1, n=9, where volunteers will be randomized in a 1:2 ratio to receive either normal saline placebo (NS) or PfSPZ Vaccine.
Efficacy will be assessed by controlled human malaria infection (CHMI) at +3 weeks (+2 to +10 weeks) after the last dose of PfSPZ Vaccine. CHMI will be by DVI of 3,200 PfSPZ Challenge. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge |
| Group 1 HIV- NS controls | Placebo comparator | Group 1: n=3, HIV negative NS placebo recipients will receive NS at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 1, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine.
Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of NS. CHMI will be by DVI of 3,200 PfSPZ Challenge. Receives: Other: Normal Saline Placebo; Biological: PfSPZ Challenge |
| Group 2a HIV+ vaccine sentinels | Experimental | Group 2a: n=3, HIV positive vaccine recipients will receive 4.5x10^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. Receives: Biological: PfSPZ Vaccine |
| Group 2b HIV+ vaccine recipients | Experimental | Group 2b: n=6, HIV positive vaccine recipients will receive 9.0x10^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 2b, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine.
Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of PfSPZ Vaccine. CHMI will be by DVI of 3,200 PfSPZ Challenge. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge |
| Group 2b HIV+ placebo controls | Placebo comparator | Group 2b: n=3, HIV positive NS placebo recipients will receive NS at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 2b, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine.
Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of NS. CHMI will be by DVI of 3,200 PfSPZ Challenge. Receives: Other: Normal Saline Placebo; Biological: PfSPZ Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PfSPZ Vaccine - solicited symptoms
Occurrence of solicited symptoms during a 7-day surveillance period after vaccination (day of vaccination (Vx) and +7 days post vaccination).
Measured: From day of vaccination to 7-days post vaccination.
Safety of PfSPZ Vaccine - unsolicited symptoms
Occurrence of unsolicited symptoms during a 28-day surveillance period after each vaccination.
Measured: From day of vaccination to 28-days post vaccination.
Safety of PfSPZ Vaccine - laboratory abnormalities
Occurrence of laboratory abnormalities including significant drops in CD4 T cell counts or increases in viral load.
Measured: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
Safety of PfSPZ Vaccine - serious adverse events
Occurrence of serious adverse events during the study period.
Measured: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
Safety of PfSPZ Vaccine - breakthrough infection
- Occurrence of Pf infection of vaccine type detected at any point after the first vaccination (retrospectively determined).
Measured: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start7 Feb 2018
- Primary completion25 Aug 2018
- Study completion25 Aug 2018
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ifakara Health Institute, Swiss Tropical & Public Health Institute, Medical Care Development, Inc.
- Responsible party
- Sponsor
- Investigators
- Said Jongo, MD, MMED, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420053
- Sponsor's protocol ID
- BSPZV3a
- Status last verified
- Apr 2019
- First submitted
- 13 Dec 2017
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jongo S, Church LWP, Milando F, Qassim M, Schindler T, Rashid M, Tumbo A, Nyaulingo G, Bakari BM, Athuman Mbaga T, Mohamed L, Kassimu K, Simon BS, Mpina M, Zaidi I, Duffy PE, Swanson PA 2nd, Seder R, Herman JD, Mendu M, Zur Y, Alter G, Kc N, Riyahi P, Abebe Y, Murshedkar T, James ER, Billingsley PF, Sim BKL, Richie TL, Daubenberger C, Abdulla S, Hoffman SL. Safety and protective efficacy of PfSPZ Vaccine administered to HIV-negative and -positive Tanzanian adults. J Clin Invest. 2024 Jan 9;134(6):e169060. doi: 10.1172/JCI169060.
PubMed 38194272
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of Direct Venous Inoculation of Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in HIV Negative and HIV Positive Tanzanian Adults
- ClinicalTrials.gov ID
- NCT03420053
- Acronym / sponsor ID
- BSPZV3a
- Conditions
- Malaria, Malaria,Falciparum
- Keywords
- PfSPZ Vaccine, HIV+, Plasmodium falciparum, Sporozoites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ifakara Health Institute, Swiss Tropical & Public Health Institute, Medical Care Development, Inc.
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 25 Aug 2018 (actual)
- First posted
- 5 Feb 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 is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV positive volunteers in Tanzania.
Detailed description
This trial is a single center trial designed to assess the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine (9.0x10^5 PfSPZ given at 0, +2, +4, +6 and +28 days (Group 1, HIV negative, and Group 2, HIV positive)). Controls will receive parallel injections with normal saline (NS). All administrations of PfSPZ or NS will be by direct venous inoculation (DVI).
Twenty-one male and female adult volunteers, aged from 18 to 45 years, who live in and around the Bagamoyo township, will be enrolled based on pre-defined inclusion and exclusion criteria. 12/21 subjects will be HIV positive volunteers (who clinical stage 1) on stable anti-retroviral therapy (ART) for at least 3 months with a CD4+ cell count above 500 cells/μL at screening. The rest (9/21) will be healthy HIV negative adults.
Treatment allocation will be double-blind within Group 1 and 2b but not between the groups or subgroups. Immunizations will begin with healthy HIV negative volunteers first (Group 1), before inoculation of HIV positive volunteers (Groups 2a and 2b). Transitioning from immunization of HIV negative to immunization of HIV positive will begin by immunizing a sentinel group of 3 HIV positive individuals with a reduced vaccine dose of 4.5x10^5 PfSPZ (Group 2a). This transition will be staggered by at least two (2) weeks, to allow for a safety data review. If the safety data do not meet pause criteria, this will signal a "go" for transitioning to immunizations of sentinel group of three (3) HIV positive volunteers. If pause criteria are met, there will be no immediate transition, and instead an ad-hoc meeting of the Safety Monitoring Committee (SMC) will be called for an independent review and recommendation. Transition from the unblinded HIV positive sentinel Group 2a to the full study cohort of double blinded placebo controlled HIV positive volunteers (Group 2b), will also be staggered for at least two (2) weeks. There will be a scheduled review by the SMC of safety data collected from the sentinel HIV positive group for up to 7 days after the fourth immunization. After the safety review, transition to the main HIV positive group (Group 2b) will take into account the SMC recommendation(s).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 HIV- vaccine recipients | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ ChallengeGroup 1: n=6, HIV negative vaccine recipients will receive 9.0x10^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 1, n=9, where volunteers will be randomized in a 1:2 ratio to receive either normal saline placebo (NS) or PfSPZ Vaccine. Efficacy will be assessed by controlled human malaria infection (CHMI) at +3 weeks (+2 to +10 weeks) after the last dose of PfSPZ Vaccine. CHMI will be by DVI of 3,200 PfSPZ Challenge. |
| Group 1 HIV- NS controls | Placebo comparator | Other: Normal Saline Placebo, Biological: PfSPZ ChallengeGroup 1: n=3, HIV negative NS placebo recipients will receive NS at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 1, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine. Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of NS. CHMI will be by DVI of 3,200 PfSPZ Challenge. |
| Group 2a HIV+ vaccine sentinels | Experimental | Biological: PfSPZ VaccineGroup 2a: n=3, HIV positive vaccine recipients will receive 4.5x10^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. |
| Group 2b HIV+ vaccine recipients | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ ChallengeGroup 2b: n=6, HIV positive vaccine recipients will receive 9.0x10^5 PfSPZ Vaccine at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 2b, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine. Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of PfSPZ Vaccine. CHMI will be by DVI of 3,200 PfSPZ Challenge. |
| Group 2b HIV+ placebo controls | Placebo comparator | Other: Normal Saline Placebo, Biological: PfSPZ ChallengeGroup 2b: n=3, HIV positive NS placebo recipients will receive NS at 0, +2, +4, +6 and +28 days. Total no. of volunteers in Group 2b, n=9, where volunteers will be randomized in a 1:2 ratio to receive either NS placebo or PfSPZ Vaccine. Efficacy will be assessed by CHMI at +3 weeks (+2 to +10 weeks) after the last dose of NS. CHMI will be by DVI of 3,200 PfSPZ Challenge. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male and female adults, from 18 to 45 years of age
- Long term (at least two years) or permanent residence in the Bagamoyo district or nearby districts in Coastal and Dar-es-Salaam regions
- Availability through mobile phone 24 hours a day during the whole study period
- Ability and willingness to complete the study visit schedule for safety follow-up and protocol compliance
- Agreement to provide personal contact information and contact information of a third party household member or close friend to study team
Key exclusion criteria (19 listed)
- Previous receipt of an investigational malaria vaccine or drug in the last 5 years
- Receipt of standard vaccinations within 4 weeks prior to the first immunization with a PfSPZ product or are planning to take standard vaccinations during the trial through 4 weeks following the last injection with a PfSPZ product
- Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the onset of the study
- Clinically significant cardiac abnormalities as indicated by history, physical examination or clinically significant abnormalities in electrocardiogram (ECG)
- Positive family history in a 1st or 2nd degree relative for cardiac disease at age< 50 years old
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 VaccineAseptic, purified, metabolically active, non-replicating, radiation-attenuated, cryopreserved Pf sporozoites. | Biological | Group 1 HIV- vaccine recipients, Group 2a HIV+ vaccine sentinels, Group 2b HIV+ vaccine recipients |
| Normal Saline Placebo0.9% sodium chloride solution | Other | Group 1 HIV- NS controls, Group 2b HIV+ placebo controls |
| PfSPZ ChallengeAseptic, purified, live, infectious, cryopreserved Pf sporozoites. | Biological | Group 1 HIV- NS controls, Group 1 HIV- vaccine recipients, Group 2b HIV+ placebo controls, Group 2b HIV+ vaccine recipients |
Primary outcome
Safety of PfSPZ Vaccine - solicited symptoms
Time frame: From day of vaccination to 7-days post vaccination.
Occurrence of solicited symptoms during a 7-day surveillance period after vaccination (day of vaccination (Vx) and +7 days post vaccination).
Safety of PfSPZ Vaccine - unsolicited symptoms
Time frame: From day of vaccination to 28-days post vaccination.
Occurrence of unsolicited symptoms during a 28-day surveillance period after each vaccination.
Safety of PfSPZ Vaccine - laboratory abnormalities
Time frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
Occurrence of laboratory abnormalities including significant drops in CD4 T cell counts or increases in viral load.
Safety of PfSPZ Vaccine - serious adverse events
Time frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
Occurrence of serious adverse events during the study period.
Safety of PfSPZ Vaccine - breakthrough infection
Time frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).
- Occurrence of Pf infection of vaccine type detected at any point after the first vaccination (retrospectively determined).
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 5 Apr 2019.
- Derived from this study: PubMed 38194272Jongo S, Church LWP, Milando F, Qassim M, Schindler T, Rashid M, Tumbo A, Nyaulingo G, Bakari BM, Athuman Mbaga T, Mohamed L, Kassimu K, Simon BS, Mpina M, Zaidi I, Duffy PE, Swanson PA 2nd, Seder R, Herman JD, Mendu M, Zur Y, Alter G, Kc N, Riyahi P, Abebe Y, Murshedkar T, James ER, Billingsley PF, Sim BKL, Richie TL, Daubenberger C, Abdulla S, Hoffman SL. Safety and protective efficacy of PfSPZ Vaccine administered to HIV-negative and -positive Tanzanian adults. J Clin Invest. 2024 Jan 9;134(6):e169060. doi: 10.1172/JCI169060.
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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.
Said Jongo, MD, MMED principal investigator
Ifakara Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PfSPZ Vaccine and PfSPZ Challenge in people with Malaria and Malaria,Falciparum, run by Sanaria Inc. at 1 site in Tanzania.
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 17 inclusion and 19 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 5 Apr 2019. 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 Tanzania. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of PfSPZ Vaccine - solicited symptoms (time frame: From day of vaccination to 7-days post vaccination.). 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 NCT03420053, 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 5 Apr 2019.