MalariaPhase 1NCT04966871
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
A Phase 1 study testing PfSPZ Vaccine, PfSPZ Challenge (7G8) for CHMI and Normal Saline in people with Malaria, run by Sanaria Inc. at 1 site in United States.
Trial summary
This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- PfSPZ Vaccine, PfSPZ Challenge (7G8) for CHMI and Normal Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to 21 Jun 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (male or non-pregnant female) 18 to 50 years of age
- Able and willing to participate for the duration of the study
- Able and willing to provide written (not proxy) informed consent
- Physical examination and laboratory results without clinically significant findings
- Individuals of childbearing potential must agree to use effective means of birth control (e.g. oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) during the entire study. Female participants with a history of surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider
- Willing to refrain from blood donation for 3 years following CHMI
- Agree not to travel to a malaria endemic region during the entire course of the trial
Who cannot join
- A history of malaria infection within 2 years prior to study participation or travel to a malaria endemic region within six months prior to first immunization
- Receipt of a malaria vaccine in a prior clinical trial
- History of a splenectomy or sickle cell disease
- History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache
- Current use of systemic immunosuppressant pharmacotherapy
- Receipt of a live vaccine within 4 weeks of first immunization or of a non-live vaccine within 2 weeks of first immunization
Show all 19Show fewer
- Individuals who are breast-feeding, pregnant or planning to become pregnant during the study period
- Known allergy to atovaquone-proguanil (Malarone®), artemether-lumefantrine (Coartem), or any component of the investigational products
- History of anaphylaxis or other life-threatening reaction to a vaccine
- Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment
- Evidence of increased cardiovascular disease risk; defined as >10% five-year risk by non-laboratory method (Gaziano, 2008)
- Plan to participate in another investigational vaccine/drug research during the study
- Plan for major surgery between enrollment until 28 days post-CHMI
- Use or planned use of any drug with anti-malarial activity that would preceed or coincide with malaria challenge.
- Anticipated use of medications known to cause drug reactions with atovaquone-proguanil or artemether-lumefantrine such as cimetidine, metoclopramide, antacids, and kaolin
- Positive HIV, HBV or HCV infection
- An abnormal electrocardiogram, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram as determined by the consulting cardiologist
- Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving.
- Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse) that, in the judgment of the PI, impairs the volunteer's ability to give informed consent, increases the risk to the subject of participation in the study, affects the ability of the subject to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Clinical Trial of a 3-dose, 28-Day Regimen of PfSPZ Vaccine in Healthy, Malaria-Naïve, Adult Subjects to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI Conducted 14, 42 or 70 Days After Immunization
This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI) conducted at varying time intervals after the third immunization (14, 42 or 70 days). The trial is designed to simulate pre-deployment immunization of military personnel. Prior studies with this regimen show high level protection (>80%) against CHMI at 21 days, but the onset and duration of protection have not been fully defined.
Read the detailed description
USSPZV6 is a single site, double-blind, randomized, placebo-controlled, clinical trial. Study groups will be randomized in a 14:4 ratio (vaccine to NS placebo) among healthy, malaria-naive adults aged 18-50 years. There will be three groups of subjects. Each of the 3 groups will have 14 subjects who receive 3 injections with 9 x 10^5 PfSPZ of PfSPZ Vaccine and 4 subjects who receive 3 injections with normal saline placebo. Subjects who complete all immunizations will receive a total 2.7 x 10^6 PfSPZ. VE will be assessed by exposure to PfSPZ Challenge (7G8) (cryopreserved infectious sporozoites originating from a Pf strain isolated in Brazil, and thus heterologous to the vaccine). The day of CHMI will vary per group with Groups A, B and C receiving PfSPZ Challenge (7G8) on days 14, 42 or 70 after Vaccination 3 (V3), respectively. Direct observation will be for 30 minutes following each dose of PfSPZ Vaccine or PfSPZ Challenge. A research/safety monitor and a Safety Monitoring Committee (SMC) will provide safety oversight. Clinical study monitoring will be the responsibility of Sanaria or Sanaria's designated and authorized representative. Screening will not precede enrollment by more than 90 days. For the second and third immunizations, allowable windows are assigned. The entire study will take approximately 8 months to complete, including 2 months of recruitment because the study will be conducted in two sequential cohorts. The period of follow-up for each immunized subject and placebo controls is through 8 weeks post-CHMI. Study participation will last between 99 and 154 days (not including screening) depending upon group assignment.
Case report forms (CRFs) will serve as the repository of source documents and other relevant data for each study subject. Only information that cannot be collected initially into the CRF (for instance, EKGs and AE medical records) will first be collected onto separate source documents before transcription into the CRF. Laboratory results will be entered from source documents directly into the database.
Solicited adverse events (AEs) will be collected for 7 days after each immunization. Unsolicited AEs will be collected from the first immunization (V1) until 28 days after the third immunization (V3) and for 28 days after CHMI. Physical exams and medical history will be assessed as indicated. Safety laboratories will be collected at screening, day of V1, 14 days after V2, 7 days after V3, day of CHMI and 28 days after CHMI. Surveillance for SAEs will occur for the duration of the study. Follow-up of AEs (including SAEs) occurs until resolution or stability.
If clinical laboratories expire (meaning they were obtained greater than 90 days prior to planned enrollment), specific safety labs will be repeated for screening purposes. Safety evaluation includes an electrocardiogram (ECG) performed at screening. Subjects with abnormal cardiovascular symptoms or findings that appear clinically significant will be excluded and if appropriate, referred to a cardiologist for further evaluation.Clinical laboratory testings will be conducted by Fred Hutchinson Cancer Research Center.
Detection of parasitemia post CHMI will be based upon qRT-PCR. Subjects who have 2 positive qRT-PCR results separated by greater than or equal to 12 hours or a single qRT-PCR result reading > 250 estimated parasites/mL will be treated with anti-malaria therapy. Anti-malarial therapy will consist of: First-line: Malarone, Second-line: Coartem.
- Conditions
- Malaria
- Being tested
- PfSPZ Vaccine, PfSPZ Challenge (7G8) for CHMI, Normal Saline
- Keywords
- PfSPZ Vaccine, Malaria, Plasmodium falciparum, Controlled human malaria infection
- 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
Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)
PfSPZ Challenge (7G8) for CHMIBiological
Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain 7G8
Normal SalineOther
normal saline placebo control
| Study group | Role | What they receive |
|---|---|---|
| Group A (PfSPZ Vaccine; PfSPZ Challenge 7G8) | Experimental | 14 volunteers will receive 3 doses of 9 x 10^5 PfSPZ Vaccine on days 1, 8, 29.
Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 14 by DVI injection. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (7G8) for CHMI |
| Group B (PfSPZ Vaccine; PfSPZ Challenge 7G8) | Experimental | 14 volunteers will receive 9 x 10^5 PfSPZ Vaccine on days 1, 8, 29.
Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 42 by DVI injection. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (7G8) for CHMI |
| Group C (PfSPZ Vaccine; PfSPZ Challenge 7G8) | Experimental | 14 volunteers will receive 9 x 10^5 PfSPZ Vaccine on days 1, 8, 29.
Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 70 by DVI injection. Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (7G8) for CHMI |
| Group A controls (Saline; PfSPZ Challenge 7G8) | Placebo comparator | 4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29.
Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 14 by DVI injection. Receives: Biological: PfSPZ Challenge (7G8) for CHMI; Other: Normal Saline |
| Group B controls (Saline; PfSPZ Challenge 7G8) | Placebo comparator | 4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29.
Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 42 by DVI injection. Receives: Biological: PfSPZ Challenge (7G8) for CHMI; Other: Normal Saline |
| Group C controls (Saline; PfSPZ Challenge 7G8) | Placebo comparator | 4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29.
Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 70 by DVI injection. Receives: Biological: PfSPZ Challenge (7G8) for CHMI; Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine efficacy (VE) of PfSPZ Vaccine against Pf malaria in adults
VE computed as one minus the estimated risk ratio for Pf infection (parasitemia) detected by qRT-PCR beginning 7 days after CHMI and censoring subjects at 28 days in the "modified Intention to Treat" (mITT) population
Measured: 7-28 days after CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- solicited AEs
The differences in proportions of vaccinees compared to controls experiencing related solicited adverse events after vaccination.
Measured: Day of first immunization until 8 weeks post CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- solicited AEs
The differences in proportions of vaccinees compared to controls experiencing related unsolicited adverse events after vaccination.
Measured: Day of first immunization until 8 weeks post CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- SAEs
The differences in proportions of vaccinees compared to controls experiencing related serious adverse events (SAEs) after vaccination.
Measured: Day of first immunization until 8 weeks post CHMI
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- Lab abnormalities
The differences in proportions of vaccinees compared to controls experiencing related laboratory abnormalities after vaccination.
Measured: Day of first immunization until 8 weeks post CHMI
Secondary outcomes (3)
Antibody responses to PfCSP post-immunization/CHMI and correlation with protection in vaccinees vs controls
Antibody levels to PfCSP measured by ELISA comparing vaccinees to controls
Measured: 2 weeks post Vaccination 2 until 4 weeks post CHMI
Antibody responses to PfCSP post-immunization/CHMI and correlation with protection in protected vs unprotected vaccinees
Antibody levels to PfCSP measured by ELISA comparing protected (no parasitemia occurring post CHMI) and non-protected (parasitemia occurring post CHMI) vaccinees.
Measured: 2 weeks post Vaccination 2 until 4 weeks post CHMI
VE between different groups with CHMI at 14, 42 or 70 days after Vaccination 3
VE computed as one minus the estimated risk ratio for Pf infection (parasitemia) detected by qRT-PCR beginning 7 days after CHMI and censoring subjects at 28 days in the mITT population
Measured: Day of first immunization until 8 weeks post CHMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start27 Sep 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fred Hutchinson Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966871
- Sponsor's protocol ID
- USSPZV6
- Status last verified
- Jul 2022
- First submitted
- 3 Jun 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of a 3-dose, 28-Day Regimen of PfSPZ Vaccine in Healthy, Malaria-Naïve, Adult Subjects to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI Conducted 14, 42 or 70 Days After Immunization
- ClinicalTrials.gov ID
- NCT04966871
- Acronym / sponsor ID
- USSPZV6
- Conditions
- Malaria
- Keywords
- PfSPZ Vaccine, Malaria, Plasmodium falciparum, Controlled human malaria infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fred Hutchinson Cancer Center
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 19 Jul 2021 (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, single site, trial of a condensed regimen of PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI) conducted at varying time intervals after the third immunization (14, 42 or 70 days). The trial is designed to simulate pre-deployment immunization of military personnel. Prior studies with this regimen show high level protection (>80%) against CHMI at 21 days, but the onset and duration of protection have not been fully defined.
Detailed description
USSPZV6 is a single site, double-blind, randomized, placebo-controlled, clinical trial. Study groups will be randomized in a 14:4 ratio (vaccine to NS placebo) among healthy, malaria-naive adults aged 18-50 years. There will be three groups of subjects. Each of the 3 groups will have 14 subjects who receive 3 injections with 9 x 10^5 PfSPZ of PfSPZ Vaccine and 4 subjects who receive 3 injections with normal saline placebo. Subjects who complete all immunizations will receive a total 2.7 x 10^6 PfSPZ. VE will be assessed by exposure to PfSPZ Challenge (7G8) (cryopreserved infectious sporozoites originating from a Pf strain isolated in Brazil, and thus heterologous to the vaccine). The day of CHMI will vary per group with Groups A, B and C receiving PfSPZ Challenge (7G8) on days 14, 42 or 70 after Vaccination 3 (V3), respectively. Direct observation will be for 30 minutes following each dose of PfSPZ Vaccine or PfSPZ Challenge. A research/safety monitor and a Safety Monitoring Committee (SMC) will provide safety oversight. Clinical study monitoring will be the responsibility of Sanaria or Sanaria's designated and authorized representative. Screening will not precede enrollment by more than 90 days. For the second and third immunizations, allowable windows are assigned. The entire study will take approximately 8 months to complete, including 2 months of recruitment because the study will be conducted in two sequential cohorts. The period of follow-up for each immunized subject and placebo controls is through 8 weeks post-CHMI. Study participation will last between 99 and 154 days (not including screening) depending upon group assignment.
Case report forms (CRFs) will serve as the repository of source documents and other relevant data for each study subject. Only information that cannot be collected initially into the CRF (for instance, EKGs and AE medical records) will first be collected onto separate source documents before transcription into the CRF. Laboratory results will be entered from source documents directly into the database.
Solicited adverse events (AEs) will be collected for 7 days after each immunization. Unsolicited AEs will be collected from the first immunization (V1) until 28 days after the third immunization (V3) and for 28 days after CHMI. Physical exams and medical history will be assessed as indicated. Safety laboratories will be collected at screening, day of V1, 14 days after V2, 7 days after V3, day of CHMI and 28 days after CHMI. Surveillance for SAEs will occur for the duration of the study. Follow-up of AEs (including SAEs) occurs until resolution or stability.
If clinical laboratories expire (meaning they were obtained greater than 90 days prior to planned enrollment), specific safety labs will be repeated for screening purposes. Safety evaluation includes an electrocardiogram (ECG) performed at screening. Subjects with abnormal cardiovascular symptoms or findings that appear clinically significant will be excluded and if appropriate, referred to a cardiologist for further evaluation.Clinical laboratory testings will be conducted by Fred Hutchinson Cancer Research Center.
Detection of parasitemia post CHMI will be based upon qRT-PCR. Subjects who have 2 positive qRT-PCR results separated by greater than or equal to 12 hours or a single qRT-PCR result reading > 250 estimated parasites/mL will be treated with anti-malaria therapy. Anti-malarial therapy will consist of: First-line: Malarone, Second-line: Coartem.
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 A (PfSPZ Vaccine; PfSPZ Challenge 7G8) | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (7G8) for CHMI14 volunteers will receive 3 doses of 9 x 10^5 PfSPZ Vaccine on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 14 by DVI injection. |
| Group B (PfSPZ Vaccine; PfSPZ Challenge 7G8) | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (7G8) for CHMI14 volunteers will receive 9 x 10^5 PfSPZ Vaccine on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 42 by DVI injection. |
| Group C (PfSPZ Vaccine; PfSPZ Challenge 7G8) | Experimental | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (7G8) for CHMI14 volunteers will receive 9 x 10^5 PfSPZ Vaccine on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 70 by DVI injection. |
| Group A controls (Saline; PfSPZ Challenge 7G8) | Placebo comparator | Biological: PfSPZ Challenge (7G8) for CHMI, Other: Normal Saline4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 14 by DVI injection. |
| Group B controls (Saline; PfSPZ Challenge 7G8) | Placebo comparator | Biological: PfSPZ Challenge (7G8) for CHMI, Other: Normal Saline4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 42 by DVI injection. |
| Group C controls (Saline; PfSPZ Challenge 7G8) | Placebo comparator | Biological: PfSPZ Challenge (7G8) for CHMI, Other: Normal Saline4 volunteers will receive Normal Saline (NS) as placebo on days 1, 8, 29. Controlled human malaria infection (CHMI) with PfSPZ Challenge (7G8) will be administered on day 70 by DVI injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults (male or non-pregnant female) 18 to 50 years of age
- Able and willing to participate for the duration of the study
- Able and willing to provide written (not proxy) informed consent
- Physical examination and laboratory results without clinically significant findings
- Individuals of childbearing potential must agree to use effective means of birth control (e.g. oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) during the entire study. Female participants with a history of surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider
Key exclusion criteria (19 listed)
- A history of malaria infection within 2 years prior to study participation or travel to a malaria endemic region within six months prior to first immunization
- Receipt of a malaria vaccine in a prior clinical trial
- History of a splenectomy or sickle cell disease
- History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache
- Current use of systemic immunosuppressant pharmacotherapy
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 VaccineMetabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine) | Biological | Group A (PfSPZ Vaccine; PfSPZ Challenge 7G8), Group B (PfSPZ Vaccine; PfSPZ Challenge 7G8), Group C (PfSPZ Vaccine; PfSPZ Challenge 7G8) |
| PfSPZ Challenge (7G8) for CHMILive, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain 7G8 | Biological | Group A (PfSPZ Vaccine; PfSPZ Challenge 7G8), Group A controls (Saline; PfSPZ Challenge 7G8), Group B (PfSPZ Vaccine; PfSPZ Challenge 7G8), Group B controls (Saline; PfSPZ Challenge 7G8), Group C (PfSPZ Vaccine; PfSPZ Challenge 7G8), Group C controls (Saline; PfSPZ Challenge 7G8) |
| Normal Salinenormal saline placebo control | Other | Group A controls (Saline; PfSPZ Challenge 7G8), Group B controls (Saline; PfSPZ Challenge 7G8), Group C controls (Saline; PfSPZ Challenge 7G8) |
Primary outcome
Vaccine efficacy (VE) of PfSPZ Vaccine against Pf malaria in adults
Time frame: 7-28 days after CHMI
VE computed as one minus the estimated risk ratio for Pf infection (parasitemia) detected by qRT-PCR beginning 7 days after CHMI and censoring subjects at 28 days in the "modified Intention to Treat" (mITT) population
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- solicited AEs
Time frame: Day of first immunization until 8 weeks post CHMI
The differences in proportions of vaccinees compared to controls experiencing related solicited adverse events after vaccination.
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- solicited AEs
Time frame: Day of first immunization until 8 weeks post CHMI
The differences in proportions of vaccinees compared to controls experiencing related unsolicited adverse events after vaccination.
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- SAEs
Time frame: Day of first immunization until 8 weeks post CHMI
The differences in proportions of vaccinees compared to controls experiencing related serious adverse events (SAEs) after vaccination.
Safety and tolerability of 3 doses of 9.0x10^5 PfSPZ of PfSPZ Vaccine- Lab abnormalities
Time frame: Day of first immunization until 8 weeks post CHMI
The differences in proportions of vaccinees compared to controls experiencing related laboratory abnormalities after vaccination.
3 secondary outcomes
Antibody responses to PfCSP post-immunization/CHMI and correlation with protection in vaccinees vs controls
Time frame: 2 weeks post Vaccination 2 until 4 weeks post CHMI
Antibody responses to PfCSP post-immunization/CHMI and correlation with protection in protected vs unprotected vaccinees
Time frame: 2 weeks post Vaccination 2 until 4 weeks post CHMI
VE between different groups with CHMI at 14, 42 or 70 days after Vaccination 3
Time frame: Day of first immunization until 8 weeks post CHMI
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 18 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, PfSPZ Challenge (7G8) for CHMI and Normal Saline in people with Malaria, run by Sanaria Inc. at 1 site in United States.
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 7 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 18 Jul 2022. 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 United States. 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?
Vaccine efficacy (VE) of PfSPZ Vaccine against Pf malaria in adults (time frame: 7-28 days after CHMI). 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?
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 18 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.