MalariaPhase 1NCT05604521
A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI
A Phase 1 study testing PfSPZ Vaccine, PfSPZ Challenge (7G8) and Normal Saline in people with Malaria and Malaria,Falciparum, run by Sanaria Inc. at 1 site in United States.
Trial summary
USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® 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) with the 7G8… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria,Falciparum
- What is being tested?
- PfSPZ Vaccine, PfSPZ Challenge (7G8) and Normal Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 5 Sep 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 informed consent and satisfactorily complete a test of understanding with a passing score >80%.
- Physical examination and laboratory results without clinically significant findings.
- Women 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. Women with a history of surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other).
- Willing to refrain from blood donation for 3 years following CHMI.
- Agree not to travel to a malaria endemic region during the trial.
Who cannot join
- Unable to provide informed consent including inability to pass the test of understanding, which is written in English for the US-based study sites.
- 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 3 or more non-live vaccines within 2 weeks of first immunization.
Show all 19Show fewer
- Women 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.
- A history of malaria in the 2 years prior to screening.
- Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected.
- Evidence of increased cardiovascular disease risk; defined as >10% five-year risk by nonlaboratory method.
- 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 precede or coincide with malaria challenge or vaccination.
- Anticipated use of medications known to cause drug reactions with atovaquone-proguanil or artemether-lumefantrine such as cimetidine, metoclopramide, antacids, and kaolin.
- Positive HBsAg or positive HIV or HCV testing consistent with active infection.
- An abnormal electrocardiogram, defined as one showing pathologic Q waves and significant STT 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 site PI, impairs the volunteer's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant 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
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Clinical Trial of a 3-dose, 28-day Regimen of PfSPZ Vaccine in Healthy, Adult Participants to Determine Safety, Tolerability and Efficacy Against Heterologous Plasmodium Falciparum Controlled Human Malaria Infection Conducted 3 or 12 Weeks After Immunization
USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® 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) with the 7G8 clone of Plasmodium falciparum (Pf) conducted at 3 or 12 weeks after the third immunization. The trial is designed to determine if individuals living in a non-malaria endemic area such as the United States (US) are protected against heterologous CHMI conducted at these time points.
Read the detailed description
- Randomized, phase 1, double-blind, placebo-controlled clinical trial enrolling healthy adult participants 18-50-years-old living in the US.
- The trial is designed to measure safety, tolerability, immunogenicity and VE against heterologous controlled human malaria vaccine conducted at 3 or 12 weeks after vaccination.
- Participants will be randomized to two study groups, vaccine and placebo, in a 3:1 ratio. Treatment assignment will be double blind; however, whether a given participant will be receiving CHMI at 3 or 12 weeks will not be blind.
- Bias will be minimized by the randomized, double-blind design and by the inability to distinguish vaccine or placebo based on appearance, tolerability or other characteristics discernable by clinical staff or study participants.
- The study will take approximately 6 to 8 months to complete, not including 2-3 months of recruitment. The period of follow-up for each immunized participant and placebo controls is through 8 weeks post-CHMI.
- Study participation by individuals will last 4 to 6 months (not including screening) depending upon group assignment.
- Conditions
- Malaria, Malaria,Falciparum
- Being tested
- PfSPZ Vaccine, PfSPZ Challenge (7G8), Normal Saline
- Keywords
- Malaria, Plasmodium falciparum, Sporozoites, 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
PfSPZ vaccine consists of radiation-attenuated, aseptic, purified Plasmodium falciparum (NF54) sporozoites (SPZ) cryopreserved in liquid nitrogen vapor phase (LNVP) at -150C to - 196C. PfSPZ Vaccine is composed of PfSPZ derived from the NF54 strain of Pf, which is thought to be from West Africa. PfSPZ Vaccine is diluted in phosphate buffered saline (PBS) with human serum albumin (HSA) to achieve the correct dosage and is administered by DVI.
PfSPZ Challenge (7G8)Biological
PfSPZ Challenge (7G8) is similar to PfSPZ Vaccine but has not been attenuated by radiation and is therefore infectious.PfSPZ Challenge (7G8) is composed of PfSPZ derived from the 7G8 clone of Pf, which is from Brazil.
Normal SalineOther
Also called Placebo
0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Group 1a: PfSPZ Vaccine | Active comparator | 45 participants will receive 3 doses of 9.0x10^5 PfSPZ Vaccine on Days 1, 8, and 29 with a total dose of 2.7x10^6 PfSPZ Vaccine.
Group 1a: Approximately half (22/23) of the volunteers will undergo CHMI 3 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (7G8) |
| Group 1b: PfSPZ Vaccine | Active comparator | 45 participants will receive 3 doses of 9.0x10^5 PfSPZ Vaccine on Days 1, 8, and 29 with a total dose of 2.7x10^6 PfSPZ Vaccine.
Group 1b: Approximately half (22/23) of the volunteers will undergo CHMI 12 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). Receives: Biological: PfSPZ Vaccine; Biological: PfSPZ Challenge (7G8) |
| Group 2a: Normal Saline Controls | Placebo comparator | 15 participants will receive 3 doses of normal saline on Days 1, 8, and 29.
Group 2a: Approximately half (7/8) of the volunteers will undergo CHMI 3 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). Receives: Biological: PfSPZ Challenge (7G8); Other: Normal Saline |
| Group 2b: Normal Saline Controls | Placebo comparator | 15 participants will receive 3 doses of normal saline on Days 1, 8, and 29.
Group 2b: Approximately half (7/8) of the volunteers will undergo CHMI 12 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). Receives: Biological: PfSPZ Challenge (7G8); Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The differences in proportions of vaccinees compared to controls experiencing related moderate, severe, or serious solicited and unsolicited adverse events and laboratory abnormalities after vaccination.
Measured: Day of immunization to 28 days post immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start6 Dec 2022
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Why it stopped: The main reason for trial discontinuation was the inability to address the primary objectives of the study following an extended gap between the second and third doses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Kirsten E Lyke, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604521
- Sponsor's protocol ID
- USSPZV7
- Other IDs
- 1U44AI167783-01
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2022
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mordmuller B, Sulyok Z, Sulyok M, Molnar Z, Lalremruata A, Calle CL, Bayon PG, Esen M, Gmeiner M, Held J, Heimann HL, Woldearegai TG, Ibanez J, Flugge J, Fendel R, Kreidenweiss A, Kc N, Murshedkar T, Chakravarty S, Riyahi P, Billingsley PF, Church LWP, Richie TL, Sim BKL, Hoffman SL, Kremsner PG. A PfSPZ vaccine immunization regimen equally protective against homologous and heterologous controlled human malaria infection. NPJ Vaccines. 2022 Aug 23;7(1):100. doi: 10.1038/s41541-022-00510-z.
PubMed 35999221Lyke KE, Singer A, Berry AA, Reyes S, Chakravarty S, James ER, Billingsley PF, Gunasekera A, Manoj A, Murshedkar T, Laurens MB, Church WP, Garver Baldwin LS, Sedegah M, Banania G, Ganeshan H, Guzman I, Reyes A, Wong M, Belmonte A, Ozemoya A, Belmonte M, Huang J, Villasante E, Sim BKL, Hoffman SL, Richie TL, Epstein JE; Warfighter II Study Team. Multidose Priming and Delayed Boosting Improve Plasmodium falciparum Sporozoite Vaccine Efficacy Against Heterologous P. falciparum Controlled Human Malaria Infection. Clin Infect Dis. 2021 Oct 5;73(7):e2424-e2435. doi: 10.1093/cid/ciaa1294.
PubMed 32920641Berry AA, Richie TL, Church LWP, Laurens MB, Boyce C, Kc N, Joshi S, Koudjra AR, Butler L, Chen MC, Abebe Y, Murshedkar T, James ER, Billingsley PF, Sim BKL, Hoffman SL, Lyke KE. Safety, tolerability and immunogenicity of a condensed, multi-dose prime regimen of PfSPZ Vaccine for the prevention of Plasmodium falciparum malaria infection. Malar J. 2025 Mar 17;24(1):88. doi: 10.1186/s12936-025-05299-5.
PubMed 40098097
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Clinical Trial of a 3-dose, 28-day Regimen of PfSPZ Vaccine in Healthy, Adult Participants to Determine Safety, Tolerability and Efficacy Against Heterologous Plasmodium Falciparum Controlled Human Malaria Infection Conducted 3 or 12 Weeks After Immunization
- ClinicalTrials.gov ID
- NCT05604521
- Acronym / sponsor ID
- USSPZV7
- Conditions
- Malaria, Malaria,Falciparum
- Keywords
- Malaria, Plasmodium falciparum, Sporozoites, PfSPZ Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The main reason for trial discontinuation was the inability to address the primary objectives of the study following an extended gap between the second and third doses.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® 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) with the 7G8 clone of Plasmodium falciparum (Pf) conducted at 3 or 12 weeks after the third immunization. The trial is designed to determine if individuals living in a non-malaria endemic area such as the United States (US) are protected against heterologous CHMI conducted at these time points.
Detailed description
- Randomized, phase 1, double-blind, placebo-controlled clinical trial enrolling healthy adult participants 18-50-years-old living in the US.
- The trial is designed to measure safety, tolerability, immunogenicity and VE against heterologous controlled human malaria vaccine conducted at 3 or 12 weeks after vaccination.
- Participants will be randomized to two study groups, vaccine and placebo, in a 3:1 ratio. Treatment assignment will be double blind; however, whether a given participant will be receiving CHMI at 3 or 12 weeks will not be blind.
- Bias will be minimized by the randomized, double-blind design and by the inability to distinguish vaccine or placebo based on appearance, tolerability or other characteristics discernable by clinical staff or study participants.
- The study will take approximately 6 to 8 months to complete, not including 2-3 months of recruitment. The period of follow-up for each immunized participant and placebo controls is through 8 weeks post-CHMI.
- Study participation by individuals will last 4 to 6 months (not including screening) depending upon group assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1a: PfSPZ Vaccine | Active comparator | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (7G8)45 participants will receive 3 doses of 9.0x10^5 PfSPZ Vaccine on Days 1, 8, and 29 with a total dose of 2.7x10^6 PfSPZ Vaccine. Group 1a: Approximately half (22/23) of the volunteers will undergo CHMI 3 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). |
| Group 1b: PfSPZ Vaccine | Active comparator | Biological: PfSPZ Vaccine, Biological: PfSPZ Challenge (7G8)45 participants will receive 3 doses of 9.0x10^5 PfSPZ Vaccine on Days 1, 8, and 29 with a total dose of 2.7x10^6 PfSPZ Vaccine. Group 1b: Approximately half (22/23) of the volunteers will undergo CHMI 12 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). |
| Group 2a: Normal Saline Controls | Placebo comparator | Biological: PfSPZ Challenge (7G8), Other: Normal Saline15 participants will receive 3 doses of normal saline on Days 1, 8, and 29. Group 2a: Approximately half (7/8) of the volunteers will undergo CHMI 3 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). |
| Group 2b: Normal Saline Controls | Placebo comparator | Biological: PfSPZ Challenge (7G8), Other: Normal Saline15 participants will receive 3 doses of normal saline on Days 1, 8, and 29. Group 2b: Approximately half (7/8) of the volunteers will undergo CHMI 12 weeks after last immunization by exposure to 3.2x10^3 PfSPZ Challenge (7G8). |
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 informed consent and satisfactorily complete a test of understanding with a passing score >80%.
- Physical examination and laboratory results without clinically significant findings.
- Women 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. Women with a history of surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other).
Key exclusion criteria (19 listed)
- Unable to provide informed consent including inability to pass the test of understanding, which is written in English for the US-based study sites.
- 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 VaccinePfSPZ vaccine consists of radiation-attenuated, aseptic, purified Plasmodium falciparum (NF54) sporozoites (SPZ) cryopreserved in liquid nitrogen vapor phase (LNVP) at -150C to - 196C. PfSPZ Vaccine is composed of PfSPZ derived from the NF54 strain of Pf, which is thought to be from West Africa. PfSPZ Vaccine is diluted in phosphate buffered saline (PBS) with human serum albumin (HSA) to achieve the correct dosage and is administered by DVI. | Biological | Group 1a: PfSPZ Vaccine, Group 1b: PfSPZ Vaccine |
| PfSPZ Challenge (7G8)PfSPZ Challenge (7G8) is similar to PfSPZ Vaccine but has not been attenuated by radiation and is therefore infectious.PfSPZ Challenge (7G8) is composed of PfSPZ derived from the 7G8 clone of Pf, which is from Brazil. | Biological | Group 1a: PfSPZ Vaccine, Group 1b: PfSPZ Vaccine, Group 2a: Normal Saline Controls, Group 2b: Normal Saline Controls |
| Normal SalineAlso: Placebo0.9% sodium chloride | Other | Group 2a: Normal Saline Controls, Group 2b: Normal Saline Controls |
Primary outcome
Adverse Events
Time frame: Day of immunization to 28 days post immunization
The differences in proportions of vaccinees compared to controls experiencing related moderate, severe, or serious solicited and unsolicited adverse events and laboratory abnormalities after vaccination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35999221Mordmuller B, Sulyok Z, Sulyok M, Molnar Z, Lalremruata A, Calle CL, Bayon PG, Esen M, Gmeiner M, Held J, Heimann HL, Woldearegai TG, Ibanez J, Flugge J, Fendel R, Kreidenweiss A, Kc N, Murshedkar T, Chakravarty S, Riyahi P, Billingsley PF, Church LWP, Richie TL, Sim BKL, Hoffman SL, Kremsner PG. A PfSPZ vaccine immunization regimen equally protective against homologous and heterologous controlled human malaria infection. NPJ Vaccines. 2022 Aug 23;7(1):100. doi: 10.1038/s41541-022-00510-z.
- Background: PubMed 32920641Lyke KE, Singer A, Berry AA, Reyes S, Chakravarty S, James ER, Billingsley PF, Gunasekera A, Manoj A, Murshedkar T, Laurens MB, Church WP, Garver Baldwin LS, Sedegah M, Banania G, Ganeshan H, Guzman I, Reyes A, Wong M, Belmonte A, Ozemoya A, Belmonte M, Huang J, Villasante E, Sim BKL, Hoffman SL, Richie TL, Epstein JE; Warfighter II Study Team. Multidose Priming and Delayed Boosting Improve Plasmodium falciparum Sporozoite Vaccine Efficacy Against Heterologous P. falciparum Controlled Human Malaria Infection. Clin Infect Dis. 2021 Oct 5;73(7):e2424-e2435. doi: 10.1093/cid/ciaa1294.
- Derived from this study: PubMed 40098097Berry AA, Richie TL, Church LWP, Laurens MB, Boyce C, Kc N, Joshi S, Koudjra AR, Butler L, Chen MC, Abebe Y, Murshedkar T, James ER, Billingsley PF, Sim BKL, Hoffman SL, Lyke KE. Safety, tolerability and immunogenicity of a condensed, multi-dose prime regimen of PfSPZ Vaccine for the prevention of Plasmodium falciparum malaria infection. Malar J. 2025 Mar 17;24(1):88. doi: 10.1186/s12936-025-05299-5.
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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.
Kirsten E Lyke, MD principal investigator
University of Maryland, Baltimore
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) and Normal Saline in people with Malaria and Malaria,Falciparum, 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: stopped early, as of the sponsor's last update on 25 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: Day of immunization to 28 days post immunization). 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 NCT05604521, which also lists 3 linked publications.
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 25 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.