DiarrheaPhase 1NCT03869333
Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
A Phase 1 study testing Invaplex[AR-DETOX] in people with Diarrhea, run by PATH at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Invaplex[AR-DETOX]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 12 Jun 2020
- 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, adult, male or female, age 18 to 50 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved ≥ 70% accuracy, two attempts allowed).
- Provide written informed consent before initiation of any study procedures.
- Agrees to complete all study visits and procedures and to provide a screening stool sample.
- Women of childbearing capacity: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following the last vaccine dose.
Who cannot join
- Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other conditions that might place the subjects at increased risk of adverse events) - study clinicians, in consultation with the Principal Investigator (PI), will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
- History of autoimmune disorders, cardiovascular and renal disease.
- Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including immunoglobulin A (IgA) deficiency (defined by serum IgA < 7 mg/dL).
- Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women.
- Participation in research involving another investigational product (defined as receipt of an investigational product or exposure to an invasive investigational device) 30 days before planned date of first vaccination or anytime throughout the duration of the study until the last in-clinic study safety visit.
- Positive blood test for hepatitis B surface antigen (HBsAG), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV)-1/HIV-2 antibody.
Show all 20Show fewer
- Clinically significant abnormalities on basic laboratory screening tests.
- Systemic antimicrobial treatment (i.e., topical treatments are not an exclusion) within 1 week before administration of the first vaccine dose.
- Allergies that may increase the risk of adverse events (AEs).
- Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy.
- Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis.
- Personal or family history of an inflammatory arthritis.
- Positive blood test for human leukocyte antigen (HLA) B27 (associated with increased risk of reactive arthritis secondary to Shigella infection)
- History of allergy to any vaccine.
- Exclusionary skin disease history/findings that would confound assessment or prevent appropriate local monitoring of AEs, or possibly increase the risk of a local AE.
- Serum immunoglobulin G (IgG) titer > 2500 to Shigella flexneri 2a lipopolysaccharide antigen (LPS).
- History of microbiologically confirmed Shigella infection.
- Received previous licensed or experimental Shigella vaccine or live Shigella challenge.
- Travel to countries where Shigella or other enteric infections are endemic (most of the developing world) within two years prior to dosing (clinician judgement).
- Occupation involving handling of Shigella bacteria currently, or in the past 3 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research Clinical Trials Center (WRAIR CTC)
Silver Spring, Maryland, 20910
About this study
Official title: A Phase 1 Double-blind, Placebo-controlled, Dose Escalating Study of Intramuscular Detoxified Shigella Flexneri 2a Artificial Invasin Complex (Invaplex[AR-DETOX]) Vaccine
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical trial in which a total of 60 volunteers will receive one of three doses of Invaplex[AR-DETOX] or placebo (saline). The vaccine will be administered via intramuscular (IM) injection on study days 1, 22, and 43. Each participant will receive the same formulation at each vaccination dependent upon group assignment. The study will be initiated with the lowest dose level (2.5 μg) and will proceed to the next highest dose in an escalating fashion. All safety data will be summarized and reviewed by the Protocol Safety Review Team (PSRT) prior to dose-escalation.
Specimens will be collected at prescribed intervals to examine systemic and mucosal immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.
- Conditions
- Diarrhea
- Being tested
- Invaplex[AR-DETOX], Placebo
- Keywords
- Shigella flexneri 2a, Enteric, Shigella
- Medical subject headings
- Diarrhea, Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invaplex[AR-DETOX]Biological
Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex[AR-Detox]) Vaccine
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Invaplex[AR-Detox] 2.5 μg | Experimental | Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. Receives: Biological: Invaplex[AR-DETOX] |
| Invaplex[AR-Detox] 10 μg | Experimental | Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. Receives: Biological: Invaplex[AR-DETOX] |
| Invaplex[AR-Detox] 25 μg | Experimental | Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. Receives: Biological: Invaplex[AR-DETOX] |
| Placebo | Placebo comparator | Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
All adverse events (AEs) were assessed for severity by the investigator according to the following scale:
Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort;
Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort;
Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort;
Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event.
An AE was considered "serious" if it resulted in any of the following outcomes:
- Death
- Life-threatening AE
- Inpatient hospitalization or prolongation of existing hospitalization
- Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- Congenital anomaly/birth defect.
The Investigator assessed the relationship of each adverse event to study drug.
Measured: From first dose up to 28 days following the third immunization (71 days)
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
The solicited AEs for this study included:
- Site pain
- Site tenderness
- Swelling
- Induration (determined by investigator exam)
- Site redness
- Pruritus
- Fever
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea (loose stools)
- Appetite change
- Fatigue
- Headache
- Myalgias (general pain or soreness in muscles)
- Arthralgias (general pain in joints)
- Malaise
Measured: 7 days after the first immunization (Days 1 to 7)
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
The solicited AEs for this study included:
- Site pain
- Site tenderness
- Swelling
- Induration (determined by investigator exam)
- Site redness
- Pruritus
- Fever
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea (loose stools)
- Appetite change
- Fatigue
- Headache
- Myalgias (general pain or soreness in muscles)
- Arthralgias (general pain in joints)
- Malaise
Measured: 7 days after the second immunization (Days 22 to 28)
Number of Participants With Solicited Adverse Events After Dose 3
The solicited AEs for this study included:
- Site pain
- Site tenderness
- Swelling
- Induration (determined by investigator exam)
- Site redness
- Pruritus
- Fever
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea (loose stools)
- Appetite change
- Fatigue
- Headache
- Myalgias (general pain or soreness in muscles)
- Arthralgias (general pain in joints)
- Malaise
Measured: 7 days after the third immunization (Days 43 to 49)
Number of Participants With Unsolicited Adverse Events After Each Dose
Measured: Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71
Secondary outcomes (12)
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Measured: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Measured: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)
Measured: Days 1 (Baseline), 8, 29, and 50
Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant
Measured: Days 1 (Baseline), 8, 29, and 50
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Measured: Days 1 (Baseline), 22 43, 50, 57 and 71
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Measured: Days 1 (Baseline), 22 43, 50, 57 and 71
Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Measured: Days 1 (Baseline), 8, 29, and 50
Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Measured: Days 1 (Baseline), 8, 29, and 50
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline
Measured: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Fold-rise in Serum IgG From Baseline
Measured: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Fold-rise in ALS IgA From Baseline
Measured: Days 1 (Baseline), 8, 29, and 50
Geometric Mean Fold-rise in ALS IgG From Baseline
Measured: Days 1 (Baseline), 8, 29, and 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start18 Mar 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
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.
- Other trials for DiarrheaStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramiro Gutierrez, MD, MPH, Principal investigator, Naval Medical Research Center (NMRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869333
- Sponsor's protocol ID
- CVIA 064
- Status last verified
- May 2020
- First submitted
- 4 Mar 2019
- Last updated
- 29 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Placebo-controlled, Dose Escalating Study of Intramuscular Detoxified Shigella Flexneri 2a Artificial Invasin Complex (Invaplex[AR-DETOX]) Vaccine
- ClinicalTrials.gov ID
- NCT03869333
- Acronym / sponsor ID
- CVIA 064
- Conditions
- Diarrhea
- Keywords
- Shigella flexneri 2a, Enteric, Shigella
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 29 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization.
Detailed description
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical trial in which a total of 60 volunteers will receive one of three doses of Invaplex[AR-DETOX] or placebo (saline). The vaccine will be administered via intramuscular (IM) injection on study days 1, 22, and 43. Each participant will receive the same formulation at each vaccination dependent upon group assignment. The study will be initiated with the lowest dose level (2.5 μg) and will proceed to the next highest dose in an escalating fashion. All safety data will be summarized and reviewed by the Protocol Safety Review Team (PSRT) prior to dose-escalation.
Specimens will be collected at prescribed intervals to examine systemic and mucosal immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Invaplex[AR-Detox] 2.5 μg | Experimental | Biological: Invaplex[AR-DETOX]Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| Invaplex[AR-Detox] 10 μg | Experimental | Biological: Invaplex[AR-DETOX]Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| Invaplex[AR-Detox] 25 μg | Experimental | Biological: Invaplex[AR-DETOX]Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received an intramuscular injection of placebo solution on Days 1, 22, and 43. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, male or female, age 18 to 50 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved ≥ 70% accuracy, two attempts allowed).
- Provide written informed consent before initiation of any study procedures.
- Agrees to complete all study visits and procedures and to provide a screening stool sample.
- Women of childbearing capacity: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following the last vaccine dose.
Key exclusion criteria (20 listed)
- Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other conditions that might place the subjects at increased risk of adverse events) - study clinicians, in consultation with the Principal Investigator (PI), will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
- History of autoimmune disorders, cardiovascular and renal disease.
- Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including immunoglobulin A (IgA) deficiency (defined by serum IgA < 7 mg/dL).
- Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women.
- Participation in research involving another investigational product (defined as receipt of an investigational product or exposure to an invasive investigational device) 30 days before planned date of first vaccination or anytime throughout the duration of the study until the last in-clinic study safety visit.
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 |
|---|---|---|
| Invaplex[AR-DETOX]Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex[AR-Detox]) Vaccine | Biological | Invaplex[AR-Detox] 10 μg, Invaplex[AR-Detox] 2.5 μg, Invaplex[AR-Detox] 25 μg |
| PlaceboSaline | Other | Placebo |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: From first dose up to 28 days following the third immunization (71 days)
All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was considered "serious" if it resulted in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly/birth defect. The Investigator assessed the relationship of each adverse event to study drug.
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Time frame: 7 days after the first immunization (Days 1 to 7)
The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Time frame: 7 days after the second immunization (Days 22 to 28)
The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Number of Participants With Solicited Adverse Events After Dose 3
Time frame: 7 days after the third immunization (Days 43 to 49)
The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Number of Participants With Unsolicited Adverse Events After Each Dose
Time frame: Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71
12 secondary outcomes
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)
Time frame: Days 1 (Baseline), 8, 29, and 50
Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant
Time frame: Days 1 (Baseline), 8, 29, and 50
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline
Time frame: Days 1 (Baseline), 22 43, 50, 57 and 71
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline
Time frame: Days 1 (Baseline), 22 43, 50, 57 and 71
Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline
Time frame: Days 1 (Baseline), 8, 29, and 50
Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline
Time frame: Days 1 (Baseline), 8, 29, and 50
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline
Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Fold-rise in Serum IgG From Baseline
Time frame: Days 1 (Baseline), 22, 43, 50, 57 and 71.
Geometric Mean Fold-rise in ALS IgA From Baseline
Time frame: Days 1 (Baseline), 8, 29, and 50
Geometric Mean Fold-rise in ALS IgG From Baseline
Time frame: Days 1 (Baseline), 8, 29, and 50
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ramiro Gutierrez, MD, MPH principal investigator
Naval Medical Research Center (NMRC)
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 Invaplex[AR-DETOX] in people with Diarrhea, run by PATH 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 5 inclusion and 20 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 29 Jul 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 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 29 Jul 2021). 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?
Percentage of Participants With Adverse Events (time frame: From first dose up to 28 days following the third immunization (71 days)). 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 29 Jul 2021.