DiarrheaPhase 1NCT03404674
Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
A Phase 1 study testing CssBA and dmLT in people with Diarrhea, run by PATH at 1 site in United States.
Trial summary
This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- CssBA and dmLT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 26 Mar 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved > 70% accuracy).
- Signed informed consent document.
- Available for the required follow-up period and scheduled clinic visits.
- Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following last vaccination.
Who cannot join
- Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other condition that might place the subject at increased risk of adverse events) - study clinicians, in consultation with the 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.
- Clinically significant abnormalities on physical examination.
- Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or 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 three (3) months beyond the last received dose and currently nursing women.
- Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit.
- Positive blood test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2.
Show all 18Show fewer
- Clinically significant abnormalities on basic laboratory screening.
- Exclusionary skin disease history/findings that would confound assessment or prevent appropriate local monitoring of adverse events (AEs), or possibly increase the risk of a local AE
- History of chronic skin disease (clinician judgement)
- Acute skin infection/eruptions on the upper arms including fungal infections, severe acne or active contact dermatitis
- Allergies that may increase the risk of 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
- History of microbiologically confirmed ETEC or cholera infection in the last 3 years
- Travel to countries where ETEC or V. cholerae or other enteric infections are endemic (most of the developing world) within 3 years prior to dosing (clinician judgement)
- Symptoms consistent with Travelers' Diarrhea or concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study
- Vaccination for or ingestion of ETEC, cholera, or E. coli heat labile toxin within 3 years prior to dosing
- Occupation involving handling of ETEC or V. cholerae 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 Trial Center
Silver Spring, Maryland, 20910
About this study
Official title: A Phase 1 Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.
Read the detailed description
This is an open-label clinical trial in which a total of 50 participants will receive three injections of either CssBA alone, dmLT alone or CssBA + dmLT. The vaccine will be administered via IM injection to alternating deltoid regions on days 1, 22, and 43. Each participant will receive the same dose at each vaccination dependent upon group assignment. Group A is considered a pilot group in which all 3 doses will be administered and participants monitored for safety 7 days after the third vaccination, prior to the enrollment of participants in Group B.
- Conditions
- Diarrhea
- Being tested
- CssBA, dmLT
- Keywords
- ETEC, Escherichia coli, enteric
- Medical subject headings
- Diarrhea, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CssBABiological
Also called spd_dsc16Bntd14CssBAB7A[His]₆
Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B
dmLTBiological
Escherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211
| Study group | Role | What they receive |
|---|---|---|
| Group A1: CssBA 5 ug | Experimental | Participants received an intramuscular injection of 5 ug CssBA on days 1, 22, and 43. Receives: Biological: CssBA |
| Group A2: DmLT 100 ng | Experimental | Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43. Receives: Biological: dmLT |
| Group B: CssBA 5 ug + DmLT 100 ng | Experimental | Participants received an intramuscular injection of 5 ug CssBA + 100 ng dmLT on days 1, 22, and 43. Receives: Biological: CssBA; Biological: dmLT |
| Group C: CssBA 5 ug + DmLT 500 ng | Experimental | Participants received an intramuscular injection of 5 ug CssBA + 500 ng dmLT on days 1, 22, and 43. Receives: Biological: CssBA; Biological: dmLT |
| Group D: CssBA 15 ug + DmLT 500 ng | Experimental | Participants received an intramuscular injection of 15 ug CssBA + 500 ng dmLT on days 1, 22, and 43. Receives: Biological: CssBA; Biological: dmLT |
| Group E: CssBA 45 ug + DmLT 500 ng | Experimental | Participants received an intramuscular injection of 45 ug CssBA + 500 ng dmLT on days 1, 22, and 43. Receives: Biological: CssBA; Biological: dmLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Adverse Events
Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting.
Adverse events were assessed for severity by the investigator according to the following:
Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort
Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort
Severe (Grade 3): Unable to perform routine activities, significant level of discomfort
Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
Measured: From first vaccination to 28 days after the third vaccination, 71 days.
Number of Participants With Unsolicited Adverse Events
Adverse events were assessed for severity by the investigator according to the following:
Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort
Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort
Severe (Grade 3): Unable to perform routine activities Significant level of discomfort
Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
Measured: From first vaccination to 28 days after the third vaccination, 71 days.
Secondary outcomes (12)
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Measured: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Measured: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against CS6 at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA.
A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Measured: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against labile toxin at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA.
A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Measured: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Measured: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Measured: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Measured: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Measured: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA.
Measured: Days 1, 8, 29 and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA.
Measured: Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA.
Measured: Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA.
Measured: Days 1, 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 posted19 Jan 2018
- Study start16 Jan 2018
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Medical Research Center, Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Tida K Lee, MD, PhD, Principal investigator, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404674
- Sponsor's protocol ID
- VAC-050
- Status last verified
- Nov 2020
- First submitted
- 10 Jan 2018
- Last updated
- 6 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
- ClinicalTrials.gov ID
- NCT03404674
- Acronym / sponsor ID
- VAC-050
- Conditions
- Diarrhea
- Keywords
- ETEC, Escherichia coli, enteric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Naval Medical Research Center, Walter Reed Army Institute of Research (WRAIR)
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Posted 6 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.
Detailed description
This is an open-label clinical trial in which a total of 50 participants will receive three injections of either CssBA alone, dmLT alone or CssBA + dmLT. The vaccine will be administered via IM injection to alternating deltoid regions on days 1, 22, and 43. Each participant will receive the same dose at each vaccination dependent upon group assignment. Group A is considered a pilot group in which all 3 doses will be administered and participants monitored for safety 7 days after the third vaccination, prior to the enrollment of participants in Group B.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A1: CssBA 5 ug | Experimental | Biological: CssBAParticipants received an intramuscular injection of 5 ug CssBA on days 1, 22, and 43. |
| Group A2: DmLT 100 ng | Experimental | Biological: dmLTParticipants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43. |
| Group B: CssBA 5 ug + DmLT 100 ng | Experimental | Biological: CssBA, Biological: dmLTParticipants received an intramuscular injection of 5 ug CssBA + 100 ng dmLT on days 1, 22, and 43. |
| Group C: CssBA 5 ug + DmLT 500 ng | Experimental | Biological: CssBA, Biological: dmLTParticipants received an intramuscular injection of 5 ug CssBA + 500 ng dmLT on days 1, 22, and 43. |
| Group D: CssBA 15 ug + DmLT 500 ng | Experimental | Biological: CssBA, Biological: dmLTParticipants received an intramuscular injection of 15 ug CssBA + 500 ng dmLT on days 1, 22, and 43. |
| Group E: CssBA 45 ug + DmLT 500 ng | Experimental | Biological: CssBA, Biological: dmLTParticipants received an intramuscular injection of 45 ug CssBA + 500 ng dmLT on days 1, 22, and 43. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment.
- Completion and review of comprehension test (achieved > 70% accuracy).
- Signed informed consent document.
- Available for the required follow-up period and scheduled clinic visits.
- Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following last vaccination.
Key exclusion criteria (18 listed)
- Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other condition that might place the subject at increased risk of adverse events) - study clinicians, in consultation with the 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.
- Clinically significant abnormalities on physical examination.
- Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or 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 three (3) months beyond the last received dose and currently nursing women.
- Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last 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 |
|---|---|---|
| CssBAAlso: spd_dsc16Bntd14CssBAB7A[His]₆Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B | Biological | Group A1: CssBA 5 ug, Group B: CssBA 5 ug + DmLT 100 ng, Group C: CssBA 5 ug + DmLT 500 ng, Group D: CssBA 15 ug + DmLT 500 ng, Group E: CssBA 45 ug + DmLT 500 ng |
| dmLTEscherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211 | Biological | Group A2: DmLT 100 ng, Group B: CssBA 5 ug + DmLT 100 ng, Group C: CssBA 5 ug + DmLT 500 ng, Group D: CssBA 15 ug + DmLT 500 ng, Group E: CssBA 45 ug + DmLT 500 ng |
Primary outcome
Number of Participants With Solicited Adverse Events
Time frame: From first vaccination to 28 days after the third vaccination, 71 days.
Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting. Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort Severe (Grade 3): Unable to perform routine activities, significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
Number of Participants With Unsolicited Adverse Events
Time frame: From first vaccination to 28 days after the third vaccination, 71 days.
Adverse events were assessed for severity by the investigator according to the following: Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort Severe (Grade 3): Unable to perform routine activities Significant level of discomfort Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
12 secondary outcomes
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
Time frame: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
Time frame: Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
Time frame: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
Time frame: Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Time frame: Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Time frame: Days 1, 8, 29 and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Time frame: Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Time frame: Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Time frame: Days 1, 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 6 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tida K Lee, MD, PhD principal investigator
Naval Medical Research Center
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 CssBA and dmLT 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 18 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 6 Jan 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. 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 6 Jan 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?
Number of Participants With Solicited Adverse Events (time frame: From first vaccination to 28 days after the third vaccination, 71 days.). The study lists 2 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 6 Jan 2021.