Hookworm InfectionPhase 1NCT02476773
Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel in Brazilian Adults
A Phase 1 study testing Na-GST-1/Alhydrogel plus GLA-AF, Na-APR-1 (M74)/Alhydrogel and Na-APR-1 (M74)/Alhydrogel plus GLA-AF in people with Hookworm Infection and Hookworm Disease, run by Baylor College of Medicine at 1 site in Brazil.
Trial summary
Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hookworm Infection, Hookworm Disease
- What is being tested?
- Na-GST-1/Alhydrogel plus GLA-AF, Na-APR-1 (M74)/Alhydrogel and Na-APR-1 (M74)/Alhydrogel plus GLA-AF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or non-pregnant females between 18 and 45 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of individual subject study participation (16 months).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Who cannot join
- Pregnancy as determined by a positive urine hCG (if female).
- Subject unwilling to use reliable contraception (as described in Section 2.3.1) from 30 days prior to the first immunization and up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
- Currently lactating and breast-feeding (if female).
- Inability to correctly answer all questions on the informed consent comprehension questionnaire.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies (a history of essential hypertension that is well controlled by medication will not be considered exclusionary.)
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).
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- Known or suspected immunodeficiency.
- Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25-times the upper reference limit).
- Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than trace protein or blood on urine dipstick testing with the exception of greater than trace blood detected in females during menses).
- Laboratory evidence of hematologic disease (absolute leukocyte count <3200/mm3; absolute leukocyte count >10.8 x 103/mm3; hemoglobin <11.4 g/dl [females] or <12.1 g/dl [males]; or, platelet count <130,000/mm3).
- Serum glucose (random) greater than 1.2-times the upper reference limit.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- Participation in another investigational vaccine or drug trial within 30 days of starting this study.
- Previous receipt of the Na-GST-1/Alhydrogel® hookworm vaccine.
- Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma as defined by the need for daily use of inhalers or emergency clinic visit or hospitalization within the last 6 months.
- Positive test for hepatitis B surface antigen (HBsAg).
- Positive confirmatory test for HIV infection.
- Positive confirmatory test for hepatitis C virus (HCV) infection.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of the volunteer's expected first vaccination in this study or planned use up to one month following the last vaccination.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to the volunteer's expected first vaccination in the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- Anti-Na-GST-1 IgE antibody level above 0.35 kUA/L by the ImmunoCAP method.
- Anti-Na-APR-1 IgE antibody level above ELISA reactivity threshold.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel® in Brazilian Adults
Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian adults living in an area of endemic hookworm infection.
Read the detailed description
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm exposed adults living in the area of Americaninhas, Minas Gerais, Brazil. Subjects will receive three doses of the assigned vaccine delivered intramuscularly on approximately Days 0, 56, and 112.
Safety will be measured from the time of each study vaccination (Day 0) through 14 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events.
Unsolicited non-serious adverse events (AEs) will be collected from the time of the first study vaccination through approximately 1 month after each study vaccination. New-onset chronic medical conditions and Serious Adverse Events (SAEs) will be collected from the time of the first study vaccination through approximately 9 months after the third study vaccination (final visit). Clinical laboratory evaluations for safety will be performed on venous blood collected approximately 14 days after each vaccination.
Immunogenicity testing will include IgG antibody responses to each vaccine antigen, by an indirect enzyme-linked immunosorbent assay (ELISA) and also by ImmunoCAP, on serum obtained prior to each study vaccination and at time points after each vaccination; antibody affinity by Surface Plasmon Resonance; functional activity of vaccine-induced antibodies via in vitro enzyme neutralization assays; and, antigen-specific memory B cell responses.
Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence.
60 subjects will be enrolled into 6 groups of 10.
- Conditions
- Hookworm Infection, Hookworm Disease
- Being tested
- Na-GST-1/Alhydrogel plus GLA-AF, Na-APR-1 (M74)/Alhydrogel, Na-APR-1 (M74)/Alhydrogel plus GLA-AF, Sterile Saline Placebo
- Keywords
- Hookworm Vaccine, Na-APR-1 (M74)/Alhydrogel® Hookworm Vaccine, Na-GST-1/Alhydrogel® Hookworm Vaccine
- Medical subject headings
- Hookworm Infections, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Na-GST-1/Alhydrogel plus GLA-AFBiological
Na-APR-1 (M74)/AlhydrogelBiological
Na-APR-1 (M74)/Alhydrogel plus GLA-AFBiological
Sterile Saline PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | * 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel with Sterile Saline Placebo administered to the alternate arm.
* 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. Receives: Biological: Na-GST-1/Alhydrogel plus GLA-AF; Biological: Na-APR-1 (M74)/Alhydrogel; Biological: Sterile Saline Placebo |
| Group 2 | Experimental | * 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm.
* 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. Receives: Biological: Na-GST-1/Alhydrogel plus GLA-AF; Biological: Na-APR-1 (M74)/Alhydrogel plus GLA-AF; Biological: Sterile Saline Placebo |
| Group 3 | Experimental | * 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel, with Sterile Saline Placebo administered to the alternate arm.
* 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. Receives: Biological: Na-GST-1/Alhydrogel plus GLA-AF; Biological: Na-APR-1 (M74)/Alhydrogel; Biological: Sterile Saline Placebo |
| Group 4 | Experimental | * 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm.
* 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. Receives: Biological: Na-GST-1/Alhydrogel plus GLA-AF; Biological: Na-APR-1 (M74)/Alhydrogel plus GLA-AF; Biological: Sterile Saline Placebo |
| Group 5 | Experimental | * 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel, with Sterile Saline Placebo administered to the alternate arm.
* 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. Receives: Biological: Na-GST-1/Alhydrogel plus GLA-AF; Biological: Na-APR-1 (M74)/Alhydrogel; Biological: Sterile Saline Placebo |
| Group 6 | Experimental | * 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm.
* 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. Receives: Biological: Na-GST-1/Alhydrogel plus GLA-AF; Biological: Na-APR-1 (M74)/Alhydrogel plus GLA-AF; Biological: Sterile Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited injection site and systemic reactogenicity, graded by severity, on the day of each study vaccination through 14 days after each study vaccination.
Measured: 14 days post-vaccination
Frequency of study vaccine-related serious adverse events from the time of the first study vaccination through approximately 9 months after the last study vaccination.
Measured: Day 380
Frequency of clinical safety laboratory adverse events.
Measured: Day 380
Frequency of unsolicited adverse events, graded by severity, from the time of each study vaccination through approximately 1 month after each study vaccination.
Measured: 30 days post-vaccination
Frequency of new-onset chronic medical conditions through approximately 9 months after the third study vaccination.
Measured: Day 380
Frequency of Adverse Events of Special Interest through approximately 9 months after the third study vaccination.
Measured: Day 380
Secondary outcomes (1)
The IgG level by an indirect enzyme-linked immunosorbent assay (ELISA) on approximately Day 126.
Measured: Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hookworm InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto René Rachou (IRR), Johns Hopkins University, University of California, San Francisco, George Washington University
- Responsible party
- Principal investigator, Maria Elena Bottazzi PhD, Baylor College of Medicine
- Investigators
- David Diemert, MD, Principal investigator, George Washington UniversityRodrigo Correa-Oliveira, PhD, Study director, Instituto René Rachou (IRR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476773
- Sponsor's protocol ID
- SVI-DBL-01
- Status last verified
- Nov 2019
- First submitted
- 17 Jun 2015
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel® in Brazilian Adults
- ClinicalTrials.gov ID
- NCT02476773
- Acronym / sponsor ID
- SVI-DBL-01
- Conditions
- Hookworm Infection, Hookworm Disease
- Keywords
- Hookworm Vaccine, Na-APR-1 (M74)/Alhydrogel® Hookworm Vaccine, Na-GST-1/Alhydrogel® Hookworm Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Instituto René Rachou (IRR), Johns Hopkins University, University of California, San Francisco, George Washington University
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Jun 2015 (estimated)
- 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.
Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian adults living in an area of endemic hookworm infection.
Detailed description
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm exposed adults living in the area of Americaninhas, Minas Gerais, Brazil. Subjects will receive three doses of the assigned vaccine delivered intramuscularly on approximately Days 0, 56, and 112.
Safety will be measured from the time of each study vaccination (Day 0) through 14 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events.
Unsolicited non-serious adverse events (AEs) will be collected from the time of the first study vaccination through approximately 1 month after each study vaccination. New-onset chronic medical conditions and Serious Adverse Events (SAEs) will be collected from the time of the first study vaccination through approximately 9 months after the third study vaccination (final visit). Clinical laboratory evaluations for safety will be performed on venous blood collected approximately 14 days after each vaccination.
Immunogenicity testing will include IgG antibody responses to each vaccine antigen, by an indirect enzyme-linked immunosorbent assay (ELISA) and also by ImmunoCAP, on serum obtained prior to each study vaccination and at time points after each vaccination; antibody affinity by Surface Plasmon Resonance; functional activity of vaccine-induced antibodies via in vitro enzyme neutralization assays; and, antigen-specific memory B cell responses.
Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence.
60 subjects will be enrolled into 6 groups of 10.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Na-GST-1/Alhydrogel plus GLA-AF, Biological: Na-APR-1 (M74)/Alhydrogel, Biological: Sterile Saline Placebo* 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. |
| Group 2 | Experimental | Biological: Na-GST-1/Alhydrogel plus GLA-AF, Biological: Na-APR-1 (M74)/Alhydrogel plus GLA-AF, Biological: Sterile Saline Placebo* 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. |
| Group 3 | Experimental | Biological: Na-GST-1/Alhydrogel plus GLA-AF, Biological: Na-APR-1 (M74)/Alhydrogel, Biological: Sterile Saline Placebo* 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. |
| Group 4 | Experimental | Biological: Na-GST-1/Alhydrogel plus GLA-AF, Biological: Na-APR-1 (M74)/Alhydrogel plus GLA-AF, Biological: Sterile Saline Placebo* 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. |
| Group 5 | Experimental | Biological: Na-GST-1/Alhydrogel plus GLA-AF, Biological: Na-APR-1 (M74)/Alhydrogel, Biological: Sterile Saline Placebo* 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. |
| Group 6 | Experimental | Biological: Na-GST-1/Alhydrogel plus GLA-AF, Biological: Na-APR-1 (M74)/Alhydrogel plus GLA-AF, Biological: Sterile Saline Placebo* 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or non-pregnant females between 18 and 45 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of individual subject study participation (16 months).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (26 listed)
- Pregnancy as determined by a positive urine hCG (if female).
- Subject unwilling to use reliable contraception (as described in Section 2.3.1) from 30 days prior to the first immunization and up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
- Currently lactating and breast-feeding (if female).
- Inability to correctly answer all questions on the informed consent comprehension questionnaire.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies (a history of essential hypertension that is well controlled by medication will not be considered exclusionary.)
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 |
|---|---|---|
| Na-GST-1/Alhydrogel plus GLA-AF | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Na-APR-1 (M74)/Alhydrogel | Biological | Group 1, Group 3, Group 5 |
| Na-APR-1 (M74)/Alhydrogel plus GLA-AF | Biological | Group 2, Group 4, Group 6 |
| Sterile Saline Placebo | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Frequency of solicited injection site and systemic reactogenicity, graded by severity, on the day of each study vaccination through 14 days after each study vaccination.
Time frame: 14 days post-vaccination
Frequency of study vaccine-related serious adverse events from the time of the first study vaccination through approximately 9 months after the last study vaccination.
Time frame: Day 380
Frequency of clinical safety laboratory adverse events.
Time frame: Day 380
Frequency of unsolicited adverse events, graded by severity, from the time of each study vaccination through approximately 1 month after each study vaccination.
Time frame: 30 days post-vaccination
Frequency of new-onset chronic medical conditions through approximately 9 months after the third study vaccination.
Time frame: Day 380
Frequency of Adverse Events of Special Interest through approximately 9 months after the third study vaccination.
Time frame: Day 380
1 secondary outcome
The IgG level by an indirect enzyme-linked immunosorbent assay (ELISA) on approximately Day 126.
Time frame: Day 126
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 3 Dec 2019.
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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.
David Diemert, MD principal investigator
George Washington University
Rodrigo Correa-Oliveira, PhD study director
Instituto René Rachou (IRR)
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 Na-GST-1/Alhydrogel plus GLA-AF, Na-APR-1 (M74)/Alhydrogel and Na-APR-1 (M74)/Alhydrogel plus GLA-AF in people with Hookworm Infection and Hookworm Disease, run by Baylor College of Medicine at 1 site in Brazil.
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 4 inclusion and 26 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
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?
Frequency of solicited injection site and systemic reactogenicity, graded by severity, on the day of each study vaccination through 14 days after each study vaccination. (time frame: 14 days post-vaccination). The study lists 6 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 3 Dec 2019.