Nipah Virus InfectionPhase 1NCT04199169
Safety and Immunogenicity of a Nipah Virus Vaccine
A Phase 1 study testing HeV-sG-V in people with Nipah Virus Infection, run by Auro Vaccines LLC at 1 site in United States.
Trial summary
A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Nipah Virus Infection
- What is being tested?
- HeV-sG-V
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 6 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant female 18 through 49 years of age at the time of consenting and IP administration.
- Provides written informed consent prior to performance of any study-specific procedure.
- Resides in study site area and is able and willing to adhere to all protocol visits and procedures, including plasmapheresis.
- Healthy, as defined by absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, safety laboratory test results, and clinical assessment of the investigator.
- Female subjects of childbearing potential* must have practiced adequate contraception** for 28 days prior to administration of IP and agree to continue adequate contraception until completion of the plasmapheresis session or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
- Females can be considered not of childbearing potential if they are with current bilateral tubal ligation or occlusion, or post-hysterectomy, or post-bilateral ovariectomy, or post-menopause.
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- Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example:
- Abstinence from penile-vaginal intercourse
- Combined estrogen and progesterone oral contraceptives
- Injectable progestogen
- Implants of etonogestrel or levonorgestrel
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device or intrauterine system
- Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and/or progesterone alone oral contraceptive
- Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration.
Who cannot join
- Previous immunization with an investigational Nipah or Hendra virus vaccine.
- History of disease known to be caused by Nipah or Hendra virus.
- Travel to Kerala state, India within the previous three years or planned travel to Kerala sate or Bangladesh during the study period.
- Known hypersensitivity to any component of the IPs.
- Known hypersensitivity to citrate or ethylene oxide.
- History of hypersensitivity to any vaccine.
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- Administration of any vaccine other than the IP within 28 days prior to IP administration or planned administration through completion of plasmapheresis or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
- Administration of any investigational or non-registered drug within 90 days prior to IP administration or planned administration during the study period.
- Administration of immunoglobulin or any blood product within 90 days prior to IP administration or planned administration during the study period.
- Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within 180 days prior to IP administration or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; topical steroids including inhaled and intranasal steroids are not exclusionary).
- Acute illness or fever (body temperature measured orally ≥ 38°C or 100.4°F) at the time of IP administration (once acute illness/fever is resolved, if appropriate, as per investigator assessment, subject may be screened again).
- History of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to immunodeficiency, autoimmunity, bleeding or psychiatric disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).
- Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
- History of chronic alcohol consumption or drug abuse that in the opinion of the investigator might compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
- Blood donation or planned blood donation within 28 days prior to IP administration through 28 days after completion of the plasmapheresis session or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
- Pregnant.
- Body weight < 50 kg.
- Body Mass Index (BMI) ≥ 40 kg/m2.
- Infection with human immunodeficiency virus 1 or 2.
- Infection with hepatitis B or hepatitis C virus.
- The following clinical safety laboratory test results will be considered exclusionary, regardless of assessment of clinical significance:
- Hemoglobin (Male) < 13.3 g/dL Hemoglobin (Female) < 12.8 g/dL Hematocrit > 55% Neutrophil count < 1,500 cells/mm3 Eosinophil count > 600 cells/mm3 Platelet count < 130,000 cells/mm3 Creatinine > 1.4 mg/dL ALT > 1.1 x upper limit of the normal range (ULN) [ per the site clinical laboratory's reference ranges]
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
About this study
Official title: A Phase 1 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of a Nipah Vaccine, HeV-sG-V (Hendra Virus Soluble Glycoprotein Vaccine), in Healthy Adults
A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.
Read the detailed description
This is a randomized, placebo-controlled, observer-blind, phase 1 trial in healthy male and non-pregnant female adults 18 through 49 years of age designed to assess the safety and immunogenicity of three ascending doses of HeV-sG-V. Different dosing regimens and number of doses will also be explored.
The study plans to accrue eligible subjects into three successive dosage escalation cohorts consisting of 12, 72, and 108 subjects, respectively (total of 192 subjects). The three HeV-sG-V dosages will be 10 mcg, 30 mcg, and 100 mcg.
In the first cohort, subjects will receive two doses of the investigational product (IP) at 28-day intervals. Subjects will be randomized in a 5:1 ratio, with 10 receiving two doses of HeV-sG-V (10 mcg dosage) and two subjects will receive placebo.
In the second cohort, subjects will be randomized in a 5:5:2 ratio with 30 receiving a 30 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), 30 receiving a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8), while 12 subjects will receive placebo at each of the same visits.
The third cohort will be randomized in a 5:5:5:3 ratio so that 30 subjects are assigned to each of three different regimens consisting of a 100 mcg dosage of HeV-sG-V and placebo administered as three doses, HeV-sG-V on Visit 1 (Day 1) with placebo on Visits 2 and 3 (Days 8 and 29), or HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), or HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8), while the remaining 18 will receive a dose of placebo at each of the same visits.
- Conditions
- Nipah Virus Infection
- Being tested
- HeV-sG-V, Normal Saline Placebo
- Keywords
- Nipah, Vaccine, Henipah
- Medical subject headings
- Henipavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeV-sG-VBiological
Also called Nipah Vaccine, HenipaVaxTM
A Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline.
Normal Saline PlaceboBiological
Also called Placebo
0.9% Saline
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Group 1 | Experimental | Ten subjects in the first cohort will receive a 10 mcg dose of HeV-sG-V on Visits 1 and 6.5 (Days 1 and 169*).
*Second dose was administered at 6 months due to study pause from local COVID-19 shutdown. Receives: Biological: HeV-sG-V |
| Cohort 1, Group 2 | Placebo comparator | Two subjects in the first cohort will receive a dose of the placebo on Visits 1 and 6.5 (Days 1 and 169*).
*Second dose was administered at 6 months due to study pause from local COVID-19 shutdown. Receives: Biological: Normal Saline Placebo |
| Cohort 2, Group 3 | Experimental | Thirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29). Receives: Biological: HeV-sG-V; Biological: Normal Saline Placebo |
| Cohort 2, Group 4 | Experimental | Thirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8) Receives: Biological: HeV-sG-V; Biological: Normal Saline Placebo |
| Cohort 2, Group 5 | Placebo comparator | Twelve subjects in the second cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29). Receives: Biological: Normal Saline Placebo |
| Cohort 3, Group 6 | Experimental | Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visit 1 (Day 1) and placebo on Visits 2 and 3 (Days 8 and 29). Receives: Biological: HeV-sG-V; Biological: Normal Saline Placebo |
| Cohort 3, Group 7 | Experimental | Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) and placebo on Visit 3 (Day 29). Receives: Biological: HeV-sG-V; Biological: Normal Saline Placebo |
| Cohort 3, Group 8 | Experimental | Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) and placebo on Visit 2 (Day 8). Receives: Biological: HeV-sG-V; Biological: Normal Saline Placebo |
| Cohort 3, Group 9 | Placebo comparator | Eighteen subjects in the third cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29). Receives: Biological: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of local and systemic solicited adverse events
e.g., headache, fatigue, fever, etc.that are specifically asked about by the doctor
Measured: for 1 week after each innoculation
Incidence of clinically significant abnormalities in clinical safety laboratory test results reported as unsolicited AEs.
e.g. hemoglobin, white blood cell count, neutrophil count, creatinine, etc.
Measured: for 1 week after each innoculation
Incidence of unsolicited adverse events
Adverse events that are reported to the doctor beyond what is asked about by the doctor. An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Measured: for 1 month after the last vaccination
Incidence of medically attended adverse events and serious adverse events
A reaction to the vaccine that require medical attention. Serious adverse events can include death, hospitalization, disability, and death.
Measured: through Day 197
Secondary outcomes (2)
Determine number of doses and timing of doses required
Quantitative measurement of antibody response to virus
Measured: through day 57
Determine number of doses and timing of doses required
Qualitative measurement of antibody response to virus
Measured: through day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start18 Feb 2020
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipah Virus InfectionStudies 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
- Model description
- Ascending dose study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auro Vaccines LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH, Coalition for Epidemic Preparedness Innovations, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Robert W. Frenck Jr., MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199169
- Sponsor's protocol ID
- CVIA 077; HeV-sG-01
- Status last verified
- Nov 2022
- First submitted
- 11 Dec 2019
- Last updated
- 17 Nov 2022
- Results posted
- No
- 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 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of a Nipah Vaccine, HeV-sG-V (Hendra Virus Soluble Glycoprotein Vaccine), in Healthy Adults
- ClinicalTrials.gov ID
- NCT04199169
- Acronym / sponsor ID
- CVIA 077; HeV-sG-01
- Conditions
- Nipah Virus Infection
- Keywords
- Nipah, Vaccine, Henipah
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Auro Vaccines LLCIndustry (pharma, biotech, devices)
- Collaborators
- PATH, Coalition for Epidemic Preparedness Innovations, Children's Hospital Medical Center, Cincinnati
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.
Detailed description
This is a randomized, placebo-controlled, observer-blind, phase 1 trial in healthy male and non-pregnant female adults 18 through 49 years of age designed to assess the safety and immunogenicity of three ascending doses of HeV-sG-V. Different dosing regimens and number of doses will also be explored.
The study plans to accrue eligible subjects into three successive dosage escalation cohorts consisting of 12, 72, and 108 subjects, respectively (total of 192 subjects). The three HeV-sG-V dosages will be 10 mcg, 30 mcg, and 100 mcg.
In the first cohort, subjects will receive two doses of the investigational product (IP) at 28-day intervals. Subjects will be randomized in a 5:1 ratio, with 10 receiving two doses of HeV-sG-V (10 mcg dosage) and two subjects will receive placebo.
In the second cohort, subjects will be randomized in a 5:5:2 ratio with 30 receiving a 30 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), 30 receiving a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8), while 12 subjects will receive placebo at each of the same visits.
The third cohort will be randomized in a 5:5:5:3 ratio so that 30 subjects are assigned to each of three different regimens consisting of a 100 mcg dosage of HeV-sG-V and placebo administered as three doses, HeV-sG-V on Visit 1 (Day 1) with placebo on Visits 2 and 3 (Days 8 and 29), or HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), or HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8), while the remaining 18 will receive a dose of placebo at each of the same visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
- Model description
- Ascending dose study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Group 1 | Experimental | Biological: HeV-sG-VTen subjects in the first cohort will receive a 10 mcg dose of HeV-sG-V on Visits 1 and 6.5 (Days 1 and 169*). *Second dose was administered at 6 months due to study pause from local COVID-19 shutdown. |
| Cohort 1, Group 2 | Placebo comparator | Biological: Normal Saline PlaceboTwo subjects in the first cohort will receive a dose of the placebo on Visits 1 and 6.5 (Days 1 and 169*). *Second dose was administered at 6 months due to study pause from local COVID-19 shutdown. |
| Cohort 2, Group 3 | Experimental | Biological: HeV-sG-V, Biological: Normal Saline PlaceboThirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29). |
| Cohort 2, Group 4 | Experimental | Biological: HeV-sG-V, Biological: Normal Saline PlaceboThirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8) |
| Cohort 2, Group 5 | Placebo comparator | Biological: Normal Saline PlaceboTwelve subjects in the second cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29). |
| Cohort 3, Group 6 | Experimental | Biological: HeV-sG-V, Biological: Normal Saline PlaceboThirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visit 1 (Day 1) and placebo on Visits 2 and 3 (Days 8 and 29). |
| Cohort 3, Group 7 | Experimental | Biological: HeV-sG-V, Biological: Normal Saline PlaceboThirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) and placebo on Visit 3 (Day 29). |
| Cohort 3, Group 8 | Experimental | Biological: HeV-sG-V, Biological: Normal Saline PlaceboThirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) and placebo on Visit 2 (Day 8). |
| Cohort 3, Group 9 | Placebo comparator | Biological: Normal Saline PlaceboEighteen subjects in the third cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male or non-pregnant female 18 through 49 years of age at the time of consenting and IP administration.
- Provides written informed consent prior to performance of any study-specific procedure.
- Resides in study site area and is able and willing to adhere to all protocol visits and procedures, including plasmapheresis.
- Healthy, as defined by absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, safety laboratory test results, and clinical assessment of the investigator.
- Female subjects of childbearing potential* must have practiced adequate contraception** for 28 days prior to administration of IP and agree to continue adequate contraception until completion of the plasmapheresis session or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
Key exclusion criteria (22 listed)
- Previous immunization with an investigational Nipah or Hendra virus vaccine.
- History of disease known to be caused by Nipah or Hendra virus.
- Travel to Kerala state, India within the previous three years or planned travel to Kerala sate or Bangladesh during the study period.
- Known hypersensitivity to any component of the IPs.
- Known hypersensitivity to citrate or ethylene oxide.
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 |
|---|---|---|
| HeV-sG-VAlso: Nipah Vaccine, HenipaVaxTMA Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline. | Biological | Cohort 1, Group 1, Cohort 2, Group 3, Cohort 2, Group 4, Cohort 3, Group 6, Cohort 3, Group 7, Cohort 3, Group 8 |
| Normal Saline PlaceboAlso: Placebo0.9% Saline | Biological | Cohort 1, Group 2, Cohort 2, Group 3, Cohort 2, Group 4, Cohort 2, Group 5, Cohort 3, Group 6, Cohort 3, Group 7, Cohort 3, Group 8, Cohort 3, Group 9 |
Primary outcome
Rate of local and systemic solicited adverse events
Time frame: for 1 week after each innoculation
e.g., headache, fatigue, fever, etc.that are specifically asked about by the doctor
Incidence of clinically significant abnormalities in clinical safety laboratory test results reported as unsolicited AEs.
Time frame: for 1 week after each innoculation
e.g. hemoglobin, white blood cell count, neutrophil count, creatinine, etc.
Incidence of unsolicited adverse events
Time frame: for 1 month after the last vaccination
Adverse events that are reported to the doctor beyond what is asked about by the doctor. An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Incidence of medically attended adverse events and serious adverse events
Time frame: through Day 197
A reaction to the vaccine that require medical attention. Serious adverse events can include death, hospitalization, disability, and death.
2 secondary outcomes
Determine number of doses and timing of doses required
Time frame: through day 57
Determine number of doses and timing of doses required
Time frame: through day 57
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 17 Nov 2022.
- 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.
Robert W. Frenck Jr., MD principal investigator
Children's Hospital Medical Center, Cincinnati
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 HeV-sG-V in people with Nipah Virus Infection, run by Auro Vaccines LLC 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 16 inclusion and 22 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 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of local and systemic solicited adverse events (time frame: for 1 week after each innoculation). The study lists 4 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 17 Nov 2022.