Zika VirusPhase 1NCT03611946
Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
A Phase 1 study testing Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) and Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml) in people with Zika Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus
- What is being tested?
- Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) and Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2018to 18 Mar 2022
- 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
- Adult male or female between 18 and 50 years of age, inclusive.
- Good general health as determined by physical examination, laboratory screening, and review of medical history.
- Available for the duration of the study, which is approximately 26 weeks.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Females only: Female subjects of childbearing potential, with the exception noted below, should be willing to use effective contraception and have no plans to undergo IVF (in vitro fertilization) during participation in the trial. Reliable methods of contraception include hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, and intrauterine device. Women must have been on an effective method of birth control for at least 30 days prior to enrollment. All female subjects will be considered as having childbearing potential, except for women who exclusively have sex with women, those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or are considered to be post-menopausal, as documented by at least 1 year since last menstrual period with a follicle-stimulating hormone (FSH) level in the menopausal range or at least 24 consecutive months of amenorrhea. Transgender men who have internal female organs and have sex with men will be considered of childbearing potential and should be willing to use effective contraception during the trial. Exception: Females who have sex with females (exclusively) and have no intention of conceiving a child during the study and women whose partners have had a vasectomy will not be required to use contraception, however they will be required to use female condoms and/or dental dams for at least 1 month following vaccination. For women whose sexual partner has had a vasectomy, the vasectomy must have been performed 30 days or more prior to enrollment.
- Males only: Males of reproductive potential should be willing to use barrier contraception for the first 3 months following vaccination* and agree to not donate sperm for the duration of the study.
- Based on CDC guidance for men returning from ZIKV-endemic areas
Who cannot join
- Females only: Currently pregnant, as determined by positive β-human choriogonadotropin (HCG) test, or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol.
- Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.
- Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history.
Show all 23Show fewer
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma (emergency room visit or hospitalization within the last 6 months).
- HIV infection, as indicated by screening and confirmatory assays.
- Hepatitis C virus (HCV) infection, as indicated by screening and confirmatory assays.
- Hepatitis B virus (HBV) infection, as indicated by hepatitis B surface antigen (HBsAg) screening.
- Any known immunodeficiency syndrome.
- History of Guillain-Barrè syndrome.
- Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
- Use of immunosuppressive corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following inoculation. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg of a prednisone equivalent per day for greater than or equal to 14 days.
- Receipt of a live vaccine within 28 days or a killed vaccine within 14 days prior to inoculation, or anticipated receipt of any vaccine during the 28 days following inoculation with the exception of COVID-19 vaccines either licensed or under EUA which can be given at any time, however all effort will be made to avoid giving COVID-19 vaccines within the above windows.
- Asplenia.
- Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following inoculation.
- History or serologic evidence of previous ZIKV or other flavivirus infection (e.g., dengue, yellow fever virus, St. Louis Encephalitis virus, or West Nile virus).
- Previous receipt of a flavivirus vaccine (licensed or experimental).
- Receipt or anticipated receipt of any investigational agent in the 28 days before or after inoculation with the exception of COVID-19 vaccines, either licensed or authorized under EUA.
- Refusal to allow specimen storage for future research.
- Is in isolation or quarantine for SARS-CoV-2 infection or exposure and cannot complete screening or enrollment for this reason.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, 21202
University of Vermont Medical Center (UVMMC), Clinical Research Center
Burlington, Vermont, 05401
About this study
Official title: Phase I Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.
Read the detailed description
Fifty-six healthy volunteers will be enrolled over 2 sequential cohorts:
Cohort 1: n=28, volunteers will be randomly assigned to a single dose of either vaccine (10^3 PFU, n=20) or placebo (n=8). Cohort 1 will be enrolled and evaluated first. If the vaccine is not found to induce seroconversion to ZIKV in > 80% of subjects inoculated with 10-^3 PFU of the vaccine, a second cohort of volunteers will be enrolled and will be inoculated with 10^4 PFU of vaccine (or placebo).
Cohort 2: n=28, volunteers will be randomly assigned to a single dose of either vaccine (10^4 PFU, n=20) or placebo (n=8).
All volunteers will be followed on an outpatient basis for 6 months following vaccination (13 follow up visits over 180 days). Follow up visits will include clinical assessments as well as sample collection for evaluation of viremia and seroconversion. Sample collection will include blood, urine, saliva, nasopharyngeal or midturbinate swab, vaginal secretion or semen collection on specified visit days throughout the 180 day follow up period.
- Conditions
- Zika Virus
- Being tested
- Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml), Single dose of placebo via subcutaneous injection (0.5ml)., Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)
- Keywords
- Zika virus, Vaccine
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)Biological
Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection
Single dose of placebo via subcutaneous injection (0.5ml).Biological
Administered by subcutaneous injection.
Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)Biological
Administered at a dose of using 10^4 plaque-forming units (PFUs) by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Vaccine | Experimental | Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml). Receives: Biological: Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) |
| Cohort 1 - Placebo | Placebo comparator | Single dose of placebo via subcutaneous injection (0.5ml). Receives: Biological: Single dose of placebo via subcutaneous injection (0.5ml). |
| Cohort 2 - Vaccine | Experimental | Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml). Receives: Biological: Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml) |
| Cohort 2 - Placebo | Placebo comparator | Single dose of placebo via subcutaneous injection (0.5ml). Receives: Biological: Single dose of placebo via subcutaneous injection (0.5ml). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local and General Adverse Events (AEs)
Evaluated using the Adverse Event Grading Table in the study protocol.
Measured: Solicited AE's assessed every visit through Day 28
To Determine the Immunogenicity of a Single Dose of rZIKV/D4Δ30-713
Determination of the serum plaque reduction neutralization titer 50% (PRNT50) to ZIKV for each subject at Study Day 28 post-inoculation. Seroconversion will be defined as achieving a PRNT50 ≥ 1:10 at any time-point through Study Day 28. The peak PRNT50 to ZIKV through Study Day 28 will be calculated for each subject included in the per-protocol an intent-to-treat analysis and the geometric mean peak titer for vaccinated subjects will be calculated.
Measured: Measured through Day 28
Secondary outcomes (5)
Viremia Induced by Vaccine (Number of Participants With Detectable Virus at Any Time Point)
Assess the frequency, quantity, and duration of viremia (virus in the blood) induced by a single dose of the rZIKV/D4Δ30-713 vaccine. The mean peak viremia, mean day of onset of viremia, and mean duration of viremia will be calculated. Viremia will be detected by culture (infectious virus) and by RT-PCR.
Measured: Measured through Day 90
Number of Vaccinees Infected With rZIKV/D4Δ30-713
Determine the number of vaccinees infected with rZIKV/D4Δ30-713. Infection is defined as recovery of infectious vaccine virus from the blood, serum or urine of a subject and/or by seroconversion to ZIKV. Seroconversion will be defined as achieving a PRNT50 ≥ 1:10 by Study Day 90 post-vaccination.
Measured: Measured through Day 180
Immunogenicity of rZIKV/D4Δ30-713 in Flavivirus-naïve Subjects
Evaluate the immunogenicity of rZIKV/D4Δ30-713 in flavivirus-naïve subjects as assessed by the PRNT50 to ZIKV, for each subject at Study Day 28, 56, and 90 post-administration of LA Zika vaccine. Expressed as geometric mean peak titer, reciprocal (median). Geometric mean titer was calculated at each time point for only those subjects with a titer of >= 10, reciprocal. Seroconversion was defined as a PRNT(50) of >= 10, reciprocal.
Measured: Measured through Day 180
Durability of Antibody Response
Determine the durability of antibody response 26 weeks after vaccination. Neutralizing antibody titers to ZIKV were measured at 0, 28, 56, 90, 150, and 180 days following vaccination, with the peak neutralizing antibody titer determined as the peak titer in the 90 days following vaccination for either dose cohort.
Measured: 26 Weeks post vaccination
Quantity and Duration of ZIKV Presence
Determine the quantity and duration of ZIKV presence as determined by:
- The peak virus titer in the blood and the duration of viremia induced by the LA Zika vaccine as determined by RT-PCR and virus culture
- The quantity and duration of possible Zika vaccine shedding in urine determined by RT-PCR and virus culture
- The quantity and duration of possible Zika vaccine shedding in vaginal secretions determined by RT-PCR and virus culture
- The quantity and duration of possible Zika vaccine shedding in semen determined by RT-PCR and virus culture
Measured: 90 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start6 Jul 2018
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
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 Zika VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anna Durbin, MD, Principal investigator, Center for Immunization Research, Johns Hopkins School of Public HealthKristen Pierce, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611946
- Sponsor's protocol ID
- CIR 318
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2018
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
- ClinicalTrials.gov ID
- NCT03611946
- Acronym / sponsor ID
- CIR 318
- Conditions
- Zika Virus
- Keywords
- Zika virus, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.
Detailed description
Fifty-six healthy volunteers will be enrolled over 2 sequential cohorts:
Cohort 1: n=28, volunteers will be randomly assigned to a single dose of either vaccine (10^3 PFU, n=20) or placebo (n=8). Cohort 1 will be enrolled and evaluated first. If the vaccine is not found to induce seroconversion to ZIKV in > 80% of subjects inoculated with 10-^3 PFU of the vaccine, a second cohort of volunteers will be enrolled and will be inoculated with 10^4 PFU of vaccine (or placebo).
Cohort 2: n=28, volunteers will be randomly assigned to a single dose of either vaccine (10^4 PFU, n=20) or placebo (n=8).
All volunteers will be followed on an outpatient basis for 6 months following vaccination (13 follow up visits over 180 days). Follow up visits will include clinical assessments as well as sample collection for evaluation of viremia and seroconversion. Sample collection will include blood, urine, saliva, nasopharyngeal or midturbinate swab, vaginal secretion or semen collection on specified visit days throughout the 180 day follow up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Vaccine | Experimental | Biological: Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml). |
| Cohort 1 - Placebo | Placebo comparator | Biological: Single dose of placebo via subcutaneous injection (0.5ml).Single dose of placebo via subcutaneous injection (0.5ml). |
| Cohort 2 - Vaccine | Experimental | Biological: Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml). |
| Cohort 2 - Placebo | Placebo comparator | Biological: Single dose of placebo via subcutaneous injection (0.5ml).Single dose of placebo via subcutaneous injection (0.5ml). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult male or female between 18 and 50 years of age, inclusive.
- Good general health as determined by physical examination, laboratory screening, and review of medical history.
- Available for the duration of the study, which is approximately 26 weeks.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Females only: Female subjects of childbearing potential, with the exception noted below, should be willing to use effective contraception and have no plans to undergo IVF (in vitro fertilization) during participation in the trial. Reliable methods of contraception include hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, and intrauterine device. Women must have been on an effective method of birth control for at least 30 days prior to enrollment. All female subjects will be considered as having childbearing potential, except for women who exclusively have sex with women, those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or are considered to be post-menopausal, as documented by at least 1 year since last menstrual period with a follicle-stimulating hormone (FSH) level in the menopausal range or at least 24 consecutive months of amenorrhea. Transgender men who have internal female organs and have sex with men will be considered of childbearing potential and should be willing to use effective contraception during the trial. Exception: Females who have sex with females (exclusively) and have no intention of conceiving a child during the study and women whose partners have had a vasectomy will not be required to use contraception, however they will be required to use female condoms and/or dental dams for at least 1 month following vaccination. For women whose sexual partner has had a vasectomy, the vasectomy must have been performed 30 days or more prior to enrollment.
Key exclusion criteria (23 listed)
- Females only: Currently pregnant, as determined by positive β-human choriogonadotropin (HCG) test, or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol.
- Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.
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 |
|---|---|---|
| Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection | Biological | Cohort 1: Vaccine |
| Single dose of placebo via subcutaneous injection (0.5ml).Administered by subcutaneous injection. | Biological | Cohort 1 - Placebo, Cohort 2 - Placebo |
| Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)Administered at a dose of using 10^4 plaque-forming units (PFUs) by subcutaneous injection. | Biological | Cohort 2 - Vaccine |
Primary outcome
Number of Participants With Solicited Local and General Adverse Events (AEs)
Time frame: Solicited AE's assessed every visit through Day 28
Evaluated using the Adverse Event Grading Table in the study protocol.
To Determine the Immunogenicity of a Single Dose of rZIKV/D4Δ30-713
Time frame: Measured through Day 28
Determination of the serum plaque reduction neutralization titer 50% (PRNT50) to ZIKV for each subject at Study Day 28 post-inoculation. Seroconversion will be defined as achieving a PRNT50 ≥ 1:10 at any time-point through Study Day 28. The peak PRNT50 to ZIKV through Study Day 28 will be calculated for each subject included in the per-protocol an intent-to-treat analysis and the geometric mean peak titer for vaccinated subjects will be calculated.
5 secondary outcomes
Viremia Induced by Vaccine (Number of Participants With Detectable Virus at Any Time Point)
Time frame: Measured through Day 90
Number of Vaccinees Infected With rZIKV/D4Δ30-713
Time frame: Measured through Day 180
Immunogenicity of rZIKV/D4Δ30-713 in Flavivirus-naïve Subjects
Time frame: Measured through Day 180
Durability of Antibody Response
Time frame: 26 Weeks post vaccination
Quantity and Duration of ZIKV Presence
Time frame: 90 days post vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- 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.
Anna Durbin, MD principal investigator
Center for Immunization Research, Johns Hopkins School of Public Health
Kristen Pierce, MD principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) and Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml) in people with Zika Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 5 Aug 2025). 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 Local and General Adverse Events (AEs) (time frame: Solicited AE's assessed every visit through Day 28). 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 5 Aug 2025.