Zika VirusPhase 1NCT05123222
Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)
A Phase 1 study testing ZIKV-SJRP/2016-184 Strain and Experimental: ZIKV-Nicaragua/2016 Strain in people with Zika Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will include 4 cohorts of 14 ZIKV and DENV-naïve female and male subjects, 18 - 40 years of age (total: up to 56 subjects). Within each cohort, 10 subjects will receive ZIKV and 4 subjects will receive a placebo on Study Day 0. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus
- What is being tested?
- ZIKV-SJRP/2016-184 Strain and Experimental: ZIKV-Nicaragua/2016 Strain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2022to 3 Sep 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult ZIKV and DENV-naïve male and non-pregnant females 18 - 40 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, approximately 26 weeks post-inoculation.
- Must be able to complete the informed consent process and comprehension assessment independently and without assistance.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Willingness to reside in the inpatient unit for 9 days (or longer for safety if necessary) following receipt of ZIKV or placebo.
Show all 10Show fewer
- Male subjects: Willingness to use barrier contraception during cervico-vaginal, anal, and oral intercourse through study day 90 (in accordance with CDC guidance).
- Female subjects: Willingness to use barrier contraception during cervico-vaginal, anal, and oral intercourse through study day 56 (in accordance with CDC guidance).
- Female subjects of childbearing potential must be willing to use effective contraception while at risk of Zika infection. CDC guidelines for the use of effective contraception of 8 weeks post-infection will be followed; time of infection is defined as inoculation with challenge virus. Reliable methods of contraception include: hormonal birth control* (implantable, hormonal patch, hormonal vaginal ring, oral contraception, Depo-Provera injection, etc.), surgical sterilization (hysterectomy, tubal ligation, or tubal coil at least 3 months prior to inoculation), and intrauterine device. All female subjects will be considered having child-bearing potential except for those with post-menopausal status documented as at least 1 year since last menstrual period and females who have sex with females (exclusively) and have no intention of conceiving a child during the study. Females who are not considered to be of childbearing potential will not be required to use contraception other than barrier contraception for the purpose of reducing potential transmission.
- Volunteers on hormonal birth control must not be on medications or other agents that decrease the effectiveness of hormonal birth control.
Who cannot join
- Currently pregnant, as determined by positive beta-human choriogonadotropin (Beta-hCG) test, breast-feeding or planning to become pregnant during the 6-month duration of the study.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- Evidence of recent opiate use based on urine toxicology screen
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), 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.
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- Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by subject history.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma (emergency room visit or hospitalization within the last 6 months).
- HIV infection, by screening and confirmatory assays.
- Hepatitis C virus (HCV) infection, by screening and confirmatory assays.
- Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening.
- History of Guillain-Barré syndrome (GBS).
- History of seizure disease or peripheral neuropathy
- History of any neuroinflammatory disorder i.e. Bell's Palsy, transverse myelitis
- Any known immunodeficiency syndrome, including that caused by malignancy.
- Use of anticoagulant medications (use of antiplatelet medication such as aspirin or non-steroidal anti-inflammatory medication is permitted and will not exclude a subject from enrollment).
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following inoculation. Immunosuppressive dose of corticosteroids is defined as ≥10 mg prednisone equivalent per day for ≥14 days.
- Receipt of a live vaccine within 21 days or a killed vaccine within the 14 days prior to inoculation or anticipated receipt of any vaccine during the 21 days following inoculation.
- 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 infection or DENV infection.
- Previous receipt of a ZIKV or DENV vaccine (licensed or investigational).
- Anticipated receipt of any investigational agent in the 28 days before or after inoculation.
- Subject has definite plans to travel to a ZIKV-endemic or dengue-endemic area during the study.
- Previous hypersensitivity to any study product component.
- Anaphylactic reaction to mosquito bites.
- Refusal to allow storage of specimens for future research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, 21202
About this study
Official title: Phase I Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)
This study will include 4 cohorts of 14 ZIKV and DENV-naïve female and male subjects, 18 - 40 years of age (total: up to 56 subjects). Within each cohort, 10 subjects will receive ZIKV and 4 subjects will receive a placebo on Study Day 0. Cohorts 1 and 2 (Dose = 10^2 PFU) will be enrolled first and will enroll only women. Cohorts 3 and 4 (Dose = 10^2 PFU) will enroll men.
Read the detailed description
This study is a placebo-controlled, double-blind study in normal healthy adult male and non-pregnant female subjects 18 - 40 years of age, inclusive, recruited from the metropolitan Baltimore/Washington, DC and Burlington, VT areas. The purpose of this study is to evaluate the clinical and virologic response to escalating doses of 2 different ZIKV strains administered subcutaneously in healthy, ZIKV and DENV-naïve, male and non-pregnant, female adult volunteers to identify the most suitable ZIKV strain and dose for use in a ZIKV CHIM. The ZIKV CHIM will then be used to evaluate the protective efficacy of candidate ZIKV vaccines prior to evaluation of these candidates in Phase 2 clinical trials. Both ZIKV strains will be studied at doses of 10^2 PFU. Placebo recipients are included in the study as a control to better assess ZIKV-associated versus non-ZIKV-associated AEs.
- Conditions
- Zika Virus
- Being tested
- ZIKV-SJRP/2016-184 Strain, Experimental: ZIKV-Nicaragua/2016 Strain, Placebo
- Keywords
- Zika virus
- 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.
ZIKV-SJRP/2016-184 StrainBiological
Zika Virus Strain (San Jose Rio Puerto)
Experimental: ZIKV-Nicaragua/2016 StrainBiological
Zika Virus Strain (Nicaragua)
PlaceboBiological
Saline
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - SJRP | Experimental | ZIKV-SJRP/2016-184 injected at dose of 10^2 PFU. Receives: Biological: ZIKV-SJRP/2016-184 Strain |
| Cohort 1 - Placebo | Placebo comparator | Volume matched placebo injection (saline) Receives: Biological: Placebo |
| Cohort 2 - Nicaragua | Experimental | ZIKV-Nicaragua/2016 injected at dose of 10^2 PFU. Receives: Biological: Experimental: ZIKV-Nicaragua/2016 Strain |
| Cohort 2 - Placebo | Placebo comparator | Volume matched placebo injection (saline) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Solicited Adverse Events
measured by count of solicited adverse events recorded following ZIKV administration
Measured: Through 90 days post-inoculation
Severity of Adverse Events
count of solicited AEs by severity grade 1 - mild, event that is easily tolerated, may require 1 dose of medication.
grade 2 - moderate, event that interferes with daily activity or requires more than 1 dose of medication.
grade 3 - severe, event that prevents daily activity and requires medical intervention.
grade 4 - life-threatening, an adverse event that is deemed by the study clinician, the medical monitor, or an outside clinician caring for the subject to be a life-threatening event.
grade 5 - death, any adverse event that results in the death of the subject.
Measured: Through 90 days post-inoculation
Number of Participants Infected by ZIKV
Infection defined as recovery of ZIKV by RT-PCR from blood and/or by seroconversion to ZIKV (50% plaque reduction neutralization titer [PRNT50]≥ 1:10)
Measured: Through 90 days post-inoculation
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Count of participants with infectious virus recovered from serum, whole blood, cervicovaginal secretions (CVS), semen, urine, and saliva as measured by RT-PCR
Measured: Through 90 days post-inoculation
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Mean peak titer of ZIKV recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva of participants by RT-PCR. Data are reported in Log10 Genome Equivalents (GE) per milliliter.
Measured: Through 90 days post-inoculation
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Mean number of days that ZIKV was recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva from participants with detectable zika as measured by RT-PCR
Measured: Through 90 days post-inoculation
Secondary outcomes (5)
Frequency of AEs by Severity
Number of AEs by grade grade 1 - mild, event that is easily tolerated, may require 1 dose of medication.
grade 2 - moderate, event that interferes with daily activity or requires more than 1 dose of medication.
grade 3 - severe, event that prevents daily activity and requires medical intervention.
grade 4 - life-threatening, an adverse event that is deemed by the study clinician, the medical monitor, or an outside clinician caring for the subject to be a life-threatening event.
grade 5 - death, any adverse event that results in the death of the subject.
Measured: Through 28 days post-inoculation
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
determined by number of participants with infectious virus in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva as measured by virus culture
Measured: Through 90 days post-inoculation
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
mean peak titer of ZIKV in participants with ZIKV recovered from serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva by virus culture. Data are reported in Log10 Genome Equivalents (GE) per milliliter.
Measured: Through 90 days post-inoculation
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
mean number of days that ZIKV was recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva from participants with detectable zika as measured by virus culture
Measured: Through 90 days post-inoculation
Peak Neutralizing Antibody Response to ZIKV
evaluate the kinetics of the serum neutralizing antibody response following primary ZIKV infection.
Measured: Through 90 days post-inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start16 Feb 2022
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study will include 4 cohorts of 14 ZIKV and DENV-naïve non-pregnant female and male subjects, 18 - 40 years of age (total: 56 subjects). Within each cohort, 10 subjects will receive ZIKV and 4 subjects will receive a placebo on Study Day 0. Cohorts 1 and 2 (Dose = 10\^2 PFU) will be enrolled first and will enroll only women. Cohorts 3 and 4 (Dose = 10\^2 PFU) will enroll men. Two strains of ZIKV will be evaluated in both men and women- San Jose Rio Puerto (Cohorts 1 and 3) and Nicaragua (Cohorts 2 and 4).
- 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, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123222
- Sponsor's protocol ID
- CIR 316
- Status last verified
- Apr 2025
- First submitted
- 26 Oct 2021
- Last updated
- 11 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)
- ClinicalTrials.gov ID
- NCT05123222
- Acronym / sponsor ID
- CIR 316
- Conditions
- Zika Virus
- Keywords
- Zika virus
- 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
- 16 Feb 2022 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Posted 11 Apr 2025
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 include 4 cohorts of 14 ZIKV and DENV-naïve female and male subjects, 18 - 40 years of age (total: up to 56 subjects). Within each cohort, 10 subjects will receive ZIKV and 4 subjects will receive a placebo on Study Day 0. Cohorts 1 and 2 (Dose = 10^2 PFU) will be enrolled first and will enroll only women. Cohorts 3 and 4 (Dose = 10^2 PFU) will enroll men.
Detailed description
This study is a placebo-controlled, double-blind study in normal healthy adult male and non-pregnant female subjects 18 - 40 years of age, inclusive, recruited from the metropolitan Baltimore/Washington, DC and Burlington, VT areas. The purpose of this study is to evaluate the clinical and virologic response to escalating doses of 2 different ZIKV strains administered subcutaneously in healthy, ZIKV and DENV-naïve, male and non-pregnant, female adult volunteers to identify the most suitable ZIKV strain and dose for use in a ZIKV CHIM. The ZIKV CHIM will then be used to evaluate the protective efficacy of candidate ZIKV vaccines prior to evaluation of these candidates in Phase 2 clinical trials. Both ZIKV strains will be studied at doses of 10^2 PFU. Placebo recipients are included in the study as a control to better assess ZIKV-associated versus non-ZIKV-associated AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study will include 4 cohorts of 14 ZIKV and DENV-naïve non-pregnant female and male subjects, 18 - 40 years of age (total: 56 subjects). Within each cohort, 10 subjects will receive ZIKV and 4 subjects will receive a placebo on Study Day 0. Cohorts 1 and 2 (Dose = 10^2 PFU) will be enrolled first and will enroll only women. Cohorts 3 and 4 (Dose = 10^2 PFU) will enroll men. Two strains of ZIKV will be evaluated in both men and women- San Jose Rio Puerto (Cohorts 1 and 3) and Nicaragua (Cohorts 2 and 4).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - SJRP | Experimental | Biological: ZIKV-SJRP/2016-184 StrainZIKV-SJRP/2016-184 injected at dose of 10^2 PFU. |
| Cohort 1 - Placebo | Placebo comparator | Biological: PlaceboVolume matched placebo injection (saline) |
| Cohort 2 - Nicaragua | Experimental | Biological: Experimental: ZIKV-Nicaragua/2016 StrainZIKV-Nicaragua/2016 injected at dose of 10^2 PFU. |
| Cohort 2 - Placebo | Placebo comparator | Biological: PlaceboVolume matched placebo injection (saline) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adult ZIKV and DENV-naïve male and non-pregnant females 18 - 40 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, approximately 26 weeks post-inoculation.
- Must be able to complete the informed consent process and comprehension assessment independently and without assistance.
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (28 listed)
- Currently pregnant, as determined by positive beta-human choriogonadotropin (Beta-hCG) test, breast-feeding or planning to become pregnant during the 6-month duration of the study.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- Evidence of recent opiate use based on urine toxicology screen
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this 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 |
|---|---|---|
| ZIKV-SJRP/2016-184 StrainZika Virus Strain (San Jose Rio Puerto) | Biological | Cohort 1 - SJRP |
| Experimental: ZIKV-Nicaragua/2016 StrainZika Virus Strain (Nicaragua) | Biological | Cohort 2 - Nicaragua |
| PlaceboSaline | Biological | Cohort 1 - Placebo, Cohort 2 - Placebo |
Primary outcome
Number of Solicited Adverse Events
Time frame: Through 90 days post-inoculation
measured by count of solicited adverse events recorded following ZIKV administration
Severity of Adverse Events
Time frame: Through 90 days post-inoculation
count of solicited AEs by severity grade 1 - mild, event that is easily tolerated, may require 1 dose of medication. grade 2 - moderate, event that interferes with daily activity or requires more than 1 dose of medication. grade 3 - severe, event that prevents daily activity and requires medical intervention. grade 4 - life-threatening, an adverse event that is deemed by the study clinician, the medical monitor, or an outside clinician caring for the subject to be a life-threatening event. grade 5 - death, any adverse event that results in the death of the subject.
Number of Participants Infected by ZIKV
Time frame: Through 90 days post-inoculation
Infection defined as recovery of ZIKV by RT-PCR from blood and/or by seroconversion to ZIKV (50% plaque reduction neutralization titer [PRNT50]≥ 1:10)
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Time frame: Through 90 days post-inoculation
Count of participants with infectious virus recovered from serum, whole blood, cervicovaginal secretions (CVS), semen, urine, and saliva as measured by RT-PCR
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Time frame: Through 90 days post-inoculation
Mean peak titer of ZIKV recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva of participants by RT-PCR. Data are reported in Log10 Genome Equivalents (GE) per milliliter.
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Time frame: Through 90 days post-inoculation
Mean number of days that ZIKV was recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva from participants with detectable zika as measured by RT-PCR
5 secondary outcomes
Frequency of AEs by Severity
Time frame: Through 28 days post-inoculation
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Time frame: Through 90 days post-inoculation
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Time frame: Through 90 days post-inoculation
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Time frame: Through 90 days post-inoculation
Peak Neutralizing Antibody Response to ZIKV
Time frame: Through 90 days post-inoculation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Durbin, MD principal investigator
Johns Hopkins University
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 ZIKV-SJRP/2016-184 Strain and Experimental: ZIKV-Nicaragua/2016 Strain in people with Zika Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 10 inclusion and 28 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 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 Solicited Adverse Events (time frame: Through 90 days post-inoculation). 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 11 Apr 2025.