Ebola Virus DiseasePhase 1NCT02368119
Ebola CVD-Mali #2000 (Bivalent) VRC-EBOAdc069-00-vp (cAd3-EBO)
A Phase 1 study testing VRC-EBOADC069-00-vp and MVA-EbolaZ in people with Ebola Virus Disease and Hemorrhagic Fever, run by University of Maryland, Baltimore at 1 site in Mali.
Trial summary
Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease, Hemorrhagic Fever
- What is being tested?
- VRC-EBOADC069-00-vp and MVA-EbolaZ
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMali
- Study dates
- Mar 2015to 27 Sep 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18 to 65 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative urine pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
- Laboratory criteria within 30 days prior to enrollment:
Show all 18Show fewer
- Hemoglobin ≥ 11.0 g/dL for women; ≥12.5 g/dL for men.
- White blood cells (WBC) = 2,500-11,000 cells/mm3.
- Neutrophil count = 1200 - 7000 cells/mm3
- Lymphocyte count ≥ 800 cells/mm3
- Eosinophil count = 0 - 500 cells/mm3
- Platelets = 125,000 - 400,000/mm3
- Alanine aminotransferase (ALT) = 10-45 IU/L
- Serum creatinine = 54-145 umol/L.
- HIV-uninfected as evidenced by a negative HIV diagnostic test.
- Seronegative for hepatitis B surface antigen (HBsAg)
- Negative β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment if woman is presumed to be of reproductive potential.
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative urine pregnancy test on the day(s) of screening and vaccination.
Who cannot join
- Recent exposure to Ebola virus infection (this is not a post-exposure vaccine)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, MVA vectored vaccine (for booster study) or any other investigational vaccine likely to impact on interpretation of the trial data
- Receipt of any live, attenuated vaccine within 28 days prior to enrolment
- Receipt of any subunit or killed vaccine within 14 days prior to enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
Show all 23Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- Any history of anaphylaxis in reaction to vaccination
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- Poorly controlled asthma or thyroid disease
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
- Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
- Any known history of cardiac disease (for the booster portion of the study only)
- Any other serious chronic illness requiring hospital specialist supervision
- Current anti-tuberculosis prophylaxis or therapy
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Any clinically significant abnormal finding on screening biochemistry or hematology blood tests
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE IB, DOUBLE-BLIND, CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF TWO DIFFERENT DOSAGE LEVELS OF EBOLA CHIMPANZEE ADENOVIRUS VECTOR VACCINE "VRC-EBOADC069-00-VP (cAd3-EBO)" AND THE HETEROLOGOUS PRIME-BOOST CANDIDATE VACCINE REGIMEN OF cAD3-EBO FOLLOWED BY MVA-VECTORED VACCINE IN HEALTHY ADULTS, 18-65 YEARS OF AGE, IN BAMAKO, MALI
Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection.
This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers, age 18-65 years (mostly health care workers and other front line workers [e.g., individuals who incinerate contaminated materials]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x 10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine.
Read more
Heterologous booster dose allocation - Each participant will be offered the opportunity to be included in the booster step of this study. After obtaining consent and the additional review of pertinent medical history, participants in each group will be randomized to receive the candidate booster vaccine, MVA-EbolaZ or placebo.
This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the first where the dosage level contains > 10(11) vp. It follows completion of a Phase Ib trial in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity of the bivalent vaccine will be compared to clinical and immunologic responses documented in in parallel studies in East African subjects (Uganda) and North American subjects (NIH, Bethesda, MD, USA).
Objectives:
- To see if an Ebola vaccine is safe and to study immune responses to it.
- To study the effect of the MVA-EbolaZ booster on the immune response
Eligibility:
- Healthy adults ages 18-65.
Read the detailed description
This is a phase 1B, double-blind, randomized study to examine the safety, tolerability and immunogenicity of two different dosage levels of investigational Ebola vaccine.
The vaccine is a recombinant chimpanzee adenovirus Type 3-vectored Ebolavirus vaccine (cAd3-EBO), VRC-EBOADC069-00-VP. The vaccine encodes wild type (WT) glycoproteins (GP) from Zaire and Sudan species of Ebola virus. The primary objective is to assess the safety of a single dose intramuscular injection of the bivalent vaccine at one of 2 dosage levels, 2.0 X 10(10) vp or 2 x 10(11) vp and to assess the safety of the heterologous prime boost regimen of cAd3-EBO followed by MVA-EbolaZ or Phosphate Buffered Saline (PBS) placebo. A secondary objective is to assess the immunogenicity generated by 2 different dosage levels of the bivalent Ebola candidate vaccine.
Enrolment of Group 1 participants:
The first 20 Malian volunteers will be vaccinated in a staggered fashion. For safety reasons, the first 10 Malian subjects to receive a vaccine dose in Group 1 will be vaccinated on day 1 and we will wait 24 hours before vaccinating 10 subsequent volunteers. After these 20 volunteers in Group 1 have been vaccinated and followed up for 7 days, an interim safety review (ISR1) will be performed by the DSMB. Enrolment of subjects into Group 2 will commence only after the DSMB has assessed the data and indicated that it is safe to do so.
Half of Group 1 participants will be randomly assigned to receive the low dose and the remaining 10 will be randomized to receive the high dose.
Enrolment of Group 2 participants:
The 40 subjects in Group 2 will be accrued as rapidly as possible. The 40 Malian volunteers in Group 2 will be vaccinated over several days to limit wastage of the available doses of cAd3 EBO. As a result, a proposed scheme would be 10 per vaccination day. This could be adjusted as needed to limit wastage but no more than 20 participants would be vaccinated in 1 day. After the total of 40 volunteers in Group 2 have been vaccinated and followed up for 7 days, an interim safety review (ISR2) will be performed by the DSMB.
Prime Boost Vaccine Randomization 4-16 weeks after priming dose: Each participant will be offered the opportunity to be included in the booster step of this study. After obtaining consent and the additional review of pertinent medical history, participants in each group will be randomized to receive the candidate booster vaccine, MVA-EbolaZ or PBS placebo
- Conditions
- Ebola Virus Disease, Hemorrhagic Fever
- Being tested
- VRC-EBOADC069-00-vp, MVA-EbolaZ, Placebo
- Medical subject headings
- Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-EBOADC069-00-vpBiological
Also called cAd3-EBO at 2x10(10) vp
IM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp)
VRC-EBOADC069-00-vpBiological
Also called cAd3-EBO at 2x10(11) vp
IM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp)
MVA-EbolaZBiological
IM injection of MVA-EbolaZ vaccine
PlaceboOther
IM injection injection of Phosphate Buffered Saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | VRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp (n=10) or VRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp (n=10). Randomization to booster of MVA-EbolaZ or PBS placebo will be completed 4 to 16 weeks after priming dose. Receives: Biological: VRC-EBOADC069-00-vp; Biological: MVA-EbolaZ; Other: Placebo |
| Group 2 | Experimental | VRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp (n=20) or VRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp (n=20). Randomization to booster of MVA-EbolaZ or PBS placebo will be completed 4 to 16 weeks after priming dose. Receives: Biological: VRC-EBOADC069-00-vp; Biological: MVA-EbolaZ; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local reactogenicity - Number of participants with the specific outcome
Occurrence of solicited local signs and symptoms following vaccination
Measured: For 7 days following each vaccination
Solicited systemic reactogenicity - Number of participants with the specific outcome
Occurrence of solicited systemic signs and symptoms following vaccination
Measured: For 7 days following each vaccination
Secondary outcomes (1)
Ebolavirus specific immunogenicity
ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining assay for T cell responses after vaccination
Measured: At 7, 14, 28, 56, 112 and 168 days after vaccination. For those who participate in booster substudy, additional samples will be collected at these time points and no further samples would be timed from the priming dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion27 Sep 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milagritos Tapia, University of Maryland, Baltimore
- Investigators
- Myrons M Levine, MD DTPH, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368119
- Sponsor's protocol ID
- HP-00062548
- Status last verified
- Sep 2019
- First submitted
- 5 Feb 2015
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE IB, DOUBLE-BLIND, CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF TWO DIFFERENT DOSAGE LEVELS OF EBOLA CHIMPANZEE ADENOVIRUS VECTOR VACCINE "VRC-EBOADC069-00-VP (cAd3-EBO)" AND THE HETEROLOGOUS PRIME-BOOST CANDIDATE VACCINE REGIMEN OF cAD3-EBO FOLLOWED BY MVA-VECTORED VACCINE IN HEALTHY ADULTS, 18-65 YEARS OF AGE, IN BAMAKO, MALI
- ClinicalTrials.gov ID
- NCT02368119
- Acronym / sponsor ID
- HP-00062548
- Conditions
- Ebola Virus Disease, Hemorrhagic Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2015 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 20 Feb 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.
Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection.
This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers, age 18-65 years (mostly health care workers and other front line workers [e.g., individuals who incinerate contaminated materials]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x 10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine.
Heterologous booster dose allocation - Each participant will be offered the opportunity to be included in the booster step of this study. After obtaining consent and the additional review of pertinent medical history, participants in each group will be randomized to receive the candidate booster vaccine, MVA-EbolaZ or placebo.
This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the first where the dosage level contains > 10(11) vp. It follows completion of a Phase Ib trial in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity of the bivalent vaccine will be compared to clinical and immunologic responses documented in in parallel studies in East African subjects (Uganda) and North American subjects (NIH, Bethesda, MD, USA).
Objectives:
- To see if an Ebola vaccine is safe and to study immune responses to it.
- To study the effect of the MVA-EbolaZ booster on the immune response
Eligibility:
- Healthy adults ages 18-65.
Detailed description
This is a phase 1B, double-blind, randomized study to examine the safety, tolerability and immunogenicity of two different dosage levels of investigational Ebola vaccine.
The vaccine is a recombinant chimpanzee adenovirus Type 3-vectored Ebolavirus vaccine (cAd3-EBO), VRC-EBOADC069-00-VP. The vaccine encodes wild type (WT) glycoproteins (GP) from Zaire and Sudan species of Ebola virus. The primary objective is to assess the safety of a single dose intramuscular injection of the bivalent vaccine at one of 2 dosage levels, 2.0 X 10(10) vp or 2 x 10(11) vp and to assess the safety of the heterologous prime boost regimen of cAd3-EBO followed by MVA-EbolaZ or Phosphate Buffered Saline (PBS) placebo. A secondary objective is to assess the immunogenicity generated by 2 different dosage levels of the bivalent Ebola candidate vaccine.
Enrolment of Group 1 participants:
The first 20 Malian volunteers will be vaccinated in a staggered fashion. For safety reasons, the first 10 Malian subjects to receive a vaccine dose in Group 1 will be vaccinated on day 1 and we will wait 24 hours before vaccinating 10 subsequent volunteers. After these 20 volunteers in Group 1 have been vaccinated and followed up for 7 days, an interim safety review (ISR1) will be performed by the DSMB. Enrolment of subjects into Group 2 will commence only after the DSMB has assessed the data and indicated that it is safe to do so.
Half of Group 1 participants will be randomly assigned to receive the low dose and the remaining 10 will be randomized to receive the high dose.
Enrolment of Group 2 participants:
The 40 subjects in Group 2 will be accrued as rapidly as possible. The 40 Malian volunteers in Group 2 will be vaccinated over several days to limit wastage of the available doses of cAd3 EBO. As a result, a proposed scheme would be 10 per vaccination day. This could be adjusted as needed to limit wastage but no more than 20 participants would be vaccinated in 1 day. After the total of 40 volunteers in Group 2 have been vaccinated and followed up for 7 days, an interim safety review (ISR2) will be performed by the DSMB.
Prime Boost Vaccine Randomization 4-16 weeks after priming dose: Each participant will be offered the opportunity to be included in the booster step of this study. After obtaining consent and the additional review of pertinent medical history, participants in each group will be randomized to receive the candidate booster vaccine, MVA-EbolaZ or PBS placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: VRC-EBOADC069-00-vp, Biological: MVA-EbolaZ, Other: PlaceboVRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp (n=10) or VRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp (n=10). Randomization to booster of MVA-EbolaZ or PBS placebo will be completed 4 to 16 weeks after priming dose. |
| Group 2 | Experimental | Biological: VRC-EBOADC069-00-vp, Biological: MVA-EbolaZ, Other: PlaceboVRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp (n=20) or VRC-EBOADC069-00 VP (cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp (n=20). Randomization to booster of MVA-EbolaZ or PBS placebo will be completed 4 to 16 weeks after priming dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy adults aged 18 to 65 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative urine pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Key exclusion criteria (23 listed)
- Recent exposure to Ebola virus infection (this is not a post-exposure vaccine)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, MVA vectored vaccine (for booster study) or any other investigational vaccine likely to impact on interpretation of the trial data
- Receipt of any live, attenuated vaccine within 28 days prior to enrolment
- Receipt of any subunit or killed vaccine within 14 days prior to enrolment
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 |
|---|---|---|
| VRC-EBOADC069-00-vpAlso: cAd3-EBO at 2x10(10) vpIM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp) | Biological | Group 1, Group 2 |
| VRC-EBOADC069-00-vpAlso: cAd3-EBO at 2x10(11) vpIM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp) | Biological | Group 1, Group 2 |
| MVA-EbolaZIM injection of MVA-EbolaZ vaccine | Biological | Group 1, Group 2 |
| PlaceboIM injection injection of Phosphate Buffered Saline | Other | Group 1, Group 2 |
Primary outcome
Solicited local reactogenicity - Number of participants with the specific outcome
Time frame: For 7 days following each vaccination
Occurrence of solicited local signs and symptoms following vaccination
Solicited systemic reactogenicity - Number of participants with the specific outcome
Time frame: For 7 days following each vaccination
Occurrence of solicited systemic signs and symptoms following vaccination
1 secondary outcome
Ebolavirus specific immunogenicity
Time frame: At 7, 14, 28, 56, 112 and 168 days after vaccination. For those who participate in booster substudy, additional samples will be collected at these time points and no further samples would be timed from the priming dose
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 26 Sep 2019.
- 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.
Myrons M Levine, MD DTPH study director
University of Maryland, Baltimore
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 VRC-EBOADC069-00-vp and MVA-EbolaZ in people with Ebola Virus Disease and Hemorrhagic Fever, run by University of Maryland, Baltimore at 1 site in Mali.
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 18 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 26 Sep 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 Mali. 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?
Solicited local reactogenicity - Number of participants with the specific outcome (time frame: For 7 days following each vaccination). 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 26 Sep 2019.