Covid19Early Phase 1NCT04818801
Safety, Reactogenicity and Immunogenicity Study of ReCOV
A Early Phase 1 study testing Recombinant two-component COVID-19 vaccine (CHO cell) in people with Covid19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 2 sites in New Zealand.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Recombinant two-component COVID-19 vaccine (CHO cell)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 18 Jun 2021to 5 May 2022
- Phase
- Early 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are eligible to be included in the study only if ALL of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Male or female subjects who are ≥18 years old at the time of Screening (signing the ICF):
- For the younger adult group: 18 to 55 years, inclusive
- For the older adult group: ≥56 to <80 years
- Have a body mass index (BMI) between 18.5 and 35.0 kg/m2.
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- Subjects who are of general good health according to the Investigator's assessment, based on a complete medical history without major pathology, and as determined by medical evaluation (including physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory tests). Subjects in the older adult population who have medically stable, well-controlled comorbidities may be enrolled at the discretion of the Investigator.
- NOTE: All clinical laboratory values should be within reference ranges unless confirmed by Investigator or delegate as not clinically significant. One repeat evaluation of ECG, vital signs, and clinical laboratory tests will be permitted, at the discretion of the Investigator.
- Subjects who test negative for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti-HBc), anti-hepatitis C virus (HCV) antibodies, and anti-human immunodeficiency virus (HIV) 1 and 2 antibodies at Screening.
- Subjects who test negative for SARS-Cov-2 infection, based on a reverse transcriptase polymerase chain reaction (RT-PCR) test and serological test for SARS-COV-2 IgM and/or IgG antibodies at Screening.
- Female subjects are eligible to participate if not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP), defined as:
- Surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the subject's medical records, medical examination, or medical history interview), or Postmenopausal (defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy [HRT]. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient). Female subjects on HRT and whose menopausal status is in doubt will be required to use 1 of the non estrogen hormonal highly effective contraception methods from Day 1 until at least 6 months after the second dose of IP if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
- Is a WOCBP who agrees to use a highly effective method of contraception consistently and correctly from Day 1 until at least 6 months after the second dose of IP.
- Nonsterilized male subjects with female partners of childbearing potential are eligible to participate if they agree to ONE of the following from Day 1 until at least 6 months after the second dose of IP and refrain from donating sperm during this period:
- Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- Agree to use a male condom and have their partner use of a contraceptive method with a failure rate of <1% per year when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
- Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration.
Who cannot join
- Subjects are excluded from the study if ANY of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- History of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the Investigator within 12 months prior to Screening.
- Individuals with behavioral or cognitive impairment in the opinion of the Investigator.
- Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
- Individuals with known or suspected impairment of the immune system, such as:
- Use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to Day 1. Use of inhaled, intranasal, or topical corticosteroids is allowed. NOTE: Systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the IP.
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- Receipt of cancer chemotherapy within 5 years prior to Day 1.
- Receipt of immunostimulants or immunosuppressants within 60 days prior to Day 1.
- Known HIV or acquired immune deficiency syndrome.
- Subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases [pIMDs]).
- Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study.
- Being treated for tuberculosis.
- History of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the IP.
- Individuals who have had a previous confirmed or suspected illness caused by SARS-CoV-1, SARS-CoV-2, or MERS-CoV.
- Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the IP (Day 1).
- History of urticaria within 1 year prior to Screening.
- History of hereditary angioneurotic edema or acquired angioneurotic edema.
- History of asplenia or functional asplenia.
- History of platelet disorder or other bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection.
- Current febrile illness or body temperature ≥38.0°C or other moderate to severe illness within 24 hours of IP administration on Day 1. This condition is considered to be temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met.
- Any current active infections, including localized infections, or any recent history (within 1 week prior to IP administration) of active infections or cough; or a history of recurrent or chronic infections (>3 infections/year).
- Individuals with a history of drug or alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 mL of beer, 150 mL of wine, or 45 mL of spirits) or drug addiction (including soft drugs like cannabis products) within the past 2 years.
- Current heavy smoker, defined as smoking ≥20 cigarettes/day (1 pack or equivalent), or a former heavy smoker who was an active smoker within the past 1 year prior to Screening.
- Individuals who faint at the sight of blood or needles.
- Participation in another interventional clinical study (including a bioequivalence study) with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the IP.
- Individuals who have received any prior investigational or approved vaccine against a coronavirus, including but not limited to SARS-CoV-1, SARS-CoV-2, and MERS-CoV.
- Individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to enrollment in this study, or those who are planning to receive any vaccine within 30 days before the first dose of IP or during the study, with the exception of the seasonal influenza vaccine.
- Individuals must not have donated blood for 30 days prior to Day 1 and must agree to not donate blood for 6 months after Day 1 (receipt of first dose of the IP).
- Individuals with any condition that, in the opinion of the Investigator, would interfere with the study objectives or pose additional subject risk.
- Any persons who are:
- An employee of the study site, Investigator, contract research organization (CRO) or Sponsor.
- A first-degree relative of an employee of the study site, the Investigator, CRO, or the Sponsor.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland Clinical Studies
Auckland
Christchurch Clinical Studies Trust
Christchurch
About this study
Official title: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of ReCOV, a Vaccine for COVID-19, in Healthy Adult Subjects
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate.
In this phase I first-in-human clinical trial, healthy volunteers in two different age cohorts and two dose cohorts will be vaccinated twice with the candidate vaccine ReCOV.
The aim of the study is to assess the safety and reactogenicity of the candidate vaccine and to characterize its immunogenicity.
Read the detailed description
A total of 100 participants will receive the following vaccine regime:
First, 20 young adult participants (18 to 55 years old) will receive 20μg of ReCOV vaccine on days 0 and 21.
Then, 20 young adult participants (18 to 55 years old) will receive 40μg of ReCOV vaccine on days 0 and 21, and 20 old adult participants (56 to 80 years old) will receive 20μg of ReCOV vaccine on days 0 and 21.
Finally, 20 old adult participants (56 to 80 years old) will receive 40μg of ReCOV vaccine on days 0 and 21.
In the same time, 8 participants for each cohort, total 32 participants will receive 0.5ml of normal saline on days 0 and 21.
Safety and immunogenicity data will be collected throughout the study, which concludes at 12 month after the second dose.
- Conditions
- Covid19
- Being tested
- Recombinant two-component COVID-19 vaccine (CHO cell), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant two-component COVID-19 vaccine (CHO cell)Biological
Also called ReCOV
The spike (S) protein is the main surface antigen of SARS-CoV-2, mediates entry of SARS CoV-2 into cells expressing the angiotensin-converting enzyme 2 (ACE2). The RBD interacts with ACE2 and can generate potent neutralizing anti-RBD antibodies.
PlaceboOther
Also called Normal saline
Normal saline (0.9% sodium chloride solution),
| Study group | Role | What they receive |
|---|---|---|
| Recombinant two-component COVID-19 vaccine (CHO cell) | Experimental | Participants received Recombinant two-component COVID-19 vaccine (CHO cell) 0.5ml reconstituted by adjuvant solution, 2 shots at a interval 21 days, intramuscular injection Receives: Biological: Recombinant two-component COVID-19 vaccine (CHO cell) |
| Placebo | Placebo comparator | Participants received placebo of 0.5ml normal saline (0.9% sodium chloride solution), 2 shots at a interval 21 days, intramuscular injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with solicited local and systemic adverse events
Incidence of solicited local and systemic adverse events up to 7 days after each dose
Measured: up to 7 days after each dose
Number of Participants with unsolicited adverse events after each dose
Incidence of unsolicited adverse events after each dose up to 30 days after the second dose
Measured: up to 30 days after the second dose
Number of Participants with serious adverse events
Incidence of serious adverse events up to 30 days after the second dose
Measured: up to 30 days after the second dose
Number of Participants with changes in clinical laboratory tests from baseline
Changes in clinical laboratory tests from baseline up to 7 days after each dose
Measured: up to 7 days after each dose
Number of Participants with changes in vital signs from baseline
Changes in vital signs from baseline up to 30 days after the second dose
Measured: up to 30 days after the second dose
Secondary outcomes (10)
Number of Participants with adverse events,serious adverse events, and adverse events of special interest
Incidence of adverse events,serious adverse events, and adverse events of special interest up to 12 months after the second dose
Measured: up to 12 months after the second dose
Number of Participants with changes in vital signs from baseline
Changes in clinical laboratory tests and vital signs from baseline up to 12 months after the second dose
Measured: up to 12 months after the second dose
Geometric mean titers(GMT)
specific IgG binding antibodies against SARS-CoV-2
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Seroconversion rates
specific IgG binding antibodies against SARS-CoV-2
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Geometric mean fold increase
specific IgG binding antibodies against SARS-CoV-2
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
IFN-γ
Positivity rate of IFN-γ measured by ELISpot
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Geometric mean titers(GMT)
specific IgG neutralizing antibodies against SARS-CoV-2
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Seroconversion rates
specific IgG neutralizing antibodies against SARS-CoV-2
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Geometric mean fold increase
specific IgG neutralizing antibodies against SARS-CoV-2
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Levels of other T cell biomarkers
CD4+/CD8+ counts, IL-4, IL-5, and IL-17
Measured: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start18 Jun 2021
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818801
- Sponsor's protocol ID
- CT61101
- Status last verified
- Sep 2022
- First submitted
- 19 Mar 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wynne C, Balgos A, Li J, Hamilton P, Tirador L, Jaen AM, Mo C, Yue Z, Ma Y, Wang Q, Wen R, Yao Z, Yu J, Yao W, Zhang J, Zheng H, Hong K, Zhu F, Liu Y. Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies. Infect Dis Ther. 2024 Jan;13(1):57-78. doi: 10.1007/s40121-023-00896-w. Epub 2023 Dec 16.
PubMed 38103161
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of ReCOV, a Vaccine for COVID-19, in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04818801
- Acronym / sponsor ID
- CT61101
- Conditions
- Covid19
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 26 Mar 2021 (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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate.
In this phase I first-in-human clinical trial, healthy volunteers in two different age cohorts and two dose cohorts will be vaccinated twice with the candidate vaccine ReCOV.
The aim of the study is to assess the safety and reactogenicity of the candidate vaccine and to characterize its immunogenicity.
Detailed description
A total of 100 participants will receive the following vaccine regime:
First, 20 young adult participants (18 to 55 years old) will receive 20μg of ReCOV vaccine on days 0 and 21.
Then, 20 young adult participants (18 to 55 years old) will receive 40μg of ReCOV vaccine on days 0 and 21, and 20 old adult participants (56 to 80 years old) will receive 20μg of ReCOV vaccine on days 0 and 21.
Finally, 20 old adult participants (56 to 80 years old) will receive 40μg of ReCOV vaccine on days 0 and 21.
In the same time, 8 participants for each cohort, total 32 participants will receive 0.5ml of normal saline on days 0 and 21.
Safety and immunogenicity data will be collected throughout the study, which concludes at 12 month after the second dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant two-component COVID-19 vaccine (CHO cell) | Experimental | Biological: Recombinant two-component COVID-19 vaccine (CHO cell)Participants received Recombinant two-component COVID-19 vaccine (CHO cell) 0.5ml reconstituted by adjuvant solution, 2 shots at a interval 21 days, intramuscular injection |
| Placebo | Placebo comparator | Other: PlaceboParticipants received placebo of 0.5ml normal saline (0.9% sodium chloride solution), 2 shots at a interval 21 days, intramuscular injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects are eligible to be included in the study only if ALL of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Male or female subjects who are ≥18 years old at the time of Screening (signing the ICF):
- Have a body mass index (BMI) between 18.5 and 35.0 kg/m2.
- Subjects who are of general good health according to the Investigator's assessment, based on a complete medical history without major pathology, and as determined by medical evaluation (including physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory tests). Subjects in the older adult population who have medically stable, well-controlled comorbidities may be enrolled at the discretion of the Investigator.
Key exclusion criteria (32 listed)
- Subjects are excluded from the study if ANY of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
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 |
|---|---|---|
| Recombinant two-component COVID-19 vaccine (CHO cell)Also: ReCOVThe spike (S) protein is the main surface antigen of SARS-CoV-2, mediates entry of SARS CoV-2 into cells expressing the angiotensin-converting enzyme 2 (ACE2). The RBD interacts with ACE2 and can generate potent neutralizing anti-RBD antibodies. | Biological | Recombinant two-component COVID-19 vaccine (CHO cell) |
| PlaceboAlso: Normal salineNormal saline (0.9% sodium chloride solution), | Other | Placebo |
Primary outcome
Number of Participants with solicited local and systemic adverse events
Time frame: up to 7 days after each dose
Incidence of solicited local and systemic adverse events up to 7 days after each dose
Number of Participants with unsolicited adverse events after each dose
Time frame: up to 30 days after the second dose
Incidence of unsolicited adverse events after each dose up to 30 days after the second dose
Number of Participants with serious adverse events
Time frame: up to 30 days after the second dose
Incidence of serious adverse events up to 30 days after the second dose
Number of Participants with changes in clinical laboratory tests from baseline
Time frame: up to 7 days after each dose
Changes in clinical laboratory tests from baseline up to 7 days after each dose
Number of Participants with changes in vital signs from baseline
Time frame: up to 30 days after the second dose
Changes in vital signs from baseline up to 30 days after the second dose
10 secondary outcomes
Number of Participants with adverse events,serious adverse events, and adverse events of special interest
Time frame: up to 12 months after the second dose
Number of Participants with changes in vital signs from baseline
Time frame: up to 12 months after the second dose
Geometric mean titers(GMT)
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Seroconversion rates
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Geometric mean fold increase
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
IFN-γ
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Geometric mean titers(GMT)
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Seroconversion rates
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Geometric mean fold increase
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Levels of other T cell biomarkers
Time frame: first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
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 27 Sep 2022.
- Derived from this study: PubMed 38103161Wynne C, Balgos A, Li J, Hamilton P, Tirador L, Jaen AM, Mo C, Yue Z, Ma Y, Wang Q, Wen R, Yao Z, Yu J, Yao W, Zhang J, Zheng H, Hong K, Zhu F, Liu Y. Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies. Infect Dis Ther. 2024 Jan;13(1):57-78. doi: 10.1007/s40121-023-00896-w. Epub 2023 Dec 16.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Recombinant two-component COVID-19 vaccine (CHO cell) in people with Covid19, run by Jiangsu Rec-Biotechnology Co., Ltd. at 2 sites in New Zealand.
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 32 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 27 Sep 2022. 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 New Zealand. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of Participants with solicited local and systemic adverse events (time frame: up to 7 days after each dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818801, which also lists 1 linked publication.
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 27 Sep 2022.