Respiratory Syncytial Virus InfectionsPhase 1NCT04851977

A First in Human Study to Evaluate the Safety and Immune Response to a Vaccine for the Treatment of a Respiratory Virus, When Administered Into the Arm in Healthy Adult Participants

A Phase 1 study testing Respiratory Syncytial Vaccine in people with Respiratory Syncytial Virus Infections, run by Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: Respiratory Syncytial Vaccine
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 siteAustralia
Study dates: 16 Oct 2018to 2 Aug 2019
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. A male or female aged 18-45 years (inclusive) at the time of the first vaccination.
2. Able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
3. Written informed consent signed prior to undertaking any protocol related procedures.
4. Haematology, clinical chemistry and urinalysis test results not deviating from the normal reference range by age and gender to a clinically relevant extent at screening.
5. Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent or, if engaged in sexual relations with a person of child-bearing potential, the participant and his partner must use an acceptable, highly effective, contraceptive method from screening and for a period of at least 3 months after the last dose of study drug. Acceptable methods of contraception are the use of condoms and an effective contraceptive for the female partner that could include: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception, or intrauterine contraception/device. The PI is to assess the adequacy of methods of contraception on a case-by-case basis.
6. Women of child-bearing potential (WOCBP) must use highly effective contraceptive measures (failure rate of < 1% per year when used consistently and correctly) throughout the study and intend to continue use of contraception for at least 3 months following the last vaccination. Highly effective contraceptive measures could include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomised partner, and sexual abstinence. The PI is to assess the adequacy of methods of contraception on a case-by-case basis.
7. Participant in otherwise general good health based on medical history and physical examination, as determined by the PI.

Who cannot join

1. Presence of clinically significant medical history, unstable chronic or acute disease, or physical, or laboratory findings that, in the opinion of the PI may potentially increase the expected risk of exposure to the investigational vaccine, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results.
2. Body Mass Index (BMI) great than or equal to 40 at screening. 3. Significant infection or other acute illness, including fever over 37.5°C/99.5°F on the day of randomisation.
4. Birthmarks, tattoos, wound or other skin conditions over the deltoid region of both arms that, in the PI's opinion, could reasonably obscure and interfere with evaluation of local injection site reactions.
5. Inadequate venous access to allow collection of blood samples. 6. Breastfeeding or pregnant as confirmed by a positive serum beta human chorionic gonadotropin (.-HCG) pregnancy test at screening or positive urine pregnancy test at subsequent clinic visits at time points as delineated in the study schedule.
7. Received any prophylactic or therapeutic vaccine, or investigational drug, within 3 months of first vaccination, or anticipated in the follow up period defined for this study.
8. History of severe allergy (requiring hospital care), severe reaction to any drug or prior vaccination, or any known or suspected allergies or sensitivities to any component of the investigational vaccine or placebo.

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9. Immunosuppression caused by disease (such as human immunodeficiency virus [HIV]) or medications, immunosuppressive therapy (such as long-term systemic corticosteroids therapy).
10. History of hepatitis B or hepatitis C infection. 11. History of autoimmune disorder. 12. History of splenectomy or of condition affecting splenic function. 13. History of malignancy of any organ system (other than localised basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
14. History of any neurological disorders or seizures. 15. Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
16. Receipt of immunoglobulins or blood products within 3 months of first vaccination.
17. Requirement for antipyretic or analgesic medication on a daily or every other day basis from randomisation through 72 hours after vaccination.
18. History of alcohol or drug abuse or psychiatric disorder that in the opinion of the PI could affect the participants' safety or compliance with study.
19. Positive urine drug screen at screening, or pre-vaccination for any drug of abuse unless there is an explanation acceptable to the PI (e.g. the participant stated in advance that they consumed a prescription or over the counter product which contained the detected drug) and/or the participant had a negative urine drug screen on retest by the pathology laboratory.
20. A positive alcohol breathalyser test at screening or pre-vaccination. 21. Participant unwilling to abstain from blood donation during the course of the study, and/or participation in any research study involving blood sampling (more than 450 mL /unit of blood), or blood donation to the Australian Red Cross Blood Service (ARCBS) or other blood bank during the 2 months prior to the screening visit.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Advanced Vaccine Laboratories Pty Ltd
Melbourne, Victoria, 3181

Other trials in Australia

About this study

Official title: A Phase I, First in Human (FIH), Randomised, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Recombinant Respiratory Syncytial Virus Vaccines (BARS13) When Administered Intramuscularly (IM) to Healthy Adult Volunteers

Read the detailed description

Advanced Vaccine Laboratories Pty Ltd is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine for the protection of children (6 months to 5 years old) and the elderly from RSV infection. Human RSV infects nearly all children by the age of two years, and it is a leading cause of severe lower respiratory tract (LRT) disease in both paediatric and elderly populations as well as in individuals was immune system is profoundly compromised. The investigational product BARS13 has not previously been administered to human subjects. The purpose of this study is to evaluate the safety of, and how the body reacts to, BARS13 investigational vaccine when administered in the arm to healthy adult participants aged 18 to 45 years according to a single (at Day 0) or repeat (at Day 0 and Day 30) vaccination schedule, with follow-up occurring for 60 days after the last vaccination.

Conditions: Respiratory Syncytial Virus Infections
Being tested: Respiratory Syncytial Vaccine, Placebo
Keywords: Respiratory Syncytial Virus (RSV), BARS13, Vaccines, Virus Diseases
Medical subject headings: Respiratory Syncytial Virus Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Respiratory Syncytial VaccineBiological
Also called BARS13
BARS13 low dose (one dose of 10 μg rRSV-G protein/10 μg CsA by IM injection to the deltoid region of one arm, and one dose of placebo [saline/mannitol] by IM injection to the deltoid region of the other arm, given sequentially).
Respiratory Syncytial VaccineBiological
Also called BARS13
BARS13 high dose (IM injection of 10 μg rRSV-G protein/10 μg CsA administered to the deltoid region of each arm [one injection of 10 μg rRSV-G protein/10 μg CsA per arm], given sequentially). The high dose is twice the strength of the low dose.
PlaceboBiological
Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm [one injection per arm], given sequentially).

Study groups in NCT04851977
Study group	Role	What they receive
Cohort 1: low dose	Experimental	IM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days. Receives: Biological: Respiratory Syncytial Vaccine
Cohort 2: low dose	Placebo comparator	IM injection on Day 0 and at Day 30 (12 active, 3 placebo) with follow up at 7 days post vaccination (Day 7 ± 1 day and Day 37 ± 1 day) and Day 60 ± 5 days and a final follow up/ EOS teleconference assessment at Day 90 ± 5 days. Receives: Biological: Placebo
Cohort 3: high dose	Experimental	IM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days. Receives: Biological: Respiratory Syncytial Vaccine
Cohort 4: high dose	Placebo comparator	IM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of systemic reactions
Incidence of the systemic reactions (fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea, diarrhoea, light-headedness, dizziness, hypersensitivity and headache) assessed by patient reported AEs and diary card
Measured: 7 days post vaccination
Incidence of local reactions
Incidence of the local reactions (pain, tenderness, erythema, swelling, other e.g. ulceration, scabs, redness, induration, ecchymosis, oedema, itching and paraesthesia) at the site of vaccination assessed by patient reported AEs and diary card
Measured: 7 days post vaccination
Occurrence of any AE during a 30-minute post-vaccination safety observation period
Occurrence of any AE during a 30-day follow-up period after each vaccination.
Measured: 30 minutes post vaccination on Day 0 and 30
Occurrence of any AE during a 30-day follow-up period after each vaccination
Occurrence of any AE during a 30-day follow-up period after each vaccination.
Measured: 30 days post vaccination
Occurrence of any Serious Adverse Event (SAE) form baseline (Day 0) to the last visit
Occurrence of any Serious Adverse Event (SAE) form baseline (Day 0) to the last visit
Measured: 60 days post last vaccination
Occurrence of any clinical laboratory abnormalities (Toxicity grade > or = 1) form baseline (Day 0) to the last visit
Occurrence of any clinical laboratory abnormalities (Toxicity grade > or = 1) form baseline (Day 0) to the last visit
Measured: 60 days post vaccination

Secondary outcomes (4)

Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Corrected post-dose Geometric Mean Titers (GMTs) of IgG antibody against RSV-G
Measured: Pre-vaccination
Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Corrected post-dose Geometric Mean Titers (GMTs) of IgG antibody against RSV-G
Measured: 30 day post each vaccination
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Post-dose Geometric Mean Fold Rises (GMFRs) from baseline of IgG antibody against RSV-G.
Measured: Pre-vaccination
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Post-dose Geometric Mean Fold Rises (GMFRs) from baseline of IgG antibody against RSV-G.
Measured: 30 day post each vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 20182 Aug 2019

First posted21 Apr 2021
Study start16 Oct 2018
Primary completion7 Apr 2019
Study completion2 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A total of up to 60 eligible participants will be enrolled and randomised in a 4:1 ratio (investigational vaccine versus placebo) to receive one of the following treatments: * BARS13 low dose (one dose of 10 μg rRSV-G protein/10 μg CsA by IM injection to the deltoid region of one arm, and one dose of placebo \[saline/mannitol\] by IM injection to the deltoid region of the other arm, given sequentially). * BARS13 high dose (IM injection of 10 μg rRSV-G protein/10 μg CsA administered to the deltoid region of each arm \[one injection of 10 μg rRSV-G protein/10 μg CsA per arm\], given sequentially). The high dose is twice the strength of the low dose. * Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm \[one injection per arm\], given sequentially).
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04851977
Sponsor's protocol ID: ADVA-BARS13-001
Status last verified: Apr 2021
First submitted: 13 Apr 2021
Last updated: 21 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The results of this clinical trial may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. The Sponsor will comply with the requirements for publication of clinical trial results.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, First in Human (FIH), Randomised, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Recombinant Respiratory Syncytial Virus Vaccines (BARS13) When Administered Intramuscularly (IM) to Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT04851977
Acronym / sponsor ID: ADVA-BARS13-001
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus (RSV), BARS13, Vaccines, Virus Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Oct 2018 (actual)
Primary completion: 7 Apr 2019 (actual)
Study completion: 2 Aug 2019 (actual)
First posted: 21 Apr 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: A total of up to 60 eligible participants will be enrolled and randomised in a 4:1 ratio (investigational vaccine versus placebo) to receive one of the following treatments: * BARS13 low dose (one dose of 10 μg rRSV-G protein/10 μg CsA by IM injection to the deltoid region of one arm, and one dose of placebo [saline/mannitol] by IM injection to the deltoid region of the other arm, given sequentially). * BARS13 high dose (IM injection of 10 μg rRSV-G protein/10 μg CsA administered to the deltoid region of each arm [one injection of 10 μg rRSV-G protein/10 μg CsA per arm], given sequentially). The high dose is twice the strength of the low dose. * Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm [one injection per arm], given sequentially).

Arm	Type	Receives
Cohort 1: low dose	Experimental	Biological: Respiratory Syncytial VaccineIM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days.
Cohort 2: low dose	Placebo comparator	Biological: PlaceboIM injection on Day 0 and at Day 30 (12 active, 3 placebo) with follow up at 7 days post vaccination (Day 7 ± 1 day and Day 37 ± 1 day) and Day 60 ± 5 days and a final follow up/ EOS teleconference assessment at Day 90 ± 5 days.
Cohort 3: high dose	Experimental	Biological: Respiratory Syncytial VaccineIM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days.
Cohort 4: high dose	Placebo comparator	Biological: PlaceboIM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

1. A male or female aged 18-45 years (inclusive) at the time of the first vaccination.
2. Able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
3. Written informed consent signed prior to undertaking any protocol related procedures.
4. Haematology, clinical chemistry and urinalysis test results not deviating from the normal reference range by age and gender to a clinically relevant extent at screening.
5. Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent or, if engaged in sexual relations with a person of child-bearing potential, the participant and his partner must use an acceptable, highly effective, contraceptive method from screening and for a period of at least 3 months after the last dose of study drug. Acceptable methods of contraception are the use of condoms and an effective contraceptive for the female partner that could include: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception, or intrauterine contraception/device. The PI is to assess the adequacy of methods of contraception on a case-by-case basis.

Key exclusion criteria (14 listed)

1. Presence of clinically significant medical history, unstable chronic or acute disease, or physical, or laboratory findings that, in the opinion of the PI may potentially increase the expected risk of exposure to the investigational vaccine, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results.
2. Body Mass Index (BMI) great than or equal to 40 at screening. 3. Significant infection or other acute illness, including fever over 37.5°C/99.5°F on the day of randomisation.
4. Birthmarks, tattoos, wound or other skin conditions over the deltoid region of both arms that, in the PI's opinion, could reasonably obscure and interfere with evaluation of local injection site reactions.
5. Inadequate venous access to allow collection of blood samples. 6. Breastfeeding or pregnant as confirmed by a positive serum beta human chorionic gonadotropin (.-HCG) pregnancy test at screening or positive urine pregnancy test at subsequent clinic visits at time points as delineated in the study schedule.
7. Received any prophylactic or therapeutic vaccine, or investigational drug, within 3 months of first vaccination, or anticipated in the follow up period defined for this study.

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
Respiratory Syncytial VaccineAlso: BARS13BARS13 low dose (one dose of 10 μg rRSV-G protein/10 μg CsA by IM injection to the deltoid region of one arm, and one dose of placebo [saline/mannitol] by IM injection to the deltoid region of the other arm, given sequentially).	Biological	Cohort 1: low dose
Respiratory Syncytial VaccineAlso: BARS13BARS13 high dose (IM injection of 10 μg rRSV-G protein/10 μg CsA administered to the deltoid region of each arm [one injection of 10 μg rRSV-G protein/10 μg CsA per arm], given sequentially). The high dose is twice the strength of the low dose.	Biological	Cohort 3: high dose
PlaceboPlacebo (IM injection of saline/mannitol administered to the deltoid region of each arm [one injection per arm], given sequentially).	Biological	Cohort 2: low dose, Cohort 4: high dose

Primary outcome

Incidence of systemic reactions
Time frame: 7 days post vaccination
Incidence of the systemic reactions (fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea, diarrhoea, light-headedness, dizziness, hypersensitivity and headache) assessed by patient reported AEs and diary card
Incidence of local reactions
Time frame: 7 days post vaccination
Incidence of the local reactions (pain, tenderness, erythema, swelling, other e.g. ulceration, scabs, redness, induration, ecchymosis, oedema, itching and paraesthesia) at the site of vaccination assessed by patient reported AEs and diary card
Occurrence of any AE during a 30-minute post-vaccination safety observation period
Time frame: 30 minutes post vaccination on Day 0 and 30
Occurrence of any AE during a 30-day follow-up period after each vaccination.
Occurrence of any AE during a 30-day follow-up period after each vaccination
Time frame: 30 days post vaccination
Occurrence of any AE during a 30-day follow-up period after each vaccination.
Occurrence of any Serious Adverse Event (SAE) form baseline (Day 0) to the last visit
Time frame: 60 days post last vaccination
Occurrence of any Serious Adverse Event (SAE) form baseline (Day 0) to the last visit
Occurrence of any clinical laboratory abnormalities (Toxicity grade > or = 1) form baseline (Day 0) to the last visit
Time frame: 60 days post vaccination
Occurrence of any clinical laboratory abnormalities (Toxicity grade > or = 1) form baseline (Day 0) to the last visit

4 secondary outcomes

Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Time frame: Pre-vaccination
Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Time frame: 30 day post each vaccination
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Time frame: Pre-vaccination
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Time frame: 30 day post each vaccination

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 21 Apr 2021.
Individual participant dataSharing planned: No. The results of this clinical trial may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. The Sponsor will comply with the requirements for publication of clinical trial results.

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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.

Ben Snyder, MBBS principal investigator

The Alfred

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 Respiratory Syncytial Vaccine in people with Respiratory Syncytial Virus Infections, run by Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. at 1 site in Australia.

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 14 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 21 Apr 2021. 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 Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of systemic reactions (time frame: 7 days post vaccination). 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?

On the ClinicalTrials.gov record for NCT04851977.

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 21 Apr 2021.