Covid19Phase 2NCT05200741
To Evaluate Safety & Immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 for COVID-19 in Healthy Adults Received 2 Doses of BNT162b2
A Phase 2 study testing DelNS1-2019-nCoV-RBD-OPT1 in people with Covid19, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- DelNS1-2019-nCoV-RBD-OPT1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Feb 2022to Feb 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an ICF indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
- BNT162b2 Vaccination Status: The subject must have received 2 doses of BNT162b2 in Hong Kong, with the second dose completed at least 180 days prior to the first vaccination.
- Gender and Age: Male or female, at the age of ≥ 18 and ≤ 75 on the day of signing the ICF.
- Body Weight and BMI: Body weight ≥ 45 kg and BMI ≥ 18.5 kg/m2 and < 25 kg/m2 at screening and baseline.
- Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
- Generally in good health with no clinically significant abnormality, as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests at screening and baseline;
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- Normal vital signs at screening and baseline, as defined by:
- Body (tympanic) temperature ≤ 37.5 oC;
- Resting pulse rate ≥ 50 and ≤ 100 bpm; and
- DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
- Contraception: Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
- A female subject who is a woman of childbearing potential (WOCBP) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from at least 30 days prior to the first vaccination until 60 days after the second vaccination;
- A male subject (i) who is sexually active with a WOCBP (except who is permanently sterile by bilateral orchiectomy or vasectomy) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from the first vaccination until 60 days after the second vaccination; and (ii) must be willing and agree to refrain from sperm donation during the aforesaid period.
- Breastfeeding: A female subject must be willing and agree to avoid engagement in breastfeeding at any time from the first vaccination until 60 days after the second vaccination.
- Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.
Who cannot join
- Medical History: History of any of the following diseases or conditions:
- COVID-19;
- SARS;
- Any significant respiratory diseases (e.g. COPD, asthma);
- Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
- Blood dyscrasias or any significant disorder of coagulation;
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- Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
- Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
- Any malignant neoplastic disease;
- Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
- Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
- Any immunodeficiency or autoimmune disease;
- Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
- Any nasal septal defect, cleft palate, nasal polyps or other nasal abnormality that might affect vaccine administration;
- History of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening.
- Medical Conditions or Diagnoses: Existence of any of the following medical conditions or diagnoses:
- Positive serum pregnancy test at screening or positive urine pregnancy test at baseline (for WOCBP);
- IgE level > 1,000 IU/ml at screening;
- Positive SARS-CoV-2 test result in deep throat saliva (DTS) within 4 days prior to the first vaccination;
- Positive HIV test result at screening;
- Positive HBsAg test result at screening;
- Positive HCV antibody test result at screening;
- Positive urine drug screen test result or positive blood alcohol test result at screening or baseline;
- Clinically significant abnormality of T3, T4 or TSH at screening;
- Clinically significant abnormality of PT (INR) or aPTT at screening.
- Prior/Concomitant Interventions: Use of or undergoing any of the following prior or concomitant medications, therapies or interventions:
- Any COVID-19 or coronavirus vaccine at any time prior to the first vaccination, except BNT162b2 or planned use of any such vaccine throughout the study;
- Any vaccine other than COVID-19 or coronavirus vaccines within 28 days prior to the first vaccination, or planned use of any such vaccine up to 28 days after the second vaccination;
- Any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to the first vaccination, or planned use of any such medication/therapy throughout the study;
- Any blood product (including blood transfusion) or immunoglobulin within 3 months prior to the first vaccination, or planned use of any such therapy throughout the study;
- Any anticoagulation medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
- Any psychotropic medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
- Regular use of any inhaled/nebulized corticosteroid;
- Any intranasal preparation within 48 hours prior to the first vaccination, or planned use of any such preparation up to 48 hours after the second vaccination;
- Any influenza antiviral medication within 48 hours prior to the first vaccination, or planned use of any such medication up to 14 days after the second vaccination;
- Any prescription or over-the-counter medication within 7 days prior to the first vaccination, unless with the investigator's approval;
- Donated ≥ 450 ml of blood within 28 days prior to the first vaccination;
- Prior nasal surgery or nasal cauterization.
- Prior/Concurrent Clinical Study: Prior or concurrent participation in any other clinical study, including:
- Prior or current participation in another COVID-19 vaccine study;
- Prior participation in any interventional clinical study and use of any investigational intervention within 90 days prior to the first vaccination;
- Concurrent participation or plan for participation in another interventional clinical study during participation in this study.
- Other Significant Medical Conditions: Any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study.
- Special Conditions: Existence of any of the following special conditions:
- Close contact with anyone known to have COVID-19 within 30 days prior to the first vaccination;
- Travelled outside Hong Kong within 14 days prior to the first vaccination;
- Planned to travel outside Hong Kong at any time during the period from screening to Day 50(±3) visit.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
HKU Phase 1 Clinical Trials Centre
Hong Kong
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as Booster Vaccine for COVID-19 in Healthy Adults Who Have Received 2 Doses of BNT162b2
To evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2
Read the detailed description
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2. Each subject will receive 2 vaccinations or matching placebo 3 weeks apart.
- Conditions
- Covid19
- Being tested
- DelNS1-2019-nCoV-RBD-OPT1, Matching 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.
DelNS1-2019-nCoV-RBD-OPT1Biological
Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray
Matching placeboBiological
Solution for Intranasal Spray
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | DelNS1-2019-nCoV-RBD-OPT1 virus titre at not less than 6.3 lg CCID50/dose, 2 doses 3 weeks apart, intranasal administration Receives: Biological: DelNS1-2019-nCoV-RBD-OPT1 |
| Reference Product | Placebo comparator | Matching placebo, 2 doses 3 weeks apart, intranasal administration Receives: Biological: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity
Occurrence of solicited local events (nasal irritation, sneezing, nasal congestion, cough, sore throat, change in smell, change in taste, change in vision and eye pain) and solicited systemic events (fever, headache, malaise, myalgia, joint pain, nausea, vomiting, diarrhea, abdominal pain, chills and sweating) for a 14-day period after each vaccination
Measured: Day 1 to 15 and Day 22 to 36
Adverse Events
Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Measured: Day 1 to Day 202(±7)
Neutralizing Antibodies in Serum against Live SARS-CoV-2 Measured by Neutralization Assay
Measurement of neutralizing antibody levels by microneutralization (MN) assay in serum samples
Measured: Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Binding Antibodies in Serum against SARS-CoV-2 RBD Measured by CMIA
Measurement of binding antibody responses by chemiluminescent microparticle immunoassay (CMIA) in serum samples
Measured: Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Secondary outcomes (2)
T-cell Responses against SARS-CoV-2 Spike Peptide Measured by ELISpot
Enumeration of antigen-specific T cells by IFN gamma ELISpot assay in serum samples
Measured: Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Total Ig Antibodies in Mucosal Secretion against SARS-CoV-2 RBD Measured by ELISA
Measurement of total Ig antibody levels in saliva samples
Measured: Day 1(pre-dose), 4(+1), 22(pre-dose), 25(+1), 36(+2) and 50(±3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start8 Feb 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Fan-ngai Hung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200741
- Sponsor's protocol ID
- CTC2235
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of this study will be publicly disseminated by ways of publication(s) in peer-reviewed scientific journal(s), presentation(s) in scientific conference(s), posting on public clinical trial registry(ies) and/or otherwise instead of individual participant data (IPD) sharing.
Publications
Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) Phase III Clinical Trial - Investigator's Brochure (Version 2.0, Dated 02-Sep-2021).
Wang P, Zheng M, Lau SY, Chen P, Mok BW, Liu S, Liu H, Huang X, Cremin CJ, Song W, Chen Y, Wong YC, Huang H, To KK, Chen Z, Xia N, Yuen KY, Chen H. Generation of DelNS1 Influenza Viruses: a Strategy for Optimizing Live Attenuated Influenza Vaccines. mBio. 2019 Sep 17;10(5):e02180-19. doi: 10.1128/mBio.02180-19.
PubMed 31530680Zheng M, Wang P, Song W, Lau SY, Liu S, Huang X, Mok BW, Liu YC, Chen Y, Yuen KY, Chen H. An A14U Substitution in the 3' Noncoding Region of the M Segment of Viral RNA Supports Replication of Influenza Virus with an NS1 Deletion by Modulating Alternative Splicing of M Segment mRNAs. J Virol. 2015 Oct;89(20):10273-85. doi: 10.1128/JVI.00919-15. Epub 2015 Jul 29.
PubMed 26223635
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as Booster Vaccine for COVID-19 in Healthy Adults Who Have Received 2 Doses of BNT162b2
- ClinicalTrials.gov ID
- NCT05200741
- Acronym / sponsor ID
- CTC2235
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 21 Jan 2022 (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.
To evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2
Detailed description
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2. Each subject will receive 2 vaccinations or matching placebo 3 weeks apart.
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 |
|---|---|---|
| Test Product | Experimental | Biological: DelNS1-2019-nCoV-RBD-OPT1DelNS1-2019-nCoV-RBD-OPT1 virus titre at not less than 6.3 lg CCID50/dose, 2 doses 3 weeks apart, intranasal administration |
| Reference Product | Placebo comparator | Biological: Matching placeboMatching placebo, 2 doses 3 weeks apart, intranasal administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Informed Consent: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an ICF indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
- BNT162b2 Vaccination Status: The subject must have received 2 doses of BNT162b2 in Hong Kong, with the second dose completed at least 180 days prior to the first vaccination.
- Gender and Age: Male or female, at the age of ≥ 18 and ≤ 75 on the day of signing the ICF.
- Body Weight and BMI: Body weight ≥ 45 kg and BMI ≥ 18.5 kg/m2 and < 25 kg/m2 at screening and baseline.
- Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
Key exclusion criteria (47 listed)
- Medical History: History of any of the following diseases or conditions:
- Medical Conditions or Diagnoses: Existence of any of the following medical conditions or diagnoses:
- Prior/Concomitant Interventions: Use of or undergoing any of the following prior or concomitant medications, therapies or interventions:
- Prior/Concurrent Clinical Study: Prior or concurrent participation in any other clinical study, including:
- Other Significant Medical Conditions: Any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in 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 |
|---|---|---|
| DelNS1-2019-nCoV-RBD-OPT1Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray | Biological | Test Product |
| Matching placeboSolution for Intranasal Spray | Biological | Reference Product |
Primary outcome
Reactogenicity
Time frame: Day 1 to 15 and Day 22 to 36
Occurrence of solicited local events (nasal irritation, sneezing, nasal congestion, cough, sore throat, change in smell, change in taste, change in vision and eye pain) and solicited systemic events (fever, headache, malaise, myalgia, joint pain, nausea, vomiting, diarrhea, abdominal pain, chills and sweating) for a 14-day period after each vaccination
Adverse Events
Time frame: Day 1 to Day 202(±7)
Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Neutralizing Antibodies in Serum against Live SARS-CoV-2 Measured by Neutralization Assay
Time frame: Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Measurement of neutralizing antibody levels by microneutralization (MN) assay in serum samples
Binding Antibodies in Serum against SARS-CoV-2 RBD Measured by CMIA
Time frame: Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Measurement of binding antibody responses by chemiluminescent microparticle immunoassay (CMIA) in serum samples
2 secondary outcomes
T-cell Responses against SARS-CoV-2 Spike Peptide Measured by ELISpot
Time frame: Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Total Ig Antibodies in Mucosal Secretion against SARS-CoV-2 RBD Measured by ELISA
Time frame: Day 1(pre-dose), 4(+1), 22(pre-dose), 25(+1), 36(+2) and 50(±3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- BackgroundInfluenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) Phase III Clinical Trial - Investigator's Brochure (Version 2.0, Dated 02-Sep-2021).
- Background: PubMed 31530680Wang P, Zheng M, Lau SY, Chen P, Mok BW, Liu S, Liu H, Huang X, Cremin CJ, Song W, Chen Y, Wong YC, Huang H, To KK, Chen Z, Xia N, Yuen KY, Chen H. Generation of DelNS1 Influenza Viruses: a Strategy for Optimizing Live Attenuated Influenza Vaccines. mBio. 2019 Sep 17;10(5):e02180-19. doi: 10.1128/mBio.02180-19.
- Background: PubMed 26223635Zheng M, Wang P, Song W, Lau SY, Liu S, Huang X, Mok BW, Liu YC, Chen Y, Yuen KY, Chen H. An A14U Substitution in the 3' Noncoding Region of the M Segment of Viral RNA Supports Replication of Influenza Virus with an NS1 Deletion by Modulating Alternative Splicing of M Segment mRNAs. J Virol. 2015 Oct;89(20):10273-85. doi: 10.1128/JVI.00919-15. Epub 2015 Jul 29.
- Accessed on 15 November 2021Link provided by the sponsor.
- Accessed on 15 November 2021Link provided by the sponsor.
- Accessed on 07 January 2021Link provided by the sponsor.
- Accessed on 15 November 2021Link provided by the sponsor.
- Individual participant dataSharing planned: No. The results of this study will be publicly disseminated by ways of publication(s) in peer-reviewed scientific journal(s), presentation(s) in scientific conference(s), posting on public clinical trial registry(ies) and/or otherwise instead of individual participant data (IPD) sharing.
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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.
Ivan Fan-ngai Hung principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DelNS1-2019-nCoV-RBD-OPT1 in people with Covid19, run by The University of Hong Kong at 1 site in Hong Kong.
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 15 inclusion and 47 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: status not confirmed, as of the sponsor's last update on 28 Oct 2022. 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 Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volunteer Resource Centre (85296812309, ctcvrc@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactogenicity (time frame: Day 1 to 15 and Day 22 to 36). The study lists 4 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 NCT05200741, which also lists 3 linked publications.
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 28 Oct 2022.