COVID-19Phase 2NCT05142514
Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)
A Phase 2 study testing COVID-19 Vaccine HIPRA and Cominarty (Pfizer-BioNtech) in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, run by Hipra Scientific, S.L.U at 1 site in Vietnam.
Trial summary
This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- COVID-19 Vaccine HIPRA and Cominarty (Pfizer-BioNtech)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 1 siteVietnam
- Study dates
- 11 Nov 2021to 6 May 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults males or females between 18-60 years of age at the day of screening.
- Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.
- Body Mass Index 18 to 40 Kg/m2 at screening.
- COVID19 negative quick test or PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination. If an enrolled subject has neutralizing antibodies at baseline, he or she will be excluded from final analysis.
- Willing to avoid all other vaccines within 4 weeks before and after each injection. Seasonal influenza vaccination is allowed if it is received at least 14 days before or after the vaccination.
- Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination.
Show all 9Show fewer
- If female of childbearing potential, willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the last injection.
- If male and not sterilized, willing to avoid impregnating female partners from screening until 8 weeks after last injection.
- Willing and able to provide written informed consent prior the initiation of any study procedures.
Who cannot join
- Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
- Positive pregnancy test at screening or prior to each vaccination.
- Any medical disease (acute, subacute, intermittent or chronic) or condition with grade 2 or above that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results.
- History of serious psychiatric condition likely to affect participation in the study.
- History of respiratory disease (e.g., chronic obstructive pulmonary disease (COPD) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.
- History of significant cardiovascular disease including hypertension (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
Show all 27Show fewer
- History of neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
- Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections.
- Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
- Acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters.
- Usage of any investigational drug ≤ 90 days prior to study entry or plan to participate in another research involving an investigational product (drug/biologic/device) within 12 months after the first study vaccination.
- History of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents.
- History of allergic disease or reactions likely to be exacerbated by any component of the COVID-19 vaccine HIPRA
- Use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination.
- Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
- Known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias.
- Known bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
- Chronic liver disease
- Positive test for HIV types 1 or 2 infection, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV Abs) at screening
- Suspected or known current alcohol abuse or any other substances abuse (except tobacco).
- History of COVID-19 infection.
- Receipt of medications intended to prevent COVID-19.
- Ever received an experimental vaccine against COVID-19.
- Close contact of anyone known to have SARS-CoV-2 infection within 15 days prior to screening visit.
- Being directly involved in the conduct of the study
- Any condition and/or laboratory finding that at the investigator consideration would interfere with the study or put at risk the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIb Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Candidate Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2) in Adult Healthy Volunteers
This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam
Read the detailed description
The study population includes 256 healthy adults aged 18-60 which will be randomized in a ratio 1:1 test:commercial vaccine. Each participant will receive 2 immunisations separated by 21 days and will be followed for 24 weeks after the second dose.
- Conditions
- COVID-19, SARS-CoV-2 Acute Respiratory Disease
- Being tested
- COVID-19 Vaccine HIPRA, Cominarty (Pfizer-BioNtech)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Vaccine HIPRABiological
Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart
Cominarty (Pfizer-BioNtech)Biological
Subjects will receive 2 injections of Cominarty administered 21 days apart
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Vaccine HIPRA | Experimental | Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart. Receives: Biological: COVID-19 Vaccine HIPRA |
| Commercial COVID-19 Vaccine | Active comparator | Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart Receives: Biological: Cominarty (Pfizer-BioNtech) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
Measured: 7 days
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.
Measured: 28 days
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Change from baseline in safety laboratory parameters at 7 days following each vaccination.
Measured: 7 days
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of serious adverse events throughout the study duration.
Measured: 30 weeks
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of adverse events of special interest (AESI) throughout the study duration.
Measured: 30 weeks
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration.
Measured: 30 weeks
Secondary outcomes (11)
Immunogenicity
Neutralization titer for each individual sample and GMT for group comparison at Day 21 and 35.
Measured: Day 21 and 35.
Immunogenicity
IC50 of beta and delta variants.
Measured: Day 21 and 35.
Immunogenicity
Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35.
Measured: Day 21 and 35.
Immunogenicity at long-term
Neutralization titer for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
Measured: 24 and 48 weeks after the second dose
Immunogenicity at long-term
IC50 of beta and delta variants.
Measured: 24 weeks after the second dose
Immunogenicity at long-term
GMFR in neutralizing antibodies titers from baseline at 24 weeks after the second dose.
Measured: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Total binding antibody titer and GMT for group comparison at Day 21 and 35.
Measured: Day 21 and 35
Immunogenicity to the SARS-CoV-2 spike glycoprotein
GMFR in total binding antibodies titer from baseline at Day 21 and 35.
Measured: Day 21 and 35
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
Total Binding antibody titer and GMT for group comparison at 24 weeks after the second dose.
Measured: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
GMFR in total binding antibodies titer from baseline at 24 weeks after the second dose.
Measured: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Percentage of subjects who seroconverted defined as a ≥4-fold change in total binding antibody titer from baseline at Day 21 and 35.
Measured: Day 21 and 35.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start11 Nov 2021
- Primary completion27 Dec 2021
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hipra Scientific, S.L.U
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratorios Hipra, S.A., National Institute of Hygiene and Epidemiology, Vietnam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142514
- Sponsor's protocol ID
- HAN-01
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Candidate Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2) in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05142514
- Acronym / sponsor ID
- HAN-01
- Conditions
- COVID-19, SARS-CoV-2 Acute Respiratory Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Hipra Scientific, S.L.UIndustry (pharma, biotech, devices)
- Collaborators
- Laboratorios Hipra, S.A., National Institute of Hygiene and Epidemiology, Vietnam
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 2 Dec 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.
This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam
Detailed description
The study population includes 256 healthy adults aged 18-60 which will be randomized in a ratio 1:1 test:commercial vaccine. Each participant will receive 2 immunisations separated by 21 days and will be followed for 24 weeks after the second dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Vaccine HIPRA | Experimental | Biological: COVID-19 Vaccine HIPRASubjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart. |
| Commercial COVID-19 Vaccine | Active comparator | Biological: Cominarty (Pfizer-BioNtech)Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults males or females between 18-60 years of age at the day of screening.
- Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.
- Body Mass Index 18 to 40 Kg/m2 at screening.
- COVID19 negative quick test or PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination. If an enrolled subject has neutralizing antibodies at baseline, he or she will be excluded from final analysis.
- Willing to avoid all other vaccines within 4 weeks before and after each injection. Seasonal influenza vaccination is allowed if it is received at least 14 days before or after the vaccination.
Key exclusion criteria (27 listed)
- Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
- Positive pregnancy test at screening or prior to each vaccination.
- Any medical disease (acute, subacute, intermittent or chronic) or condition with grade 2 or above that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results.
- History of serious psychiatric condition likely to affect participation in the study.
- History of respiratory disease (e.g., chronic obstructive pulmonary disease (COPD) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.
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 |
|---|---|---|
| COVID-19 Vaccine HIPRASubjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart | Biological | COVID-19 Vaccine HIPRA |
| Cominarty (Pfizer-BioNtech)Subjects will receive 2 injections of Cominarty administered 21 days apart | Biological | Commercial COVID-19 Vaccine |
Primary outcome
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Time frame: 7 days
Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Time frame: 28 days
Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Time frame: 7 days
Change from baseline in safety laboratory parameters at 7 days following each vaccination.
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Time frame: 30 weeks
Number and percentage of serious adverse events throughout the study duration.
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Time frame: 30 weeks
Number and percentage of adverse events of special interest (AESI) throughout the study duration.
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Time frame: 30 weeks
Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration.
11 secondary outcomes
Immunogenicity
Time frame: Day 21 and 35.
Immunogenicity
Time frame: Day 21 and 35.
Immunogenicity
Time frame: Day 21 and 35.
Immunogenicity at long-term
Time frame: 24 and 48 weeks after the second dose
Immunogenicity at long-term
Time frame: 24 weeks after the second dose
Immunogenicity at long-term
Time frame: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Time frame: Day 21 and 35
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Time frame: Day 21 and 35
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
Time frame: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
Time frame: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Time frame: Day 21 and 35.
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 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
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 COVID-19 Vaccine HIPRA and Cominarty (Pfizer-BioNtech) in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, run by Hipra Scientific, S.L.U at 1 site in Vietnam.
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 9 inclusion and 27 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 Feb 2024. 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 Vietnam. 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 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?
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?
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers (time frame: 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.