Covid19Phase 1/2NCT05007509
Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19)
A Phase 1/2 study testing COVID-19 vaccine HIPRA 10, COVID-19 vaccine HIPRA 20 and COVID-19 vaccine HIPRA 40 in people with Covid19 and SARS CoV 2 Infection, run by Laboratorios Hipra, S.A. at 2 sites in Spain.
Trial summary
This is a first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS CoV 2 Infection
- What is being tested?
- COVID-19 vaccine HIPRA 10, COVID-19 vaccine HIPRA 20 and COVID-19 vaccine HIPRA 40
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Aug 2021to 30 Sep 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults males or females between 18-39 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 PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination.
- 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.
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- 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 18 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 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 (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
- 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.
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- 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
2 sites in 1 country.
Spain2 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitari Dr. Josep Trueta
Girona, 17007
About this study
Official title: A Phase I/IIa Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers
This is a first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers.
Read the detailed description
The study population includes 30 healthy adults aged 18-39 which will be distributed in 3 cohorts, receiving three different doses of antigen, 10 µg, 20 µg and 40 µg. In each cohort, patients will be randomized in ratio of 10:2 test:commercial vaccine, following an staggered enrolment with a sentinel subject in each cohort. Each participant will receive 2 immunisations separated by 21 days, and will be followed for 48 weeks after the second dose
- Conditions
- Covid19, SARS CoV 2 Infection
- Being tested
- COVID-19 vaccine HIPRA 10, COVID-19 vaccine HIPRA 20, COVID-19 vaccine HIPRA 40, Commercial COVID-19 vaccine
- 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 HIPRA 10Biological
Also called COHORT 1
One sentinel subject and 4 additional subjects will be assigned to COVID-19 vaccine HIPRA 10 µg
COVID-19 vaccine HIPRA 20Biological
Also called COHORT 2
One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 20 µg
COVID-19 vaccine HIPRA 40Biological
Also called COHORT 3
One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 40 µg
Commercial COVID-19 vaccineBiological
One subject in cohort 1 and 2 subjects in Cohort 2 and 3 will be assigned to Commercial COVID-19 vaccine
| 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 10; Biological: COVID-19 vaccine HIPRA 20; Biological: COVID-19 vaccine HIPRA 40 |
| Commercial COVID-19 vaccine | Active comparator | Subjects will receive 2 injections of commercial COVID-19 vaccine administered 21 days apart. Receives: Biological: Commercial COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
Measured: 7 days
Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.
Measured: 28 days
Secondary outcomes (14)
Change from baseline in hematology and biochemistry laboratory values at 7 days following each vaccination
Measured: 7 days
Number and percentage of serious adverse events throughout the study duration.
Measured: 357 days
Number and percentage of adverse events of special interest (AESI) throughout the study
Measured: 357 days
Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration
Measured: 357 days
Neutralization titer measured as Inhibitory concentration 50 (IC50) for each individual sample and geometric mean titer (GMT) for group comparison at Day 21 and 35
Measured: Day 21 and 35
Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35.
Measured: Day 21 and 35
Neutralization titer measured as IC50 for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose
Measured: week 27 and week 51
GMFR in neutralizing antibodies titers from baseline at 24 and 48 weeks after the second dose.
Measured: week 27 and week 51
Binding antibody IgG titer measured for each individual sample and GMT for group comparison at Day 21 and 35
Measured: Day 21 and 35
GMFR in IgG titer from baseline at Day 21 and 35
Measured: Day 21 and 35
Binding antibody IgG titer measured for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
Measured: week 27 and week 51
GMFR in IgG titer from baseline at 24 and 48 weeks after the second dose
Measured: week 27 and week 51
T-cell-mediated response to the SARS-CoV-2 S protein as measured by whole PBMC stimulation by ELISpot at baseline and at Day 35.
Measured: Day 35
CD4+/CD8+ T-cell response to the SARS-CoV-2 S protein as measured by in vitro PBMC stimulation by cytokine staining assays at baseline and at Day 35
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start16 Aug 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 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
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Hipra, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elia Torroella, Study chair, Laboratorios Hipra, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007509
- Sponsor's protocol ID
- HIPRA-HH-1
- Other IDs
- 2021-001411-82
- Status last verified
- Feb 2023
- First submitted
- 12 Aug 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Publications
Leal L, Pich J, Ferrer L, Nava J, Marti-Lluch R, Esteban I, Pradenas E, Raich-Regue D, Prenafeta A, Escobar K, Pastor C, Ribas-Aulinas M, Trinite B, Munoz-Basagoiti J, Domenech G, Clotet B, Corominas J, Corpes-Comes A, Garriga C, Barreiro A, Izquierdo-Useros N, Arnaiz JA, Soriano A, Rios J, Nadal M, Plana M, Blanco J, Prat T, Torroella E, Ramos R; HIPRA-HH-1 study group. Safety and immunogenicity of a recombinant protein RBD fusion heterodimer vaccine against SARS-CoV-2. NPJ Vaccines. 2023 Sep 29;8(1):147. doi: 10.1038/s41541-023-00736-5.
PubMed 37775521
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05007509
- Acronym / sponsor ID
- HIPRA-HH-1
- Conditions
- Covid19, SARS CoV 2 Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratorios Hipra, S.A.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Aug 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 first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers.
Detailed description
The study population includes 30 healthy adults aged 18-39 which will be distributed in 3 cohorts, receiving three different doses of antigen, 10 µg, 20 µg and 40 µg. In each cohort, patients will be randomized in ratio of 10:2 test:commercial vaccine, following an staggered enrolment with a sentinel subject in each cohort. Each participant will receive 2 immunisations separated by 21 days, and will be followed for 48 weeks after the second dose
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 vaccine HIPRA | Experimental | Biological: COVID-19 vaccine HIPRA 10, Biological: COVID-19 vaccine HIPRA 20, Biological: COVID-19 vaccine HIPRA 40Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart. |
| Commercial COVID-19 vaccine | Active comparator | Biological: Commercial COVID-19 vaccineSubjects will receive 2 injections of commercial COVID-19 vaccine administered 21 days apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults males or females between 18-39 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 PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination.
- 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 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 (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
- 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 HIPRA 10Also: COHORT 1One sentinel subject and 4 additional subjects will be assigned to COVID-19 vaccine HIPRA 10 µg | Biological | COVID-19 vaccine HIPRA |
| COVID-19 vaccine HIPRA 20Also: COHORT 2One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 20 µg | Biological | COVID-19 vaccine HIPRA |
| COVID-19 vaccine HIPRA 40Also: COHORT 3One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 40 µg | Biological | COVID-19 vaccine HIPRA |
| Commercial COVID-19 vaccineOne subject in cohort 1 and 2 subjects in Cohort 2 and 3 will be assigned to Commercial COVID-19 vaccine | Biological | Commercial COVID-19 vaccine |
Primary outcome
Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
Time frame: 7 days
Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.
Time frame: 28 days
14 secondary outcomes
Change from baseline in hematology and biochemistry laboratory values at 7 days following each vaccination
Time frame: 7 days
Number and percentage of serious adverse events throughout the study duration.
Time frame: 357 days
Number and percentage of adverse events of special interest (AESI) throughout the study
Time frame: 357 days
Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration
Time frame: 357 days
Neutralization titer measured as Inhibitory concentration 50 (IC50) for each individual sample and geometric mean titer (GMT) for group comparison at Day 21 and 35
Time frame: Day 21 and 35
Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35.
Time frame: Day 21 and 35
Neutralization titer measured as IC50 for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose
Time frame: week 27 and week 51
GMFR in neutralizing antibodies titers from baseline at 24 and 48 weeks after the second dose.
Time frame: week 27 and week 51
Binding antibody IgG titer measured for each individual sample and GMT for group comparison at Day 21 and 35
Time frame: Day 21 and 35
GMFR in IgG titer from baseline at Day 21 and 35
Time frame: Day 21 and 35
Binding antibody IgG titer measured for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
Time frame: week 27 and week 51
GMFR in IgG titer from baseline at 24 and 48 weeks after the second dose
Time frame: week 27 and week 51
T-cell-mediated response to the SARS-CoV-2 S protein as measured by whole PBMC stimulation by ELISpot at baseline and at Day 35.
Time frame: Day 35
CD4+/CD8+ T-cell response to the SARS-CoV-2 S protein as measured by in vitro PBMC stimulation by cytokine staining assays at baseline and at Day 35
Time frame: Day 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 1 Mar 2023.
- Derived from this study: PubMed 37775521Leal L, Pich J, Ferrer L, Nava J, Marti-Lluch R, Esteban I, Pradenas E, Raich-Regue D, Prenafeta A, Escobar K, Pastor C, Ribas-Aulinas M, Trinite B, Munoz-Basagoiti J, Domenech G, Clotet B, Corominas J, Corpes-Comes A, Garriga C, Barreiro A, Izquierdo-Useros N, Arnaiz JA, Soriano A, Rios J, Nadal M, Plana M, Blanco J, Prat T, Torroella E, Ramos R; HIPRA-HH-1 study group. Safety and immunogenicity of a recombinant protein RBD fusion heterodimer vaccine against SARS-CoV-2. NPJ Vaccines. 2023 Sep 29;8(1):147. doi: 10.1038/s41541-023-00736-5.
- Individual participant dataSharing planned: Undecided. To be decided
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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.
Elia Torroella study chair
Laboratorios Hipra, S.A.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing COVID-19 vaccine HIPRA 10, COVID-19 vaccine HIPRA 20 and COVID-19 vaccine HIPRA 40 in people with Covid19 and SARS CoV 2 Infection, run by Laboratorios Hipra, S.A. at 2 sites in Spain.
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 1 Mar 2023. 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 Spain. 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 combined 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.
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?
Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007509, 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 1 Mar 2023.