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)
- 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
- Short title
- 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)
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2022-05-06
- First posted
- 2021-12-02
- Registry last updated
- 2024-02-26
- Primary completion date
- 2021-12-27
- Start date
- 2021-11-11
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hipra Scientific, S.L.U
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05142514
- ClinicalTrials.gov ID
- NCT05142514
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Single group
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 30 weeks
Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration.
Immunogenicity
Timeframe: Day 21 and 35.
Neutralization titer for each individual sample and GMT for group comparison at Day 21 and 35.
Immunogenicity
Timeframe: Day 21 and 35.
IC50 of beta and delta variants.
Immunogenicity
Timeframe: Day 21 and 35.
Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35.
Immunogenicity at long-term
Timeframe: 24 and 48 weeks after the second dose
Neutralization titer for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
Immunogenicity at long-term
Timeframe: 24 weeks after the second dose
IC50 of beta and delta variants.
Immunogenicity at long-term
Timeframe: 24 weeks after the second dose
GMFR in neutralizing antibodies titers from baseline at 24 weeks after the second dose.
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Timeframe: Day 21 and 35
Total binding antibody titer and GMT for group comparison at Day 21 and 35.
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Timeframe: Day 21 and 35
GMFR in total binding antibodies titer from baseline at Day 21 and 35.
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
Timeframe: 24 weeks after the second dose
Total Binding antibody titer and GMT for group comparison at 24 weeks after the second dose.
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
Timeframe: 24 weeks after the second dose
GMFR in total binding antibodies titer from baseline at 24 weeks after the second dose.
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Timeframe: Day 21 and 35.
Percentage of subjects who seroconverted defined as a ≥4-fold change in total binding antibody titer from baseline at Day 21 and 35.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- 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.
- 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.
- National Institute of Hygiene and EpidemiologyHanoi, Vietnam
Related records
Drugs (1)
Collaborators (2)
- Laboratorios Hipra, S.A.
- National Institute of Hygiene and Epidemiology, Vietnam
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition