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)

NCT05142514 | Completed Phase 2

• 1 other identifier: HAN-01
• Study Type: interventional
• Target: 629
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COVID-19; SARS-CoV-2 Acute Respiratory Disease

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  30 weeks

Secondary Outcomes (11)

• Immunogenicity

  Day 21 and 35.

• Immunogenicity

  Day 21 and 35.

• Immunogenicity

  Day 21 and 35.

• Immunogenicity at long-term

  24 and 48 weeks after the second dose

• Immunogenicity at long-term

  24 weeks after the second dose

Other Outcomes (5)

• Number of participants with symptomatic SARS-CoV-2 infections in participants without evidence of infection before COVID-19 HIPRA vaccination.

  30 weeks

• Number of COVID-19 severe infections after receiving COVID-19 HIPRA vaccine.

  30 weeks

• Number of COVID-19 severe infections after receiving COVID-19 HIPRA vaccine.

  30 weeks

Study Arms (2)

COVID-19 Vaccine HIPRA

EXPERIMENTAL

Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart.

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

Biological: Cominarty (Pfizer-BioNtech)

Interventions

COVID-19 Vaccine HIPRA BIOLOGICAL

Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart

COVID-19 Vaccine HIPRA

Cominarty (Pfizer-BioNtech) BIOLOGICAL

Subjects will receive 2 injections of Cominarty administered 21 days apart

Commercial COVID-19 Vaccine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hipra Scientific, S.L.U: lead
• Laboratorios Hipra, S.A.: collaborator
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator

Study Sites (1)

National Institute of Hygiene and Epidemiology

Hanoi, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Interventions

HIPRA COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 2, 2021
• Study Start: November 11, 2021
• Primary Completion: December 27, 2021
• Study Completion: May 6, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)