NCT05007509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Aug 2021

Typical duration for phase_1 covid19

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

August 12, 2021

Last Update Submit

February 28, 2023

Conditions

Covid19SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (2)

  • Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.

    7 days

  • Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.

    28 days

Secondary Outcomes (14)

  • Change from baseline in hematology and biochemistry laboratory values at 7 days following each vaccination

    7 days

  • Number and percentage of serious adverse events throughout the study duration.

    357 days

  • Number and percentage of adverse events of special interest (AESI) throughout the study

    357 days

  • Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration

    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

    Day 21 and 35

  • +9 more secondary outcomes

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 10Biological: COVID-19 vaccine HIPRA 20Biological: 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.

Biological: Commercial COVID-19 vaccine

Interventions

COVID-19 vaccine HIPRA 10BIOLOGICAL

One sentinel subject and 4 additional subjects will be assigned to COVID-19 vaccine HIPRA 10 µg

Also known as: COHORT 1
COVID-19 vaccine HIPRA
COVID-19 vaccine HIPRA 20BIOLOGICAL

One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 20 µg

Also known as: COHORT 2
COVID-19 vaccine HIPRA
COVID-19 vaccine HIPRA 40BIOLOGICAL

One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 40 µg

Also known as: COHORT 3
COVID-19 vaccine HIPRA
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

Commercial COVID-19 vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

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 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.
  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain

Location

Related Publications (1)

  • 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.

    PMID: 37775521DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

KPNA1 protein, human

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Elia Torroella

    Laboratorios Hipra, S.A.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 16, 2021

Study Start

August 16, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

ES(2)