Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX for the Prevention of COVID-19 in Adolescents From 12 Years to Less Than 18 Years of Age.

Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX as Heterologous Booster for the Prevention of Coronavirus Disease 2019 (COVID-19) in Adolescents From 12 Years to Less Than 18 Years of Age.

This is a Phase IIb, open-label, uncontrolled, multi-centre, non-inferiority clinical trial, to assess the safety and immunogenicity of BIMERVAX® as a heterologous booster dose in adolescents.

In this study a total of 300 adolescents from 12 to less than 18 years will be enrolled and followed for 12 months.

Study Overview

• Status: Recruiting
• Conditions: SARS CoV 2 Infection
• Intervention / Treatment: Biological: BIMERVAX

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Teresa Prat; Phone Number: 972430660; Email: teresa.prat@hipra.com
• Study Contact Backup: Name: Mar Armengol, PhD; Phone Number: 972430660; Email: mar.armengol@hipra.com

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Vall Hebron
    • Contact: Pere Soler
  • Girona, Spain, 17007
    • Recruiting
    • Hospital Josep Trueta
    • Contact: Borja Guarch
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital La Paz
    • Contact: Cristina Calvo
  • Barcelona
    • Centelles, Barcelona, Spain, 08540
      • Recruiting
      • CAP Centelles
      • Contact: Silvia Narejos
  • Girona
    • Peralada, Girona, Spain, 17491
      • Recruiting
      • CAP Peralada
      • Contact: Pyrene Martínez
  • Madrid
    • Boadilla Del Monte, Madrid, Spain, 28660
      • Recruiting
      • Hospial HM Montepríncipe
      • Contact: Silvina Natalini
    • Móstoles, Madrid, Spain, 28938
      • Recruiting
      • Hospital HM Puerta del Sur
      • Contact: Silvina Natalini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescents aged from 12 to less than 18 years at Screening.
• Participant's parent(s)/legal guardian(s) willing and able to sign the informed consent and can comply with all study visits and procedures. A written assent will be required for all participants in the study. Note: Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
• Participant must have received two previous doses of Comirnaty, last dose being at least 6 months before screening.
• Participant has a body mass index at or above the third percentile according to local Child Growth Standards at Screening Visit.
• Healthy participants and participants with pre-existing, chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment, are eligible for inclusion in the study. Note: Healthy participants are determined by medical history, physical examination, and clinical judgment of the investigator. Healthy participants with pre-existing stable diseases, are defined as diseases not requiring significant change in the therapy or hospitalisation for worsening disease during the 6 weeks before enrolment.
• Has a negative Rapid Antigen Test (RAT) at Day 0 before BIMERVAX® vaccine administration.
• Participants biologically able to have children may be enrolled in the study if the participant fulfils all the following criteria:
• Has a negative urine pregnancy test at Screening (Day 0), only for those participants who are biologically able to become pregnant.
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the booster dose, only for those participants who are biologically able to become pregnant.

• Has agreed to continue adequate contraception or abstinence through 3 months following the booster dose.

  1. Participants with female reproductive system:

     1. Hormonal contraception (progestogen only or combined: oral, injectable or transdermal (patch)
     2. Intrauterine device.
     3. Vasectomized partner (the vasectomized partner should be the sole partner for that participant).
     4. Condom.

  2. Participants with male reproductive system:

     1. Vasectomized participants.
     2. Agree to use a condom in partners biologically able to become pregnant.
• Participant must have a body weight >50 kg at Screening visit to be eligible for the cellular immunology assays.

Exclusion Criteria:

• Acute illness with fever ≥ 38.0°C at Screening or within 24 hours prior to vaccination. Participant can be rescheduled for Screening when they have completed 24 hours without fever. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
• Received medications intended to prevent or treat COVID-19 before Screening, except for Comirnaty vaccines.
• Previous or current diagnosis of MIS-C.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results.

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals defined as those with primary and secondary immune deficiencies and those receiving chemotherapy or immunosuppressant drugs other than steroids and glucocorticoids (maximum 1 mg/kg/day of prednisone or total dose of 20mg/day by any administration route for a maximum of 30 consecutive days), within 90 days prior to vaccination or during the study.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Female who is pregnant or breastfeeding.
• Receipt of blood/plasma products, immunoglobulin, monoclonal antibodies, or receipt of any passive antibody therapy, within 90 days prior to vaccination or during the study.
• Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
• Received any non-study vaccine (including seasonal Influenza vaccine) within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
• History of illegal substance use or alcohol abuse within the past 2 years.
• History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
• Individuals who are family members of the Investigators.
• Individuals with documented medical history of microbiologically confirmed COVID-19 will not be eligible for the immunogenicity group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIMERVAX	Biological: BIMERVAX; BIMERVAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in immunogenicity against Omicron BA.1	Neutralisation titre against Omicron BA.1 measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample at Baseline and Day 14.	14 days
Changes in immunogenicity against Omicron BA.1	Geometric Mean Titre (GMT) for group comparison with HIPRA-HH-2 at Baseline and Day 14.	14 days
Incidence of solicited local and systemic reactions (Safety and tolerability of PHH-1V)	Solicited local and systemic reactions through Day 7 after vaccination.	7 days
Incidence of unsolicited local and systemic adverse events (Safety and tolerability of PHH-1V)	Unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination.	28 days
Incidence of related adverse events and serious adverse events (Safety and tolerability of PHH-1V)	Related adverse events (AEs) and all serious adverse events (SAEs) through the end of the study.	1 year
Incidence of adverse events of special interest (Safety and tolerability of PHH-1V)	Adverse event of special interest (AESI) through the end of the study.	1 year
Incidence of related medically attended adverse events (Safety and tolerability of PHH-1V)	Related medically attended adverse events (MAAE) through the end of the study.	1 year
Incidence of Grade 2, Grade 3 and Grade 4 changes in safety laboratory parameters (Safety and tolerability of PHH-1V)	Grade 2, Grade 3 and Grade 4 changes from Baseline in safety laboratory parameters through Day 14 after vaccination.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in immunogenicity against VOCs	Neutralisation titre against VOCs (at least Beta and Delta) measured as IC50 by PBNA and reported as log10 concentration for each individual sample at Baseline and Days 14, 84, 168 and 336.	Days 14, 84, 168 and 336
Changes in immunogenicity against VOCs	GMT at Baseline and Days 14, 84, 168 and 336.	Days 14, 84, 168 and 336
Changes in immunogenicity against Omicron BA.1 and VOCs	GMFR in neutralising antibodies titres against Omicron BA.1 and VOCs (at least Beta and Delta) at Baseline and Day 14.	Day 14

Collaborators and Investigators

• Sponsor: Hipra Scientific, S.L.U
• Collaborators: Veristat, Inc.; Asphalion; VHIR

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HIPRA-HH-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No