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.

NCT06234956 | Completed Phase 2 DMC

• 1 other identifier: HIPRA-HH-3
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Changes in immunogenicity against VOCs

  Days 14, 84, 168 and 336

• Changes in immunogenicity against VOCs

  Days 14, 84, 168 and 336

• Changes in immunogenicity against Omicron BA.1 and VOCs

  Day 14

Study Arms (1)

BIMERVAX

EXPERIMENTAL

Biological: BIMERVAX

Interventions

BIMERVAX BIOLOGICAL

BIMERVAX

BIMERVAX

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.
• Participants with female reproductive system:
• Hormonal contraception (progestogen only or combined: oral, injectable or transdermal (patch)
• Intrauterine device.
• Vasectomized partner (the vasectomized partner should be the sole partner for that participant).
• Condom.
• Participants with male reproductive system:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hipra Scientific, S.L.U: lead
• Veristat, Inc.: collaborator
• VHIR: collaborator
• Asphalion: collaborator

Study Sites (7)

Hospital Vall Hebron

Barcelona, Barcelona, 08035, Spain

Location

CAP Centelles

Centelles, Barcelona, 08540, Spain

Location

Hospital Josep Trueta

Girona, Girona, 17007, Spain

Location

CAP Peralada

Peralada, Girona, 17491, Spain

Location

Hospital HM Montepríncipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

MeSH Terms

Conditions

COVID-19

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: January 31, 2024
• Study Start: June 8, 2023
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)