A Phase III Trial to Assess the Safety and Immunogenicity of a HIPRA's Candidate Booster Vaccination Against COVID-19.

NCT05246137 | Completed Phase 3 DMC

• 1 other identifier: HIPRA-HH-5
• Study Type: interventional
• Target: 2,646
• Locations: 2 countries
• Sites: 18

Brief Summary

This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

  Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.

  Day 7

• Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)

  Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination

  Day 28

• Incidence of Serious Adverse Events (Safety and tolerability) (SAE)

  Number and percentage of serious adverse events (SAEs) through the end of the study.

  Day 365

• Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).

  Number and percentage of adverse event of special interest (AESI) through the end of the study.

  Day 365

• Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs)

  Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study.

  Day 365

• Incidence of Adverse Events in laboratory parameters (Safety and tolerability)

  Grade 3 and 4 changes from baseline in safety laboratory parameters at Days 14, 91 and 182 after vaccination. through the end of the study.

  Day 365

Secondary Outcomes (5)

• Changes in the immunogenicity measured by pseudovirus neutralisation

  Day 365

• Changes in the immunogenicity measured by pseudovirus neutralisation

  Day 14

• Changes in the immunogenicity measured by means of total antibody against RBD

  Day 365

• Changes in the immunogenicity measured by means of total antibody against RBD.

  Day 14

• Changes in the immunogenicity measured by means of total antibody against RBD

  Day 14

Other Outcomes (8)

• To assess number of subjects with SARS-CoV-2 infections ≥14 days after PHH-1V booster.

  Day 365

• To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V. SARS-CoV-2 infections ≥14 days after PHH-1V booster.

  Day 365

• To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V and hospital admissions SARS-CoV-2 infections ≥14 days after PHH-1V booster.

  Day 365

Study Arms (1)

Experimental: COVID-19 Vaccine HIPRA 40 ug/dose

EXPERIMENTAL

COVID-19 Vaccine HIPRA, where subjects will receive one intramuscular injection of COVID-19 vaccine developed by HIPRA

Biological: COVID-19 Vaccine 40 ug/dose

Interventions

COVID-19 Vaccine 40 ug/dose BIOLOGICAL

Intramuscular injection of 0,5 ml with 40 ug of recombinant PHH-1V

Experimental: COVID-19 Vaccine HIPRA 40 ug/dose

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥ 16 years old at Day 0.
• Willing to provide consent indicating that she or he understands the purpose and potential risks and is willing and able to participate in the study and comply with all the study requirements and procedures.
• Have a recognized primary vaccination scheme recognized by the authorities with Comirnaty, Spikevax, Vaxevria or Janssen at least 91 days and preferably a maximum of 240 days before Day 0.
• If having an underlying illnesses must be stable and well-controlled according to the investigator judgment.
• Participant is willing to avoid receiving live attenuated vaccines (licensed) within 4 weeks before screening or after receiving any study vaccine, or other not live vaccines (licensed) within 14 days before and after receiving any study vaccine.
• Participant agrees not to donate blood, blood products and bone marrow at least 3 months before and after vaccination.
• Female participant of childbearing potential must have a negative pregnancy test on the on Day 0 prior to vaccination.
• Female participant of childbearing potential must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (hormonal contraception: oral, injectable or transdermal patch, intrauterine device, vasectomized partner, sexual abstinence or condom).
• Male participants must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (vasectomized participants, condom, sexual abstinence).
• Male participants must refrain from donating sperm for at least 28 days after day 0.

You may not qualify if:

• History of anaphylaxis to any prior vaccine.
• Previous severe SARS-CoV-2 infections that required \>24 hous of hospitalisation.
• Participant received or plans to receive live attenuated vaccines within 4 weeks before and after day 0; or other not live vaccines within 14 days before and after day 0.
• Pregnancy or breast-feeding at screening or Day 0 or willingness/intention to become pregnant during the study.
• Having a clinically significant acute illness or fever (temperature ≥38º C (100.4ºF)) at screening or within 48 hours prior to Day 0.
• Participant had a surgery requiring hospitalization before vaccination and he/she has not received the hospital discharge at day 0; or has a surgery requiring hospitalization planned within 12 weeks after study vaccine administration.
• Having any active malignancy even if under treatment except for non-melanoma skin cancer, uterine cervical carcinoma, anal carcinoma, localized prostate cancer.
• Having ongoing severe and non-stable psychiatric condition likely to affect participation in the study.
• Having problematic or risk use of substances including alcohol that can compromise the study follow-up.
• Having a bleeding disorder or has any condition that in the opinion of the investigator contraindicates intramuscular injections.
• Having abnormal function of the immune system, except stable clinical conditions like controlled HIV.
• Having clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder judged by the investigator within 3 months before screening.
• Chronic or recurrent administration of systemic immunosuppressant medication.
• Having received immunoglobulins and/or blood-derived products 12 weeks prior vaccination (Day 0) or expects to receive them during the study.
• Having received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days before day 0.

Sponsors & Collaborators

• Hipra Scientific, S.L.U: lead

Study Sites (18)

Hospital de Niguarda

Milan, 20162, Italy

Location

Hospital Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de Mollet

Mollet del Vallès, Barcelona, 08100, Spain

Location

Hospital Principe de Asturias

Meco, Madrid, 28805, Spain

Location

Hospital HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital HM Delfos

Barcelona, 08023, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Vall Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 17170, Spain

Location

Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital HM Montepríncipe

Madrid, 28660, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

Hospital Clínico de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• Moros A, Prenafeta A, Barreiro A, Perozo E, Fernandez A, Canete M, Gonzalez L, Garriga C, Pradenas E, Marfil S, Blanco J, Cebollada Rica P, Sistere-Oro M, Meyerhans A, Prat Cabanas T, March R, Ferrer L. Immunogenicity and safety in pigs of PHH-1V, a SARS-CoV-2 RBD fusion heterodimer vaccine candidate. Vaccine. 2023 Aug 7;41(35):5072-5078. doi: 10.1016/j.vaccine.2023.07.008. Epub 2023 Jul 16.

  PMID: 37460353 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: February 3, 2022
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (17)