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COVID-19Phase 2NCT05305573

Assessing the Immunogenicity and Safety of a HIPRA's Candidate Booster Vaccination in Adults Fully Vaccinated With Adenovirus Vaccine Against COVID-19.

A Phase 2 study testing COVID-19 Vaccine HIPRA 40 ug/dose and Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injection in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, run by Hipra Scientific, S.L.U at 7 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase IIb clinical trial to assess the Immunogenicity and Safety of a HIPRA's Candidate Booster vaccination (PHH-1V) in adults fully vaccinated with the adenovirus vaccine Vaxevria against COVID-19. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
COVID-19 Vaccine HIPRA 40 ug/dose and Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
7 sitesSpain
Study dates
25 Mar 2022to 1 Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all the following criteria to be considered eligible for the study:
  • Male or female, ≥ 18 years old at Day 0.
  • Participant must 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 (scheduled visits, laboratory tests, complete diaries, etc).
  • Participant who has been vaccinated with two doses of Vaxzevria at least 91 days before Day 0 and a maximum of 365 days of the second dose.
  • Has a negative Rapid Antigen Test (RAT) at Day 0
  • Participants may have underlying illnesses if are stable and well-controlled according to the investigator judgment. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to screening and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future.
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  • Participant agrees not to donate blood, blood products and bone marrow at least 12 weeks before and after vaccination.
  • Contraceptive use should be consistent with local regulation for participants in clinical trials.
  • Female participants of childbearing potential [defined as any female who has experienced menarche and until becoming postmenopausal* (defined as having ≥ 12 months amenorrhea prior to screening without an alternative cause) unless is surgically sterile]: i. Have a negative pregnancy test on the day of vaccination. ii. Use of any acceptable contraceptive method that should be started at screening and until 8 weeks after vaccination except hormonal contraception. Acceptable contraceptive methods are:
  • 1. Hormonal contraception (progestogen-only or combined): oral, injectable or transdermal (patch) at least 30 days before Day 0 and until 8 weeks after vaccination.
  • 2. Intrauterine device. 3. Vasectomized partner (the vasectomized partner should be the sole partner for that participant).
  • 4. Sexual abstinence , as a form of contraception, is acceptable if in line with the participant's lifestyle.
  • 5. Condom
  • Male participants: i. Vasectomized participants. ii. Refrain from donating sperm for at least 28 days after day 0. iii. Agree to use a male condom may be considered in women of childbearing potential partners, from screening and for at least 28 days after day 0. iv. Sexual abstinence**, as a form of contraception, is acceptable if in line with the participant's lifestyle.
  • A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.
  • Sexual abstinence is considered an effective method only if defined as refraining from heterosexual intercourse from screening until 8 weeks after receiving the vaccine for female participants and from screening until 4 weeks for male participants. Periodic abstinence (e.g., calendar, ovulation) and withdrawal are not acceptable methods of contraception.

Who cannot join

  • Participants meeting any of the following criteria will be excluded from the study:
  • 8. History of anaphylactic shock of any kind.
  • 9. History of COVID-19 infection.
  • 10. Participant received or plans to receive:
  • Live attenuated vaccines (licensed) within 4 weeks before or after receiving any study vaccine.
  • Other not live vaccines (licensed) within 14 days before and after receiving any study vaccine.
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  • 11. Pregnancy or breast-feeding at screening or Day 0 (vaccination time-point) or willingness/intention to become pregnant during the study.
  • Medical conditions:
  • 12. Participant has a clinically significant acute illness (this does not include minor self-limited illness such as mild diarrhoea) or fever (temperature ≥38º C (100.4ºF) at screening or within 48 hours prior to the planned vaccination (Day 0).
  • 13. Participant had a surgery requiring hospitalization (defined as inpatient stay for > 24 hours) 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. Minor surgical procedures not requiring hospitalization are accepted.
  • 14. Participant has any active malignancy even if under treatment except for (at the discretion of the investigator): a. Non-melanoma adequately treated skin cancer without evidence of disease.
  • Adequately treated uterine cervical carcinoma in situ without evidence of disease.
  • Adequately treated anal carcinoma in situ without evidence of disease. d. Localized prostate cancer.
  • 15. Participant has ongoing severe and non-stable psychiatric condition likely to affect participation in the study (e.g., ongoing and non-stable severe depression, recent suicidal ideation, severe eating disorder, psychosis).
  • 16. Participant has a problematic or risk use of substances including alcohol (except tobacco) that can compromise the study follow-up. Problematic or risk use of psychoactive substances is understood as the one that causes evident damage, whether it is dependence or any other physical, psychological, or social problem or that carries a high risk of suffering these damages. The negative consequences that consumption causes to third parties could be included.
  • 17. Participant has a bleeding disorder (e.g., factor deficiency, platelet disorder), blood dyscrasia, or continuous use of anticoagulants or has any condition that in the opinion of the investigator contraindicates intramuscular injections or frequent phlebotomy. The use of ≤ 325mg of aspirin or ≤ 75mg of clopidogrel per day as prophylaxis is permitted but not combined.
  • 18. Participant has abnormal function of the immune system as in autoimmune diseases, asplenia, recurrent infections or congenital/acquired immunodeficiency. Participants under immune-modifying treatment for any cause. Permitted: participants with stable clinical conditions (e.g., autoimmune thyroiditis, celiac disease, type 1- diabetes) and participants living with HIV with CD4 T cell count ≥ 400 cells/mm3 under stable antiretroviral treatment with a fully suppressed viral load ≥ 1 year are permitted [one or two non-consecutives blips (HIV viral load ≤ 500 viral copies)].
  • 19. Participants have clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder as judged by the investigator and defined as disease requiring hospitalization or addition of new treatments or major dose adjustments within 3 months before screening.
  • 20. Chronic or recurrent administration (during at least 14 days) of systemic immunosuppressant medication (defined as given by oral or parenteral routes) within 12 weeks preceding the planned administration of study vaccine (Day 0). The use of an oral prednisone dose <10mg per day or equivalent, ocular, topical, inhaled and nasal corticoids are allowed.
  • 21. Subject has received immunoglobulins and/or blood-derived products 12 weeks prior vaccination (Day 0) or expects to receive them during the study.
  • 22. Participant received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days preceding the planned administration of study vaccine. Monoclonal antibodies for other indications are allowed.
  • 23. Participation in any research involving an investigational product (drug, biologic, device) within 12 weeks prior to vaccination and during the study.
  • 24. Participant has donated ≥ 450ml of blood products within 12 weeks before screening.
  • 25. Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Spain7 sites

  • Hospital HM Modelo

    A Coruña

  • Hospital Gregorio Marañón

    Madrid

  • Hospital HM Sanchinarro

    Madrid

  • Hospital HM Puerta del Sur

    Móstoles

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital HM Rosaleda

    Santiago de Compostela

  • Complejo Hospitalario Universitario de Vigo

    Vigo

Other trials in Spain

About this study

Official title: A Phase IIb, Double-Blind, Randomized, Active Controlled, Multi-center, Non-inferiority Trial to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Fully Vaccinated With Adenovirus Vaccine Against COVID-19

Phase IIb clinical trial to assess the Immunogenicity and Safety of a HIPRA's Candidate Booster vaccination (PHH-1V) in adults fully vaccinated with the adenovirus vaccine Vaxevria against COVID-19.

Read the detailed description

The study population includes healthy adults aged above 18 years old who have received two doses of the Vaxevria vaccine, and are at least 91 days and less than 365 days after their second dose. Participants will be randomly assigned into two treatment arms. In each arm, volunteers will be randomized in a ratio Test vaccine:Comirnaty of 2:1. Each participant will receive one booster immunisation and will be followed for 6 months to evaluate immunogenicity response and assess the safety of the test vaccine in comparison to Comirnaty.

Being tested
COVID-19 Vaccine HIPRA 40 ug/dose, Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injection
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 Vaccine HIPRA 40 ug/doseBiological

    Subjects will receive one injection of COVID-19 Vaccine HIPRA (PHH-1V)

  • Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injectionBiological

    Subjects will receive one injection of Comirnaty Vaccine

Study groups in NCT05305573
Study groupRoleWhat they receive
COVID-19 Vaccine HIPRA 40 ug/doseExperimentalNot described
Receives: Biological: COVID-19 Vaccine HIPRA 40 ug/dose
Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injectionActive comparatorNot described
Receives: Biological: Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of the immunogenicity against Omicron strain at Day 14

    Neutralisation titre against Omicron strain measured as inhibitory concentration 50 (IC50) by a pseudovirion-based neutralisation assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titre (GMT) for descriptive statistics analysis at Baseline and at Day 14.

    Measured: Day 14

  2. Safety and tolerability of PHH-1V as a booster dose

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

    Measured: Day 7

  3. Safety and tolerability of PHH-1V as a booster dose

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

    Measured: Day 28

  4. Safety and tolerability of PHH-1V as a booster dose

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

    Measured: Day 182

  5. Safety and tolerability of PHH-1V as a booster dose

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

    Measured: Day 182

  6. Safety and tolerability of PHH-1V as a booster dose

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

    Measured: Day 182

  7. Safety and tolerability of PHH-1V as a booster dose

    Change from Baseline in safety laboratory parameters at Days 14, 98 and 182 after vaccination.

    Measured: Days 14, 98 and 182

Secondary outcomes (7)

  1. Changes of the immunogenicity measured by PBNA against the Variants of Concern (VOC)

    Neutralisation titre against VOCs (Beta and Delta) measured as IC50 by PBNA and reported as reciprocal concentration for each individual sample and GMT for treatment group comparison at Baseline and Days 14, 98 and 182.

    Measured: Days 14, 98 and 182

  2. Changes of the immunogenicity measured by PBNA against Omicron

    Geometric mean fold rise (GMFR) in neutralising antibodies titres against Omicron and VOCs (Beta and Delta) for treatment group comparison at Baseline and Day 14.

    Measured: Day 14

  3. Changes of the immunogenicity measured by PBNA against Omicron

    Neutralisation titre against Omicron measured as IC50 by PBNA and reported as reciprocal concentration for each individual sample and GMT for treatment group comparison at Days 98 and 182.

    Measured: Days 98 and 182

  4. Changes of the immunogenicity measured by VNA against Omicron

    Neutralisation titre measured as inhibitory dilution 50 (ID50) against Omicron by a VNA and reported as reciprocal dilution for each individual sample, and GMT for treatment group comparison at Baseline and Day 14, 98 and 182. This analysis will only be performed in a subset of participants.

    Measured: Days 14, 98 and 182

  5. Changes of the immunogenicity measured by total antibody quantification using ECLIA

    Binding antibodies titre measured for each individual sample and GMT for treatment group comparison at Baseline and Days 14, 98 and 182.

    Measured: Days 14, 98 and 182

  6. Changes of the immunogenicity measured by total antibody quantification using ECLIA

    Geometric mean fold rise (GMFR) in binding antibodies titre from Baseline and Days 14.

    Measured: Day 14

  7. Changes of the immunogenicity measured by total antibody quantification using ECLIA

    Percentage of subjects that, after a booster dose, have a ≥4-fold change in binding antibodies titre from Baseline and Days 14, 98 and 182.

    Measured: Days 14, 98 and 182

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start25 Mar 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase IIb, double-blind, randomized, active controlled, multi-center, non-inferiority trial that aims to assess the immunogenicity and safety of a booster vaccination with a candidate vaccine.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305573
Sponsor's protocol ID
HIPRA HH-10
Status last verified
Feb 2023
First submitted
29 Mar 2022
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing COVID-19 Vaccine HIPRA 40 ug/dose and Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injection in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, run by Hipra Scientific, S.L.U at 7 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of the immunogenicity against Omicron strain at Day 14 (time frame: Day 14). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05305573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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Clinical Trial NCT05305573 | AzTrials