Assessing the Immunogenicity and Safety of a HIPRA's Candidate Booster Vaccination in Adults Fully Vaccinated With Adenovirus Vaccine Against COVID-19.
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
1 other identifier
interventional
26
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 covid19
Started Mar 2022
Shorter than P25 for phase_2 covid19
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2022
CompletedFirst Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 1, 2023
February 1, 2023
6 months
March 29, 2022
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
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.
Day 14
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.
Day 7
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.
Day 28
Safety and tolerability of PHH-1V as a booster dose
Number and percentage of serious adverse events (SAEs) through the study duration.
Day 182
Safety and tolerability of PHH-1V as a booster dose
Number and percentage of adverse event of special interest (AESI) through the study duration.
Day 182
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.
Day 182
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.
Days 14, 98 and 182
Secondary Outcomes (7)
Changes of the immunogenicity measured by PBNA against the Variants of Concern (VOC)
Days 14, 98 and 182
Changes of the immunogenicity measured by PBNA against Omicron
Day 14
Changes of the immunogenicity measured by PBNA against Omicron
Days 98 and 182
Changes of the immunogenicity measured by VNA against Omicron
Days 14, 98 and 182
Changes of the immunogenicity measured by total antibody quantification using ECLIA
Days 14, 98 and 182
- +2 more secondary outcomes
Study Arms (2)
COVID-19 Vaccine HIPRA 40 ug/dose
EXPERIMENTALComirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injection
ACTIVE COMPARATORInterventions
Subjects will receive one injection of COVID-19 Vaccine HIPRA (PHH-1V)
Subjects will receive one injection of Comirnaty Vaccine
Eligibility Criteria
You may qualify if:
- 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.
- 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:
- \. Hormonal contraception (progestogen-only or combined): oral, injectable or transdermal (patch) at least 30 days before Day 0 and until 8 weeks after vaccination.
- \. Intrauterine device. 3. Vasectomized partner (the vasectomized partner should be the sole partner for that participant).
- \. Sexual abstinence \*\*, as a form of contraception, is acceptable if in line with the participant's lifestyle.
- \. Condom
- b. 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.
- +1 more criteria
You may not qualify if:
- Participants meeting any of the following criteria will be excluded from the study:
- \. History of anaphylactic shock of any kind.
- \. History of COVID-19 infection.
- \. 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.
- \. Pregnancy or breast-feeding at screening or Day 0 (vaccination time-point) or willingness/intention to become pregnant during the study.
- Medical conditions:
- \. 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).
- \. 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.
- \. 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.
- b. Adequately treated uterine cervical carcinoma in situ without evidence of disease.
- c. Adequately treated anal carcinoma in situ without evidence of disease. d. Localized prostate cancer.
- \. 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).
- \. 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hospital HM Modelo
A Coruña, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital HM Sanchinarro
Madrid, Spain
Hospital HM Puerta del Sur
Móstoles, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital HM Rosaleda
Santiago de Compostela, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double (Participant, Investigator) Subjects and the clinical study team will remain blinded to treatment allocation. Clinical/pharmacy staff involved in study drug preparation will be aware of which vaccine the subject is receiving.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2022
First Posted
March 31, 2022
Study Start
March 25, 2022
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share