Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vacci… (NCT05142553) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Healthy Adults Volunteers Fully Vaccinated Followed by an Extension Period to Study a Fourth Dose Administration.
Spain887 participantsStarted 2021-11-16
Plain-language summary
This Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine).
The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part A: Inclusion Criteria:
* Male or female, by birth, ≥ 18 years old at Screening.
* Willing and able to comply with scheduled visits, laboratory tests, complete diaries, and other study procedures.
* Body Mass Index (BMI) between 18 to 40 kg/m2.
* Has received a complete COVID-19 vaccination programme (two administrations, prime and boosting) at least 182 days and with a maximum of 365 days before Screening with Comirnaty vaccine.
* Has a negative COVID-19 polymerase chain reaction (PCR) test at Screening.
* Willing to avoid all other vaccines within 4 weeks before and after vaccination in this study (Day 0). Seasonal influenza vaccination is allowed if it is received at least 14 days before or after vaccination.
* Willing to refrain from blood donation during the study.
* Women of childbearing potential must have a negative urine pregnancy test at Screening and prior to vaccination.
* Women of childbearing potential must be willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the vaccination.
* Males who are not sterilised, must be willing to avoid impregnating female partners from Screening until 8 weeks after vaccination.
* Willing and able to provide written informed consent prior the initiation of any study procedures.
Part A: Exclusion criteria:
* Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
* Positive pregnancy test at Screening or v…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Changes of the immunogenicity against Wuhan
Timeframe: 14 days
2
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: 7 days
3
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: 28 days
4
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: 364 days
5
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: Days 14, 28, 182, and 364
6
Part B: Changes of the immunogenicity against Omicron BA.1