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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
26
Subjects will receive one injection of COVID-19 Vaccine HIPRA (PHH-1V)
Subjects will receive one injection of Comirnaty Vaccine
Hospital HM Modelo
A Coruña, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital HM Sanchinarro
Madrid, Spain
Hospital HM Puerta del Sur
Móstoles, Spain
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 28
Safety and tolerability of PHH-1V as a booster dose
Number and percentage of serious adverse events (SAEs) through the study duration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 14, 98 and 182
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Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital HM Rosaleda
Santiago de Compostela, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Spain
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.
Time frame: Days 14, 98 and 182
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.
Time frame: Day 14
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.
Time frame: Days 98 and 182
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.
Time frame: Days 14, 98 and 182
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.
Time frame: Days 14, 98 and 182
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.
Time frame: Day 14
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.
Time frame: Days 14, 98 and 182