This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam
The study population includes 256 healthy adults aged 18-60 which will be randomized in a ratio 1:1 test:commercial vaccine. Each participant will receive 2 immunisations separated by 21 days and will be followed for 24 weeks after the second dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
629
Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart
Subjects will receive 2 injections of Cominarty administered 21 days apart
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
Time frame: 7 days
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.
Time frame: 28 days
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Change from baseline in safety laboratory parameters at 7 days following each vaccination.
Time frame: 7 days
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of serious adverse events throughout the study duration.
Time frame: 30 weeks
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of adverse events of special interest (AESI) throughout the study duration.
Time frame: 30 weeks
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration.
Time frame: 30 weeks
Immunogenicity
Neutralization titer for each individual sample and GMT for group comparison at Day 21 and 35.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 21 and 35.
Immunogenicity
IC50 of beta and delta variants.
Time frame: Day 21 and 35.
Immunogenicity
Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35.
Time frame: Day 21 and 35.
Immunogenicity at long-term
Neutralization titer for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
Time frame: 24 and 48 weeks after the second dose
Immunogenicity at long-term
IC50 of beta and delta variants.
Time frame: 24 weeks after the second dose
Immunogenicity at long-term
GMFR in neutralizing antibodies titers from baseline at 24 weeks after the second dose.
Time frame: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Total binding antibody titer and GMT for group comparison at Day 21 and 35.
Time frame: Day 21 and 35
Immunogenicity to the SARS-CoV-2 spike glycoprotein
GMFR in total binding antibodies titer from baseline at Day 21 and 35.
Time frame: Day 21 and 35
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
Total Binding antibody titer and GMT for group comparison at 24 weeks after the second dose.
Time frame: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
GMFR in total binding antibodies titer from baseline at 24 weeks after the second dose.
Time frame: 24 weeks after the second dose
Immunogenicity to the SARS-CoV-2 spike glycoprotein
Percentage of subjects who seroconverted defined as a ≥4-fold change in total binding antibody titer from baseline at Day 21 and 35.
Time frame: Day 21 and 35.