COVID-19
Conditions
Interventions
Inactivated COVID-19 vaccines cohort group 1:Recombinant COVID-19 Vaccine (Sf9 Cell)
Inactivated COVID-19 vaccines cohort group 2:COVID-19 Vaccine (Vero Cell), Inactivated
mRNA COVID-19 vaccines cohort group 1:Recombinant COVID-19 Vaccine (Sf9 Cell)
mRNA COVID-19 vaccines cohort group 2:COVID-19 Vaccine (Vero Cell), Inactivated
Viral Vector COVID-19 vaccines cohort group 1:Recombinant COVID-19 Vaccine (Sf9 Cell)
Viral Vector COVID-19 vaccines cohort group 2:COVID-19 Vaccine (Vero Cell), Inactivated
Sponsors
Iloilo Doctors Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give written informed consent for participation in the trial. 2. Male or Female, aged 18 years or above and in good health as determined by a trial clinician. 3. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation. See Section Contraception and Pregnancy for definition of child-bearing potential and definition of effective contraception. 4. In the Investigators opinion, is able and willing to comply with all trial requirements. 5. Willing to allow investigators to discuss the volunteers medical history with their General Practitioner and access all medical records when relevant to study procedures. 6. Agreement to refrain from blood donation during the study. 7. Participants who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines (full approval, CMA or EUA) and is at least 6 months post second vaccination.
Exclusion criteria
Exclusion criteria: 1. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination (one week for licensed seasonal influenza vaccine or pneumococcal vaccine). 2. Prior or planned receipt of any other investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. adenovirus vectored vaccines, any coronavirus vaccines). 3. Positive SARS-CoV-2 RT-PCR at screening. 4. Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination. 5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines. 6. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days). 7. History of allergic disease or reactions likely to be exacerbated by any component of study vaccines. 8. Any history of anaphylaxis. 9. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 10.Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. 11.Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban). 12.History of cerebral venous sinus thrombosis, antiphospholipid syndrome or heparin induced thrombocytopenia and thrombosis (HITT or HIT type 2). 13.Suspected or known current alcohol or drug dependency. 14.Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. 15.Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed). 16.History of active or previous auto-immune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). 17.Significant renal or hepatic impairment 18.Scheduled elective surgery during the trial 19.Participant with life expectancy of less than 6 months 20.Prior medical history of a severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus infections or diseases. 21.Axillary temperature = 37.3?.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions (ADRs);Geometric mean titer (GMT) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2;Seroconversion rate (= 4 folds increase from baseline) of serum anti-SARS-CoV-2 neutralizing antibody titers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of AEs 0 to 7 days after the booster dose;Incidence of AEs 0 to 28 days after the booster dose;Incidence of SAEs within 6 months after the booster dose;The percentage of participants with abnormal hematology, chemistry and urinalysis laboratory values 3 days after the booster dose;The percentage of participants with grading shifts in hematology, chemistry and urinalysis laboratory assessments between baseline and 3 days after the booster dose.;GMT of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2 on day 28, month 3 and month 6 after the booster dose.;GMI of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2 on day 28, month 3 and month 6 after the booster dose. ;GMT and GMI of IgG antibody against S-RBD of SARS-CoV-2 on day 14, day 28, month 3 and month 6 after the booster dose.; | — |
Countries
Philippines
Contacts
Public ContactAnjuli May P. Jaen
Iloilo Doctors Hospital
Outcome results
None listed