COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20220317003

Thitiporn Mooksombat

Thitiporn.m@mpgroup.co.th

2022-03-17

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

1. Adults aged more than 18 years. 2. Completed primary series of COVID-19 vaccine with either homologous primary vaccination with 2 doses of ChAdOx-1 or Heterologous Sinovac-AstraZeneca at least 90 days before screening heterologous primary vaccination with CoronaVac (Sinovac) following by ChAdOx-1 at least 90 days before screening 3. Has provided written informed consent prior to performance of any study-specific procedure 4. No history of fever or PUI symptoms within 7 days

1. Any confirmed or suspected immunosuppressive or immunodeficient state. 2. No history of COVID infection. 3. Pregnancy 4. History of vaccination with other vaccines within 2 weeks prior to enrollment. 5. Having a plan to receive any vaccines within two weeks after enrolment 6. acute febrile illness with body temperature higher than 38 degrees Celsius on the day of enrolment, or any other acute illness 7. history of anaphylaxis to other vaccines 8. Uncontrolled of personal medical illness, i.e., heart disease, neurological condition. 9. Bleeding tendency, abnormality of platelet functions, or ongoing use of antithrombotic prophylaxis

1

Thammasat University Hospital

18

100

Thailand

Healthy volunteers

N/A

444

Immunogenicity at baseline and day 28 after booster dose Measure Anti-S IgG geometric mean titer;Immunogenicity at baseline and day 28 after booster dose Measure Geometric mean of fold rising (GMFR) in anti-S-RBD IgG;Immunogenicity at baseline and 28 days after booster dose Measure Percentage of seroconversion response from the increase of Anti-S IgG;Immunogenicity at baseline and day 28 after booster dose Measure GMT in NT50 dilution by SARS-CoV-2 pseudovirus neutralisation assay (PVNT) to wild type; Delta and Omicron VOC;Immunogenicity at baseline and day 28 after booster dose Measure GMT in SARS-CoV-2 Variants Neutralizing Antibody by SVNT against Wild type (Euroimmun) Delta (BIOTEC) Omicron Variant (cPass);Immunogenicity at baseline and day 28 after booster dose Measure percentage of NT50 dilution by SARS-CoV-2 pseudovirus neutralisation assay (PVNT) to wild type; Delta and Omicron VOC;Immunogenicity at baseline and day 28 after booster dose Measure percentage of SARS-CoV-2 Variants Neutralizing Antibody by SVNT against Wild type (Euroimmun) Delta (BIOTEC) Omicron Variant (cPass);Immunogenicity at baseline and day 28 after booster dose Measure GMT in interferon gamma of reactive T lymphocytes response against SARS-CoV2 protein which measured by interferon gamma release assay (IGRA);Safety and tolerability for 7 days following booster vaccination Patient report number and severity of solicited local and systemic of solicited local and systemic AEs in AE form. ;Safety and tolerability for 14 days following booster vaccination Patient report number and severity of solicited local and systemic of solicited local and systemic AEs in AE form;Safety and tolerability throughout the study Monitoring number and severity of solicited local and systemic of solicited local and systemic AEs.

Phase 2

[{"arm_notes": "homologous or heterologous primary vaccination", "treatment_id": 1828, "treatment_name": "Phh-1v", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]