ChangGungMH
Taoyuan, Taiwan, 333
NCT Number: NCT05054621
This is a prospective, single blinded randomized homologous/heterologous prime-boost vaccine clinical study, designed to assess the immunogenicity of heterologous prime-boost immunization with AZD1222 and MVC-COV1901 in adults.
Participants will be healthy adults at the age of 20-70 years who have had their first dose of COVID-19 vaccine, AZD1222. All eligible participants of 2 prime-boost interval strata (28 to 42, 56 to 70 days) will be 1:1 randomly assigned to receive a single dose of either:
* Homologous group: Intramuscular injection the same vaccine as their prime dose AZD1222 * Heterologous group: Medigen COVID-19 vaccine MVC-COV1901. The treatment phase of this study will be conducted in a single-blind fashion such that the subject will not know the identity of the subjects' study treatment assignment. After receiving the treatment, the participants will remain on study for 168 days following the boost vaccination.
For the study primary objective, immunogenicity will be assessed during the duration of the study, including serologic neutralizing antibody titer against SARS-CoV-2, serological quantification of binding antibody to SARS-CoV-2 antigen, SARS-CoV-2 antigen specific B cell and T cell frequencies and cytokine levels.
And Safety will be assessed during the duration of the study as follows:
* Solicited adverse events (AEs; local and systemic) will be assessed for 7 days following each vaccination (Day 0 through Day 7 for the boost vaccination). * Unsolicited AEs will be recorded for 28 days following the boost vaccination. * Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 168. * Adverse events of special interest (AESIs) will be recorded from the boost vaccination through Day 168.
This study is going to be conducted in a single medical center in Taiwan. An appropriate number of participants will be screened to achieve approximately 44 evaluable participants for each group. Participants in each group will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.
Looking for future studies?
Notify Me20 year–70 year
All sexes
Interventional
Phase 2
Taoyuan, Taiwan, 333
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Acceptable forms include:
i. Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system ii. Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c. Have a negative pregnancy test.
Exclusion criteria
-
The participant may not enter the trial if ANY of the following apply:
Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.
Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.
Time frame: Day 28 after booster dose
To determine if the immune response to heterologous prime-boost immunization with ChAdOx1 nCOV-19 (AZD1222) and MVC-COV1901 is non-inferior to homologous prime-boost immunization with ChAdOx1 nCOV-19, in enrolled adult participants
Time frame: base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine
Further determination of Anti-SARS-CoV-2 Spike antibodies in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines
Time frame: through study completion, 6 months.
To evaluate the safety of heterologous & homologous prime-boost immunization of COVID-19 vaccines
Time frame: base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine
Further determination of immunogenicity of Anti-SARS-CoV-2 Nucleocapsid in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines.
Time frame: baseline (Day 0) and during the. intervention at day 10 and 28 after booster dose of vaccine
Further determination of T cellular immune responses by ELISpot in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines.
Chang Gung Memorial Hospital
Other
A Single-blind, Randomized Study to Evaluate the Immunogenicity of Heterologous Prime-boost COVID-19 Vaccine Schedule
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05765773
COVID-19, Corona Virus Infection
Moscow, Russia
View Trial DetailsNCT04549636
Asthma, Bronchial Diseases
Hamilton, Ontario, Canada
View Trial DetailsNCT05718518
COVID-19, Coronaviridae Infections
Hangzhou, Zhejiang, China
View Trial DetailsNCT04754698
AIDS, Acquired Immunodeficiency Syndrome
São Paulo, Brazil
View Trial Details