Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary#Objectives #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose.
Secondary#Immunogenicity:
Secondary#Safety:
To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with two Sinopharm doses.
Exploratory#Cell-mediated immunity:
To describe the cellular immune response profile at D01, D08, D15, in a subset of 30 participants for each study group.
Exploratory#Efficacy:
To describe theoccurrence ofvirologically-confirmedCOVID-19 like illness and serologicallyconfirmed SARS-CoV-2 infection.
Endpoint:
Immunogenicity Endpoints:
GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on D01, D15.
Immunogenicity Endpoints:
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method.
Safety Endpoints:
Exploratory#Cell-mediated immunity Endpoints:
INF-γ will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S-antigen peptides.
Exploratory#Efficacy Endpoints Occurrence of confirmed symptomatic cases during the study period
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single 25 μg dose mRNA vaccine SW-BIC-213 | Experimental | Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular |
|
| A third dose of COVID-19 Inactivated vaccine | Active Comparator | Intervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration: injection Intramuscular |
|
| A single 30μg dose mRNA vaccine Pfizer(BNT162b2) | Active Comparator | Type :mRNA COVID -19 vaccine - Pfizer(BNT162b2) Dose :Formulation mRNA Unit Dose Strength(s) :30ug; Dosage Level(s) :0.3ml; Route of Administration: injection Intramuscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SW-BIC-213;SARS-Cov-2. | Biological | The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on day1 , day 15 | day1, day15 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
The participant may not enter the study if ANY of the following apply:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mayfong Mayxay, doctor | National Ethics Committee for Health Research(NECHR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Savannakhét Provincial hospital | Savannakhet | Sava | Laos |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
a randomized observer-blinded parallel controlled trial#Experimental group#mRNA vaccine# and positive control group#inactive vaccine#
Not provided
Not provided
This study uses an observer-blinded design, and the investigators and participants will all remain blinded before unblinding and do not know which group the participant belongs to.
|
| Sinopharm (BIBP);SARS-Cov-2. | Biological | The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life. |
|
| Pfizer(BNT162b2);SARS-Cov-2. | Biological | The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life. |
|