COVID-19 InfectionPhase 2NCT05049226
Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine
A Phase 2 study testing AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Pfizer/BioNTech BNT162b2 vaccine (PF) full dose and AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose in people with COVID-19 Infection and COVID-19 VACCINE, run by Mahidol University at 7 sites in Thailand.
Trial summary
This prospective, multi-center, randomized, observer-blind Phase 2 study. A total of 1320 participants will be divided into 2 groups (660 each) receiving either full dose or half dose of either AZ or PF. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection, COVID-19 VACCINE
- What is being tested?
- AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Pfizer/BioNTech BNT162b2 vaccine (PF) full dose and AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 7 sitesThailand
- Study dates
- 24 Sep 2021to 22 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female age equal or more than 20 years with Thai ID cards
- Received two doses (21-28 days apart) of Sinovac inactivated COVID-19 vaccine who will be divided according to their intervals 60-less than 90 days, 90-less than120 days and 120-180 days
- Has provided written informed consent prior to performance of any study-specific procedure
- No history of fever or PUI symptoms within 7 days
Who cannot join
- Any confirmed or suspected immunosuppressive or immunodeficient state.
- Contraindication to AZ or PF according to labelling of the products
- History of COVID infection within 3 months period
- Pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Thailand7 sites
Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital, Mahidol University
Bang Phli, Changwat Samut Prakan, 10540
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
Faculty of Medicine Thammasat University
Khlong Luang, Changwat Pathum Thani, 12121
Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002
Faculty of Medicine Chulalongkorn University
Pathum Wan, Bangkok, 10330
About this study
Official title: A Randomized, Observer-blind Trial to Assess the Immunogenicity and Safety of Third Dose Vaccination With AstraZeneca COVID-19 Vaccine or Pfizer/BioNTech COVID-19 Vaccine Among Thai Adults Receiving Two Doses of Sinovac
This prospective, multi-center, randomized, observer-blind Phase 2 study. A total of 1320 participants will be divided into 2 groups (660 each) receiving either full dose or half dose of either AZ or PF.
Each group is further stratified into 3 subgroups according to three interval duration in term of days after second dose of SV for 60 to less than 90 days, 90 to less than120 days and 120 to 180 days. Each group will be randomized to receive either AZ or PF in 1:1 ratio.
Subjects who fulfilled eligibility criteria will be randomly assigned to receive either full dose or half dose of AZ or PF in 1:1 ratio as an IM injection in the deltoid muscle at Visit 1 (V1). Subjects will be follow-up for assessing immunity at day 28 (V3), day 60 (V4) and day 90 (V5) and for safety at day 7 (V2), day 28 (V3), day 60 (V4) and day 90 (V5). At least 50% from each subgroup will be randomly selected to provide additional blood at baseline (V1, day 0) and day 28 (V3) to be used for assessment of T-cell-mediated immunity (CMI)
Read the detailed description
This study has been designed to assess immune response and safety of third dose vaccination with AstraZeneca ChAdOx1AZD1222 vaccine or Pfizer/BioNTech BNT162b2 vaccine among Thai subjects who have received two doses of Sinovac.
The types of vaccines provided by the government included 7.7 million doses of inactivated vaccine manufactured by Sinovac and 6.5 million doses of AstraZeneca ChAdOx1 AZD1222 vaccine.
With the limited supplies of COVID vaccines in many regions of the world especially in LMIC including Thailand and the evidences of waning immunity of especially inactivated vaccine have raised the concerns whether third dose is needed.
The third dose that available now in Thailand are AstraZeneca ChAdOx1AZD1222 vaccine (AZ)/ Pfizer/BioNTech BNT162b2 vaccine (PF) and whether this can be provided with half dose so that the vaccination coverage is going to be higher in spite of limited vaccine supplies.
A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. However, the vaccines do not only reduce the chance of infection, but they also help to mitigate disease severity.
Study population: Male and female adults aged equal or more than 20 years who received two doses of Inactivated COVID-19 vaccine developed by Sinovac (given at 21-28 days apart) at different intervals of 60 to less than 90 days, 90 to less than120 days and 120 to 180 days
This prospective, multi-center, randomized, observer-blind Phase 2 study, A total of 1320 participants will be divided into 2 groups (660 each) receiving either full dose or half dose of either AZ or PF.
Each group is further stratified into 3 subgroups according to three interval duration in term of days after second dose of SV for 60-less than 90 days, 90-less than120 days and 120-180 days respectively. Subjects who fulfilled eligibility criteria will be randomly assigned to receive either full dose or half dose of AZ or PF in 1:1 ratio as an IM injection in the deltoid muscle at Visit 1 (V1).
All participants will be randomized based on dose given either full dose or half dose and further stratify accordingly by Interactive web-based response system (IWRS). There will be unblinded team which consists of pharmacist and nurse who will give injection. All the safety assessment will be performed independently by clinical team.
Subjects will be follow-up for assessing immunity at day 28 (V3), day 60 (V4) and day 90 (V5) and for safety at day 7 (V2), day 28 (V3), day 60 (V4) and day 90 (V5).
- Conditions
- COVID-19 Infection, COVID-19 VACCINE
- Being tested
- AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Pfizer/BioNTech BNT162b2 vaccine (PF) full dose, AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose, Pfizer/BioNTech BNT162b2 vaccine (PF) half dose
- Keywords
- COVID-19 Infection, COVID-19 Respiratory Infection, COVID-19 VACCINE, AstraZeneca COVID-19 VACCINE, AstraZeneca COVID-19 (ChAdOx1 AZD1222) vaccine, Pfizer/BioNTech COVID-19 VACCINE, Pfizer/BioNTech COVID-19 (BNT162b2) vaccine, Thai adults, full dose AstraZeneca COVID-19 VACCINE, half dose AstraZeneca COVID-19 VACCINE, full dose Pfizer/BioNTech COVID-19 VACCINE, half dose Pfizer/BioNTech COVID-19 VACCINE, Sinovac COVID-19 Vaccine, immunogenicity, safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full doseBiological
Astrazeneca COVID-19 (ChAdOx1 AZD1222) vaccine:
One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles (vp)
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
Administer: Intramuscular (IM) injection in the deltoid muscle
Pfizer/BioNTech BNT162b2 vaccine (PF) full doseBiological
Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:
Diluent: 0.9% sodium chloride (normal saline, preservative-free)
Administer: Intramuscular (IM) injection in the deltoid muscle
AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half doseBiological
Astrazeneca COVID-19 (ChAdOx1 AZD1222) vaccine:
One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles (vp)
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
Administer: Intramuscular (IM) injection in the deltoid muscle
Pfizer/BioNTech BNT162b2 vaccine (PF) half doseBiological
Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:
Diluent: 0.9% sodium chloride (normal saline, preservative-free)
Administer: Intramuscular (IM) injection in the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| Two doses of SV at interval 60 to less than 90 days | Experimental | Participants who have received two doses of SV at interval 60 to less than 90 days Receives: Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose; Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose; Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose; Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half dose |
| Two doses of SV at interval 90 to less than 120 days | Experimental | Participants who have received two doses of SV at interval 90 to less than 120 days Receives: Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose; Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose; Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose; Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half dose |
| Two doses of SV at interval 120 to 180 days | Experimental | Participants who have received two doses of SV at interval 120 to 180 days Receives: Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose; Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose; Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose; Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT Anti-S IgG at baseline and after vaccination
GMT Anti-S IgG at baseline and after vaccination at day 28, day 60 and day 90
Measured: Day 0, Day 28, Day 60 and Day 90
GMFR changed from baseline in anti-S IgG GMT after vaccination
GMFR changed from baseline in anti-S IgG GMT at 28,60 and 90 days after vaccination
Measured: Day 28, Day 60 and Day 90
Anti-S IgG Seroresponses changed from baseline after vaccination
Frequency and percentage of participants with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline at 28, 60 and 90 days after vaccination (2) a ≥ 10-fold increase from baseline at 28,60 and 90 days after vaccination
Measured: Day 28, Day 60 and Day 90
GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline and after vaccination
GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline and after vaccination at day 28 and day 90
Measured: Day 0, Day 28 and Day 90
GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus after vaccination
GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus at 28 and 90 days vaccination
Measured: Day 28 and Day 90
Frequency of solicited reportable local adverse event after vaccination
Frequency and percentage of solicited reportable local adverse events (pain or tenderness, erythema, swelling or induration) of vaccination
Measured: Day 0 through Day 7
Frequency of solicited reportable systemic adverse event after vaccination
Frequency and percentage of solicited reportable systemic adverse events (fever, headache, fatigue or malaise, myalgia, arthralgia, nausea or vomitting) of vaccination
Measured: Day 0 through Day 7
Frequency of all unsolicited AEs
Frequency and percentage of all unsolicited AEs
Measured: Day 0 through Day 28
Frequency of SAEs
Frequency and percentage of SAEs throughout the entire study period
Measured: Day 0 through Day 90
Secondary outcomes (3)
NT50 GMT against SARS-Cov-2 by micro neutralization assay at baseline and day 28 and day 90 after vaccination
NT50 GMT against SARS-Cov-2 by micro neutralization assay at baseline and day 28 and 90 after vaccination
Measured: Day 0, Day 28 and Day 90
GMFR changed from baseline in NT50 against SARS-CoV-2 (micro NT Delta/WT NA) at 28 and 90 days after vaccination among those positives by PNT assay
GMFR changed from baseline in NT50 against SARS-CoV-2 (micro NT Delta/WT NA) at 28 and 90 days after vaccination among those positives by PNT assay
Measured: Day 28 and Day 90
NT50 seroresponses against SARS-CoV-2 using micro NT changed from baseline at 28 and 90 days after vaccination among those positive by PVNT assay
Frequency and percentage of participants with NT50 seroresponses against SARS-CoV-2 using micro NT as defined by (1) a ≥ 4-fold increase from baseline at 28 and 90 days after vaccination compare to baseline among those positive by PVNT assay
Measured: Day 28 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start24 Sep 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Clinixir Co., Ltd., Program Management Unit-C (PMU-C), governed by Ministry of Higher Education, Science, Research and Innovation (MHESI)
- Responsible party
- Sponsor
- Investigators
- Punnee Pitisuttithum, MD, Study chair, Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol UniversityAtibordee Meesing, MD, Principal investigator, Khon Kaen UniversityRomanee Chaiwarith, MD,MHS, Principal investigator, Faculty of Medicine, Chiang Mai UniversitySarunyou Chusri, MD,PhD, Principal investigator, Faculty of Medicine, Prince of Songkla UniversitySira Nanthapisal, MD,PhD, Principal investigator, Faculty of Medicine, Thammasat UniversitySuppachok Kirdlarp, MD, Principal investigator, Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital,Mahidol UniversitySuvimol Niyomnaitham, MD,PhD, Principal investigator, Mahidol UniversitySarawut Siwamogsatham, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049226
- Sponsor's protocol ID
- TVTN001
- Status last verified
- Jul 2022
- First submitted
- 14 Sep 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data or left over specimen will be shared for future study ONLY subject who consent allow using their data/specimens. Sharing will be done without personnel identification
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-blind Trial to Assess the Immunogenicity and Safety of Third Dose Vaccination With AstraZeneca COVID-19 Vaccine or Pfizer/BioNTech COVID-19 Vaccine Among Thai Adults Receiving Two Doses of Sinovac
- ClinicalTrials.gov ID
- NCT05049226
- Acronym / sponsor ID
- TVTN001
- Conditions
- COVID-19 Infection, COVID-19 VACCINE
- Keywords
- COVID-19 Infection, COVID-19 Respiratory Infection, COVID-19 VACCINE, AstraZeneca COVID-19 VACCINE, AstraZeneca COVID-19 (ChAdOx1 AZD1222) vaccine, Pfizer/BioNTech COVID-19 VACCINE, Pfizer/BioNTech COVID-19 (BNT162b2) vaccine, Thai adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Clinixir Co., Ltd., Program Management Unit-C (PMU-C), governed by Ministry of Higher Education, Science, Research and Innovation (MHESI)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multi-center, randomized, observer-blind Phase 2 study. A total of 1320 participants will be divided into 2 groups (660 each) receiving either full dose or half dose of either AZ or PF.
Each group is further stratified into 3 subgroups according to three interval duration in term of days after second dose of SV for 60 to less than 90 days, 90 to less than120 days and 120 to 180 days. Each group will be randomized to receive either AZ or PF in 1:1 ratio.
Subjects who fulfilled eligibility criteria will be randomly assigned to receive either full dose or half dose of AZ or PF in 1:1 ratio as an IM injection in the deltoid muscle at Visit 1 (V1). Subjects will be follow-up for assessing immunity at day 28 (V3), day 60 (V4) and day 90 (V5) and for safety at day 7 (V2), day 28 (V3), day 60 (V4) and day 90 (V5). At least 50% from each subgroup will be randomly selected to provide additional blood at baseline (V1, day 0) and day 28 (V3) to be used for assessment of T-cell-mediated immunity (CMI)
Detailed description
This study has been designed to assess immune response and safety of third dose vaccination with AstraZeneca ChAdOx1AZD1222 vaccine or Pfizer/BioNTech BNT162b2 vaccine among Thai subjects who have received two doses of Sinovac.
The types of vaccines provided by the government included 7.7 million doses of inactivated vaccine manufactured by Sinovac and 6.5 million doses of AstraZeneca ChAdOx1 AZD1222 vaccine.
With the limited supplies of COVID vaccines in many regions of the world especially in LMIC including Thailand and the evidences of waning immunity of especially inactivated vaccine have raised the concerns whether third dose is needed.
The third dose that available now in Thailand are AstraZeneca ChAdOx1AZD1222 vaccine (AZ)/ Pfizer/BioNTech BNT162b2 vaccine (PF) and whether this can be provided with half dose so that the vaccination coverage is going to be higher in spite of limited vaccine supplies.
A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. However, the vaccines do not only reduce the chance of infection, but they also help to mitigate disease severity.
Study population: Male and female adults aged equal or more than 20 years who received two doses of Inactivated COVID-19 vaccine developed by Sinovac (given at 21-28 days apart) at different intervals of 60 to less than 90 days, 90 to less than120 days and 120 to 180 days
This prospective, multi-center, randomized, observer-blind Phase 2 study, A total of 1320 participants will be divided into 2 groups (660 each) receiving either full dose or half dose of either AZ or PF.
Each group is further stratified into 3 subgroups according to three interval duration in term of days after second dose of SV for 60-less than 90 days, 90-less than120 days and 120-180 days respectively. Subjects who fulfilled eligibility criteria will be randomly assigned to receive either full dose or half dose of AZ or PF in 1:1 ratio as an IM injection in the deltoid muscle at Visit 1 (V1).
All participants will be randomized based on dose given either full dose or half dose and further stratify accordingly by Interactive web-based response system (IWRS). There will be unblinded team which consists of pharmacist and nurse who will give injection. All the safety assessment will be performed independently by clinical team.
Subjects will be follow-up for assessing immunity at day 28 (V3), day 60 (V4) and day 90 (V5) and for safety at day 7 (V2), day 28 (V3), day 60 (V4) and day 90 (V5).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Two doses of SV at interval 60 to less than 90 days | Experimental | Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose, Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half doseParticipants who have received two doses of SV at interval 60 to less than 90 days |
| Two doses of SV at interval 90 to less than 120 days | Experimental | Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose, Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half doseParticipants who have received two doses of SV at interval 90 to less than 120 days |
| Two doses of SV at interval 120 to 180 days | Experimental | Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose, Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half doseParticipants who have received two doses of SV at interval 120 to 180 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or female age equal or more than 20 years with Thai ID cards
- Received two doses (21-28 days apart) of Sinovac inactivated COVID-19 vaccine who will be divided according to their intervals 60-less than 90 days, 90-less than120 days and 120-180 days
- Has provided written informed consent prior to performance of any study-specific procedure
- No history of fever or PUI symptoms within 7 days
Key exclusion criteria (4 listed)
- Any confirmed or suspected immunosuppressive or immunodeficient state.
- Contraindication to AZ or PF according to labelling of the products
- History of COVID infection within 3 months period
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full doseAstrazeneca COVID-19 (ChAdOx1 AZD1222) vaccine: One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles (vp) *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells. Administer: Intramuscular (IM) injection in the deltoid muscle | Biological | Two doses of SV at interval 120 to 180 days, Two doses of SV at interval 60 to less than 90 days, Two doses of SV at interval 90 to less than 120 days |
| Pfizer/BioNTech BNT162b2 vaccine (PF) full dosePfizer-BioNTech COVID-19 (BNT162b2) vaccine: Diluent: 0.9% sodium chloride (normal saline, preservative-free) Administer: Intramuscular (IM) injection in the deltoid muscle | Biological | Two doses of SV at interval 120 to 180 days, Two doses of SV at interval 60 to less than 90 days, Two doses of SV at interval 90 to less than 120 days |
| AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half doseAstrazeneca COVID-19 (ChAdOx1 AZD1222) vaccine: One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles (vp) *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells. Administer: Intramuscular (IM) injection in the deltoid muscle | Biological | Two doses of SV at interval 120 to 180 days, Two doses of SV at interval 60 to less than 90 days, Two doses of SV at interval 90 to less than 120 days |
| Pfizer/BioNTech BNT162b2 vaccine (PF) half dosePfizer-BioNTech COVID-19 (BNT162b2) vaccine: Diluent: 0.9% sodium chloride (normal saline, preservative-free) Administer: Intramuscular (IM) injection in the deltoid muscle | Biological | Two doses of SV at interval 120 to 180 days, Two doses of SV at interval 60 to less than 90 days, Two doses of SV at interval 90 to less than 120 days |
Primary outcome
GMT Anti-S IgG at baseline and after vaccination
Time frame: Day 0, Day 28, Day 60 and Day 90
GMT Anti-S IgG at baseline and after vaccination at day 28, day 60 and day 90
GMFR changed from baseline in anti-S IgG GMT after vaccination
Time frame: Day 28, Day 60 and Day 90
GMFR changed from baseline in anti-S IgG GMT at 28,60 and 90 days after vaccination
Anti-S IgG Seroresponses changed from baseline after vaccination
Time frame: Day 28, Day 60 and Day 90
Frequency and percentage of participants with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline at 28, 60 and 90 days after vaccination (2) a ≥ 10-fold increase from baseline at 28,60 and 90 days after vaccination
GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline and after vaccination
Time frame: Day 0, Day 28 and Day 90
GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline and after vaccination at day 28 and day 90
GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus after vaccination
Time frame: Day 28 and Day 90
GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus at 28 and 90 days vaccination
Frequency of solicited reportable local adverse event after vaccination
Time frame: Day 0 through Day 7
Frequency and percentage of solicited reportable local adverse events (pain or tenderness, erythema, swelling or induration) of vaccination
Frequency of solicited reportable systemic adverse event after vaccination
Time frame: Day 0 through Day 7
Frequency and percentage of solicited reportable systemic adverse events (fever, headache, fatigue or malaise, myalgia, arthralgia, nausea or vomitting) of vaccination
Frequency of all unsolicited AEs
Time frame: Day 0 through Day 28
Frequency and percentage of all unsolicited AEs
Frequency of SAEs
Time frame: Day 0 through Day 90
Frequency and percentage of SAEs throughout the entire study period
3 secondary outcomes
NT50 GMT against SARS-Cov-2 by micro neutralization assay at baseline and day 28 and day 90 after vaccination
Time frame: Day 0, Day 28 and Day 90
GMFR changed from baseline in NT50 against SARS-CoV-2 (micro NT Delta/WT NA) at 28 and 90 days after vaccination among those positives by PNT assay
Time frame: Day 28 and Day 90
NT50 seroresponses against SARS-CoV-2 using micro NT changed from baseline at 28 and 90 days after vaccination among those positive by PVNT assay
Time frame: Day 28 and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Yes. data or left over specimen will be shared for future study ONLY subject who consent allow using their data/specimens. Sharing will be done without personnel identification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Punnee Pitisuttithum, MD study chair
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Atibordee Meesing, MD principal investigator
Khon Kaen University
Romanee Chaiwarith, MD,MHS principal investigator
Faculty of Medicine, Chiang Mai University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Pfizer/BioNTech BNT162b2 vaccine (PF) full dose and AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose in people with COVID-19 Infection and COVID-19 VACCINE, run by Mahidol University at 7 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMT Anti-S IgG at baseline and after vaccination (time frame: Day 0, Day 28, Day 60 and Day 90). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.