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Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine

NCT ID: NCT05049226

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-24

Study Completion Date

2022-02-22

Brief Summary

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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)

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Detailed Description

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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

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COVID-19 Infection COVID-19 VACCINE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Unblinded study staff will be responsible for preparing study products (in accordance with the randomly determined assignment), administering the study vaccine, and handling all drug accountability procedures. These personnel will not participate in the other aspects of the clinical trial, to help ensure the integrity of the blind at the site. Unblinded staff will retrieve a participant's randomization assignment after being informed by the PI or designee that a participant is eligible for randomization. They will prepare study vaccine (AZ or PF) with dose (full or half dose) based on the participant's randomization

Study Groups

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Two doses of SV at interval 60 to less than 90 days

Participants who have received two doses of SV at interval 60 to less than 90 days

Group Type EXPERIMENTAL

AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:

Diluent: 0.9% sodium chloride (normal saline, preservative-free)

Administer: Intramuscular (IM) injection in the deltoid muscle

Two doses of SV at interval 90 to less than 120 days

Participants who have received two doses of SV at interval 90 to less than 120 days

Group Type EXPERIMENTAL

AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:

Diluent: 0.9% sodium chloride (normal saline, preservative-free)

Administer: Intramuscular (IM) injection in the deltoid muscle

Two doses of SV at interval 120 to 180 days

Participants who have received two doses of SV at interval 120 to 180 days

Group Type EXPERIMENTAL

AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

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 dose

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:

Diluent: 0.9% sodium chloride (normal saline, preservative-free)

Administer: Intramuscular (IM) injection in the deltoid muscle

Interventions

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AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose

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

Intervention Type BIOLOGICAL

Pfizer/BioNTech BNT162b2 vaccine (PF) full dose

Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:

Diluent: 0.9% sodium chloride (normal saline, preservative-free)

Administer: Intramuscular (IM) injection in the deltoid muscle

Intervention Type BIOLOGICAL

AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose

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

Intervention Type BIOLOGICAL

Pfizer/BioNTech BNT162b2 vaccine (PF) half dose

Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:

Diluent: 0.9% sodium chloride (normal saline, preservative-free)

Administer: Intramuscular (IM) injection in the deltoid muscle

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Adult male or female age equal or more than 20 years with Thai ID cards
2. 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
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

Exclusion Criteria

1. Any confirmed or suspected immunosuppressive or immunodeficient state.
2. Contraindication to AZ or PF according to labelling of the products
3. History of COVID infection within 3 months period
4. Pregnancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinixir Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Program Management Unit-C (PMU-C), governed by Ministry of Higher Education, Science, Research and Innovation (MHESI)

UNKNOWN

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Punnee Pitisuttithum, MD

Role: STUDY_CHAIR

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Atibordee Meesing, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Khon Kaen University

Romanee Chaiwarith, MD,MHS

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Chiang Mai University

Sarunyou Chusri, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Prince of Songkla University

Sira Nanthapisal, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Thammasat University

Suppachok Kirdlarp, MD

Role: PRINCIPAL_INVESTIGATOR

Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital,Mahidol University

Suvimol Niyomnaitham, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Sarawut Siwamogsatham, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status

Faculty of Medicine Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Site Status

Faculty of Medicine Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status

Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital, Mahidol University

Bang Phli, Changwat Samut Prakan, Thailand

Site Status

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Faculty of Medicine, Chiang Mai University

Chiang Mai, , Thailand

Site Status

Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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TVTN001

Identifier Type: -

Identifier Source: org_study_id

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