## Protocol Section
### Identification Module
**NCT ID:** NCT05065879

**Brief Title:** Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes

**Official Title:** A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Beijing): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes

#### Organization Study ID Info
**ID:** COVAX (HT/DM)-Beijing
#### Organization
**Class:** INDUSTRY
**Full Name:** China National Biotec Group Company Limited
### Status Module
#### Completion Date
**Date:** 2022-01-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-01-10

**Type:** ACTUAL

**Last Update Submit Date:** 2022-01-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-01-05

**Type:** ACTUAL

#### Start Date
**Date:** 2021-10-05

**Type:** ACTUAL

**Status Verified Date:** 2022-01

#### Study First Post Date
**Date:** 2021-10-04
**Type:** ACTUAL
**Study First Submit Date:** 2021-09-28
**Study First Submit QC Date:** 2021-10-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Hunan Provincial Center for Disease Control and Prevention

**Class:** OTHER

**Name:** Guizhou Center for Disease Control and Prevention

**Class:** OTHER

**Name:** Center for Disease Control and Prevention, Fujian

**Class:** INDUSTRY

**Name:** Beijing Institute of Biological Products Co Ltd.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** China National Biotec Group Company Limited

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.

**Detailed Description:** After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells). Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine. Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose. Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events.

### Conditions Module

**Conditions:**

- COVID-19 Pneumonia

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Serum testing technicians will be masked.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1440

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older).

**Intervention Names:**

- Biological: COVAX

**Label:** Hypertension group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older).

**Intervention Names:**

- Biological: COVAX

**Label:** Diabetes group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older).

**Intervention Names:**

- Biological: COVAX

**Label:** Combined Diseases group

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older).

**Intervention Names:**

- Biological: COVAX

**Label:** Healthy people group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Combined Diseases group

- Diabetes group

- Healthy people group

- Hypertension group

**Description:** 2 doses of Covid-19 vaccine

**Name:** COVAX

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** the rate of positive seroconversion against coronavirus

**Measure:** Seroconversion rate

**Time Frame:** Up to 28 days after the second dose

**Description:** neutralizing antibody level against coronavirus

**Measure:** Neutralizing antibody level

**Time Frame:** Up to 28 days after the second dose

#### Secondary Outcomes

**Description:** analyse the incidence of adverse events following immunization, both solicited and unsolicited

**Measure:** Adverse events following vaccination

**Time Frame:** up to 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ≥60 years old individuals with full civil capacity.
* Clinically confirmed body temperature of \<37.3°C before enrolling in this study.
* Able and willing to participate in the study plan during the entire study and follow-up period.
* Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol.
* Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure \<160 mmHg and diastolic pressure \<100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose ≤13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment.

Exclusion Criteria:

* Previously confirmed or asymptomatic COVID-19 patient.
* Has been immunized with a SARS-CoV-2 vaccine.
* Illiterate.
* Known allergy to any ingredient (including excipient) of this product.
* Received non-specific immunoglobulin injection within 1 month before enrollment.
* Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization.
* Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea).
* Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome.
* Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases.
* Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
* Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated.
* Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications.
* Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study.

**Healthy Volunteers:** True

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Quanzhou

**Country:** China

**Facility:** Nan'an Center for Disease Control and Prevention

**State:** Fujian

**Location 2:**

**City:** Sanming

**Country:** China

**Facility:** Yong'an Center for Disease Control and Prevention

**State:** Fujian

**Location 3:**

**City:** Sanming

**Country:** China

**Facility:** Youxi Center for Disease Control and Prevention

**State:** Fujian

**Location 4:**

**City:** Tongren

**Country:** China

**Facility:** Songtao Miao Autonomous County Center for Disease Control and Prevention

**State:** Guizhou

**Location 5:**

**City:** Changde

**Country:** China

**Facility:** Linli County Center for Disease Control and Prevention

**State:** Hunan

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
