Heterologous Boost Immunization with Ad5-nCoV After Three-dose Priming with an Inactivated SARS-CoV-2 Vaccine

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 4

Conditions: COVID-19

Treatments: Biological: Ad5-nCoV-IH; Biological: Ad5-nCoV-IM; Biological: CoronaVac

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05303584

JSVCT153

Details and patient eligibility

About

This is an open-label, randomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolized (Ad5-nCoV-IH) or intramuscular (Ad5-nCoV-IM) Ad5-nCoV after three-dose priming with an inactivated COVID-19 vaccine (CoronaVac) in adults aged 18 years and above. A total of 360 subjects will be included. Approximately 210 subjects who have completed three doses of CoronaVac more than 6 months ago in the prior clinical trial and other 150 eligible subjects will be recruited and randomized respectively in a ratio of 1:1:1 to receive a booster dose of Ad5-nCoV-IH or Ad5-nCoV-IM or ICV. The occurrence of adverse reactions within 28 days and serious adverse events within 6 months after vaccination will be observed in all participants. In addition, blood and saliva samples will be collected from all participants on the day 0 before and 14, 28 days and 3, 6 months after the booster vaccination. Each subject will remain in this study for approximately 6 months.

Enrollment: 362 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health subjects aged ≥18 years
• The subject can provide with informed consent and sign informed consent form (ICF).
• The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
• Participants who have received three-dose of inactivated SARS-CoV-2 vaccine more than 6 months ago.

Exclusion criteria

• Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
• Be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
• Vaccine-related SAE occurred after previous vaccination with COVID-19 vaccine.
• Women with positive urine pregnancy test or in lactation.
• Have acute febrile diseases or infectious diseases or have a history of SARS.
• Axillary temperature>37.0℃
• Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field)
• Have severe chronic diseases or condition is not stable, such as asthma, diabetes, thyroid disease
• Congenital or acquired angioedema / neuroedema.
• Have the history of urticaria 1 year before.
• Have asplenia or functional asplenia.
• Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
• Have history of SARS-CoV-2 infection or COVID-19.
• Have symptoms of upper respiratory tract infection.
• Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-2.
• Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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362 participants in 3 patient groups

Group A

Experimental group

Description:

Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of aerosolized Ad5-nCoV after three-dose priming with ICV

Treatment:

Biological: Ad5-nCoV-IH

Group B

Experimental group

Description:

Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of intramuscular Ad5-nCoV after three-dose priming with CoronaVac

Treatment:

Biological: Ad5-nCoV-IM

Group C

Experimental group

Description:

Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive homologous fourth dose of CoronaVac.

Treatment:

Biological: CoronaVac