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

NCT05303584 | Completed Phase 4 DMC

• 1 other identifier: JSVCT153
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

SARS-CoV-2; Ad5-nCoV; Inactivated Vaccine; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse reactions within 28 days after the booster dose

  Incidence of adverse reactions within 28 days after the booster dose.

  Within 28 days the booster dose

• GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

  GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

  On day 28 after the booster dose

Secondary Outcomes (7)

• Geometric Mean Fold Increase (GMI) and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

  On day 28 after the boost vaccination

• GMT, GMI and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.

  On day 14, month 3 and 6 after the booster dose

• Geometric mean concentration (GMC), GMI and seroconversion of anti-SARS-CoV-2 NP-specific, RBD-specific and NTD-specific IgG measured by ELISA on day 14, day 28 and month 3 and 6 after the booster dose.

  On day 14, day 28 and month 3 and 6 after the booster dose

• Incidence of adverse reactions within 30 minutes after the booster dose.

  Within 30 minutes after the booster dose

• Incidence of adverse reactions within 14 days after the booster dose.

  Within 14 days after the booster dose

Other Outcomes (6)

• GMT, GMI and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.

  On day 28 after the booster dose

• The levels of IFN-γ、TNF-α、IL-2 secreted by specific T cells stimulated with a peptide pool covering the full-length spike glycoprotein on day 14 after the booster vaccination.

  On day 14 after the booster vaccination

• The levels of anti-SARS-CoV-2 RBD-specific binding IgA in saliva on day 14, day 28 and month 3 and 6 after the booster dose.

  On day 28 after the booster dose

Study Arms (3)

Group A

EXPERIMENTAL

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

Biological: Ad5-nCoV-IH

Group B

EXPERIMENTAL

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

Biological: Ad5-nCoV-IM

Group C

EXPERIMENTAL

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

Biological: CoronaVac

Interventions

Ad5-nCoV-IH BIOLOGICAL

The orally aerosolized Ad5-nCoV is a replication defective Ad5 vectored COVID-19 vaccine expressing the full-length spike gene of wide-type SARS-CoV-2, Wuhan-Hu-1. The Ad5-nCoV vaccine was supplied in 1.5mL/vial, at a concentration of 1.0 × 1011 viral particles per mL as a liquid formulation. 0.1 ml of Ad5-nCoV vaccine will be aerosolized by using Continuous Vapouring System. Then, the aerosolized droplets will be poured into a disposable suction cup and be inhaled by participants through mouth.

Also known as: aerosolized Ad5-nCoV, Convidecia

Group A

Ad5-nCoV-IM BIOLOGICAL

The Ad5-nCoV is a replication defective Ad5 vectored COVID-19 vaccine expressing the full-length spike gene of wide-type SARS-CoV-2, Wuhan-Hu-1. It was supplied in 1·5mL/vial, at a concentration of 1.0 × 1011 viral particles per mL as a liquid formulation. Participants will be administrated 0.5ml（5×1010VP）of Ad5-nCoV vaccine intramuscularly.

Also known as: intramuscular Ad5-nCoV

Group B

CoronaVac BIOLOGICAL

CoronaVac is an inactivated whole-virion vaccine with aluminium hydroxide as the adjuvant, prepared with a novel coronavirus (CZ02 strain) inoculated in African green monkey kidney cells (Vero cells). One dose of CoronaVac contains 3 μg of SARS-CoV-2 virion in a 0.5 mL aqueous suspension for injection with 0.45 mg/mL of aluminium.

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Location

Related Publications (2)

• Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134.

  PMID: 37202147 DERIVED

• Tang R, Zheng H, Wang BS, Gou JB, Guo XL, Chen XQ, Chen Y, Wu SP, Zhong J, Pan HX, Zhu JH, Xu XY, Shi FJ, Li ZP, Liu JX, Zhang XY, Cui LB, Song ZZ, Hou LH, Zhu FC, Li JX; CanSino COVID-19 Study Group. Safety and immunogenicity of aerosolised Ad5-nCoV, intramuscular Ad5-nCoV, or inactivated COVID-19 vaccine CoronaVac given as the second booster following three doses of CoronaVac: a multicentre, open-label, phase 4, randomised trial. Lancet Respir Med. 2023 Jul;11(7):613-623. doi: 10.1016/S2213-2600(23)00049-8. Epub 2023 Mar 7.

  PMID: 36898400 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jingxin Li, PhD

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: April 23, 2022
• Primary Completion: June 20, 2022
• Study Completion: May 31, 2023
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)