COVID-19Phase 4NCT04952727

Study on Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) in Elderly Adults

A Phase 4 study testing Recombinant SARS-CoV-2 Ad5 vectored vaccine and Inactive SARS-CoV-2 vaccine (Vero cell) in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Recombinant SARS-CoV-2 Ad5 vectored vaccine and Inactive SARS-CoV-2 vaccine (Vero cell)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteChina
Study dates: 26 Aug 2021to 15 May 2022
Phase: Phase 4
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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Health subjects aged 60 and above, who have been completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2 vaccine in the past 1-3 months.
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.
Axillary temperature ≤ 37.0#.
Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization

Who cannot join

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.
women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
have acute febrile diseases and infectious diseases.
have severe chronic diseases or condition in progress cannot be controlled.
congenital or acquired angioedema / neuroedema

Show all 14Show fewer

have the history of urticaria 1 year before receiving the investigational vaccine.
have asplenia or functional asplenia.
have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
have needle sickness.
have the history of immunosuppressive therapy, anti-allergy therapy,cytotoxic therapy or inhaled corticosteroids (excluding corticosteroidspray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
have received blood products within 4 months before injection of investigational vaccines.
under anti-tuberculosis treatment.
not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to variousmedical, psychological, social or other conditions.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu

Other trials in China

About this study

Official title: Safety and Immunogenicity of Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) inChinese Healthy Adults Aged 60 and Above: a Randomized, Observer-blind,Parallel-controlled Clinical Trial

This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant COVID-19 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 60 and above after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 60 and above will be recruited in this study. Of them, 200 subjects who have been vaccinated with two dose of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 3~6 months later. Other 100 subjects who have been vaccinated with one dose of inactivated SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 1~3 months later. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on day 0 before the boosting with ad5 vectored vaccine and on day 14, 28 and month 6 after the boosting. Serum antibody levels, cellular immune responses and the subgroups or germlines of the specific B cells will be analyzed. Each subject will remain in this study for approximately 6 months.

Conditions: COVID-19
Being tested: Recombinant SARS-CoV-2 Ad5 vectored vaccine, Inactive SARS-CoV-2 vaccine (Vero cell)
Keywords: COVID-19 Vaccine, Sequential immunization, Heterologous prime-boost, Ad5 vectored vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant SARS-CoV-2 Ad5 vectored vaccineBiological
Also called Ad5-nCoV
This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.
Inactive SARS-CoV-2 vaccine (Vero cell)Biological
Also called CoronaVac
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.

Study groups in NCT04952727
Study group	Role	What they receive
heterologous boost arm with Ad5 vectored vaccine	Experimental	Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3~6 months. Receives: Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine
homogeneous boost arm with inactive vaccine	Active comparator	Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster dose of inactive SARS-CoV-2 vaccine after 3~6 months. Receives: Biological: Inactive SARS-CoV-2 vaccine (Vero cell)
heterologous regimen with Ad5 vectored vaccine	Experimental	Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1~3 months Receives: Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine
homogeneous regimen arm with inactive vaccine	Active comparator	Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of inactive SARS-CoV-2 vaccine after 1~3 months. Receives: Biological: Inactive SARS-CoV-2 vaccine (Vero cell)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse reactions within 28 days after the booster dose.
Incidence of adverse reactions within 28 days after vaccination.
Measured: Within 28 days after the booster dose
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.
Measured: On day 14 after the booster dose

Secondary outcomes (10)

Incidence of solicited AE within 14 days after the booster dose
Incidence of solicited adverse events (AE) within 14 days after the booster vaccination.
Measured: within 14 days after the booster dose
Incidence of unsolicited AE within 28 days after the booster dose.
Incidence of unsolicited adverse events (AE) within 28 days after vaccination.
Measured: within 28 days after the booster dose
Incidence of serious adverse events (SAE) till the 6 months after the booster dose.
Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.
Measured: within 6 months after the booster dose
GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose.
GMT of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 14, day 28 and month 6after the booster vaccination.
Measured: on day 14, day 28 and month 6 after the booster vaccination
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
Measured: on day 28 and month 6 after the last dose of vaccination
Fold increase of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Fold increase of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Measured: on day 14, day 28 and month 6 after the booster vaccination
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Measured: on day 14, day 28 and month 6 after the last dose of vaccination
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Measured: on day 14, day 28 and month 6 after the booster vaccination
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus on day 14, day 28 and month 6 after the booster vaccination.
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus, as compared to baseline, at Day 14, Day 28 and Month 6 after the booster vaccination.
Measured: on day 14, day 28 and month 6 after the booster vaccination
Specific T cell responses on day 14 after the booster vaccination.
Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT.
Measured: on day 14 after the booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 202115 May 2022

First posted7 Jul 2021
Study start26 Aug 2021
Primary completion26 Nov 2021
Study completion15 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects who have been primed with one dose or two doses of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive abooster dose of inactive SARS-CoV-2 vaccine or recombinant SARS-CoV-2Ad5 vectored vaccine
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04952727
Sponsor's protocol ID: JSVCT117
Status last verified: Mar 2022
First submitted: 3 Jul 2021
Last updated: 16 Aug 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Jin PF, Guo XL, Gou JB, Hou LH, Song ZZ, Zhu T, Pan HX, Zhu JH, Shi FJ, Du P, Huang HT, Liu JX, Zheng H, Wang X, Chen Y, Wan P, Wu SP, Wang XW, Xu XY, Yan FR, Li JX, Chen W, Zhu FC. Immunogenicity and safety of heterologous immunisation with Ad5-nCOV in healthy adults aged 60 years and older primed with an inactivated SARS-CoV-2 vaccine (CoronaVac): a phase 4, randomised, observer-blind, non-inferiority trial. Lancet Reg Health West Pac. 2023 Jun 20;38:100829. doi: 10.1016/j.lanwpc.2023.100829. Online ahead of print.
PubMed 37360864

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) inChinese Healthy Adults Aged 60 and Above: a Randomized, Observer-blind,Parallel-controlled Clinical Trial
ClinicalTrials.gov ID: NCT04952727
Acronym / sponsor ID: JSVCT117
Conditions: COVID-19
Keywords: COVID-19 Vaccine, Sequential immunization, Heterologous prime-boost, Ad5 vectored vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Collaborators: CanSino Biologics Inc.
Study start: 26 Aug 2021 (actual)
Primary completion: 26 Nov 2021 (actual)
Study completion: 15 May 2022 (actual)
First posted: 7 Jul 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
Model description: Subjects who have been primed with one dose or two doses of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive abooster dose of inactive SARS-CoV-2 vaccine or recombinant SARS-CoV-2Ad5 vectored vaccine

Arm	Type	Receives
heterologous boost arm with Ad5 vectored vaccine	Experimental	Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccineSubjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3~6 months.
homogeneous boost arm with inactive vaccine	Active comparator	Biological: Inactive SARS-CoV-2 vaccine (Vero cell)Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster dose of inactive SARS-CoV-2 vaccine after 3~6 months.
heterologous regimen with Ad5 vectored vaccine	Experimental	Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccineSubjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1~3 months
homogeneous regimen arm with inactive vaccine	Active comparator	Biological: Inactive SARS-CoV-2 vaccine (Vero cell)Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of inactive SARS-CoV-2 vaccine after 1~3 months.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Health subjects aged 60 and above, who have been completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2 vaccine in the past 1-3 months.
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.
Axillary temperature ≤ 37.0#.
Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization

Key exclusion criteria (14 listed)

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.
women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
have acute febrile diseases and infectious diseases.
have severe chronic diseases or condition in progress cannot be controlled.

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
Recombinant SARS-CoV-2 Ad5 vectored vaccineAlso: Ad5-nCoVThis vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.	Biological	heterologous boost arm with Ad5 vectored vaccine, heterologous regimen with Ad5 vectored vaccine
Inactive SARS-CoV-2 vaccine (Vero cell)Also: CoronaVacThis vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.	Biological	homogeneous boost arm with inactive vaccine, homogeneous regimen arm with inactive vaccine

Primary outcome

Incidence of adverse reactions within 28 days after the booster dose.
Time frame: Within 28 days after the booster dose
Incidence of adverse reactions within 28 days after vaccination.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.
Time frame: On day 14 after the booster dose
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.

10 secondary outcomes

Incidence of solicited AE within 14 days after the booster dose
Time frame: within 14 days after the booster dose
Incidence of unsolicited AE within 28 days after the booster dose.
Time frame: within 28 days after the booster dose
Incidence of serious adverse events (SAE) till the 6 months after the booster dose.
Time frame: within 6 months after the booster dose
GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
Time frame: on day 28 and month 6 after the last dose of vaccination
Fold increase of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 14, day 28 and month 6 after the last dose of vaccination
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
Specific T cell responses on day 14 after the booster vaccination.
Time frame: on day 14 after the booster vaccination

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 16 Aug 2022.
Derived from this study: PubMed 37360864Jin PF, Guo XL, Gou JB, Hou LH, Song ZZ, Zhu T, Pan HX, Zhu JH, Shi FJ, Du P, Huang HT, Liu JX, Zheng H, Wang X, Chen Y, Wan P, Wu SP, Wang XW, Xu XY, Yan FR, Li JX, Chen W, Zhu FC. Immunogenicity and safety of heterologous immunisation with Ad5-nCOV in healthy adults aged 60 years and older primed with an inactivated SARS-CoV-2 vaccine (CoronaVac): a phase 4, randomised, observer-blind, non-inferiority trial. Lancet Reg Health West Pac. 2023 Jun 20;38:100829. doi: 10.1016/j.lanwpc.2023.100829. Online ahead of print.

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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.

Jing-Xin Li, PhD principal investigator

Jiangsu Provincial Center for Diseases Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 14 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Incidence of adverse reactions within 28 days after the booster dose. (time frame: Within 28 days after the booster dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04952727, which also lists 1 linked publication.

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 16 Aug 2022.