Clinical trial NCT05293223: Phase IIB Study of Recombinant Novel Coronavirus Vaccine
Official title: An Open-label Clinical Trial Phase IIB to Evaluate the Immunogenicity and Safety of Recombinant Novel Coronavirus Vaccine in Participants Aged 18 Years and Above That Previously Received One Dose of Sputnik V
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19 Vaccine
Lead sponsor: Fundación Huésped
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: CanSino Biologics Inc.
First posted: 2022-03-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The ratio of Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody in participants on Day 21 post-vaccination of Ad5-nCoV (previously received a 1st dose of Sputnik V) (Group A) and two doses of Sputnik V (Group B) is used for the evaluation of this hypothesis.
Primary purpose: PREVENTION

Brief summary: This is an open-label and non-randomized study to demonstrate the immunogenicity and safety profile in adults that received the Ad5-nCoV vaccine at least 21 days but no later than 90 days after the first dose of Sputnik V.

The non-inferiority hypothesis is used for the evaluation of the exploratory objective. The ratio of Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody in participants on Day 21 post-vaccination of Ad5-nCoV (previously received a 1st dose of Sputnik V) (Group A) and two doses of Sputnik V (Group B) is used for the evaluation of this hypothesis.

It is assumed to enroll about 100 subjects for each group. Additionally, 45 participants will be selected from Group A (to enter the immunogenicity subgroup for cellular immune response analysis. According to the above, considering extra subjects for compensating about 10% dropouts, the sample size of Group A is designed to be 450, for Group B is 200. Participants enrolled in Group A (1st dose of Sputnik V plus 1 dose of Ad5-nCoV) must have only received the 1st dose of Sputnik V and the interval between the previous injection (1st dose of Sputnik V) and the day of vaccination with Ad5-nCoV should be between 21 and 90 days. The comparator (Group B) will be the samples stored at the immunology lab of the Buenos Aires University Medical School, corresponding to individuals vaccinated with 2 doses of Sputnik V.

Detailed description: There are 4 planned site visits in total: V1 (day0), V2 (day21), V3 (month 3), V4 (month 6) Healthy adults aged 18 years and above in Argentina will be informed by a procedure approved by the ethical review committee before consent is sought to be a volunteer. After passing the physical examination and screening according to the inclusion and exclusion criteria, they will be eligible to participate in this study.

Group B is a comparator group, in which samples stored corresponding to individuals who have already received 2 doses of Sputnik V will be used for the immunogenicity evaluation.

Study Procedures

* Informed consent
* Check inclusion and exclusion criteria All inclusion and exclusion criteria will be checked at the screening in-person visit and be reviewed at each in-person visit.
* Collect demographic data and contact information
* Medical history Obtain the participant's medical history by interview and/or review of the participant's medical records and record any pre-existing conditions or signs and/or symptoms present prior to injection in the EDC. This will include reviewing of any health condition that may prevent the participant from enrolling in the study, such as an unstable health condition or known positive HIV status (with less than 200 CD4 cells/mL).
* Check contraindications, warnings and precautions to injection Contraindications, warnings and precautions to injection must be checked before vaccination.
* Urine Pregnancy Test/Birth Control Women of child-bearing age will be asked to perform a urine pregnancy test at the day of enrollment. The result of the urine pregnancy test must be negative. In addition, participants who are able to become pregnant or could impregnate a partner are required to have used approved contraception at least 30 days prior to the study vaccination and for 90 days' post-vaccination.
* Physical examination Screening conclusion Participants will be deemed eligible to participate upon reviewing medical history and inclusion and exclusion criteria. This will occur prior to vaccination.
* Study group and treatment number allocation The eligible participants will be enrolled into Group A. Each participant will be assigned a treatment identification number (Subject ID).
* Check and record prior medications and concomitant medication/injection
* Check and record intercurrent medical conditions
* Pre-vaccination serology Approximately 10 mL of whole blood will be collected from each participant in Group A at Day 0 and separated for serum.
* Injection of study vaccine After completing all prerequisite procedures prior to injection, one dose of the assigned vaccine will be administered IM in the deltoid muscle of the upper arm for participants in Group A.
* Safety participant contacts Participants in group A need to record any AEs they may experience within 21 days post-vaccination. There is an on-site visit on the 21st day post-vaccination and the subjects need to submit their diary card.

Following up serology All participants in group A will have an in-person visit at Day 21, Month 3, and Month 6 post-vaccination of either Ad5-nCoV. Approximately 10 mL of whole blood will be collected from each participant and separated for serum.

Eligibility criteria: Inclusion Criteria:

1. Participants aged 18 years and above at the time of randomization.
2. Provide written informed consent.
3. Axillary temperature ≤ 37℃.
4. Never received any investigational or licensed COVID-19 vaccine other than the 1st dose of Sputnik V with an interval of 21-90 days before the study.
5. Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.

Exclusion Criteria:

1. Have a history of seizures, epilepsy, encephalopathy, psychosis.
2. History of anaphylaxis to any vaccine component.
3. Positive urine pregnancy test result, pregnant, lactation women, or intend to become pregnant within the next 6 months.
4. Congenital or acquired angioedema/neuroedema.
5. Medical history of Guillain-Barré syndrome.
6. Asplenia or functional absence of spleen.
7. Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
8. Any confirmed or suspected immunosuppressive or immunodeficient state; received immunosuppressive therapy, cytotoxic therapy, or chronic corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) within the past 6 months,
9. History of chronic systematic infection.
10. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
11. Receiving anti-tuberculosis or cancer treatment.
12. History of laboratory-confirmed COVID-19, or has a positive result at the examination of SARS-CoV-2 antigen before vaccination.
13. Planned to receive any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination.
14. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban).
15. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Primary outcomes:
measure: The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody
timeFrame: 21 days from baseline
Secondary outcomes:
measure: The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody
timeFrame: Month 3 and Month 6 from baseline
measure: solicited adverse events
timeFrame: from baseline to 7 days post-vaccination
measure: SARS-CoV-2 specific T-cell response
timeFrame: Day 21 post-vaccination of Ad5-nCoV
measure: The GMT of S-protein receptor binding domain (S-RBD) antibody
timeFrame: Day 21, Month 3, and Month 6
measure: unsolicited adverse events (AEs)
timeFrame: from baseline to 21 days post-vaccination
measure: serious adverse events (SAEs)
timeFrame: from baseline to week 24
Other outcomes:
Locations:
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Fundación Huésped
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro de vacunación PREVIVAX
state: Ciudad Autónoam De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigación y Prevención Cardiovascular CIPREC
Study officials:
References: