Open-label, Non-randomized, Non-comparative, Phase II Study in Adult Subjects to Assess Safety and Immunogenicity of Combination of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, and rAd26-S, a Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for COVID-19 Prevention
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- R-Pharm
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread.
Detailed Description
This clinical study is a prospective, single-center, open-label, non-comparative, non-randomized single-arm study. It will enroll adult subjects aged ≥ 18 years old with absence of active COVID-19 infection to be verified by the results of reverse transcription polymerase chain reaction (RT-PCR). 100 subjects meeting inclusion criteria are expected to be screened, 100 of them meeting eligibility criteria will receive one intramuscular injection of AZD1222 vaccine at 5×10\^10 viral particles (nominal dose) and at least 90 subjects per one intramuscular injection of rAd26-S at (10±0.5) 1\*10\^11 viral particles with a 4-week interval on study days 1 and 29, respectively. Duration of the subject participation in the study will be 6 months (180±10 days) from the day of administration of the first dose of AZD1222 vaccine. 10 visits are scheduled for each subject, 8 of them being obligatory personal visits to the study site. Safety will be assessed for the duration of the study as follows: * Solicited adverse events (AEs) (local and systemic) will be assessed for 7 days following each vaccination (ie, on days 1-7 after the first vaccination and on study days 29-35 to account for AEs after second vaccination) at the study visits and based on the results of Subject Diary review. * Unsolicited AEs will be recorded within 29 days after administration of each dose of AZD1222/rAd26-S vaccine (i.e. on days 1-29 and on days 29 to 57). * Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 180 * Adverse events of special interest (AESI) will be documented from the first vaccination until day 180. Immunogenicity will also be assessed throughout the study and include serological assay of levels of antibodies specific for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen as well as level of seroconversion, tests for neutralising antibodies. At least 100 subjects are expected to receive at least one dose of the study product in 1 study site on the territory of Republic Azerbaijan.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants are:
- •Overtly healthy as determined by medical examination, or
- •Medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow up.
- •(A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment.)
- •Able to understand and comply with study requirements/procedures based on the assessment of the investigator.
- •Female participants
- •Women of childbearing potential must:
- •Have a negative pregnancy test on the day of screening and Day
- •Use of a highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1 % per year when used consistently and correctly (see the table below). Periodic abstinence, the rhythm method, and withdrawal are NOT acceptable methods of contraception.
- •Women are considered of childbearing potential unless they meet either of the following criteria:
Exclusion Criteria
- •Known past confirmed SARS-CoV-2 infection less than 6 month prior to screening (the date of diagnosis must be confirmed by an official document).
- •Positive SARS-CoV-2 Reverse transcriptase polymerase chain reaction (RT-PCR) test at screening.
- •Significant infection or other illness including fever \> 37.8 °C on the day prior to or day of vaccination.
- •Thrombocytopenia of grade ≥ 2 (i.e., \<100,000/ mm3)
- •Clinically significant neutropenia (as determined by the investigator).
- •Clinically significant anemia (as determined by the investigator).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including infection caused by human immunodeficiency virus (HIV); asplenia; recurring and severe infections and administration of chronic immunosuppressive drugs within previous 6 months ( ≥ 20 mg/day of prednisone or another steroid at an equivalent dose used daily or every other day for ≥ 15 days within the 30-day period preceding immunization) except for topical/inhalation steroids or short-term oral steroids (courses ≤14 days).
- •Note: enrollment of HIV-positive subjects with CD4 levels \> 500 cells/mL3 ≥12 months receiving stable antiretroviral therapy for HIV therapy is allowed.
- •Note: topical use of tacrolimus is permitted unless it was used within 14 days prior to enrollment.
- •History of allergic reactions to any of the product ingredients.
Outcomes
Primary Outcomes
Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination.
Time Frame: Day 57
Antibody seroconversion rate (≥4-fold increase from baseline) to SARS CoV-2 Spike protein 29 days after the second vaccination.
Secondary Outcomes
- Antibody seroconversion rate of neutralizing antibodies to SARS-CoV-2 antigen - 29 days after each vaccination(day 29, 57)
- Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose(from Day 1 to Day 8 and From Day 29 to Day 36)
- Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest(up to day 29, up to day 57)
- Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens(Day 1, 15, 29, 57, 180)
- Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination.(day 29)
- Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination.(day 29, 57)
- Change from baseline Geometric mean fold rise (GMFR) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens(Day 1, 15, 29, 57, 180)
- Change from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2(Day 1, 15, 29, 57, 180)
- Change from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2(Day 1, 15, 29, 57, 180)