Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines
- Conditions
- Covid19
- Interventions
- Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)Biological: Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein),Biological: Placebo - Normal saline (0.9% sodium chloride solution)
- Registration Number
- NCT04998240
- Lead Sponsor
- International Vaccine Institute
- Brief Summary
This is an observer-blind, randomized study which aims to assess the immune response and the safety of two different approved vaccines for first and second dose in healthy adults.
- Detailed Description
This is a phase 2, observer-blind, randomized study to assess the safety and the immunogenicity of heterologous prime-boost COVID-19 vaccines regimens in healthy adults aged 18 to 65 years using two approved vaccines (Sinopharm / CNBG Vaccine (BBIBP-CorV) and Johnson \& Johnson Vaccine (Ad26.COV2.S)).
The study will consist of 2 cohorts, one for main immunology endpoints (N=260, 65 per study arm) and one for more detailed immunological assessment (N=100, 25 per study arm). Two doses of vaccine will be administered intramuscularly 4 week apart. All the study participants will be follow-up for 12 months from the administration of first vaccine dose.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 360
- Individuals aged 18 to 65 years old at the time of consent.
- Residing within the area of the study and planning to stay for the study duration.
- HIV negative test result on the day of screening (for those who do not have a documented HIV test results in the last three months of screening).
- Female volunteers of childbearing potential with a negative pregnancy test on the day(s) of screening and vaccination, practicing/willing to practice continuous effective contraception* recommended by the National Health System up to 12 weeks after the booster vaccination..
- Agreement to refrain from blood donation during the course of the study.
- Able and willing to comply with all study requirements, based on the assessment of the investigator.
- Willingness to provide written informed consent before any trial procedure * Effective contraception is defined as follows: contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), and abstinence.
- Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the booster dose.
- Prior receipt/ planned receipt of any vaccine other than the study intervention within 28 days before and after each study vaccination.
- Previous participation in any COVID-19 vaccination trial or vaccination campaign.
- Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine.
- Known infection with hepatitis B, C virus.
- Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.
- History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Continuous use of the anticoagulants, such as coumarins and related anticoagulants.
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, renal disease, liver disease, endocrine disorders, and neurological illness (mild/moderate well controlled comorbidities are allowed).
- Any clinically significant abnormal finding on screening as judged by the investigator.
- Confirmed SARS-CoV-2 infection at enrollment.
- Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within 3 months prior to recruitment (topical steroids are allowed).
- Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prime BBIBP-CorV, Boost Ad26.COV2.S (A1) Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), The randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of Ad26.COV2.S vaccine (A1). Prime Ad26.COV2.S, Boost BBIBP-CorV (B1) BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) The randomized study participants will receive Prime Ad26.COV2.S vaccine followed by Booster dose of BBIBP-CorV vaccine (B1). Prime BBIBP-CorV, Boost Ad26.COV2.S (A1) BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) The randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of Ad26.COV2.S vaccine (A1). Prime BBIBP-CorV, Boost BBIBP-CorV (A2) BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) The randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of BBIBP-CorV vaccine (A2). Prime Placebo, Boost Ad26.COV2.S (B2) Placebo - Normal saline (0.9% sodium chloride solution) The randomized study participants will receive Prime Placebo vaccine followed by Booster dose of Ad26.COV2.S (B2). Prime Placebo, Boost Ad26.COV2.S (B2) Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), The randomized study participants will receive Prime Placebo vaccine followed by Booster dose of Ad26.COV2.S (B2). Prime Ad26.COV2.S, Boost BBIBP-CorV (B1) Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), The randomized study participants will receive Prime Ad26.COV2.S vaccine followed by Booster dose of BBIBP-CorV vaccine (B1).
- Primary Outcome Measures
Name Time Method Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies Four Weeks after second dose Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies using a neutralization assay four weeks after the second dose, in COVID-19 seronegative participants following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens.
Incidence of SAEs and AESI observed at any time point during the entire study period Till 12 months follow-up visit Incidence of SAEs and AESI observed at any time point during the entire study period, among all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens
Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions) Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens.
Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination Within 28 days after each vaccination Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination, in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens
Incidence of unsolicited adverse events that are within 28 days after each vaccination Within 28 days after each vaccination Incidence of unsolicited adverse events that are within 28 days after each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR) Till 12 months follow-up visit * GMTs of anti-SARS-CoV-2 anti-spike IgG as measured by immunoassay, anti-SARS-CoV-2 pseudoneutralizing antibodies as measured by pseudo-neutralization assay, and anti-SARS-CoV-2 anti-nucleocapsid IgG at Day 0, Day 28, Day 56, Day 196, Day 364
* GMFR from baseline of anti-SARS-CoV-2 anti-spike IgG as measured by immunoassay, anti-SARS-CoV-2 pseudo-neutralizing antibodies as measured by pseudo-neutralization assay, and anti-SARS-CoV-2 anti-nucleocapsid IgG at Day 0, Day 28, Day 56, Day 196, Day 364
* Percentage of participants achieving 4-fold or more rise from baseline for anti-SARS-CoV-2 anti-spike IgG as measured by immunoassay, anti-SARS-CoV-2 pseudoneutralizing antibodies as measured by pseudo-neutralization assay, and anti-SARS-CoV-2 anti-nucleocapsid IgG at Day 0, Day 28, Day 56, Day 196, Day 364
Trial Locations
- Locations (2)
Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo
🇲🇬Antananarivo, Madagascar
Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde
🇲🇿Maputo, Mozambique