- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998240
Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines
A Phase 2, Observer-blind, Randomized Study to Assess the Safety and Immunogenicity of Heterologous Prime-boost COVID-19 Vaccines Regimens in Individuals Aged 18 to 65 Years in Mozambique and Madagascar.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Birkneh Tilahun Tadesse, PhD
- Phone Number: +821098041348
- Email: birkneh.tadesse@ivi.int
Study Contact Backup
- Name: Florian Marks, PhD
- Phone Number: +821087033813
- Email: fmarks@ivi.int
Study Locations
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Antananarivo, Madagascar, 101
- Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo
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Maputo, Mozambique
- Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Prime BBIBP-CorV, Boost Ad26.COV2.S (A1)
The randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of Ad26.COV2.S vaccine (A1).
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The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose). Mode of Administration: Intramuscular Storage Conditions: 2°C to 8°C Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), manufactured by Johnson and Johnson in the United States of America. Dose formulation: One dose (0.5 ml) contains contains 5 x 10 10 virus particles Mode of administration: Intramuscular Storage Conditions: 2°C to 8°C |
Experimental: Prime BBIBP-CorV, Boost BBIBP-CorV (A2)
The randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of BBIBP-CorV vaccine (A2).
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The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose). Mode of Administration: Intramuscular Storage Conditions: 2°C to 8°C |
Experimental: Prime Ad26.COV2.S, Boost BBIBP-CorV (B1)
The randomized study participants will receive Prime Ad26.COV2.S vaccine followed by Booster dose of BBIBP-CorV vaccine (B1).
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The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose). Mode of Administration: Intramuscular Storage Conditions: 2°C to 8°C Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), manufactured by Johnson and Johnson in the United States of America. Dose formulation: One dose (0.5 ml) contains contains 5 x 10 10 virus particles Mode of administration: Intramuscular Storage Conditions: 2°C to 8°C |
Experimental: Prime Placebo, Boost Ad26.COV2.S (B2)
The randomized study participants will receive Prime Placebo vaccine followed by Booster dose of Ad26.COV2.S (B2).
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Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), manufactured by Johnson and Johnson in the United States of America. Dose formulation: One dose (0.5 ml) contains contains 5 x 10 10 virus particles Mode of administration: Intramuscular Storage Conditions: 2°C to 8°C Placebo - Normal saline (0.9% sodium chloride solution) Dose formulation: Not Applicable Mode of administration: Intramuscular Storage conditions: 15°C to 30°C |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies
Time Frame: Four Weeks after second dose
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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.
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Four Weeks after second dose
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Incidence of SAEs and AESI observed at any time point during the entire study period
Time Frame: Till 12 months follow-up visit
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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
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Till 12 months follow-up visit
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Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions)
Time Frame: Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination
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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.
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Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination
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Incidence of unsolicited adverse events that are within 28 days after each vaccination
Time Frame: Within 28 days after each vaccination
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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.
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Within 28 days after each vaccination
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Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination
Time Frame: Within 28 days after each vaccination
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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
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Within 28 days after each vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)
Time Frame: Till 12 months follow-up visit
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Till 12 months follow-up visit
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Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)
Time Frame: Till 12 months follow-up visit
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Till 12 months follow-up visit
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cellular immune responses against SARS-CoV-2
Time Frame: Till 12 months follow-up visit
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Cellular immune responses against SARS-CoV-2 by ELISpot and by Intracellular Cytokine Staining (ICS) (Th1/Th2) at days 0, 14, 28, 42, 56, 196, 364, following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens, in the participants of immunology cohort.
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Till 12 months follow-up visit
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GMTs, GMFR from baseline
Time Frame: Till 12 months follow-up visit
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Till 12 months follow-up visit
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Genome sequencing of SARS-CoV-2 viruses isolated post prime or booster dose
Time Frame: After diagnosis of SARS-CoV-2 infection
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Genome sequencing of SARS-CoV-2 viruses isolated post prime or boost, after diagnosis of SARS-CoV-2 infection, in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens
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After diagnosis of SARS-CoV-2 infection
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Profile of vaccine-induced humoral response against SARS-CoV-2
Time Frame: Till 12 months follow-up visit
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Profile of vaccine-induced humoral response against SARS-CoV-2 using systems serology at days 0, 14, 28, 42, 56, 196, 364, in study participants of immunology subset cohort, following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens.
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Till 12 months follow-up visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Florian Marks, PhD, International Vaccine Institute
- Principal Investigator: Ilesh Jani, PhD, Instituto Nacional de Saúde
- Principal Investigator: Raphael Rakotozandrindrainy, MD, Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Immunologic Factors
- Myeloma Proteins
- Paraproteins
Other Study ID Numbers
- IVI-ECOVA-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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