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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
360
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
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
Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies
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.
Time frame: Four Weeks after second dose
Incidence of SAEs and AESI observed at any time point during the entire study period
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
Time frame: Till 12 months follow-up visit
Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions)
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.
Time frame: Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination
Incidence of unsolicited adverse events that are 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.
Time frame: Within 28 days after each vaccination
Incidence of changes in laboratory safety measures from baseline to day 28 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
Time frame: Within 28 days after each vaccination
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Placebo - Normal saline (0.9% sodium chloride solution) Dose formulation: Not Applicable Mode of administration: Intramuscular Storage conditions: 15°C to 30°C
Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)
* GMTs of anti-SARS-CoV-2 neutralizing antibodies as measured by neutralization assay at Day 0, Day 28, Day 196, Day 364 * GMFR from baseline of anti-SARS-CoV-2 neutralizing antibodies as measured by neutralization assay at Day 0, Day 28, Day 196, Day 364 * Percentage of participants achieving 4-fold or more rise from baseline of anti-SARS-CoV-2 neutralizing antibodies as measured by neutralization assay at Day 0, Day 28, Day 196, Day 364
Time frame: Till 12 months follow-up visit
Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)
* 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
Time frame: Till 12 months follow-up visit