Covid19 Clinical Trial
Official title:
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.
Verified date | April 2023 |
Source | International Vaccine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 360 |
Est. completion date | February 28, 2024 |
Est. primary completion date | September 26, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Madagascar | Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo | Antananarivo | |
Mozambique | Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde | Maputo |
Lead Sponsor | Collaborator |
---|---|
International Vaccine Institute | Harvard University, Heidelberg University, Instituto Nacional de Saúde (INS), Mozambique, International Centre for Diarrhoeal Disease Research, Bangladesh, The Coalition for Epidemic Preparedness Innovations (CEPI), University of Antananarivo |
Madagascar, Mozambique,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cellular immune responses against SARS-CoV-2 | 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. | Till 12 months follow-up visit | |
Other | GMTs, GMFR from baseline | GMTs of anti-SARS-CoV-2 anti-spike IgG, anti-nucleocapsid IgG against SARS-CoV-2, nAbs and pnAbs against SARS-CoV-2, cellular immune response against SARS-CoV-2, post prime or boost dose, and within one week in all participants being found to be SARS-CoV-2 positive by testing.
GMFR from baseline of anti-SARS-CoV-2 anti-spike IgG, anti-nucleocapsid IgG against SARS-CoV-2, nAbs and pnAbs against SARS-CoV-2, cellular immune response against SARS-CoV-2, post prime or boost dose, and within one week in all participants being found to be SARS-CoV-2 positive by testing. Percentage of participants achieving 4-fold or more rise from baseline for anti-SARS-CoV-2 anti-spike IgG, anti-nucleocapsid IgG against SARS-CoV-2, nAbs and pnAbs against SARS-CoV-2, cellular immune response against SARS-CoV-2, post prime or boost dose, and within one week in all participants being found to be SARS-CoV-2 positive by testing. |
Till 12 months follow-up visit | |
Other | Genome sequencing of SARS-CoV-2 viruses isolated post prime or booster dose | 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 | After diagnosis of SARS-CoV-2 infection | |
Other | Profile of vaccine-induced humoral response against SARS-CoV-2 | 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. | Till 12 months follow-up visit | |
Primary | 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. | Four Weeks after second dose | |
Primary | 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 | Till 12 months follow-up visit | |
Primary | 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. | Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination | |
Primary | 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. | Within 28 days after each vaccination | |
Primary | 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 | Within 28 days after each vaccination | |
Secondary | 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 |
Till 12 months follow-up visit | |
Secondary | 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 |
Till 12 months follow-up visit |
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