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NCT04984408
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Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection. |
Not yet recruiting |
Phase 3 |
Oct/01/2021 |
Sep/30/2024 |
- Alternative id - IVI-ECOVA-01
- Interventions - Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)|Biological: influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 8825
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease|Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs)|Protection conferred by BBIBP-CorV vaccine against symptomatic COVID-19 disease|Protection conferred by BBIBP-CorV vaccine against asymptomatic SARS-CoV-2 infection (any SARS-CoV-2 variant)|Protection conferred by BBIBP-CorV vaccine against severe COVID-19 disease and COVID-19 associated death|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants|Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) in HIV-infected adults|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants in HIV-infected adults|SARS-CoV-2 sequence variants among HIV-infected and HIV-uninfected, BBIBP-CorV vaccine and placebo recipients|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in the Arm 3 as compared to Arm 1 and 2 (subset participants).|Incidence of adverse event (AE) after each vaccination, serious adverse event (SAE), adverse events of special interests (AESIs) according to Brighton Collaboration list for COVID-19 vaccine studies among participants receiving the study vaccines.|Humoral and cellular immune responses of HIV-infected participants as compared to HIV-uninfected vaccine and control arms (subset participants of Arms 1 and 2)|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody following booster dose of BBIBP-CorV vaccine|Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) among HIV uninfected adults.
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NCT05105295
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Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With HIV Infected |
Not yet recruiting |
Phase 4 |
Dec/01/2021 |
Jun/30/2022 |
- Alternative id - BIBP2021HIV-third dose
- Interventions - Biological: Inactivated COVID-19 vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Zhejiang provincial center for disease control and prevention, Hangzhou, Zhejiang, China
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 400
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Seroconversion rate|Neutralizing antibody level|Adverse events rate|Serious adverse event rate|T cell count|HIV viral load
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NCT04993560
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Safety and Efficacy of COVID-19 Prime-boost Vaccine in Bahrain |
Completed |
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Jul/18/2021 |
Oct/19/2021 |
- Alternative id - CRT- COVID2021-143
- Interventions - Biological: BBIBP-CorV|Biological: BNT162b2
- Study type - Observational
- Study results - No Results Available
- Locations - Royal College of Surgeons in Ireland - Bahrain, Manama, Bahrain
- Study designs - Observational Model: Ecologic or Community|Time Perspective: Cross-Sectional
- Enrollment - 305
- Age - 21 Years and older (Adult, Older Adult)
- Outcome measures - Change from Baseline Immunogenicity at 8 weeks|Reactogenicity
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NCT04885764
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Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams University |
Recruiting |
Phase 2|Phase 3 |
Feb/23/2021 |
Dec/01/2021 |
- Alternative id - FMASU P01b / 2021
- Interventions - Biological: Astrazeneca/Oxford Vaccine|Biological: Sinopharm vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center, Cairo, Non-US, Egypt
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 4000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Short-term effectiveness
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NCT05285384
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Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine |
Recruiting |
Not Applicable |
Feb/04/2022 |
Apr/30/2022 |
- Alternative id - VAC.CIN.PT.BOOSTER.KTR|IRCT20150303021315N28
- Interventions - Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Study type - Interventional
- Study results - No Results Available
- Locations - Shaheed Labbafinezhad Hospital, Tehran, Iran, Islamic Republic of
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 100
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of participants with seroconversion for S1 binding IgG antibodies|Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies|Geometric mean fold rise (GMFR) for S1 binding IgG antibodies|Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline|Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline|Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies|Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline|Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline|Change in T-cell IFN-γ secretion from baseline to one month after the booster dose|Incidence of solicited adverse events|Incidence of unsolicited adverse events
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NCT05104216
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Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in Elderly People With Chronic Bronchitis and COPD |
Not yet recruiting |
Phase 4 |
Dec/01/2021 |
Jun/30/2022 |
- Alternative id - BIBP2021COPD-third dose
- Interventions - Biological: Inactivated COVID-19 vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Zhejiang provincial center for disease control and prevention, Hangzhou, Zhejiang, China
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 400
- Age - 60 Years and older (Adult, Older Adult)
- Outcome measures - Seroconversion rate|Neutralizing antibody level|Adverse events rate|Serious adverse event rate
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NCT04998240
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Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines in Mozambique |
Not yet recruiting |
Phase 2 |
Sep/01/2021 |
Oct/30/2022 |
- Alternative id - IVI-ECOVA-02
- Interventions - Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)|Biological: AZD1222 (replication-deficient Ad type 5 vector expressing full-length spike protein)
- Study type - Interventional
- Study results - No Results Available
- Locations - Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde, Maputo, Mozambique
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 360
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies|Incidence of SAEs and AESI observed at any time point during the entire study period|Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions)|Incidence of unsolicited adverse events that are within 28 days after each vaccination|Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination|Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)
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NCT05249816
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Phase 3 Study to Evaluate a Single Booster of the NVX-CoV2373 COVID19 Vaccine in Adults |
Not yet recruiting |
Phase 3 |
Mar/01/2022 |
Sep/30/2022 |
- Alternative id - G42-HC-2021001
- Interventions - Drug: NVX-CoV2373 with Matrix-M adjuvant Injection|Drug: BBIBP-CorV vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates|Sheikh Khalifa Medical City (SKMC), Abu Dhabi, United Arab Emirates
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 1000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Utilizing ratio of IgG GMTs and difference in seroconversion rates to compare IgG antibody responses between the vaccines.|Utilizing Case Report Forms and safety follow up via telephone to measure and assess incidence, duration, and severity of solicited local and systemic adverse events (AEs)|Utilizing Case Report Forms to measure and assess Incidence, duration, severity, and relationship of unsolicited AEs|Utilizing Case Report Forms to measure incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study.|Utilizing Plaque Reduction Neutralization Tests (PRNT) to compare neutralizing antibody responses
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NCT05205083
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Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of BBIBP-CorV |
Recruiting |
Phase 1|Phase 2 |
Nov/10/2021 |
Jul/01/2022 |
- Alternative id - IIT-LKM-2021-NCV03-01
- Interventions - Biological: Recombinant novel coronavirus vaccine (CHO cells)
- Study type - Interventional
- Study results - No Results Available
- Locations - Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 480
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Immunogenicity endpoint|Safety endpoint
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