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Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes in an Elderly Population

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ClinicalTrials.gov Identifier: NCT04983537
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Ministerio de Salud de Ciudad Autónoma de Buenos Aires

Brief Summary:
To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with counterpart regimens currently in use in Argentina among a population of persons aged 66 or above.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccines Drug: Gam-COVID-Vac / Gam-COVID-Vac Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All personnel involved in antibody determination shall remain blinded to the assigned strategy.
Primary Purpose: Health Services Research
Official Title: Randomised Phase II Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes in an Elderly Population (rAd26-rAd5, ChAdOx1 nCoV-19 and BBIBP-CorV).
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : September 26, 2021
Estimated Study Completion Date : September 26, 2021

Arm Intervention/treatment
Active Comparator: Gam-COVID-Vac / Gam-COVID-Vac Drug: Gam-COVID-Vac / Gam-COVID-Vac
A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and the Gam-COVID-Vac / ChAdOx1 nCoV-19 and Gam-COVID-Vac / BBIBP-CorV groups as comparators.Comparisons will be made by contrasting the geometric means of antibody levels between each of the study arms. In addition, comparisons will be made as to whether or not the median antibody values of the alternative treatment groups are lower than: a) the 25th percentile of the median antibody value of the Gam COVID combination and b) whether the lower limit of the confidence interval of the differences in the GMC rate is lower than the conventional cut-off point of non-inferiority set at 0.67.
Other Names:
  • Gam-COVID-Vac / ChAdOx1 nCoV-19
  • Gam-COVID-Vac / BBIBP-CorV

Active Comparator: Gam-COVID-Vac / ChAdOx1 nCoV-19 Drug: Gam-COVID-Vac / Gam-COVID-Vac
A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and the Gam-COVID-Vac / ChAdOx1 nCoV-19 and Gam-COVID-Vac / BBIBP-CorV groups as comparators.Comparisons will be made by contrasting the geometric means of antibody levels between each of the study arms. In addition, comparisons will be made as to whether or not the median antibody values of the alternative treatment groups are lower than: a) the 25th percentile of the median antibody value of the Gam COVID combination and b) whether the lower limit of the confidence interval of the differences in the GMC rate is lower than the conventional cut-off point of non-inferiority set at 0.67.
Other Names:
  • Gam-COVID-Vac / ChAdOx1 nCoV-19
  • Gam-COVID-Vac / BBIBP-CorV

Active Comparator: Gam-COVID-Vac / BBIBP-CorV Drug: Gam-COVID-Vac / Gam-COVID-Vac
A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and the Gam-COVID-Vac / ChAdOx1 nCoV-19 and Gam-COVID-Vac / BBIBP-CorV groups as comparators.Comparisons will be made by contrasting the geometric means of antibody levels between each of the study arms. In addition, comparisons will be made as to whether or not the median antibody values of the alternative treatment groups are lower than: a) the 25th percentile of the median antibody value of the Gam COVID combination and b) whether the lower limit of the confidence interval of the differences in the GMC rate is lower than the conventional cut-off point of non-inferiority set at 0.67.
Other Names:
  • Gam-COVID-Vac / ChAdOx1 nCoV-19
  • Gam-COVID-Vac / BBIBP-CorV




Primary Outcome Measures :
  1. ELISA assessment of IgG anti Spike (UI/ml) [ Time Frame: 28 days ]

    To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with currently used counterpart regimens.

    The determination of the antibody concentration in each of the study arms will be assessed by measuring the IgG antibody concentration using ELISA expressed in IU/ml.


  2. Serious adverse events Adverse events of special interest [ Time Frame: 28 days ]
    To report the combine and specific rate of serious adverse defined as death for any reason, any life-threatening event or any event that require inpatient hospitalization.


Secondary Outcome Measures :
  1. Neutralising antibodies against SARS-CoV-2 [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Persons who have received a dose of Gam-COVID-Vac more than 30 days and less than 90 days ago.
  • Age > 65 years.
  • Both genders.
  • Who have voluntarily agreed to participate in the clinical trial and have provided informed consent.

Exclusion Criteria:

  • Known history of COVID in the 6 months prior to study inclusion.
  • Known or suspected immunocompromised status by the study investigator for any cause.
  • Use of oral or parenteral corticosteroids in the last 30 days.
  • Known history of allergy to any vaccine.
  • History of anaphylaxis.
  • Pregnant or lactating women.
  • Known history of autoimmune diseases.
  • Persons under treatment for any neoplastic disease within the last 6 months.
  • Any serious illness or condition at the discretion of the study investigator (including but not limited to the presence of chronic obstructive pulmonary disease, heart failure, poorly controlled hypertension, poorly controlled diabetes, renal failure).
  • Planned medical procedures within two months of randomisation.
  • Previous vaccination within the last 30 days with any vaccine.
  • Known participation in an ongoing clinical trial.
  • Ongoing acute illness.
  • Fever (≥37.8 C) at the time of randomisation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04983537


Contacts
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Contact: Daniel Ferrante, MD 5441233221 danielferrante@buenosaires.gob.ar

Locations
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Argentina
Hospital Ramos Mejía Recruiting
Ciudad Autonoma de Buenos Aire, CBA, Argentina, 1121
Contact: Marcelo Losso, MD    41270203    mlosso@hivramos.org.ar   
Ministerio de Salud de la Ciudad Autónoma de Buenos Aires Recruiting
Ciudad Autónoma de Buenos Aires, Argentina, 1284
Contact: Alejandro Macchia, MD    +541141233221    amacchia@buenosaires.gob.ar   
Sponsors and Collaborators
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
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Responsible Party: Ministerio de Salud de Ciudad Autónoma de Buenos Aires
ClinicalTrials.gov Identifier: NCT04983537    
Other Study ID Numbers: 5143_2
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ministerio de Salud de Ciudad Autónoma de Buenos Aires:
COVID-19 Serological Testing
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases