CIGB-Mambisa/Abdala in convalescents

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Phase I / II clinical trial to evaluate the safety and immunogenicity of vaccine candidates X and Y (tp) intramuscularly. Study to boost immunity in convalescent subjects of the viral disease COVID-19

Secondary indentifying numbers:

IG/CIGB-66I-669N/SARS-CoV-2/2101

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba. Ministry of Public Health (MINSAP), Cuba

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Iglermys

Last name:

Figueroa Garcia

Medical Specialty :

Doctor in Medicine. Second degree specialist in Allergy. First degree specialist in Comprehensive General Medicine. Master in Infectious Diseases.

Affiliation:

Surgical Clinical Hospital “Hermanos Ameijeiras”.

Postal address:

San Lazaro street 701 corner Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761898

Email address:

iglermis@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

13/07/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

COVID-19 Convalescence

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Stage I Group A: Vaccine candidate CIGB-669 (RBD 50 µg + 40 µg de HBcAg)/200 µL spray by nasal route, 1 shot in each nostril, single dose (Mambisa group). Group B: Vaccine candidate CIGB-669 (RBD 50 µg + 40 µg de HBcAg)/200 µL drops by nasal route, 2 drops in each nostril, single dose (Mambisa group). Group C: Vaccine candidate CIGB-669 (RBD 50 µg + 40 µg de HBcAg)/200 µL Cuban prototype spray by nasal route, 1 shot in each nostril, single dose (Mambisa group). Group D: Vaccine candidate CIGB-66 (RBD 50 µg + Aluminum hydroxide 0,30 mg)/0,5 mL by intramuscular route, in the deltoid region, single dose (Abdala group). Stage II Mambisa Group: Vaccine candidate CIGB-669 (RBD 50 µg + 40 µg de HBcAg)/200 µL of the variant selected by nasal route, single dose (Mambisa group). Abdala Group D: Vaccine candidate CIGB-66 (RBD 50 µg + Aluminum hydroxide 0,30 mg)/0,5 mL by intramuscular route, in the deltoid region, single dose (Abdala group).

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Single Dose

Injections, Intramuscular

Administration, Intranasal

Nasal Sprays

Instillation, Drug

Intervention keyword:

CIGB-669, CIGB-66, MAMBISA, ABDALA

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1.-Quantification of specific anti-RBD IgG antibody titers (AU / mL). Measurement time: at 14 days after the administration of the dose with respect to the baseline. 2.-Percentage (%) of inhibition of the binding of the RBD protein to the ACE2 receptor in serum. Measurement time: on days 14 and 28 after the administration of the dose, and every 28 days until the decrease in titers.

Key secondary outcomes:

1.- Quantification of specific anti-RBD IgA antibody titers (AU / mL) in saliva and nasal discharge. Measurement time: baseline and on days 14 y 28 after the administration of the dose, and only in stage 1, every 28 days until titers decline. 2.- Title of neutralization of SARS-CoV-2. Measurement time: on days 14 and 28 after the administration of the dose, and every 28 days until the decrease in titers. 3.- Percentage (%) of seroconversion. Measurement time: on days 14 and 28 after the administration of the dose and every 28 days until the decrease in titers.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

80 years

Inclusion criteria:

1. Subjects aged between 19 and 80 years, both inclusive. 2. Subjects convalescing from COVID-19 with at least 2 months of being discharged. 3. Subjects who express, in writing, their consent to participate in the study.

Exclusion criteria:

1. Subjects with a current confirmed history of COVID-19 +. 2. Subjects considered contacts or suspects of COVID-19 at the time of inclusion. 3. Subjects who report any of the following symptoms: - fever, - cough or shortness of breath, - loss of smell (anosmia), - loss of taste (ageusia) or - acute infection during the 15 days prior to inclusion 4. Subjects with decompensated chronic diseases at the time of inclusion. 5. Subjects with a finding or medical condition in the nostrils that makes it difficult to properly administer the product and follow-up (Example: chronic obstructive allergic rhinitis, obstructive nasal septum deviation, benign and malignant nasal tumors such as polyposis and squamous cell carcinoma). 6. Subjects with tattoos in both deltoid regions that make it difficult to see the injection site, taking into account the random nature of the treatment assignment. 7. Obese subjects (BMI ≥ 35 Kg / m2) or underweight (BMI ≤18 Kg / m2). 8. Subjects who previously received treatment with a coronavirus-specific licensed or investigational vaccine. 9. Subjects who received treatment with any investigational product within 3 months prior to recruitment, or who anticipate their planning during the study period. 10. Subjects who received treatment with immunomodulators (Example: some type of Interferon, Transfer Factor, Biomodulin T, Immunoferon, Thymosin), steroids or cytostatics within the three months prior to recruitment or that may require it during the course of the study due to any condition of base. 11. Subjects who received treatment with blood, immunoglobulins and / or any blood product within the three months prior to enrollment. 12. Subjects with a history of allergy to Thiomersal or to any other component of the formulations under study. 13. Subjects with a history or suspicion of alcoholism or drug dependence. 14. Women who are pregnant, breastfeeding or willing to become pregnant during the study. 15. Women of childbearing potential who do not agree to use a contraceptive method during the study. 16. Subjects with mental and / or psychiatric disorders that prevent or limit the signing of the informed consent or the follow-up of the volunteer.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

1-2

Target sample size:

120

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yinet

Last Name:

Barrese Perez

Specialty:

Degree in Pharmaceutical Sciences. Master in Clinical Pharmacy.

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

5ta A street, 6020 between 60 and 62, Miramar, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164226, +53-72164225

Email :

yinet@cencec.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Gerardo

Middle Name:

Enrique

Last Name:

Guillen Nieto

Specialty:

Doctor in Biological Sciences.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

31 Av. between 158 and 190, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-72718008 ext. 7204

Email :

gerardo.guillen@cigb.edu.cu [3]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Surgical Clinical Hospital “Hermanos Ameijeiras”

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

03/06/2021

Postal address of Ethic Committee :

San Lazaro street 701 corner Belascoain, Centro Habana, Havana ZC 10300, Cuba

Telephone:

+53-78383963

Email:

alvaca@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

11/12/2021

Date of available results:

27/12/2021

Date of first publication:

20/01/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000382

Date of Registration in Primary Registry:

09/07/2021

Record Verification Date:

2021/08/09

Next update date:

2022/08/09

Link to the spanish version:

Click here [4]