Evaluation of the safety and immunogenicity of the vaccine candidate ABDALA in children and adolescents

Phase 1

• Conditions: COVID-19; SARS-CoV2; Disease Prevention; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000381
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study Completion: 2021-10-30
• Results First Posted: 2021-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 592

Inclusion Criteria

1. Participation on a voluntary basis (signing of the Informed Consent by parents or legal guardians with legal and mental capacity to represent the minor, as well as the signing of the Informed Consent for participants over 12 years of age).
2. Female or male sex and ages between 3 and 18 years at the time of inclusion.
3. Apparently healthy child or adolescent, based on medical history, physical examination, and evaluation by the investigating pediatrician.
4. Nutritional assessment: Weight / height between 10 and 90 percentile for children between 3 and 9 years old.
Body Mass Index (BMI) for the age between 10 and 90 percentile for adolescents between 10 and 18 years.
According to the cut-off points for the Cuban pediatric population.
5. Laboratory tests within or outside the reference range, but not clinically significant (Phase I only).

Exclusion Criteria

1. Reported or documented history of SARS-CoV-2 infection.
2. Contact or suspect of COVID-19 at the time of inclusion.
3. Body temperature equal to or greater than 37ºC. It will be possible to wait until 48 hours after the date in which the vaccination corresponds to apply it.
4. Acute infectious disease at the time of the vaccine application or in the three days prior to the administration of the vaccine.
5. History of chronic diseases.
6. Children with a history of allergic diseases or diseases of the immune system.
7. History of having received a vaccine against SARS-CoV-2 or against other coronaviruses.
8. Have received any other vaccine, in the 14 days prior to the administration of each dose.
9. Use of any investigational product within 30 days prior to recruitment, or planned for during the study period.
10. Having been treated within the previous 30 days or the possibility of requiring treatment during the trial for any underlying condition with: immunomodulators (eg some type of Interferon, Transfer factor, Biomodulin T, Immunoferon, thymosin), or with steroids by any route of administration, or with cytostatics.
11. Have received blood, or any blood product within the three months prior to inclusion.
12. Allergy to Thimerosal or any other component of the formulation under study.
13. Pregnancy or breastfeeding. Positive urine pregnancy test, before the administration of any of the three doses in female participants who are biologically capable of having a pregnancy (history of menarche).
14. Tattoos in both deltoid regions that make it difficult to see the injection site.
15. History or suspicion of alcoholism or drug dependence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of serious adverse events related to the investigational product (Adverse events classified as serious with a causal association consistent with vaccination according to the Cuban vaccine pharmacovigilance system). Measurement time: up to 28 days after the third dose.<br>2. Proportion of subjects with seroconversion of SARS-CoV-2 anti-RBD IgG antibodies (Considering seroconversion as = 4 times the initial determination of the antibody titer). Measurement time: day 56.<br><br>

Secondary Outcome Measures

Name	Time	Method
1. Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Seriousness of adverse events (Serious, Not serious), -Causality relationship (causal association consistent with vaccination, Indeterminate, Inconsistent causal association with vaccination, not classifiable), - Result (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: 1, 24, 48 and 72 hours and, 7 days after the administration of each dose, 14 days after the administration of the 1st and the 2nd dose, respectively, and up to 28 days after the 3rd dose of the vaccine candidate.<br>2. Inhibition to ACE2 by ELISA. Measurement time: days 0 and 56.<br>As a variable for exploration:<br>3. Percentage of SARS-CoV-2 viral neutralization response. Measurement time: Day 56. (Only 10% of those with = 30% inhibition to ACE2 will be evaluated by ELISA at a 1/100 dilution of the sample).