Phase 2 clinical trial in adults previously vaccinated against SARS-CoV-2 in Chile with an initial schedule of two doses of CoronaVac® plus two booster doses with different vaccines. Subjects will randomly receive a third booster dose with Omicron, trivalent, or CoronaVac® vaccine. The humoral immunogenicity against COVID-19 will be compared in subjects that received the Omicron or the Trivalent vaccines with subjects that received CoronaVac® to determine the superiority of the two candidate vaccines versus CoronaVac®. Subjects will be followed for 6 months after the booster dose administration.
This study will be a phase 2 randomized, double-blind, multicenter clinical trial in fully vaccinated adults, males, and females, who have previously received an initial schedule of two doses of CoronaVac® plus two booster doses with different vaccines against SARS-CoV-2 in Chile. Two groups of participants will be included: Heterologous group: subjects who had received two booster doses with mRNA or viral vector-based vaccine); and homologous group: subjects who have received two booster doses of CoronaVac® in a previous clinical trial (CoronaVac03CL). Subjects of the heterologous group will randomly receive a booster dose with Omicron, trivalent, or CoronaVac® vaccine. On the other hand, subjects of the homologous group will randomly receive a booster dose of Omicron or trivalent vaccine. The humoral immunogenicity against COVID-19 will be compared in subjects of the heterologous group that will receive Omicron or trivalent vaccine with subjects that will receive CoronaVac®, to determine the superiority of the two candidate vaccines versus CoronaVac®. Subjects will be followed for 6 months after the booster dose administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
551
The active ingredient is the SARS-CoV-2 virus (CZ02 strain, ancestral) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, and it is packed in pre-load syringes (0.5 mL) with 600 SU/0.5mL of inactivated SARS-CoV-2.
An experimental intervention consisting of a booster dose of an inactivated Omicron variant vaccine. The active ingredient is the SARS-CoV-2 virus (Omicron variant) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, packed in a pre-load syringe, and contains one dose (0.5mL) of 1200 SU of inactivated SARS-CoV-2 Omicron variant.
An experimental intervention consisting of a booster dose of an inactivated trivalent (CZ02 strain, ancestral, Delta, and Omicron variants) variant vaccine. The active ingredient is the SARS-CoV-2 virus (CZ02 strain, ancestral, Delta, and Omicron variants) grown in Vero cells and inactivated, in aluminum hydroxide. The vaccine is preservative-free, and it is packed in a pre-load syringe containing one dose (0.5mL) (1200 SU of inactivated SARS-CoV-2 WT, 1200 SU of inactivated SARS-CoV-2 Delta variant, and 1200 SU of inactivated SARS-CoV-2 Omicron variant).
Universidad del Desarrollo - Clínica Alemana
Santiago, RM, Chile
Pontificia Universidad Católica - Marcoleta Center
Santiago, Santiago Metropolitan, Chile
Universidad San Sebastián
Santiago, Santiago Metropolitan, Chile
Superiority in humoral immunogenicity of the neutralizing antibodies against the Delta and Omicron variants in response to a booster dose of the trivalent vaccine compared to CoronaVac® in adults previously immunized against SARS-CoV-2.
Differences in the humoral immunogenicity (GMT ratio \>1) of the neutralizing antibodies against the Delta and Omicron variants in response to a booster dose of the trivalent vaccine compared to CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines against SARS-CoV-2 different from CoronaVac® (mRNA or viral vectors (heterologous group)) will be evaluated.
Time frame: Up until 6 months after intervention
Superiority in humoral immunogenicity of neutralizing antibodies against the Omicron variant in response to a booster dose with the Omicron vaccine when compared with CoronaVac® in adults previously immunized against SARS-CoV-2.
Differences in the humoral immunogenicity (GMT ratio \>1) of the neutralizing antibodies against the Omicron variant generated in response to a booster dose with the Omicron vaccine when compared with CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines against SARS-CoV-2 different from CoronaVac® (mRNA or viral vectors (heterologous group)) will be evaluated.
Time frame: Up until 6 months after intervention
Non-inferiority of neutralizing antibodies against the Omicron and Delta variants generated by a booster dose of trivalent vaccine when compared to CoronaVac® in adults previously immunized against SARS-CoV-2 in a heterologous schedule.
Evaluation of the non-inferiority (seroconversion rate ≥5%) of neutralizing antibodies against the Omicron and Delta variants generated by a booster dose of trivalent vaccine when compared to CoronaVac® in adults who have initially received two doses of CoronaVac® and two booster doses with vaccines from other platforms (mRNA or viral vectors (heterologous group)).
Time frame: Up until 6 months after intervention
Non-inferiority of neutralizing antibodies against the Omicron variant generated by a booster dose with Omicron vaccine when compared with CoronaVac® in adults previously immunized against SARS-CoV-2 in a heterologous schedule.
Evaluation of the non-inferiority (seroconversion rate ≥5%) of neutralizing antibodies against the Omicron variant generated by a booster dose with Omicron vaccine when compared with CoronaVac® in adults who have two doses of CoronaVac® and two booster doses with vaccines from other platforms (mRNA or viral vectors (heterologous group)).
Time frame: Up until 6 months after intervention
Frequency of adverse events within the 7 and 28 days after the administration of a booster dose of Omicron, trivalent or CoronaVac® vaccines.
Evaluate whether there are differences in the frequency of adverse events within the 7 and 28 days after the administration of a booster dose of Omicron, trivalent or CoronaVac® vaccines.
Time frame: 28 days after intervention
Serious adverse events (SAE) and adverse events of special interest (AESI) in participants who received a booster dose of the Omicron, trivalent, or CoronaVac® vaccines.
Follow up of serious adverse events (SAE) and adverse events of special interest (AESI) will be performed for participants who received a booster dose of the Omicron, trivalent, or CoronaVac® vaccines.
Time frame: Up until 6 months after intervention
Humoral immunogenicity against the ancestral strain induced by a booster dose with Omicron vaccine or trivalent vaccine in adults previously immunized against SARS-CoV-2 in a heterologous schedule.
Evaluation of the humoral immunogenicity (GMT and seroconversion rate of neutralizing antibodies) against the ancestral strain, induced by a booster dose with Omicron vaccine or trivalent vaccine in adults who have two doses of CoronaVac® and two booster doses with vaccines from other platforms (mRNA or viral vectors (heterologous group)).
Time frame: Up until 6 months after intervention
Humoral immunogenicity induced by a booster dose with Omicron or trivalent vaccine in adults previously immunized against SARS-CoV-2 in a homologous schedule.
To evaluate the humoral immunogenicity (GMT and seroconversion of neutralizing antibodies) induced by a booster dose with Omicron or trivalent vaccine in adults who have previously received four doses of CoronaVac® (homologous group) against the ancestral strain, the Omicron, and Delta variants.
Time frame: Up until 6 months after intervention
Cellular immunogenicity generated, in a subgroup of participants, by the administration of a booster dose with Omicron, trivalent or CoronaVac® vaccines against the ancestral strain, the Omicron and Delta variants.
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To evaluate, in a subgroup of participants, the cellular immunogenicity (T cell activation and cytokines secretion) generated by the administration of a booster dose with Omicron, trivalent or CoronaVac® vaccines against the ancestral strain, the Omicron and Delta variants.
Time frame: Up until 6 months after intervention
Levels of neutralizing antibodies -and in a subgroup of subjects, the cellular immunity- against the ancestral, Omicron and Delta strains at 6 months after the intervention.
Evaluation of the levels of neutralizing antibodies in every participant and the cellular immunity in a subgroup of subjects against the ancestral strain, the Omicron and Delta variants at 6 months after the administration of a booster dose of the Omicron, trivalent or CoronaVac® vaccines.
Time frame: 6 months after intervention