Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
| 1. Background | |
|---|---|
| Registration Number | INA-M05FOH8 |
| Date of registry approval | 22-02-2023 |
| Registration Date | 14-02-2023 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | PT Bio Farma (Sponsor) |
| Secondary identifier number | CoV2-Booster-Children-0222 |
| Scientific study title | Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age |
| Public (popular study title) | Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT Bio Farma (Persero) |
| Source(s) of monetary or material support | PT Bio Farma |
| Other partners | Departemen/KSM Ilmu Kesehatan Anak RSHS/FK UNPAD, PT Equilab International (CRO) |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Dr. Eddy Fadlyana, dr., SpA(K), M Kes |
| City | Bandung |
| Country | Indonesia |
| Principal investigator's affiliation | Departemen/KSM Ilmu Kesehatan Anak RSHS/FK UNPAD |
| Principal Investigator's email address | edfadlyana@yahoo.com |
| Public Queries | |
| Contact person name for public queries | Not Specified |
| Address for public queries | Dr. Eddy Fadlyana, dr.,SpA(K), M Kes |
| City | Bandung |
| Country | Indonesia |
| ZIP | 40161 |
| Affiliation for public queries | Departemen/KSM Ilmu Kesehatan Anak RSHS/FK UNPAD |
| Email address for public queries | Not Specified |
| Phone number for public queries | Not Specified |
| Scientific Queries | |
| Name of Contact for scientific queries | Same as PI |
| Address for scientific queries | not specified |
| City | not specified |
| Country | not specified |
| ZIP | Not Specified |
| Affiliation of scientific queries contact | not specified |
| Email address for scientific queries | not specified |
| 4. IRB & Regulatory | |
| Ethical Approval number | LB.02.01/X.6.5/465/2022 |
| Name of Ethics committee | Komite Etik Penelitian RSUP Dr. Hasan Sadikin Bandung |
| Date of Ethic approval | 15-02-2023 |
| Contact details of Ethic Committee (phone, email, and office) | (022)2034953, rsup@rshs.web.id |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.06.1.3.02.23.09 |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | Puskesmas Garuda Bandung |
| Recruitment status | Complete |
| Date of first enrollment | 28-02-2023 |
| Targeted Sample size | 00150 - |
| Number of enrolled participants | 151 |
| Date of study completion (last participant, last visit) | 18-02-2024 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | COVID-19 |
| Purpose of the study | Prevention |
| Study type | Interventional |
| Interventional Study category | Clinical trial |
| Study phase | Phase 2 |
| Method of allocation | Not Applicable (single arm study) |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | No (open) |
| Study intervention (study arm) | IndoVac® - SARS-CoV-2 Protein Subunit Recombinant Vaccine Adjuvanted with Alum + CpG 1018 |
| Control intervention (control arm) | Not Applicable |
| Intervention assignment | Single arm |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 12 |
| Maximum age | 17 |
| Inclusion criteria | Not Specified |
| Exclusion criteria | Not Specified |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | To evaluate immune response to SARS-CoV-2 neutralizing antibody of IndoVac® before and 14 days after booster dose. |
| Metric/method of measurement | Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2 |
| Timepoint(s) of measurement | 14 days |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | Seropositive rate of neutralizing antibody at baseline (before booster dose), 14 days, 3 months, 6 months, and 12 months after booster vaccination |
| Metric/method of measurement (SO1) | Neutralizing antibody |
| Timepoint(s) of measurement (SO1) | 14 days |
| Secondary outcome 2 | |
| Name of secondary outcome 2 (SO2) | Seroconversion rate of neutralizing antibody at baseline (before booster dose) and 14 days after booster vaccination. |
| Metric/method of measurement (SO2) | Neutralizing antibody |
| Timepoint(s) of measurement (SO2) | 14 days |
| Secondary outcome 3 | |
| Name of secondary outcome 3 (SO3) | Seropositive rate, Geometric means of titers (GMTs) and GMFR of SARS-CoV-2 (RBD)-binding IgG antibody measured by chemiluminescent microparticle immunoassay (CMIA) at baseline (before booster dose), 14 days, 3 months, 6 months, 12 months after booster vaccination |
| Metric/method of measurement (SO3) | IgG antibody |
| Timepoint(s) of measurement (SO3) | baseline (before booster dose), 14 days, 3 months, 6 months, 12 months after booster vaccination. |
| Secondary outcome 4 | |
| Name of secondary outcome 4 (SO4) | Seroconversion rate of SARS-CoV-2 (RBD)-binding IgG antibody measured by chemiluminescent microparticle immunoassay (CMIA) at baseline (before booster dose) and 14 days after booster vaccination |
| Metric/method of measurement (SO4) | IgG antibody |
| Timepoint(s) of measurement (SO4) | Baseline (before booster dose) and 14 days after booster vaccination. |
| Secondary outcome 5 | |
| Name of secondary outcome 5 (SO5) | Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2, measured by virus neutralization assay (against omicron variant) at 3 months, 6 months, and 12 months after booster vaccination. |
| Metric/method of measurement (SO5) | Neutralizing antibody |
| Timepoint(s) of measurement (SO5) | 3 months, 6 months, and 12 months after booster vaccination. |
| 9. Study Results | |
| Brief summary of study results | The vaccine has favourable safety and immunogenicity profile as booster dose of participants who previously received primary doses of Sinovac vaccine. The administration of the investigational product until 12 months after booster dose was well tolerated and all AEs reported were recovered. |
| Date of results summaries | 18-02-2024 |
| Participant flow | A total of 151 subjects enrolled in the study, and 149 completed the whole study visits. |
| Baseline characteristic | A total of 150 participants had received IndoVac booster dose. Overall, there were 65 male participants (43.3%) and 85 female participants (56.7%) with mean age 14.71 ± 1.8 years. Majority of the participants’ education was in senior high school (42.0%). The participants came from various ethnic groups, mostly from Sundanese (81.3%), followed by Javanese (6.7%), and Javanese-Sundanese (5.3%). |
| Adverse events | "Overall, the incidence rate of AEs until 28 days after the booster dose were 82.7%, with higher number of local events reported. Most reported solicited AEs were local pain (57.3%), followed by myalgia (40.0%), with mostly mild intensity (75.3%). Unsolicited AEs varied with each of the incidence rate under 10%, with mostly mild intensity (14.0%).
Until 12 months follow up after booster dose, there was no reported of Adverse Events Special Interest (AESI). " |
| Outcome measures | "Administration of booster dose of IndoVac to participants who previously received primary doses of Sinovac (inactivated) vaccine increased neutralizing antibodies based on the pre-booster baseline to the Omicron variant spike protein. The study showed that there was favourable increase of GMT after given a single booster dose of IndoVac. The neutralizing antibody GMT (IU/mL) at baseline, 14 days, 3 months, 6 months, and 12 months after booster dose were 303.26, 2661.21, 2021.09, 1172.74, and 868.73, respectively. The GMFR at 14 days, 3 months, 6 months, and 12 months after booster dose were 8.78 (7.028 – 10.956), 6.67 (5.217 – 8.536), 3.87 (3.068 – 4.886), and 2.87 (2.232 – 3.685), respectively.
Seropositive rate of neutralizing antibody at baseline (before booster dose), 14 days, 3 months, 6 months, and 12 months after booster vaccination were 92.67%, 100%, 100%, 100%, and 100%, respectively. The seroconversion rates of neutralizing antibody based on 4-fold increase at 14 days, 3 months, 6 months, and 12 months after booster dose were 69.78%, 58.70%, 48.55%, and 39.13%, respectively; while based on the change from seronegative to seropositive at 14 days, 3 months, 6 months, and 12 months after booster dose, the rates were 100%. The IgG antibody GMT (BAU/mL) at baseline, 14 days, 3 months, 6 months, and 12 months after booster dose were 277.75, 3479.22, 2631.52, 1686.36, and 1243.33, respectively. Thus, the Geometric Mean Fold Rise (GMFR) at 14 days, 3 months, 6 months, and 12 months after booster dose were 12.53 (95% CI 10.521 – 14.914), 9.49 (95% CI 7.921 – 11.369), 6.08 (95% CI 5.042 – 7.334), and 4.48 (95% CI 3.71 – 5.418) compared to pre-booster. The seropositive rates of IgG antibody at baseline, 14 days, 3 months, 6 months, and 12 months after booster dose were 100%. The seroconversion rates of IgG antibody based on 4-fold increase at 14 days, 3 months, 6 months, and 12 months after booster dose were 84.00%, 77.18%, 61.07%, and 51.68%, respectively. " |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | https://doi.org/10.3390/vaccines12080938 |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | Yes |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | Not Specified |