UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects

COVID-19 Pandemic Clinical Trial

Official title:

Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) as Heterologue Booster in Adolescent Subjects in Indonesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06272253
• Other study ID #: UNAIR-MP-INAKTIF-R-010
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 19, 2023
• Est. completion date: July 19, 2024

Study information

• Verified date: February 2024
• Source: Dr. Soetomo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months. The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.

Description:

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months. The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the 7 and 28 days safety data following the vaccine, and then the 3 and 6 months safety data. The immunogenicity data will be evaluated until 6 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: July 19, 2024
• Est. primary completion date: March 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Healthy males and females, adolescents age 12-17 years old. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.

2. Subjects already received 2 (two) doses of Coronavac (Sinovac) vaccines at least 3 months prior to this study.

3. Subjects and the parents or guardian have been informed properly regarding the study and signed the informed consent form

4. Subject and the parents or guardian will commit to comply with the instructions of the investigator and the schedule of the trial

5. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the vaccine.

6. Participants and the parents or guardian must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial

2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrent or within 7 days prior to study vaccination. This includes respiratory or constitutional symptms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)

3. Known history of allergy to any component of the vaccines

4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection

5. Any autoimmune or immunodeficiency disease/condition

6. Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted. Inhaled glucocorticoids are prohibited.

7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.

8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives

9. Subjects already immunized with any other vaccines within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose

10. Individuals who have a previously ascertained Covid-19 in the period of 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19.

11. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to the vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator.

12. History of alcohol or substance abuse

13. HIV patients.

14. Malignancy patients within 3 years prior to study vaccination.

15. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc

16. Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision.

17. Women who are pregnant or who plan to become pregnant during the study.

18. Participant has major psychiatric problem or illness

19. Participant cannot communicate reliably with the investigator

20. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.

21. Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the vaccination.

22. Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results

23. Study team members.

24. Subject planning to move from the study area before the end of study period.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• COVID-19 Vaccines

Intervention

Biological:
• INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 µg
Dose : 1 dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride.

Locations

Country	Name	City	State
Indonesia	Dr. Soetomo General Hospital	Surabaya	Jawa Timur

Sponsors (4)

Lead Sponsor	Collaborator
Dr. Soetomo General Hospital	Indonesia-MoH, PT Biotis Pharmaceuticals, Indonesia, Universitas Airlangga

Country where clinical trial is conducted

Indonesia, 

References & Publications (24)

Abbasi J. Studies Suggest COVID-19 Vaccine Boosters Save Lives. JAMA. 2022 Jan 11;327(2):115. doi: 10.1001/jama.2021.23455. No abstract available. — View Citation

Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin — View Citation

Badan POM Republik Indonesia. Dowloaded from https://www.pom.go.id/new/ view/more/pers/605/Pastikan-Keamanan-danMutu-Vaksin---Badan-POM-Kawal- Uji-Klinik-Vaksin-Merah-Putih.html. Accessed 11 October 2021.

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, — View Citation

Bhattacharya S, Dasgupta R. Smallpox and polio eradication in India: comparative histories and lessons for contemporary policy. Cien Saude Colet. 2011 Feb;16(2):433-44. doi: 10.1590/s1413-81232011000200007. — View Citation

Biswas M, Rahaman S, Biswas TK, Haque Z, Ibrahim B. Association of Sex, Age, and Comorbidities with Mortality in COVID-19 Patients: A Systematic Review and Meta-Analysis. Intervirology. 2020 Dec 9:1-12. doi: 10.1159/000512592. Online ahead of print. — View Citation

Burckhardt RM, Dennehy JJ, Poon LLM, Saif LJ, Enquist LW. Are COVID-19 Vaccine Boosters Needed? The Science behind Boosters. J Virol. 2022 Feb 9;96(3):e0197321. doi: 10.1128/JVI.01973-21. Epub 2021 Nov 24. — View Citation

Excler JL, Saville M, Berkley S, Kim JH. Vaccine development for emerging infectious diseases. Nat Med. 2021 Apr;27(4):591-600. doi: 10.1038/s41591-021-01301-0. Epub 2021 Apr 12. — View Citation

Irwin A. What it will take to vaccinate the world against COVID-19. Nature. 2021 Apr;592(7853):176-178. doi: 10.1038/d41586-021-00727-3. No abstract available. — View Citation

Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnso — View Citation

Kyriakidis NC, Lopez-Cortes A, Gonzalez EV, Grimaldos AB, Prado EO. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates. NPJ Vaccines. 2021 Feb 22;6(1):28. doi: 10.1038/s41541-021-00292-w. — View Citation

Mahase E. Covid-19: Pfizer's paxlovid is 89% effective in patients at risk of serious illness, company reports. BMJ. 2021 Nov 8;375:n2713. doi: 10.1136/bmj.n2713. No abstract available. — View Citation

Mattiuzzi C, Lippi G. Efficacy of COVID-19 vaccine booster doses in older people. Eur Geriatr Med. 2022 Feb;13(1):275-278. doi: 10.1007/s41999-022-00615-7. Epub 2022 Jan 24. — View Citation

Mendonca SA, Lorincz R, Boucher P, Curiel DT. Adenoviral vector vaccine platforms in the SARS-CoV-2 pandemic. NPJ Vaccines. 2021 Aug 5;6(1):97. doi: 10.1038/s41541-021-00356-x. — View Citation

Noh JY, Song JY, Yoon JG, Seong H, Cheong HJ, Kim WJ. Safe hospital preparedness in the era of COVID-19: The Swiss cheese model. Int J Infect Dis. 2020 Sep;98:294-296. doi: 10.1016/j.ijid.2020.06.094. Epub 2020 Jun 30. — View Citation

Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthc — View Citation

Parker EPK, Desai S, Marti M, Nohynek H, Kaslow DC, Kochhar S, O'Brien KL, Hombach J, Wilder-Smith A. Response to additional COVID-19 vaccine doses in people who are immunocompromised: a rapid review. Lancet Glob Health. 2022 Mar;10(3):e326-e328. doi: 10. — View Citation

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tre — View Citation

Pollard AJ, Bijker EM. A guide to vaccinology: from basic principles to new developments. Nat Rev Immunol. 2021 Feb;21(2):83-100. doi: 10.1038/s41577-020-00479-7. Epub 2020 Dec 22. Erratum In: Nat Rev Immunol. 2021 Jan 5;: — View Citation

So AD, Woo J. Reserving coronavirus disease 2019 vaccines for global access: cross sectional analysis. BMJ. 2020 Dec 15;371:m4750. doi: 10.1136/bmj.m4750. — View Citation

Tanriover MD, Doganay HL, Akova M, Guner HR, Azap A, Akhan S, Kose S, Erdinc FS, Akalin EH, Tabak OF, Pullukcu H, Batum O, Simsek Yavuz S, Turhan O, Yildirmak MT, Koksal I, Tasova Y, Korten V, Yilmaz G, Celen MK, Altin S, Celik I, Bayindir Y, Karaoglan I, — View Citation

Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Fen — View Citation

Wang C, Wang Z, Wang G, Lau JY, Zhang K, Li W. COVID-19 in early 2021: current status and looking forward. Signal Transduct Target Ther. 2021 Mar 8;6(1):114. doi: 10.1038/s41392-021-00527-1. — View Citation

Yadav T, Srivastava N, Mishra G, Dhama K, Kumar S, Puri B, Saxena SK. Recombinant vaccines for COVID-19. Hum Vaccin Immunother. 2020 Dec 1;16(12):2905-2912. doi: 10.1080/21645515.2020.1820808. Epub 2020 Nov 24. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Endpoints-Whole Genome Sequencing	Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from positive Covid-19 cases	Through study completion, an average of 6 months after the study product administration
Primary	Humoral Immune Response (Neutralizing antibody)	SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days following vaccination with INAVAC vaccine as heterologue booster in healthy adolescents age 12-17 years old.	28 days after the booster vaccination
Secondary	Incidence of Adverse Events	Solicited - clinical (local and systemic) adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old.; Unsolicited adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old.; Serious adverse events (SAE) throughout the study.	7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster.
Secondary	Humoral Immune Response - The neutralizing antibody	SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, for 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy Adolescent subjects.	3 and 6 months following vaccination with INAVAC vaccine as heterologue booster
Secondary	Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA	IgG RBD SARS-CoV-2 (CLIA): analysis of IgG RBD SARS-CoV-2 antibodies for 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy Adolescent subjects.	28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster

External Links

•   Badan POM Republik Indonesia. Dowloaded from https://www.pom.go.id/siaran-pers/pastikan-keamanan-dan-mutu-vaksin-badan-pom-kawal-uji-klinik-vaksin-merah-putih. Accessed 11 October 2021.
•   New York Vaccine Tracker. Downloaded from https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine- tracker.html. Accessed 30 April 2022.
•   Worldometer coronavirus cases. Downloaded from https://www.worldometers.info/coronavirus/. Accessed 30 April 2022.