1.
ClinicalTrials.gov; 18/02/2024; TrialID: NCT06272253
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06272253
ABSTRACT
Condition:
COVID-19 Pandemic;COVID-19 VaccinesIntervention:
Biological: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 µgPrimary outcome:
Humoral Immune Response (Neutralizing antibody)Criteria:
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.
2.
ClinicalTrials.gov; 05/02/2024; TrialID: NCT06259578
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06259578
ABSTRACT
Condition:
COVID-19 Pandemic;COVID-19 Vaccines;COVID-19 Virus DiseaseIntervention:
Biological: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 µgPrimary outcome:
Humoral Immune ReponseCriteria:
Inclusion Criteria:
1. Healthy adults and elderly, males and females, 18 years of age and above. 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 INAVAC vaccines (5 ug), mostly during the
phase I/II/III clinical trial of this vaccine. The interval between the second primary
injection and the booster is 12-18 months.
3. Subjects have been informed properly regarding the study and signed the informed
consent form
4. Subjects will commit to comply with the instructions of the investigator and the
schedule of the trial
5. Female subjects of childbearing potential must agree to postpone pregnancy from at
least 21 days before enrollment and through 6 months after the vaccination.
6. Participants agree not to donate bone marrow, blood, and blood products from the first
study vaccine administration until 3 months after receiving the vaccine.
7. Participants must be willing to provide verifiable identification, have 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) concurrently or within 7 days before study
vaccination. This includes respiratory or constitutional symptoms 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 steroids 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, and
diabetes requiring the use of medicine. The final decision regarding this condition
will be made by the attending field clinicians or investigators.
8. Any abnormality or chronic disease which according to the investigator might interfere
with the assessment of the trial objectives
9. Individuals who previously received any vaccines against Covid-19, other than INAVAC.
10. Subjects already immunized with any other vaccines within 4 weeks prior and expect to
receive other vaccines within 60 days following the booster dose
11. Individuals who have a previously ascertained COVID-19 in 1 month (for mild, moderate,
or asymptomatic people) or 3 months (for severe COVID-19) before the first recruit of
this study, or in close contact in the last 14 days with a confirmed case of Covid-19.
12. Positive test for SARS-CoV-2 (Antigen or PCR) at screening before the vaccination.
Testing may be repeated during the screening period if exposure to a positive
confirmed case of SARS-CoV-2 is suspected, at the discretion of the investigator.
13. History of alcohol or substance abuse
14. HIV patients.
15. Malignancy patients within 3 years before study vaccination.
16. Any neurological disease or history of significant neurological disorder such as
meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
17. 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.
18. Women who are pregnant or who plan to become pregnant during the study.
19. Participant has a major psychiatric problem or illness
20. Participant cannot communicate reliably with the investigator
21. Participant has contraindications to intramuscular injection and blood draws, such as
bleeding disorders or phobia.
22. The participant had major surgery within 12 weeks before vaccination which will not be
fully recovered, or has major surgery planned during the time the participant is
expected to participate in the study or within 6 months after the last dose of study
vaccine administration.
23. 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
24. Study team members.
25. Subject planning to move from the study area before the end of the study period.
3.
ClinicalTrials.gov; 21/06/2023; TrialID: NCT05918939
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05918939
ABSTRACT
Condition:
COVID-19 Pandemic;COVID-19 VaccinesIntervention:
Biological: Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg;Biological: CoronaVac Biofarma COVID-1 9 Vaccine 3 µgPrimary outcome:
The Humoral Immunogenicity ProfileCriteria:
Inclusion Criteria:
1. Healthy adults and elderly, males and females, 18 years of age and above. 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 inactivated vaccines at least 6
months prior to this study.
3. Subjects have been informed properly regarding the study and signed the informed
consent form
4. Subject will commit to comply with the instructions of the investigator and the
schedule of the trial
5. Female subjects of childbearing potential must agree to consistently use any methods
of contraception (except the periodic abstinence) from at least 21 days prior to
enrollment and through 6 months after the vaccination.
6. Participants agree not to donate bone marrow, blood, and blood products from the
vaccine administration until 3 months after receiving the vaccine.
7. Participants 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. Individuals who previously receive any booster vaccine against Covid-19.
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
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 last dose of study vaccine
administration.
22. Any condition that in the opinion of the investigators would pose a helath 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.
4.
ClinicalTrials.gov; 18/08/2022; TrialID: NCT05508477
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05508477
5.
ClinicalTrials.gov; 15/02/2022; TrialID: NCT05246124
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05246124
ABSTRACT
Condition:
Burnout, Psychological;AnxietyIntervention:
Other: Zumba dance exercisePrimary outcome:
State-Trait Anxiety Inventory (STAI);Brief Resiliency Scale (BRS);Maslach Burnout Inventory (MBI);Cortisol;CD4;Interleukin-6 (IL-6);Neutrophil to lymphocyte ratio (NLR)Criteria:
Inclusion Criteria:
- Residents of anesthesiology and internal medicine department at Dr. Soetomo General
Hospital Surabaya
- Residents managing COVID-19 patients in the special isolation room
Exclusion Criteria:
- Residents that did not fill in the questionnaires completely
- Residents with comorbidities (diabetes, hypertension, heart disease or autoimmune
disorders)
- Residents that were infected with COVID-19
- Residents currently or previously diagnosed with psychosis
- Residents refusing to participate in the study.
6.
ClinicalTrials.gov; 20/01/2022; TrialID: NCT05226429
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05226429
ABSTRACT
Condition:
COVID-19 Pandemic;Vaccine ReactionIntervention:
Biological: UNAIR Inactivated COVID-19 Vaccine;Biological: CoronaVac Biofarma COVID-19 VaccinePrimary outcome:
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events;Solicited clinical (local and systemic), laboratory, and unsolicited adverse events;SARS-CoV-2 neutralization antibodies;SARS-CoV-2 binding antibodies;Th1 and Th2Criteria:
Inclusion Criteria:
1. Healthy adults and elderly, males and females, 18 years of age and above. 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 have been informed properly regarding the study and signed the informed
consent form
3. Subject will commit to comply with the instructions of the investigator and the
schedule of the trial
4. Female subjects of childbearing potential must agree to consistently use any methods
of contraception (except the periodic abstinence) from at least 21 days prior to
enrollment and through 6 months after the last vaccination.
5. Participants agree not to donate bone marrow, blood, and blood products from the first
study vaccine administration until 3 months after receiving the last dose of study
vaccine.
6. Participants 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 trial.
2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever
(axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior
to first study vaccination. This includes respiratory or constitutional symptoms
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 has 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 is prohibited.
7. Chronic disease, inclusive of uncontrolled hypertension, congestive heart failure,
chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring
use of medicine
8. Any abnormality or chronic disease which according to the investigator might interfere
with the assessment of the trial objectives
9. Individuals who previously receive any vaccines against Covid-19
10. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive
other vaccines within 60 days following the first dose
11. Individuals who have a previously ascertained Covid-19 in the period of 3 months
before the first recruit of this study, or in a close contact in the last 14 days with
confirmed case of Covid-19
12. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to first 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.
13. History of alcohol or substance abuse
14. HIV patients.
15. Malignancy patients within 5 years prior to first study vaccination.
16. Any neurological disease or history of significant neurological disorder such as
meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
17. 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.
18. Women who are pregnant, breastfeeding, or who plan to become pregnant during the
study.
19. Participant has major psychiatric problem or illness
20. Participant cannot communicate reliably with the investigator
21. Participant has contraindication to intramuscular injection and blood draws, such as
bleeding disorders or phobia.
22. 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 last dose of study vaccine
administration.
23. 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
24. Study team members.
25. Subject planning to move from the study area before the end of study period.