Status unknownNCT05162482COMBAT-COVIDUpdated Feb 18, 2022

Combination Assessment Trial of COVID-19 Vaccines (COMBAT-COVID)

A Phase 2 interventional study of BIBP (CNBG, Sinopharm) WIV and CanSinoBIO in COVID 19 Vaccine, sponsored by Aga Khan University Hospital, Pakistan. Status unknown at 3 sites in Pakistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Aga Khan University Hospital, Pakistan · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 1,680
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a randomized, phase II trial which will be conducted among volunteers aged 18 years and above in Karachi, Lahore and Islamabad, Pakistan. The trial will have nine arms and is an open label study. Trained persons will administer the vaccine and draw blood under strict aseptic measures. The immune responses using pseudo neutralizing antibodies against SARS-CoV-2 in COVID-19 seronegative participants receiving heterologous and homologous COVID-19 vaccines will be assessed. Anti-spike IgG antibodies by ELISA and pseudo neutralizing antibodies against SARS-CoV-2 will also be measured. The safety and reactogenicity will also be assessed by recording serious adverse events (SAE), adverse events of special interest (AESI), solicited local and systemic reactions and medically attended adverse reactions through biochemical and hematological tests or safety measures throughout the study. In most cases the adverse events are mild and self-limiting but can require medication and/or hospitalization in rare cases. Participants suffering from any adverse event causally related to the to the trial intervention will be facilitated and the cost of treatment including laboratory investigations will be provided to them. Data confidentiality will be ensured by delinking names in forms and through password protection.

Read the detailed description

This is a randomized, phase II trial which will be conducted among volunteers aged 18 years and above in Karachi, Lahore and Islamabad, Pakistan. The investigators will be assessing the safety and reactogenicity of heterologous and homologous COVID-19 vaccines and characterize the immune responses using pseudo neutralizing antibodies against SARS-CoV-2 in COVID seronegative participants immunized with heterologous and homologous COVID-19 vaccines regimens. This approach will allow combination of different vaccines in case the same vaccine is not available at the time of boosting (follow-up dose) and will help mitigate the shortage of available COVID-19 vaccines. Furthermore, the combination strategy might prove to be more effective against the variants of concern of SARS CoV-2.

The total duration of the trial will be approximately 2 ½ years. The study will enroll participants which will be divided into 2 cohorts, one for a more detailed immunological assessment and one for main immunology endpoints. The study will include 9 study groups with different combinations of COVID-19 vaccine schedule (6 heterologous combinations and 3 homologous combinations plus booster in homologous arms). The investigators will be measuring Anti-spike IgG antibodies by ELISA at week 14 (4 weeks post booster dose) and pseudo neutralizing antibodies against SARS-CoV-2 at day 0, and weeks 4, 14, 24, 28, 48, 60 and 96 as per schedule of events for the immunology cohort and at baseline and 4 weeks post second dose in general cohort. This is a pragmatic trial where the interval between the two doses will be kept longer than the conventional recommendations of 21/28 days. Additionally, the investigators will also be assessing safety and reactogenicity by recording serious adverse events (SAE), adverse events of special interest (AESI), solicited local and systemic reactions within 7 days post each dose, unsolicited reactions within 28 days post each dose, medically attended adverse reactions up to 3 months post booster dose and changes from baseline to 4 weeks post each dose in biochemical and hematological tests or safety measures throughout the study.

A trained person will administer the vaccine and draw blood samples under strict aseptic techniques to ensure minimum discomfort and reduce the risk of infection. There is a risk of adverse events associated with all vaccines and there can be some risks associated with vaccine administration and blood collection procedures like pain, redness, itch, swelling, fever, feverishness, chills, joint pains, muscle pains, fatigue, headache, malaise, nausea, vomiting, diarrhea etc. However, in most cases the adverse events are mild and self-limiting but can require medication and/or hospitalization in rare cases. Participants suffering from any adverse event causally related to the to the trial intervention will be facilitated and the cost of treatment including laboratory investigations will be provided to them. The participants will also be compensated for their time, the inconvenience of getting jabs and providing blood samples.

Confidentiality of all the data collected from the population is a top priority. All the names and personal information regarding any individual will not to be disclosed separately. The data will be published collectively. All the names present in the forms will be de linked and forms will be coded accordingly all the data files will be password protected. Data that will be shared with University of Oxford, International Vaccine Institute (IVI), Seoul, Republic of Korea, Ragon Institute, Harvard School of Medicine, USA, National Institute of Health (NIH) Pakistan will have multi-layered security with several layers of encryption to protect data. Blood samples from patients enrolled will be stored at our research office in Infectious disease research laboratory at Aga Khan University Karachi, labelled with identification numbers not participant name. During the storage, only dedicated members of our study team will have access to the samples. De-identified research data maybe be stored indefinitely. If volunteers consent to be contacted for future research, a record of this consent will be recorded, retained, and stored securely and separately from the research data. If volunteers consent to have their samples stored and used for future research, information about their consent form will be retained and stored securely as per Biobanking procedures and SOPs. Identifiable information such as contact details will be stored for a minimum of 5 years from the end of the study. This includes storage of consent forms. Storage of data will be reviewed every 5 years and files will be confidentially destroyed if storage is no longer required. During the storage, only the local PIs and researchers designated by them will have access to the data or samples.

Conditions studied

COVID 19 Vaccine

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,680 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Aga Khan University Hospital, Pakistan is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Adult male and female volunteers aged 18 years and above and volunteers with well controlled mild or moderate comorbidities will be enrolled to participate in trial.

Participant is willing and able to give written informed consent for participation in the trial.
Male or Female aged 18 years or above and in good health as determined by a trial clinician. Participants may have well controlled mild-moderate comorbidity.
In the Investigator's opinion, is able and willing to comply with all trial requirements.
Residing in the study areas.

Exclusion criteria

Exclusion Criteria:

The participant may not enter in the trial if ANY of the following apply:

Pregnant women or those who are planning to conceive within next 70 days.
Women who are breast feeding
Already received any COVID-19 vaccine or any other vaccine likely to impact on interpretation of the trial data (e.g., Adenovirus vectored vaccines).
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days)
History of allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g., hypersensitivity to the active substance of the COVID-19 vaccines included in the study groups
Any history of anaphylaxis.
Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
Bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of thrombotic events and/or significant bleeding or bruising following IM injections or venipuncture.
Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e., warfarin)
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness (mild/moderate well controlled comorbidities are allowed)
History of active or previous auto-immune neurological disorders (e.g., multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell's palsy will not be an exclusion criterion.
History of laboratory confirmed COVID-19 within 6 months prior to enrolment (history of SARS-CoV-2 detection by PCR or antibody to SARS-CoV-2).
Scheduled elective surgery during the trial.
Participants enrolled in any other research trial.
Participants planning to migrate out of the study area within 2 years of the study.

Temporary Exclusion Criteria:

If the volunteer has any of the following, they will not be enrolled that day.

Acute respiratory illness (moderate or severe illness with or without fever)
Fever (temperature greater than 38°C) They may be considered for enrolment later in the trial if they recover in sufficient time.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,680 participants (estimated)

Study arms

Active comparator
Heterologous 1
BIBP (CNBG, Sinopharm) WIV (0.5ml) at baseline CanSinoBIO (0.5ml) after 70±7 days (10 wks±2) (160 participants)
Biological: BIBP (CNBG, Sinopharm) WIV · Biological: CanSinoBIO
Active comparator
Heterologous 2
BIBP (CNBG, Sinopharm) WIV (0.5ml) at baseline AstraZeneca ChAdOx (0.5ml) after 70±7 days (10 wks±2) (160 participants)
Biological: BIBP (CNBG, Sinopharm) WIV · Biological: AstraZeneca ChAdOx
Active comparator
Heterologous 3
CanSinoBIO (0.5ml) at baseline BIBP (CNBG, Sinopharm) WIV (0.5ml) after 70±7 days (10 wks±2) (160 participants)
Biological: BIBP (CNBG, Sinopharm) WIV · Biological: CanSinoBIO
Active comparator
Heterologous 4
CanSinoBIO (0.5ml) at baseline AstraZeneca ChAdOx (0.5ml) after 70±7 days (10 wks±2) (160 participants)
Biological: CanSinoBIO · Biological: AstraZeneca ChAdOx
Active comparator
Heterologous 5
AstraZeneca ChAdOx (0.5ml) at baseline BIBP (CNBG, Sinopharm) WIV(0.5ml) after 70±7 days (10 wks±2) (160 participants)
Biological: BIBP (CNBG, Sinopharm) WIV · Biological: AstraZeneca ChAdOx
Active comparator
Heterologous 6
AstraZeneca ChAdOx (0.5ml) at baseline CanSinoBIO (0.5ml) after 70±7 days (10 wks±2) (160 participants)
Biological: CanSinoBIO · Biological: AstraZeneca ChAdOx
Active comparator
Homologous 7
BIBP (CNBG, Sinopharm) WIV (0.5ml) at baseline BIBP (CNBG, Sinopharm) WIV (0.5ml) after 70±7 days (10 wks±2) Full dose booster: 80 participants (0.5ml) 6 months after second dose Fractional dose booster: 80 participants (dose to be decided) 6 months after second dose No booster: 80 participants (240 participants)
Biological: BIBP (CNBG, Sinopharm) WIV
Active comparator
Homologous 8
CanSinoBIO (0.5ml) at baseline CanSinoBIO (0.5ml) after 70±7 days (10 wks±2) Full dose booster: 80 participants (0.5ml) 6 months after second dose Fractional dose booster: 80 participants (dose to be decided) 6 months after second dose No booster: 80 participants (240 participants)
Biological: CanSinoBIO
Active comparator
Homologous 9
AstraZeneca ChAdOx (0.5ml) at baseline AstraZeneca ChAdOx (0.5ml) after 70±7 days (10 wks±2) Full dose booster: 80 participants (0.5ml) 6 months after second dose Fractional dose booster: 80 participants (dose to be decided) 6 months after second dose No booster: 80 participants (240 participants)
Biological: AstraZeneca ChAdOx

Interventions

BiologicalBIBP (CNBG, Sinopharm) WIV
BIBP (CNBG, Sinopharm) WIV (Whole Inactivated Virus in a single dose, prefilled syringe with a storage temperature of 2-8°C)
BiologicalCanSinoBIO
CanSinoBIO (Viral Vector in a single dose, prefilled syringe with a storage temperature of 2-8°C)
BiologicalAstraZeneca ChAdOx
AstraZeneca ChAdOx (Viral Vector in a multi-dose vial consisting of 10 doses with a storage temperature of 2-8°C)

What researchers measure

Primary outcomes

Primary Endpoint
Anti-spike IgG antibodies by ELISA will be measured in serum
Time frame: At weeks 14 and 38

Secondary outcomes

Secondary Endpoint 1a
Serious adverse events (SAE) and adverse events of special interest (AESI) assessed through phone calls using a structured questionnaire
Time frame: Through study completion, an average of 2 and a half years
Secondary Endpoint 1b
Solicited local and systemic reactions assessed through phone calls using a structured questionnaire
Time frame: Within 7 days post each dose
Secondary Endpoint 1c
Unsolicited adverse reactions assessed through phone calls using a structured questionnaire
Time frame: Within 28 days post each dose
Secondary Endpoint 1d
Medically attended adverse reactions assessed through phone calls using a structured questionnaire
Time frame: Up to 3 months post booster dose
Secondary Endpoint 1e:1
Detect changes in urea levels in serum Unit of measurement: mg/dL
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:2
Detect changes in sodium levels in serum Unit of measurement: mEq/L
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:3
Detect changes in potassium levels in serum Unit of measurement: mEq/L
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:4
Detect changes in creatinine levels in serum Unit of measurement: mg/dL
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:5
Detect changes in bilirubin levels in serum Unit of measurement: mg/dL
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:6
Detect changes in Alanine Aminotransferase (ALT) levels in serum Unit of measurement: IU/L
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:7
Detect changes in ALT-phosphatase levels in serum Unit of measurement: IU/L
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:8
Detect changes in albumin levels in serum Unit of measurement: g/dL
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:9
Detect changes in Aspartate Aminotransferase (AST) levels in serum Unit of measurement: units/L
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 1e:10
Detect changes in blood hematology tests through complete blood count (CBC) using whole blood
Time frame: From baseline to 4 weeks post each dose
Secondary Endpoint 2
Neutralizing antibody response (pseudo-virus neutralization assay) against SARS-CoV-2 in serum
Time frame: At day 0, and weeks 4, 14, 24, 28, 48, 60 and 96 as per schedule of events (only immunology cohort) and at baseline and 4 weeks post booster dose in general cohort
Secondary Endpoint 3a
Anti-spike IgG responses measured by ELISA will be measured in serum
Time frame: Measured at Day 0, and Weeks 4, 10, 14, 24, 28, 48, 60 and 96 as per schedule of events (in full cohort)
Secondary Endpoint 3b
Anti-nucleocapsid IgG will be measured in serum
Time frame: Measured at Day 0, and Week 2, 14, 24, 48, 60, and 96 as per schedule of events (in full cohort)
Secondary Endpoint 3c
ELISpot assays will be performed using peripheral blood mononuclear cells polymorphonuclear cells (PBMC)
Time frame: At Day 0, and week 2, 4, 10, 12, 14, 24, 48, 96 (immunology cohort)

Other outcomes

Exploratory Endpoint 1a
Neutralizing antibody response (pseudo-virus neutralization assay) against SARS-CoV-2 and anti-spike IgG responses measured by ELISA in serum
Time frame: Within 1 week of breakthrough infection among the participants
Exploratory Endpoint 1b
Sequencing of SARS-CoV-2 viruses of breakthrough infections in vaccine recipients by extracting DNA from nasal swabs
Time frame: Througout the study
Exploratory Endpoint 1c
NNeutralizing antibody response (pseudo-virus neutralization assay) against SARS-CoV-2 VOCs circulating in Pakistan in serum through ELISAVOCs circulating in Pakistan
Time frame: Througout the study
Exploratory Endpoint 1d
Intracellular cytokine staining (ICS) will be performed to assess the phenotypic characteristics of CD4 and CD8 T cells recognizing the antigen by high throughput multicolor flow cytometry by extracting peripheral blood mononuclear cells (PBMC)
Time frame: Througout the study
Exploratory Endpoint 1e
Strategic stage-gated Systems Serology analysis using Luminex in serum samples
Time frame: Througout the study

Study locations

3 sites

National Institute of Health
Islamabad, Punjab, Pakistan
- Omera Naseer · Contact · omera_shuaib@hotmail.com
Chughtai Lab
Lahore, Punjab, Pakistan
- Shazia Sultana · Contact · shazia.sultana@aku.edu · 03332122381
Aga Khan University
Karachi, Sindh, Pakistan
- Rakshanda Ambreen · Contact · 03322290106

References and documents

Publications

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Study documents

Protocol and statistical analysis plan · Oct 22, 2021
Informed consent form · Oct 18, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05162482
Lead sponsor: Aga Khan University Hospital, Pakistan
Collaborators: Coalition for Epidemic Preparedness Innovations, University of Oxford, International Vaccine Institute, Harvard Medical School (HMS and HSDM), Chughtai Lab, National Institute of Health, Pakistan
Responsible party: Dr. Farah Qamar (Associate Professor, Aga Khan University Hospital, Pakistan) — Principal investigator
First posted: Dec 17, 2021
Start date: Mar 1, 2022 (estimated)
Primary completion: Jun 30, 2024 (estimated)
Completion: Jun 30, 2024 (estimated)
Last update: Feb 18, 2022

Study contacts

Farah Qamar

Contact

farah.qamar@aku.edu

02134865035

Tahir Yousafzai

Contact

tahir.yousafzai@aku.edu

02134864031

Farah Qamar

principal investigator · Aga Khan University Hospital, Pakistan (AKU)

Tahir Yousafzai