Home » Trials » SLCTR/2022/008

Heterologous covid-19 vaccine intervention effect on reactogenicity


SLCTR Registration Number


Date of Registration

05 Apr 2022

The date of last modification

Apr 05, 2022

Application Summary

Scientific Title of Trial

Heterologous covid-19 vaccine intervention effect on reactogenicity

Public Title of Trial

Short term vaccine reactions due to mixing and matching of COVID-19 vaccines

Disease or Health Condition(s) Studied

Reactogenicity of vaccine

Scientific Acronym


Public Acronym


Brief title

COVID-19 vaccines reactogenicity

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

ERC / ID /194; ERC, Army medical college, Pakistan

Trial Details

What is the research question being addressed?

What is the frequency of short term reaction to vaccines in patients receiving heterologous COVID-19 vaccine compared to homologous vaccine?

Type of study


Study design


Randomized controlled trial


Double blinded : Participants, Healthcare providers


Standard therapy/practice




Health services research

Study Phase

Phase 4

Intervention(s) planned

Study setting: Public sector medical college Rawalpindi. Intervention of Ad5-nCoV and mRNA-1273 vaccine is planned . Name of vaccine administered: Ad5-nCoV and mRNA-1273 vaccine. Strength and volume: 0.5 ml of Ad5-nCoV and 0.25 ml of mRNA-1273 Route of administration: Intramuscular. Intervention is planned by Public sector medical college.

It is a controlled study with absence of active control group. Participants history of vaccine reactogencity with homologous first booster dose will be compared with reactogenicity of heterologous second vaccine booster intervention.

Homologous first booster dose reactogenicity of BBIBP-CorV will be control group in this study. Intervention of Ad5-nCoV and mRNA-1273 vaccine will be planned and they both will serves as intervention group.

College medical facility is well equipped with every health care facility possible and is capable to cope up with mild to severe reactions. The participants will be given symptomatic relief for milder vaccine reactions. Severe vaccine reactions will be dealt with recommended medical guidelines.

Inclusion criteria

  • Adults 18 years of age or older
  • Men and women
  • Healthy or with stable chronic medical conditions specifically including asthma, stable HIV, hepatitis B virus, or hepatitis C virus infection, will be eligible for participation in the trial while all rest comorbidities will be an exclusion.
  • Must have history of 2 times homologous vaccine intervention of BBIBP-CorV vaccine.

Exclusion criteria

  • People with known comorbidities (Diabetes, hypertension, heart diseases, chronic respiratory diseases like bronchiectasis, COPD etc) except those mentioned above in inclusion.
  • People who will have not received homologous vaccine two doses of BBIBP-CorV vaccine or those whose previous medical record of last 2 doses will be missing .
  • Difference between homologous vaccine and heterologous vaccine if less than 6 months
  • Pregnancy
  • History of flu or cough at that time
  • Medical history of COVID-19 at time of trial
  • On immunosuppressive therapy
  • Diagnosed with an immunocompromising condition

Primary outcome(s)


Number of participants with anaphylactic reactions ( 3 to 4 hour post vaccine)


3 to 4 hour post vaccine


Number of participants with fever

Number of participants with myalgia

Number of participants with pain and redness at injection site

Number of participants feeling cold

Number of participants with dizziness

Number of participants with paresthesia in arm

Number of participants with lightheadedness (participants of point 2 to 8 will report back if they experience any of these symptoms or need any health service)


2- Participants of point 2 to 8 will report back if they experience any of these symptoms or need any health service) within first 7 days of giving vaccine


Number of participants with no reaction experienced or observed at all (after 7 days) they will all report back after 7 days to tell


No reaction experienced or observed at all after 7 days of vaccination


Number of participants with dyspnea (till 3 to 4 hour)


Till 3 to 4 hours post vaccination


Number of participants with tachycardia (24 hours )


Till 24 hours post


Secondary outcome(s)




Target number/sample size


Countries of recruitment


Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

University and Government of Pakistan

Regulatory approvals


State of Ethics Review Approval



Date of Approval


Approval number

ERC / ID /194

Details of Ethics Review Committee

Name: Ethical Review Committee of Army Medical College, Pakistan
Institutional Address:Army Medical College, Abid Majeed Road, Rawalpindi cantt
Email: erc@amc.numspak.edu.pk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Ms. Wajeha Najeeb
Army Medical College Rawalpindi, Pakistan


Contact Person for Public Queries

Prof. Palvasha Waheed
Professor of Biochemistry
Army Medical College Rawalpindi, Pakistan


Primary study sponsor/organization

Public Sector Medical College, Rawalpindi
Rawalpindi, Pakistan
Abid Majeed, Rawalpindi cantt


Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Individual participants will not be available only de-identified data which will include tables text and graph will be shared. Statistical analysis plan will also be available. Data will be shared beginning from 3 months and ending 5 years following article publication. Data will be available for anyone who wishes to access data, for any purpose. Data will be available indefinitely at provided link to proposed IPD database

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results