Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001492842
Ethics application status
Approved
Date submitted
26/10/2021
Date registered
2/11/2021
Date last updated
5/10/2022
Date data sharing statement initially provided
2/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
COVID-19 vaccination of vulnerable populations (COVULPOP)
Scientific title
Profiling the immune response to COVID-19 vaccination in vulnerable populations (COVULPOP).
Secondary ID [1] 305656 0
None
Universal Trial Number (UTN)
Trial acronym
COVULPOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 vaccine response 324121 0
COVID-19 324147 0
Condition category
Condition code
Inflammatory and Immune System 321600 321600 0 0
Normal development and function of the immune system
Respiratory 321621 321621 0 0
Other respiratory disorders / diseases
Infection 321622 321622 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For all participants apart from pregnant women, participation will require that they are due to have a COVID-19 vaccination. Pregnant women who don’t want a COVID-19 vaccination will have the opportunity to participate at the time of their next scheduled pregnancy vaccine – either dTap, QIV or both.
The COVID-19 vaccine can be first dose, second dose or subsequent booster doses. If the participant has had a COVID-19 vaccine (1 or 2 doses) they will be asked to participate for their second or booster dose only. If they have not had a COVID-19 vaccination, they will be invited to provide venous blood samples for both their primary vaccinations. Vaccines will be administered intramuscularly into the deltoid muscle by a trained nurse. Participants presenting for their first dose will be offered the opportunity to provide 24hr, 1 week and 4-week samples at the time of their second doses too.
The study will initially focus on the Pfizer mRNA COVID-19 vaccine Comirnaty in the younger age groups since this is the preferred choice in Australia for people <60 years of age, but will test other vaccines such as the Moderna mRNA vaccine or Novavax’s spike protein vaccine once available and authorised for use in Australia. Younger people may also choose to have the AstraZeneca vaccine. Older individuals may be offered COVID-19 Vaccine AstraZeneca or Comirnaty, depending on availability, but other vaccines may also become available to them. Anyone who has a mixed schedule with 2 different vaccines for any reason (e.g. severe adverse reaction to the first vaccine, original vaccine not available, personal choice) will remain eligible for the study since there are very limited data about the effects of using mixed schedules and this will provide valuable information.
The second dose of Pfizer/Moderna or other licensed COVID-19 vaccine will be given at ~4 weeks, thus the 4-week bleed will serve as the baseline for the second vaccination. The second dose of COVID-19 Vaccine AstraZeneca can be given at 4-12 weeks, but most are given at 12 weeks. Therefore, an additional dose 2 baseline sample will need to be collected. Younger participants including pregnant women may request AstraZeneca and participants can also be given a mixed schedule e.g. AZ/Pfizer if clinically indicated or requested.
Intervention code [1] 322046 0
Treatment: Other
Intervention code [2] 322072 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329364 0
Measurement and comparison of the vaccine-induced cellular immune responses to COVID-19 vaccination from blood samples of pregnant women, the elderly, healthy adult men and non-pregnant women.
Timepoint [1] 329364 0
24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2). Cord blood will also be collected from pregnant participants at delivery.
Primary outcome [2] 329386 0
Measurement and comparison of the vaccine-induced humoral immune responses to COVID-19 vaccination from blood samples of pregnant women, the elderly, healthy adult men and non-pregnant women.
Timepoint [2] 329386 0
24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2). Cord blood will also be collected from pregnant participants at delivery.
Secondary outcome [1] 402335 0
Assessment of mood as a comorbidity for clinical interventions, as well as the impact of attitudes to vaccination on mood, using the depression, anxiety and stress survey (DASS-21).
Timepoint [1] 402335 0
24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).
Secondary outcome [2] 402406 0
Assessment of antenatal depression in pregnant women, using the Edinburgh postnatal depression scale (EPDS).
Timepoint [2] 402406 0
24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).
Secondary outcome [3] 402407 0
Assessment of both nutrition and lifestyle using the CardioMed survey tool.
Timepoint [3] 402407 0
24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2).

Eligibility
Key inclusion criteria
Younger adults: aged 18 to 45 years, healthy with no major co-morbidities .
Elderly: 65 years of age or older with or without co-morbidities.
Pregnant women: healthy uncomplicated pregnancy at any stage of gestation
All participants:
- Ability to communicate in English
- Ability to communicate by mobile telephone and text messaging
- Written informed consent to participate in the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Outside the specified age range
- Inability to speak and/or understand English
- Diagnosed with a cognitive impairment or inability to provide informed consent
- Known allergy or contraindication to COVID-19 (or dTap or influenza vaccination in pregnant women)
- Unwilling to give consent to participate

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 310015 0
Charities/Societies/Foundations
Name [1] 310015 0
Clifford Craig Medical Research Trust
Country [1] 310015 0
Australia
Primary sponsor type
Individual
Name
Prof Katie Flanagan
Address
Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 311069 0
None
Name [1] 311069 0
Address [1] 311069 0
Country [1] 311069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309722 0
University of Tasmania Research Integrity and Ethics Unit
Ethics committee address [1] 309722 0
University of Tasmania, Newnham Drive, Newnham, Launceston TAS 7250
Ethics committee country [1] 309722 0
Australia
Date submitted for ethics approval [1] 309722 0
Approval date [1] 309722 0
28/09/2021
Ethics approval number [1] 309722 0

Summary
Brief summary
The current provisional or emergency use approvals of COVID-19 vaccines are based on interim phase 3 clinical trial results indicating that these vaccines have an acceptable safety profile, are immunogenic and protect against symptomatic COVID-19. To date, it has not been possible to obtain robust safety and immunogenicity data for pregnant women or the very elderly; two groups at increased risk of developing severe COVID-19, because the initial trials focused on healthy adults. It is probable that the elderly will have less robust responses to COVID-19 vaccination, whereas pregnant women may or may not respond similarly to non-pregnant adults. We propose to conduct COVID-19 vaccination studies in these vulnerable groups and compare vaccine-specific antibody and T cell responses to those induced in young healthy non-pregnant individuals.
The COVID-19 pandemic has seen the rapid development of multiple candidate COVID-19 vaccines, many using new platforms never before used for licensed human vaccines, including mRNA and viral vectors vaccines. While we know that they elicit SARS-CoV-2 specific antibody and T cell responses, we have no information about their broad effects on the immune system. Systems vaccinology is a newly emerging approach to studying vaccine effects by utilising various ‘omics’ platforms such as transcriptomics and metabolomics to provide unique insights into mechanisms of adverse events, reactogenicity and immunogenicity of vaccines. We will therefore use an exploratory systems vaccinology approach to interrogate the broad immunological effects of COVID-19 vaccination on the immune system of participants, providing important data for their future deployment and development. The interrogation of responses in those more vulnerable to the serious outcomes of COVID-19, and also more likely to have suboptimal immune responses, may identify mechanisms and strategies to optimise COVID-19 vaccines for vulnerable populations.
Given the well-established links between nutrition, microbiome, mood and the immune system, there is a strong rationale and urgent need to conduct multidisciplinary studies that include both molecular and lifestyle factors. Standard questionnaires will therefore be administered prior to each blood collection (pre- and post-vaccination) to assess mood, nutrition and lifestyle. The results will be correlated with the key molecular findings from the immunological analyses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115166 0
Prof Katie Flanagan
Address 115166 0
Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250
Country 115166 0
Australia
Phone 115166 0
+61 3 6777 4081
Fax 115166 0
Email 115166 0
katie.flanagan@ths.tas.gov.au
Contact person for public queries
Name 115167 0
Prof Katie Flanagan
Address 115167 0
Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250
Country 115167 0
Australia
Phone 115167 0
+61 3 6777 4081
Fax 115167 0
Email 115167 0
katie.flanagan@ths.tas.gov.au
Contact person for scientific queries
Name 115168 0
Prof Katie Flanagan
Address 115168 0
Head of Infectious Diseases, Launceston General Hospital, 274-280 Charles St, Launceston TAS 7250
Country 115168 0
Australia
Phone 115168 0
+61 3 6777 4081
Fax 115168 0
Email 115168 0
katie.flanagan@ths.tas.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13784Informed consent form    383027-(Uploaded-26-10-2021-11-33-40)-Study-related document.pdf
13785Ethical approval    383027-(Uploaded-26-10-2021-11-33-52)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.